Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT00432159
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lwilso45@its.jnj.com', 'phone': '508-880-8109', 'title': 'Lynn Wilson', 'organization': 'Depuy Synthes'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Enrollment terminated early, and beginning in March 2013, follow-up visits beyond 24 months were limited to Discover subjects only.'}}, 'adverseEventsModule': {'timeFrame': '24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.', 'description': 'The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.', 'eventGroups': [{'id': 'EG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.', 'otherNumAtRisk': 186, 'otherNumAffected': 158, 'seriousNumAtRisk': 186, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.', 'otherNumAtRisk': 166, 'otherNumAffected': 135, 'seriousNumAtRisk': 166, 'seriousNumAffected': 44}, {'id': 'EG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.', 'otherNumAtRisk': 39, 'otherNumAffected': 38, 'seriousNumAtRisk': 39, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.', 'otherNumAtRisk': 89, 'otherNumAffected': 83, 'seriousNumAtRisk': 89, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Airway complication of anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Areflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': "Bartholin's cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 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Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.4', 'spread': '17.97', 'groupId': 'OG000'}, {'value': '-33.2', 'spread': '18.04', 'groupId': 'OG001'}, {'value': '-32.8', 'spread': '20.62', 'groupId': 'OG002'}, {'value': '-32.9', 'spread': '22.10', 'groupId': 'OG003'}, {'value': '-34.3', 'spread': '21.00', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.', 'unitOfMeasure': 'NDI Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'Neck Pain VAS Scores - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-47.0', 'spread': '30.43', 'groupId': 'OG000'}, {'value': '-41.5', 'spread': '30.57', 'groupId': 'OG001'}, {'value': '-36.1', 'spread': '33.15', 'groupId': 'OG002'}, {'value': '-27.2', 'spread': '26.14', 'groupId': 'OG003'}, {'value': '-46.3', 'spread': '33.60', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': "Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'Maximum Arm Pain VAS - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. 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The subject is instructed to indicate the amount of pain they feel in their arm.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'Average Arm Pain VAS - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. 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Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.1', 'spread': '25.62', 'groupId': 'OG000'}, {'value': '-28.8', 'spread': '20.88', 'groupId': 'OG001'}, {'value': '-30.5', 'spread': '25.90', 'groupId': 'OG002'}, {'value': '-20.6', 'spread': '26.33', 'groupId': 'OG003'}, {'value': '-26.6', 'spread': '24.70', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': "Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). 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Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. 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The subject is instructed to indicate the amount of pain they feel in their shoulder.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'Average Shoulder Pain VAS - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. 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The subject is instructed to indicate the amount of pain they feel in their shoulder.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'Dysphagia Disability Index - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '7.91', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '7.22', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '10.19', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '5.89', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '9.56', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'SF-36 - Physical Composite Scores (PCS) - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'OG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'OG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '10.50', 'groupId': 'OG001'}, {'value': '15.2', 'spread': '9.23', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '10.18', 'groupId': 'OG003'}, {'value': '15.2', 'spread': '10.73', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).'}, {'type': 'SECONDARY', 'title': 'SF-36 - Mental Composite Scores (MCS) - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. 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Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'BG001', 'title': '1-level ACDF With Plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'BG002', 'title': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'BG003', 'title': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.'}, {'id': 'BG004', 'title': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '8.63', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '7.63', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '7.94', 'groupId': 'BG002'}, {'value': '44.4', 'spread': '7.74', 'groupId': 'BG003'}, {'value': '42.3', 'spread': '7.49', 'groupId': 'BG004'}, {'value': '43.4', 'spread': '8.0', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '260', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '240', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}, {'value': '470', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '453', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '4.97', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '4.83', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '4.97', 'groupId': 'BG002'}, {'value': '30.0', 'spread': '3.61', 'groupId': 'BG003'}, {'value': '28.9', 'spread': '5.12', 'groupId': 'BG004'}, {'value': '28.3', 'spread': '4.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index in units of kilogram per meter squared', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2007-02-05', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2007-02-05', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-15', 'studyFirstPostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': '24 months', 'description': 'Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.'}], 'secondaryOutcomes': [{'measure': 'NDI Success', 'timeFrame': '24 months', 'description': '15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.'}, {'measure': 'Neurological Component of Success', 'timeFrame': '24 months', 'description': 'no new clinically significant permanent abnormalities in neurological function'}, {'measure': 'Subsequent Secondary Surgery Component of Success', 'timeFrame': '24 months', 'description': 'no subsequent secondary surgical intervention at the index level'}, {'measure': 'Device-Related SAE Component of Success', 'timeFrame': '24 months', 'description': 'no device related serious adverse events'}, {'measure': 'NDI - Change From Baseline', 'timeFrame': '24 months', 'description': 'Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.'}, {'measure': 'Neck Pain VAS Scores - Change From Baseline', 'timeFrame': '24 months', 'description': "Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck."}, {'measure': 'Maximum Arm Pain VAS - Change From Baseline', 'timeFrame': '24 months', 'description': "Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm."}, {'measure': 'Average Arm Pain VAS - Change From Baseline', 'timeFrame': '24 months', 'description': "Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm."}, {'measure': 'Maximum Shoulder Pain VAS - Change From Baseline', 'timeFrame': '24 months', 'description': "Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder."}, {'measure': 'Average Shoulder Pain VAS - Change From Baseline', 'timeFrame': '24 months', 'description': "Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder."}, {'measure': 'Dysphagia Disability Index - Change From Baseline', 'timeFrame': '24 months', 'description': 'Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.'}, {'measure': 'SF-36 - Physical Composite Scores (PCS) - Change From Baseline', 'timeFrame': '24 months', 'description': 'Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)'}, {'measure': 'SF-36 - Mental Composite Scores (MCS) - Change From Baseline', 'timeFrame': '24 months', 'description': 'Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)'}, {'measure': 'Work Status Assessment', 'timeFrame': '24 months'}, {'measure': 'Return to Work', 'timeFrame': '24 months', 'description': 'Estimated Proportion of Subjects Returning to Work'}, {'measure': 'Activity', 'timeFrame': '24 months', 'description': 'Clinical Assessment of Activity'}, {'measure': 'Subject Satisfaction', 'timeFrame': '24 months', 'description': 'Subject Satisfaction (Would you have this procedure again?)'}, {'measure': 'Global Cervical Range of Motion - Change From Baseline', 'timeFrame': '24 months'}, {'measure': 'Average Radiographic Disc Height (mm) - Change From Post-op', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cervical', 'spinal', 'arthroplasty', 'disc', 'surgical', 'ACDF', 'DDD'], 'conditions': ['Cervical Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.', 'detailedDescription': 'This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement\n* Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management\n* Moderate Neck Disability Index (NDI) score\n* Able to give informed consent for study participation\n* Able and willing to return for all follow-up visits\n\nKey Exclusion Criteria:\n\n* Significant cervical degenerative disc disease\n* Prior fusion procedure at any level(s) (C1-T1)\n* Marked cervical instability on lateral or flexion/extension radiographs\n* Presence of systemic infection or infection at the surgical site\n* Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing\n* History of alcohol and/or drug abuse\n* Any known allergy to a metal alloy or polyethylene\n* Morbid obesity\n* Any significant general illness (e.g., metastatic cancer, HIV)'}, 'identificationModule': {'nctId': 'NCT00432159', 'briefTitle': 'Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Spine'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease', 'orgStudyIdInfo': {'id': '06-DISCOVER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.', 'interventionNames': ['Device: Cervical TDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1-level ACDF with plate', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.', 'interventionNames': ['Device: ACDF with plate']}, {'type': 'EXPERIMENTAL', 'label': '2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.', 'interventionNames': ['Device: Cervical TDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-level ACDF', 'description': 'Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.', 'interventionNames': ['Device: ACDF with plate']}, {'type': 'EXPERIMENTAL', 'label': 'Training: 1 & 2-level Cervical TDR', 'description': 'Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.', 'interventionNames': ['Device: Cervical TDR']}], 'interventions': [{'name': 'Cervical TDR', 'type': 'DEVICE', 'otherNames': ['cervical arthroplasty', 'cervical disc', 'c-TDR', 'DISCOVER disc'], 'description': 'Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.', 'armGroupLabels': ['1-level Cervical TDR', '2-level Cervical TDR', 'Training: 1 & 2-level Cervical TDR']}, {'name': 'ACDF with plate', 'type': 'DEVICE', 'otherNames': ['ACDF', 'Slim-Loc', 'Anterior cervical discectomy and fusion with plate'], 'description': 'Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.', 'armGroupLabels': ['1-level ACDF with plate', '2-level ACDF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Olympia Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Associates in Orthopedic Medicine, PC', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Orthopaedics and Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University/Midwest Orthopaedics', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medical Faculty Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Johnson County Spine', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21210', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02458', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Spine Group', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Medical Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Spine', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Regional Medical Center", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'St. Patrick Hospital Neurological Associates', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Spine Center, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center for Diseases and Surgery of the Spine', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '13790', 'city': 'Johnson City', 'state': 'New York', 'country': 'United States', 'facility': 'Southern NY Neurosurgical Group', 'geoPoint': {'lat': 42.11563, 'lon': -75.95881}}, {'zip': '13202', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Medical College/SUNY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Neurosurgery & Spine Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Triangle Orthopaedic Associates', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Neurospine Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Spine Care at Baylor Health', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Back Institute', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '4215', 'city': 'Queensland', 'country': 'Australia', 'facility': 'Pacific Private Clinic'}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'St. Elisabeth Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Spine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}