Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 10:46 PM
Study NCT ID:
NCT02539394
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gangh@hss.edu', 'phone': '917-260-4603', 'title': 'Catherine Himo Gang', 'organization': 'HospitalSS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria:\n\nMild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 42, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 46, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cardiovascular', 'notes': 'ABLA, Acute Cardiac, Arrhythmia, DVT, Hyperkalemia, Hypertension, Hyponatremia, Hypotension/Hypovolemia, Leukocytosis, VTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Digestive', 'notes': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'notes': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'notes': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'notes': 'Constipation, Dysphagia, Nausea / Vomiting, Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematologic', 'notes': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Integumentary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic', 'notes': 'Dizziness/Vertigo, Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Non-Radicular, Radicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'notes': 'Aspiration, Atelectasis, Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skeletal', 'notes': 'Hardware Complication, Pseudoarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'notes': 'Hematoma, Infection, SSI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'GastroIntestinal', 'notes': 'Constipation, Dysphagia, Nausea / Vomiting, Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skeletal', 'notes': 'Hardware Complication, Pseudoarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Burden)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '87.5'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '87.5'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.394', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Eating Desire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '58.3', 'upperLimit': '100'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '58.3', 'upperLimit': '100'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '68.75', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.606', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.155', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Eating Duration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '93.75'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '37.5', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '18.75', 'upperLimit': '87.5'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '37.5', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '43.75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.019', 'groupIds': ['OG000'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Food Selection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '93.75'}, {'value': '93.75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '100'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.300', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Communication)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '81.25', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '90.625', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.858', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Fear Swallow)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.75', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '56.25', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '76.6', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.75', 'groupId': 'OG000', 'lowerLimit': '84.4', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93.75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Social)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '56.25', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.280', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.483', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.200', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Mental)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '100'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '100'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Sleep)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '81.25', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '75'}, {'value': '56.25', 'groupId': 'OG001', 'lowerLimit': '37.5', 'upperLimit': '87.5'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '75'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '75'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '81.25'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '87.5'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '87.5'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '87.5'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.763', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.178', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'PRIMARY', 'title': 'Degree of Dysphagia Patients Experience (Fatigue)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'groupId': 'OG000', 'lowerLimit': '54.17', 'upperLimit': '100'}, {'value': '83.33', 'groupId': 'OG001', 'lowerLimit': '60.42', 'upperLimit': '100'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '70.83'}, {'value': '58.33', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '83.33'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '33.33', 'upperLimit': '75'}, {'value': '66.67', 'groupId': 'OG001', 'lowerLimit': '41.67', 'upperLimit': '83.33'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '41.67', 'upperLimit': '75'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '58.33', 'upperLimit': '97.92'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '58.33', 'upperLimit': '91.67'}, {'value': '83.33', 'groupId': 'OG001', 'lowerLimit': '70.83', 'upperLimit': '100'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '58.33', 'upperLimit': '91.67'}, {'value': '83.33', 'groupId': 'OG001', 'lowerLimit': '66.67', 'upperLimit': '100'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '66.67', 'upperLimit': '91.67'}, {'value': '91.67', 'groupId': 'OG001', 'lowerLimit': '66.67', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.602', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '43 patient in each group need to achieved \\>80% power to detect a 15 point differences in SWAL-QOL survey'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Patient Reported Swallowing Difficulty Over 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-operative Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'POD1 Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '19.5'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '4.25', 'upperLimit': '20.75'}]}]}, {'title': 'POD1 Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '19.5'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '18'}]}]}, {'title': 'POD2 Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '25.5'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '21.75'}]}]}, {'title': 'POD2 Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '20.5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '17.75'}]}]}, {'title': '4-6 weeks Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11.5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': '4-6 weeks Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9.5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': '3 months Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '3 months Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '6 months Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '6 months Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '1 year Eat-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '1 year Eat-10 modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.933', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.950', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of Pre-operative modified Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD1 modified Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of POD2 modified Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.\n\nModified Eat-10 : Eat-10 questionnaire without questions 1 ("My swallowing problem has caused me to lose weight") and 2 ("My swallowing problem interferes with my ability to go out for meals") to be applicable during hospitalization.\n\nEat-10 interpretation: Score ranging from 0 to 40 (best-worst)\n\n* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question\'s response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)\n* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question\'s response', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Bazaz Dysphagia Score - Liquid", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '6-4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000'], 'groupDescription': 'Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of POD1 Bazaz Liquid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of POD2 Bazaz Liquid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': "Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Bazaz Dysphagia Score - Solid", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '6-4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Rare', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Occasionally (only with specific food)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Frequent (majority of solids)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of Pre-operative Bazaz Solid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of POD1 Bazaz Solid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of POD2 Bazaz Solid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}, {'pValue': '0.279', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': "Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Neck Disability", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '19.4', 'groupId': 'OG001'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The means Pre-operative NDI for the two populations is equal', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.234', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The means 4-6 weeks NDI for the two populations is equal', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Neck Disability Index (NDI) Range from 0 to 100 (best-worst)', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'People with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Pain Scores on the Visual Analog Scale - Neck Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '70'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '61.5'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '77'}, {'value': '48.25', 'groupId': 'OG001', 'lowerLimit': '8.025', 'upperLimit': '61.125'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '69'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '49.125'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '40'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '30.25'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '49'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '25'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '45'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '19.375'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.25', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '52.125'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '0.875', 'upperLimit': '14.125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '52'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '53.9'}]}]}, {'title': 'POD1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '5.35', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17'}]}]}, {'title': 'POD2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '6.45', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16.5'}]}]}, {'title': '4-6 weeks', 'categories': [{'measurements': [{'value': '6.45', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '2.75', 'groupId': 'OG001', 'lowerLimit': '0.125', 'upperLimit': '13'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17.5'}, {'value': '1.175', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21.5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': "Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '67'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '38.4'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20.5'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}]}]}, {'title': '4-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11.9'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '40'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26.25'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Change in Pre-vertebral Soft Tissue Swelling Over 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'timeFrame': 'Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against.'}, {'type': 'SECONDARY', 'title': 'Fusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': '1. Flex-Ex X-rays\n2. Bony bridging on a CT scan\n3. Obvious bony remodeling on lateral X-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with 12 month follow up visit with X-rays. All others were excluded.'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'classes': [{'title': 'Any Adverse Event?', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Mild/Moderate Adverse Event?', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Severe Adverse Event?', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event Related to Operated Site?', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event Unrelated to Operated Site?', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Mild/Moderate Adverse Event Related to Operated Site?', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Mild/Moderate Adverse Event Unrelated to Operated Site?', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Severe Adverse Event Related to Operated Site?', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Severe Adverse Event Unrelated to Operated Site?', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event Potentially Related to Steroid Use?', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event Unrelated to Steroid use?', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Mild/Moderate Adverse Event Potentially Related to Steroid Use?', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Mild/Moderate Adverse Event Unrelated to Steroid use?', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Severe Adverse Event Potentially Related to Steroid Use?', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Severe Adverse Event Unrelated to Steroid use?', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Adverse Event (AE) following surgical treatment.\n\nAdverse event were classified by severity based on the AO-ISSG criteria and treatment required:\n\nMild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.\n\nAE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Incomplete dataset', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.\n\nMethylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.\n\nHemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Not Applicable', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Former (quit > 30 days)', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Current (within the last 30 days)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Spondylosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Herniated disc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Osteoarthritis of the Cervical Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Myelopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Radiculopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Myeloradiculopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Cervical disk disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Foraminal Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Disk degrative disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Charlson Comorbidities Index (CCI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.', 'unitOfMeasure': 'index', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-23', 'size': 211168, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-05T12:36', 'hasProtocol': True}, {'date': '2016-04-19', 'size': 454247, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-23T10:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2015-08-27', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2015-08-31', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-16', 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Dysphagia Patients Experience (Burden)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Eating Desire)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Eating Duration)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Food Selection)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Communication)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Fear Swallow)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Social)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Mental)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Sleep)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)'}, {'measure': 'Degree of Dysphagia Patients Experience (Fatigue)', 'timeFrame': 'Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Swallowing Difficulty Over 1 Year', 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.\n\nModified Eat-10 : Eat-10 questionnaire without questions 1 ("My swallowing problem has caused me to lose weight") and 2 ("My swallowing problem interferes with my ability to go out for meals") to be applicable during hospitalization.\n\nEat-10 interpretation: Score ranging from 0 to 40 (best-worst)\n\n* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question\'s response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)\n* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question\'s response'}, {'measure': "Patients' Bazaz Dysphagia Score - Liquid", 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': "Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods."}, {'measure': "Patients' Bazaz Dysphagia Score - Solid", 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': "Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods."}, {'measure': "Patients' Neck Disability", 'timeFrame': 'Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Neck Disability Index (NDI) Range from 0 to 100 (best-worst)'}, {'measure': "Patients' Pain Scores on the Visual Analog Scale - Neck Pain", 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)'}, {'measure': "Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain", 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)'}, {'measure': "Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain", 'timeFrame': 'Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)'}, {'measure': 'Change in Pre-vertebral Soft Tissue Swelling Over 1 Year', 'timeFrame': 'Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months', 'description': 'We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected.'}, {'measure': 'Fusion Rate', 'timeFrame': '12 Months', 'description': '1. Flex-Ex X-rays\n2. Bony bridging on a CT scan\n3. Obvious bony remodeling on lateral X-ray'}, {'measure': 'Adverse Event', 'timeFrame': '12 month', 'description': 'Adverse Event (AE) following surgical treatment.\n\nAdverse event were classified by severity based on the AO-ISSG criteria and treatment required:\n\nMild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.\n\nAE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anterior Cervical Discectomy and Fusion', 'Dysphagia', 'ACDF'], 'conditions': ['Cervical Disc Herniation', 'Cervical Degenerative Disc Disease', 'Cervical Spondylotic Myelopathy', 'Dysphagia', 'Osteoarthritis of Cervical Spine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.', 'detailedDescription': 'Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion.\n\nStudy Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either:\n\n1. treatment arm or\n2. control arm.\n\nBoth arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. The only difference is that the treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues.\n\nOutcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient \\> 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion\n\nExclusion Criteria:\n\n* Patients undergoing revision surgery\n* Pediatric patients\n* Trauma patients with cervical spine fractures\n* Patients with cancer\n* Patients with active infection\n* Patients with a known allergy to Methylprednisolone Acetate\n* Patients who refuse to participate\n* Non English speakers'}, 'identificationModule': {'nctId': 'NCT02539394', 'briefTitle': 'Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial', 'orgStudyIdInfo': {'id': '2014-145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.', 'interventionNames': ['Drug: Methylprednisolone Acetate', 'Other: Hemostatic Matrix Kit']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.', 'interventionNames': ['Other: Hemostatic Matrix Kit']}], 'interventions': [{'name': 'Methylprednisolone Acetate', 'type': 'DRUG', 'otherNames': ['Depo-Medrol'], 'description': 'Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.', 'armGroupLabels': ['Treatment']}, {'name': 'Hemostatic Matrix Kit', 'type': 'OTHER', 'description': 'Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Todd Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}