Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00291018
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2006-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059145', 'term': 'Total Disc Replacement'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eprifog1@its.jnj.com', 'phone': '508-977-6451', 'title': 'Erin Prifogle', 'organization': 'DePuy Synthes Spine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '84 Months (i.e. 7 years)', 'description': 'All adverse events were captured from time of consent through the end of study (i.e. 84 Months)', 'eventGroups': [{'id': 'EG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group', 'otherNumAtRisk': 103, 'otherNumAffected': 98, 'seriousNumAtRisk': 103, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group', 'otherNumAtRisk': 106, 'otherNumAffected': 100, 'seriousNumAtRisk': 106, 'seriousNumAffected': 53}, {'id': 'EG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group', 'otherNumAtRisk': 136, 'otherNumAffected': 121, 'seriousNumAtRisk': 136, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Pain - Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 43, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 62, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 86, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 58, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 57, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Surgery - Other', 'notes': 'Surgery not at the index (cervical) level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 41, 'numAffected': 24}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 46, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 43, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 39, 'numAffected': 29}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Numbness Non-Index Level Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Back and Lower Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 33, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Neck and Upper Extremities with Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Neck and Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Neck and Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Infection - Other Non-Wound Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Upper Extremities with Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Musculoskeletal Spasms - Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Surgery - Index Level', 'notes': 'Surgery at the index level (cervical)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}], 'seriousEvents': [{'term': 'Pain - Back and Lower Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Surgery - Index Level', 'notes': 'Surgery at the original index level of the cervical spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Surgery - Other', 'notes': 'Surgery not at the index (cervical level)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 37, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 29, 'numAffected': 18}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Neck and Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Syncode'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': "Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material", 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data at 84 months'}, {'type': 'SECONDARY', 'title': 'Neurologic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000'}, {'value': '89.1', 'groupId': 'OG001'}, {'value': '93.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 months', 'description': "% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)", 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who were "per protocol" excluding device failures'}, {'type': 'SECONDARY', 'title': 'NDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (greater than 20% change)', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}, {'value': '81.7', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (3% to 20% change)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3% to 3% change)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (less than -3% change)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 months', 'description': "NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain.\n\nThe NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.\n\nMean duration of the test is 3-8 minutes and the results can be interpreted as:\n\n* 0-4 points (0-8%) no disability;\n* 5-14 points (10-28%) mild disability;\n* 15-24 points (30-48%) moderate disability;\n* 25-34 points (50-64%) severe disability;\n* 35-50 points (70-100%) complete disability", 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed the NDI Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'SF-36 Physical Composite Score (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (>15% change)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '68.9', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (3% to 15% change)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3% to 3% change)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (less than -3% change)', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}, {'value': '17.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.\n\nIt can take patients at least half an hour to complete the SF-36.\n\nThe Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the SF-36 questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'SF-36 Mental Composite Score (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (>15% change)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '54.4', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (3% to 15% change)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}, {'value': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3% to 3% change)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (less than -3% change)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.\n\nIt can take patients at least half an hour to complete the SF-36.\n\nThe Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the SF-36 questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'VAS Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'categories': [{'measurements': [{'value': '86.16', 'spread': '23.750', 'groupId': 'OG000'}, {'value': '82.09', 'spread': '29.331', 'groupId': 'OG001'}, {'value': '86.51', 'spread': '23.531', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction \\[with the surgery/outcome\\]" at 0mm and "Complete Satisfaction \\[with the surgery/outcome\\]" at 100mm.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the VAS Satisfaction Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'VAS Neck Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (more than -20mm change)', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}, {'value': '78.5', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (-3mm to -20mm change)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}, {'value': '17.2', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3mm to 3mm change)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (more than 3mm)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \\[Neck\\] Pain" at 0mm and "Worst \\[Neck\\] Pain Possible" at 100mm.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'VAS Neck Pain Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (more than -20mm change)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (-3mm to -20mm change)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3mm to 3mm change)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (more than 3mm)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \\[Neck\\] Pain" at 0mm and "All of the Time \\[Neck\\] Pain" at 100mm.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'VAS Arm Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (more than -20mm change)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '68.8', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (-3mm to -20mm change)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3mm to 3mm change)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (more than 3mm)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \\[Arm\\] Pain" at 0mm and "Worst \\[Arm\\] Pain Possible" at 100mm.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'VAS Arm Pain Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Significant Improvement (more than -20mm change)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '75.4', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Improvement (-3mm to -20mm change)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'No Change (-3mm to 3mm change)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Deterioration (more than 3mm)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \\[Arm\\] Pain" at 0mm and "All of the Time \\[Arm\\] Pain" at 100mm.', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months'}, {'type': 'SECONDARY', 'title': 'Surgery Again', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'OG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'OG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}, {'value': '91.3', 'groupId': 'OG002'}]}]}, {'title': 'Maybe', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '14.1', 'groupId': 'OG001'}, {'value': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '84 Months', 'description': '% of subjects who would opt to have the surgery again if given the choice at 84 months', 'unitOfMeasure': '% of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed this questionnaire at 84 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group'}, {'id': 'FG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized Group'}, {'id': 'FG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled and Treated. 111 PDC subjects were Enrolled but only 103 were Treated.', 'groupId': 'FG000', 'numSubjects': '103'}, {'comment': 'Enrolled and Treated. 117 ACDF subjects were Enrolled but only 106 were Treated.', 'groupId': 'FG001', 'numSubjects': '106'}, {'comment': 'Enrolled and Treated. 140 PDC-CA subjects were Enrolled but only 136 were Treated.', 'groupId': 'FG002', 'numSubjects': '136'}]}, {'type': 'Evaluated at 24 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Evaluated at 84 Months', 'groupId': 'FG000', 'numSubjects': '78'}, {'comment': 'Evaluated at 84 Months', 'groupId': 'FG001', 'numSubjects': '64'}, {'comment': 'Evaluated at 84 Months', 'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Not Consented or Declined PAS', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Failures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized'}, {'id': 'BG001', 'title': 'Control', 'description': 'Anterior Cervical Discectomy and Fusion ACDF Randomized'}, {'id': 'BG002', 'title': 'ProDisc-C Continued Access', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '8.42', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '7.15', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '7.95', 'groupId': 'BG002'}, {'value': '43.1', 'spread': '7.86', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'number of subjects who are female or male', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '5.32', 'groupId': 'BG000'}, {'value': '27.3', 'spread': '5.54', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '5.07', 'groupId': 'BG002'}, {'value': '26.8', 'spread': '5.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Neck/Arm Pain', 'classes': [{'title': '< 6 weeks', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '6 weeks to 1 year', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}, {'title': '> 1 year', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}], 'populationDescription': 'Number of subjects enrolled and treated'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2006-02-10', 'resultsFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-17', 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': '84 Months', 'description': "Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material"}], 'secondaryOutcomes': [{'measure': 'Neurologic Success', 'timeFrame': '84 months', 'description': "% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)"}, {'measure': 'NDI', 'timeFrame': '84 months', 'description': "NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain.\n\nThe NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.\n\nMean duration of the test is 3-8 minutes and the results can be interpreted as:\n\n* 0-4 points (0-8%) no disability;\n* 5-14 points (10-28%) mild disability;\n* 15-24 points (30-48%) moderate disability;\n* 25-34 points (50-64%) severe disability;\n* 35-50 points (70-100%) complete disability"}, {'measure': 'SF-36 Physical Composite Score (PCS)', 'timeFrame': '84 Months', 'description': 'The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.\n\nIt can take patients at least half an hour to complete the SF-36.\n\nThe Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions.'}, {'measure': 'SF-36 Mental Composite Score (MCS)', 'timeFrame': '84 Months', 'description': 'The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.\n\nIt can take patients at least half an hour to complete the SF-36.\n\nThe Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions.'}, {'measure': 'VAS Satisfaction', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction \\[with the surgery/outcome\\]" at 0mm and "Complete Satisfaction \\[with the surgery/outcome\\]" at 100mm.'}, {'measure': 'VAS Neck Pain Intensity', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \\[Neck\\] Pain" at 0mm and "Worst \\[Neck\\] Pain Possible" at 100mm.'}, {'measure': 'VAS Neck Pain Frequency', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \\[Neck\\] Pain" at 0mm and "All of the Time \\[Neck\\] Pain" at 100mm.'}, {'measure': 'VAS Arm Pain Intensity', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \\[Arm\\] Pain" at 0mm and "Worst \\[Arm\\] Pain Possible" at 100mm.'}, {'measure': 'VAS Arm Pain Frequency', 'timeFrame': '84 Months', 'description': 'The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \\[Arm\\] Pain" at 0mm and "All of the Time \\[Arm\\] Pain" at 100mm.'}, {'measure': 'Surgery Again', 'timeFrame': '84 Months', 'description': '% of subjects who would opt to have the surgery again if given the choice at 84 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ProDisc', 'ProDisc-C', 'Spinal Fusion', 'Anterior cervical diskectomy', 'Cervical spine', 'Disc disease', 'Implant', 'Degenerative disc disease', 'Intervertebral disc'], 'conditions': ['Symptomatic Cervical Disc Disease']}, 'referencesModule': {'references': [{'pmid': '23138404', 'type': 'DERIVED', 'citation': 'Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Girardi FP. Development of an expectations survey for patients undergoing cervical spine surgery. Spine (Phila Pa 1976). 2013 Apr 20;38(9):718-25. doi: 10.1097/BRS.0b013e31827bf204.'}, {'pmid': '23080427', 'type': 'DERIVED', 'citation': 'Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height.\n* Age between 18 and 60 years.\n* Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.\n* NDI score greater than or equal to 15/50 (30%).\n* Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* More than one vertebral level requiring treatment.\n* Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level.\n* Has a fused level adjacent to the level to be treated.\n* Radiographic confirmation of severe facet joint disease or degeneration.\n* Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.\n* Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion.\n* Prior surgery at the level to be treated.\n* Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (\\<2°).\n* Neck or arm pain of unknown etiology.\n* Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis).\n* Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).\n* Severe diabetes mellitus requiring daily insulin management.\n* Pregnant or interested in becoming pregnant in the next three years.\n* Active infection - systemic or local.\n* Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).\n* Rheumatoid arthritis or other autoimmune disease.\n* Systemic disease including AIDS, HIV, hepatitis.\n* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years."}, 'identificationModule': {'nctId': 'NCT00291018', 'briefTitle': 'Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synthes USA HQ, Inc.'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)', 'orgStudyIdInfo': {'id': 'PDC-08122003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ProDisc-C', 'description': 'ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7', 'interventionNames': ['Device: Total Disc Replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'ACDF', 'interventionNames': ['Device: ACDF']}], 'interventions': [{'name': 'Total Disc Replacement', 'type': 'DEVICE', 'otherNames': ['ProDisc-C'], 'description': 'Total Disc Replacement using ProDisc-C', 'armGroupLabels': ['ProDisc-C']}, {'name': 'ACDF', 'type': 'DEVICE', 'otherNames': ['Control'], 'description': 'Anterior Cervical Discectomy and Fusion', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synthes USA HQ, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}