Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT00882661
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2009-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmyer@globusmedical.com', 'phone': '610-930-1800', 'title': 'Jacqueline Myer', 'organization': 'Globus Medical'}, 'certainAgreement': {'otherDetails': 'To prevent premature disclosure of information, Investigators agree not to present, publish, or disclose study results or information about the Investigational Device without the express written consent of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc', 'otherNumAtRisk': 236, 'otherNumAffected': 121, 'seriousNumAtRisk': 236, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion', 'otherNumAtRisk': 144, 'otherNumAffected': 80, 'seriousNumAtRisk': 144, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal Tunnel Syndrome (CTS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Compressive Peripheral Neuropathy (Non-CTS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysesthesia - Lower Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysesthesia - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysesthesia - Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Superficial Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Back and/or Lower Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Neck and Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Neck and Upper Extremities with Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Neck with Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Upper Extremities with Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal Tunnel Syndrome (CTS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Compressive Periph Neuro (Non-CTS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Back and/or Lower Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Upper Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - Adjacent Level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - Index Level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - Lumbar Level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - Other Cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery - Thoracic Level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urogenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Individual Patient Overall Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'Neck Disability Index (NDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'Neck Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'Left Arm Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'Right Arm Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'SF-36 PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Health Status Survey SF-36 physical composite scores: 15% improvement from baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'SF-36 MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Health Status Survey SF-36 mental composite scores: 15% improvement from baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.'}, {'type': 'SECONDARY', 'title': 'Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'OG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'OG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Patient satisfaction (definitely/mostly): proportion of patients', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'FG001', 'title': 'ASSURE Cervical Plate and an Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}], 'periods': [{'title': 'Investigational Training', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc'}, {'id': 'BG001', 'title': 'ASSURE Cervical Plate and Allograft Interbody Spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion'}, {'id': 'BG002', 'title': 'Non-Randomized SECURE-C Cervical Artificial Disc', 'description': 'The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '44.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '8.13', 'groupId': 'BG002'}, {'value': '43.9', 'spread': '7.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2009-04-14', 'resultsFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-07', 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual Patient Overall Success', 'timeFrame': '24 months', 'description': 'Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion'}], 'secondaryOutcomes': [{'measure': 'Neck Disability Index (NDI)', 'timeFrame': '24 months', 'description': 'Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline'}, {'measure': 'Neck Pain Visual Analog Scale (VAS)', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)'}, {'measure': 'Left Arm Pain Visual Analog Scale (VAS)', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)'}, {'measure': 'Right Arm Pain Visual Analog Scale (VAS)', 'timeFrame': '24 months', 'description': 'Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)'}, {'measure': 'SF-36 PCS', 'timeFrame': '24 months', 'description': 'Health Status Survey SF-36 physical composite scores: 15% improvement from baseline'}, {'measure': 'SF-36 MCS', 'timeFrame': '24 months', 'description': 'Health Status Survey SF-36 mental composite scores: 15% improvement from baseline'}, {'measure': 'Satisfaction', 'timeFrame': '24 months', 'description': 'Patient satisfaction (definitely/mostly): proportion of patients'}]}, 'conditionsModule': {'keywords': ['Neck Pain', 'Arm Pain'], 'conditions': ['Symptomatic Cervical Disc Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.\n\nThe purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc', 'detailedDescription': 'Ages Eligible for Study: 18 to 60 years\n\nGenders Eligible for Study: Both\n\nAccepts Healthy Volunteers: No'}, '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, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:\n* Herniated nucleus pulposus;\n* Radiculopathy or myelopathy;\n* Spondylosis (defined by the presence of osteophytes); or\n* Loss of disc height.\n* Age between 18 and 60 years\n* Failed at least 6 weeks of conservative treatment\n* Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)\n* Able to understand and sign informed consent form\n* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms\n* Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months\n* Able to follow postoperative management program\n\nExclusion Criteria:\n\n* More than one vertebral level requiring treatment\n* Prior fusion surgery adjacent to the vertebral level being treated\n* Prior surgery at the level to be treated\n* Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma\n* Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve\n* Marked cervical instability on resting lateral or flexion/extension radiographs:\n* Translation greater than 3mm, and/or\n* More than 11° of rotational difference from that of either adjacent level.\n* Severe spondylosis at the level to be treated as characterized by any of the following:\n* Bridging osteophytes;\n* A loss of disc height greater than 50%; or\n* Absence of motion (\\<2°)\n* Neck or arm pain of unknown etiology\n* Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease\n* Pregnant or interested in becoming pregnant in the next 2 years\n* Active systemic or local infection\n* Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum\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 has been no clinical signs or symptoms of the malignancy for at least 5 years\n* Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.\n* Acute mental illness or substance abuse\n* Use of bone growth stimulator within past 30 days\n* Participation in other investigational device or drug clinical trials within 30 days of surgery\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT00882661', 'briefTitle': 'SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Globus Medical Inc'}, 'officialTitle': 'A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study', 'orgStudyIdInfo': {'id': 'GPR002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SECURE-C Cervical Artificial Disc', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc', 'interventionNames': ['Device: SECURE-C Cervical Artificial Disc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ASSURE Cervical plate and an allograft interbody spacer', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion', 'interventionNames': ['Device: ASSURE Cervical plate and an allograft interbody spacer']}], 'interventions': [{'name': 'SECURE-C Cervical Artificial Disc', 'type': 'DEVICE', 'description': 'Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc', 'armGroupLabels': ['SECURE-C Cervical Artificial Disc']}, {'name': 'ASSURE Cervical plate and an allograft interbody spacer', 'type': 'DEVICE', 'description': 'Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion', 'armGroupLabels': ['ASSURE Cervical plate and an allograft interbody spacer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph M Marzluff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trident Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Globus Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}