Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT00534235
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003664', 'term': 'Decompression'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fran.magee@paradigmspine.com', 'phone': '212-367-7274', 'title': 'Fran Magee, DVM', 'organization': 'Paradigm Spine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE):\n\n* is life threatening\n* results in permanent impairment of a body function or permanent damage to a body structure; or\n* necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure', 'eventGroups': [{'id': 'EG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 101, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 64}, {'id': 'EG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 199, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 109}], 'otherEvents': [{'term': 'Component Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Component Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Component Breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incidental Durotomy (<= 5mm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain; new, increased frequency, or worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 61}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer/Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye, Ear, Nose, Throat (EENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine/Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 119}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric/Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and Subcutaneous Tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Component Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Component Breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tear > 5mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma Requiring Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (deep)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain; new, increased frequency, or worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer/Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye, Ear, Nose and Throat (EENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine/Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric/Substance Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and Subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Improvement of at Least 15 Points in ODI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The accounting #s in the Patient Flow include all subjects available for CCS evaluation; therefore, the overall # of participants analyzed for each Outcome Measure will differ from the number provided in the Participant Flow as the number provided for each Outcome Measure is the number of patients who completed or were assessed for that measure.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Major Device Related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Assessment of major device-related complications at 5 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Epidural Injection(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Assessment of lumbar epidural injections', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'No persistent new or increasing sensory or motor deficit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Persistent New or Increasing Sensory Deficit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'No persistent new or increasing sensory deficit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Persistent New or Increasing Motor Deficit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'No persistent new or increasing motor deficit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With no Reoperations or Epidural (Up to Day 1825)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. 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Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Oswestry Disability Index (ODI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Visual Analog Scale Back Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '31.0', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '27.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Visual Analog Scale Leg (Worse) Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '28.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Visual Analog Scale (VAS) Leg (Right) Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Visual Analog Scale (VAS) Leg (Left) Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '2.17', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '1.81', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Short Form-12 Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Short Form-12 Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Survey: Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Subjects who responded "Very Satisfied" or "Somewhat Satisfied".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Survey: Recommendation of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Subjects who responded "Definitely Yes" or "Probably Yes"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Management: Class II Narcotics Usage by Device Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of subjects using Class II narcotics', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of subjects using NSAIDs/ASA/Acetaminophen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Rotation (F to E) in Degrees - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '3.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rotation (F to E) in Degrees - Below Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '5.62', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '4.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level below the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rotation (F to E) in Degrees - Above Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '3.59', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '3.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level above the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (mm) - Below Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level below the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (mm) - Above Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level above the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '3.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Posterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '4.56', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (F to E) in Percent (%) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (F to E) in Percent (%) - Below Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level below the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translation (F to E) in Percent (%) - Above Level of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '2.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed at the level above the 1- or 2-level device construct in both groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.82', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Disc Angle in Degrees - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '6.02', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '5.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '2.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.57', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '3.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '17.33', 'spread': '2.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.81', 'spread': '1.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bony Bridging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heterotopic Ossification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'title': 'NA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Grade I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade II', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Grade III', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Bony Bridging', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fusion Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'units': 'Levels', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'OG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not fused', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}, {'title': 'Fused', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Interface Remodeling - At Level(s) of Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'None', 'measurements': [{'value': '75', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Condition (Coflex Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Intact', 'measurements': [{'value': '184', 'groupId': 'OG000'}]}, {'title': 'Deformed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Fractured', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Migrated', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Dislodged', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Condition (Fusion Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Intact', 'measurements': [{'value': '90', 'groupId': 'OG000'}]}, {'title': 'Failed Graft', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Loose Screws', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Fractured Hardware', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Levels', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'classes': [{'categories': [{'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '< 5 mm', 'measurements': [{'value': '181', 'groupId': 'OG000'}]}, {'title': '>= 5 mm', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.', 'unitOfMeasure': 'Levels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Levels', 'denomUnitsSelected': 'Levels', 'populationDescription': 'This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'FG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nPosterolateral Fusion and Implantation of Pedicle Screws'}, {'id': 'BG001', 'title': 'Coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression\n\nDecompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain\n\nImplantation of coflex Interlaminar Technology'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian / Alaskan Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '187.7', 'spread': '38.1', 'groupId': 'BG000'}, {'value': '190.3', 'spread': '35.4', 'groupId': 'BG001'}, {'value': '189.5', 'spread': '36.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Smoker', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Cardiovascular', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'Musculoskeletal', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Back Pain', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Fewer than 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '6 months to a year', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'More than one year', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Leg Pain (maximum)', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Fewer than 6 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': '6 months to a year', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'More than one year', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Buttock Pain', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Fewer than 6 months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '6 months to a year', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'More than one year', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Groin Pain', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Fewer than 6 months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '6 months to a year', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'More than one year', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2007-09-20', 'resultsFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-05', 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Rotation (F to E) in Degrees - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Rotation (F to E) in Degrees - Below Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.'}, {'measure': 'Rotation (F to E) in Degrees - Above Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.'}, {'measure': 'Translation (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Translation (mm) - Below Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.'}, {'measure': 'Translation (mm) - Above Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.'}, {'measure': 'Anterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Posterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Translation (F to E) in Percent (%) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Translation (F to E) in Percent (%) - Below Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.'}, {'measure': 'Translation (F to E) in Percent (%) - Above Level of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.'}, {'measure': 'Average Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Disc Angle in Degrees - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.'}, {'measure': 'Bony Bridging', 'timeFrame': '5 years', 'description': 'Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.'}, {'measure': 'Heterotopic Ossification', 'timeFrame': '5 years', 'description': 'Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.'}, {'measure': 'Fusion Status', 'timeFrame': '5 years', 'description': 'The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.'}, {'measure': 'Interface Remodeling - At Level(s) of Implant', 'timeFrame': '5 years', 'description': 'Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.'}, {'measure': 'Device Condition (Coflex Arm)', 'timeFrame': '5 years', 'description': 'Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.'}, {'measure': 'Device Condition (Fusion Control)', 'timeFrame': '5 years', 'description': 'Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.'}, {'measure': 'Device Mobility', 'timeFrame': '5 years', 'description': 'Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.'}], 'primaryOutcomes': [{'measure': 'Number of Subjects With Improvement of at Least 15 Points in ODI', 'timeFrame': '5 years', 'description': 'The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).'}, {'measure': 'Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation', 'timeFrame': '5 years', 'description': 'Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).'}, {'measure': 'Number of Subjects With no Major Device Related Complications', 'timeFrame': '5 years', 'description': 'Assessment of major device-related complications at 5 years'}, {'measure': 'Number of Subjects With no Epidural Injection(s)', 'timeFrame': '5 years', 'description': 'Assessment of lumbar epidural injections'}, {'measure': 'Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit', 'timeFrame': '5 years', 'description': 'No persistent new or increasing sensory or motor deficit'}, {'measure': 'Number of Subjects With no Persistent New or Increasing Sensory Deficit', 'timeFrame': '5 years', 'description': 'No persistent new or increasing sensory deficit'}, {'measure': 'Number of Subjects With no Persistent New or Increasing Motor Deficit', 'timeFrame': '5 years', 'description': 'No persistent new or increasing motor deficit'}, {'measure': 'Number of Subjects With no Reoperations or Epidural (Up to Day 1825)', 'timeFrame': '5 years', 'description': 'No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points', 'timeFrame': '5 years', 'description': 'ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.'}, {'measure': 'Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points', 'timeFrame': '5 years', 'description': 'ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.'}, {'measure': 'Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline."}, {'measure': 'Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline."}, {'measure': 'Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.'}, {'measure': 'Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.'}, {'measure': 'Mean Oswestry Disability Index (ODI) Score', 'timeFrame': '5 years', 'description': 'Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.'}, {'measure': 'Mean Visual Analog Scale Back Pain Score', 'timeFrame': '5 years', 'description': 'Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.'}, {'measure': 'Mean Visual Analog Scale Leg (Worse) Pain Score', 'timeFrame': '5 years', 'description': 'Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.'}, {'measure': 'Mean Visual Analog Scale (VAS) Leg (Right) Pain Score', 'timeFrame': '5 years', 'description': 'Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.'}, {'measure': 'Mean Visual Analog Scale (VAS) Leg (Left) Pain Score', 'timeFrame': '5 years', 'description': 'Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.'}, {'measure': 'Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.'}, {'measure': 'Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm', 'timeFrame': '5 years', 'description': 'Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.'}, {'measure': 'Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score', 'timeFrame': '5 years', 'description': 'Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.'}, {'measure': 'Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score', 'timeFrame': '5 years', 'description': 'Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.'}, {'measure': 'Mean Short Form-12 Physical Component Score', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health."}, {'measure': 'Mean Short Form-12 Mental Component Score', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health."}, {'measure': 'Patient Survey: Satisfaction', 'timeFrame': '5 years', 'description': 'Subjects who responded "Very Satisfied" or "Somewhat Satisfied".'}, {'measure': 'Patient Survey: Recommendation of Treatment', 'timeFrame': '5 years', 'description': 'Subjects who responded "Definitely Yes" or "Probably Yes"'}, {'measure': 'Pain Management: Class II Narcotics Usage by Device Group', 'timeFrame': '5 years', 'description': 'Number of subjects using Class II narcotics'}, {'measure': 'Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group', 'timeFrame': '5 years', 'description': 'Number of subjects using NSAIDs/ASA/Acetaminophen'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '23725394', 'type': 'DERIVED', 'citation': 'Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.'}], 'seeAlsoLinks': [{'url': 'http://www.paradigmspine.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis', 'detailedDescription': 'The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False}, 'identificationModule': {'nctId': 'NCT00534235', 'briefTitle': 'Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paradigm Spine'}, 'officialTitle': 'Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients', 'orgStudyIdInfo': {'id': 'PS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Posterolateral Fusion w/Pedicle Screws', 'description': 'Control: Posterolateral fusion and implantation of pedicle screws after decompression', 'interventionNames': ['Procedure: Decompression', 'Device: Posterolateral Fusion and Implantation of Pedicle Screws']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'coflex Interlaminar Technolgy', 'description': 'Investigative: Implantation of coflex Interlaminar Technology after decompression', 'interventionNames': ['Procedure: Decompression', 'Device: Implantation of coflex Interlaminar Technology']}], 'interventions': [{'name': 'Decompression', 'type': 'PROCEDURE', 'description': 'Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain', 'armGroupLabels': ['Posterolateral Fusion w/Pedicle Screws', 'coflex Interlaminar Technolgy']}, {'name': 'Posterolateral Fusion and Implantation of Pedicle Screws', 'type': 'DEVICE', 'armGroupLabels': ['Posterolateral Fusion w/Pedicle Screws']}, {'name': 'Implantation of coflex Interlaminar Technology', 'type': 'DEVICE', 'armGroupLabels': ['coflex Interlaminar Technolgy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paradigm Spine', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MCRA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}