Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 7:19 PM
Study NCT ID:
NCT02667067
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Simplify® Cervical Artificial Disc
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nczaplewski@nuvasive.com', 'phone': '308-660-2021', 'title': 'Nicole Czaplewski', 'organization': 'NuVasive, Inc.'}, 'certainAgreement': {'otherDetails': 'Publication results vary per investigator and per clinical trial agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'ACDF data is presented as a historical control fusion group from the Kineflex®\\|C Disc trial'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.', 'eventGroups': [{'id': 'EG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 65, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 89, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections (All other infections NOT at cervical surgical site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adjacent Segment Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (No narcotic given)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Compressive Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (Narcotic given)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infections (all other infections - NOT at cervical surgical site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseduoarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (narcotic given)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adjacent Segment Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery at a location other than the spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection; localized to cervical surgical site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep wound infection; localized to cervical surgical site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant Collapse or Subsidence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (No Narcotic Given)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Composite Clinical Success (CCS) of Simplify Disc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months.\n\nIndividual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months.\n\nNDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Success is presented on observed data only'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': '15-Point Improvement (Yes)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': '15-Point Improvement (No)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 Months', 'description': 'Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is presented on available NDI scores.'}, {'type': 'SECONDARY', 'title': 'VAS Neck and Arm Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Presented data available for comparison (preop and at month 24)'}, {'type': 'SECONDARY', 'title': 'Neurological Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Maintained', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Deteriorated', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were analyzed based on available 24-month data.'}, {'type': 'SECONDARY', 'title': 'SF-12 Physical Component Score (PCS) Maintenance or Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Maintenance or Improvement', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Absence of Maintenance or Improvement', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.\n\nData was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed based on available data at month 24. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'type': 'SECONDARY', 'title': 'SF-12 Mental Component Score (MCS) Maintenance or Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Maintenance or Improvement', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Absence of Maintenance or Improvement', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.\n\nData was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed based on available data at month 24. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'type': 'SECONDARY', 'title': 'Patient Questionnaires- Treatment Satisfaction Health Survey-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Months', 'description': 'Question 1 - "how does the subject rate satisfaction with the treated received" was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Presented data on available survey responses at Month 24'}, {'type': 'SECONDARY', 'title': "Odom's Criteria Results", 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Months', 'description': "Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Data presented on subject's with Odom's Criteria result at Month 24"}, {'type': 'SECONDARY', 'title': 'Dysphagia Handicap Index (DHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '8.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 Months', 'description': 'Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100.\n\nData was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed based on available 24-month DHI scores. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'type': 'SECONDARY', 'title': 'Average Disc Height (Index Level)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Average Disc Height (Above the Index Level)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Average Disc Height (Below the Index Level)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Superior Adjacent Level Disc Degeneration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Unable to assess', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Inferior Adjacent Level Disc Degeneration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unable to assess', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Device Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'OG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Anterior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Posterior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Right', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unable to assess', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Device migration assesses significant movement of the implant postoperatively', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24'}, {'type': 'SECONDARY', 'title': 'Facet Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unable to Assess', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 24 Months', 'description': 'Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline.\n\nFacet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data presented on available images at Month 24. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'FG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Subjects were recruited across 16 clinical sites in the United States', 'preAssignmentDetails': 'This is a non-randomized study. The 117 ACDF subjects are a historical control group. (Kineflex C Study; NCT#00374413)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anterior Cervical Discectomy & Fusion (ACDF)', 'description': 'Anterior Cervical Discectomy \\& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.'}, {'id': 'BG001', 'title': 'Simplify Disc', 'description': 'Simplify Disc\n\nSimplify Disc: Simplify Disc at one level in the cervical spine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '43.5', 'spread': '8.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One hundred sixty-six (166) subjects were enrolled in the Simplify® Cervical Artificial Disc population. Of these, 16 Simplify® Cervical Artificial Disc subjects were training subjects. The historical ACDF control population included 133 subjects. Of these, 117 control subjects were retained in the final PS designed sample'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 592157, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-04T08:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2015-10-08', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-10', 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Composite Clinical Success (CCS) of Simplify Disc', 'timeFrame': 'Baseline, 24 Months', 'description': 'Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months.\n\nIndividual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months.\n\nNDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)', 'timeFrame': 'Baseline, 3 Months', 'description': 'Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.'}, {'measure': 'VAS Neck and Arm Pain', 'timeFrame': 'Baseline, 24 Months', 'description': 'Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain)'}, {'measure': 'Neurological Status', 'timeFrame': 'Baseline, 24 Months', 'description': 'Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination.'}, {'measure': 'SF-12 Physical Component Score (PCS) Maintenance or Improvement', 'timeFrame': 'Baseline, 24 Months', 'description': 'The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.\n\nData was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'measure': 'SF-12 Mental Component Score (MCS) Maintenance or Improvement', 'timeFrame': 'Baseline, 24 Months', 'description': 'The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.\n\nData was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'measure': 'Patient Questionnaires- Treatment Satisfaction Health Survey-', 'timeFrame': '24 Months', 'description': 'Question 1 - "how does the subject rate satisfaction with the treated received" was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied.'}, {'measure': "Odom's Criteria Results", 'timeFrame': '24 Months', 'description': "Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria."}, {'measure': 'Dysphagia Handicap Index (DHI)', 'timeFrame': 'Baseline, 24 Months', 'description': 'Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100.\n\nData was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.'}, {'measure': 'Average Disc Height (Index Level)', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.'}, {'measure': 'Average Disc Height (Above the Index Level)', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.'}, {'measure': 'Average Disc Height (Below the Index Level)', 'timeFrame': 'Baseline, 24 Months', 'description': 'Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.'}, {'measure': 'Superior Adjacent Level Disc Degeneration', 'timeFrame': 'Baseline, 24 Months', 'description': 'Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level.'}, {'measure': 'Inferior Adjacent Level Disc Degeneration', 'timeFrame': 'Baseline, 24 Months', 'description': 'Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level.'}, {'measure': 'Device Migration', 'timeFrame': 'Baseline, 24 Months', 'description': 'Device migration assesses significant movement of the implant postoperatively'}, {'measure': 'Facet Deterioration', 'timeFrame': 'Baseline, 24 Months', 'description': 'Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline.\n\nFacet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.', 'detailedDescription': 'The objective of this clinical study is to evaluate the safety and effectiveness of the Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space that is unresponsive to conservative management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be between 18 and 60 years of age;\n* Have symptoms of cervical degenerative disc disease (DDD) at one cervical level from C3 to C7 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and radiographic evidence of at least one of the following;\n\n 1. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or;\n 2. Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or\n 3. Disc herniation on CT or MRI;\n* Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;\n\n 1. Pain or paresthesias in a specific nerve root distribution from C3 to C7,\n 2. Decreased muscle strength of at least one level on the 0-5 scale, or\n 3. Abnormal sensation, including hyperesthesia or hypoesthesia.\n* Have at least one of the following:\n\n 1. At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose);\n 2. The presence of progressive symptoms (e.g., increasing numbness or tingling) or\n 3. Signs of nerve root compression.\n* Have a Neck Disability Index (NDI) greater than or equal to 40 on a scale of 100 (moderate disability);\n* Be appropriate for treatment using an anterior surgical approach;\n* Be likely to return for all follow-up visits and\n* Be willing and able to provide Informed Consent for study participation.\n\nExclusion Criteria:\n\n* Marked cervical instability on resting lateral or flexion/ extension X-ray (translation \\> 3 mm or \\> 11 degrees rotation to that of either adjacent non-treatment level);\n* Non discogenic neck pain or non discogenic source of symptoms (e.g., tumor, rotator cuff injury, etc.);\n* Radiographic confirmation of severe facet disease or facet degeneration;\n* Bridging osteophytes;\n* Less than 2 degrees of motion at index level;\n* Prior surgery at the level to be treated, except laminotomy without accompanying facetectomy;\n* Prior fusion at any cervical level;\n* More than one neck surgery via anterior approach;\n* Previous trauma to the C3-C7 levels resulting in compression or bursting;\n* Documented presence of a free nuclear fragment at cervical levels other than the study level;\n* Axial neck pain only (no radicular or myelopathy symptoms);\n* Symptomatic DDD at more than one cervical level;\n* Severe myelopathy (less than 3/5 muscle strength);\n* Any paralysis;\n* Recent history (within previous six months) of chemical or alcohol dependence;\n* Active systemic infection;\n* Infection at the site of surgery;\n* Prior disc space infection or osteomyelitis in the cervical spine;\n* Any terminal, systemic or autoimmune disease;\n* Metabolic bone disease (e.g., osteoporosis/osteopenia , gout, osteomalacia, Paget's disease);\n* Any disease, condition or surgery which might impair healing, such as;\n\n 1. Diabetes mellitus requiring daily insulin management,\n 2. Active malignancy,\n 3. History of metastatic malignancy.\n* Current or extended use (\\> 6 months) of any drug known to interfere with bone or soft tissue healing;\n* Known PEEK, ceramic, titanium allergy;\n* Arachnoiditis;\n* Significant cervical anatomical deformity at the index level or clinically compromised cervical vertebral bodies at the index level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion, or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis);\n* Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin;\n* Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery ;\n* Use of spinal stimulator at any cervical level prior to surgery;\n* Currently a prisoner;\n* Currently involved in spinal litigation which may influence the subjects reporting of symptoms or\n* Participation in any other investigational drug, biologic or medical device study within the last 30 days prior to study surgery."}, 'identificationModule': {'nctId': 'NCT02667067', 'briefTitle': 'Investigation of the Simplify® Cervical Artificial Disc', 'organization': {'class': 'INDUSTRY', 'fullName': 'NuVasive'}, 'officialTitle': 'Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc', 'orgStudyIdInfo': {'id': 'G140154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Anterior cervical discectomy & fusion (ACDF)', 'interventionNames': ['Device: Anterior Cervical Discectomy & Fusion']}, {'type': 'EXPERIMENTAL', 'label': 'Simplify Disc', 'description': 'Simplify Disc', 'interventionNames': ['Device: Simplify Disc']}], 'interventions': [{'name': 'Simplify Disc', 'type': 'DEVICE', 'description': 'Simplify Disc at one level in the cervical spine.', 'armGroupLabels': ['Simplify Disc']}, {'name': 'Anterior Cervical Discectomy & Fusion', 'type': 'DEVICE', 'otherNames': ['ACDF'], 'description': 'This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.', 'armGroupLabels': ['Anterior cervical discectomy & fusion (ACDF)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'city': 'Lockport', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.17061, 'lon': -78.69031}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Addison', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.96179, 'lon': -96.82917}}, {'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}], 'overallOfficials': [{'name': 'Kyle Malone', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NuVasive'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuVasive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}