Return to Clinical Trials Search Results

Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease

Primary outcome measures: NDI Score Subsequent surgery rates Device-related complications Mean NDI scores, rates of subsequent surgery and incidence of device-related complications will be compared to those at 7 years post-surgery. Secondary outcome measures: The following parameters will be measured as secondary endpoints and compared to 7-year follow-up results: Overall Success 1. Pain/Disability improvement of at least 15 points in the Neck Disability Index (NDI) compared with baseline scores; 2. No secondary surgeries at the index level, including revisions, removals, reoperations or supplemental fixations; 3. No potentially (possibly or probably) device-related adverse events; 4. Maintenance or improvement in all components of neurologic status; and Neck pain Arm pain SF-12 Patient satisfaction Neurologic assessment Radiologic assessments for Investigational Arm: Heterotopic ossification Adjacent segment degeneration Device failure, including displacement or migration Radiographic outcomes (range of motion, disc height) Radiologic assessments for Control Arm: Adjacent segment degeneration Device failure

Primary outcome measures: NDI Score Subsequent surgery rates Device-related complications Mean NDI scores, rates of subsequent surgery and incidence of device-related complications will be compared to those at 7 years post-surgery. Secondary outcome measures: The following parameters will be measured as secondary endpoints and compared to 7-year follow-up results: Overall Success 1. Pain/Disability improvement of at least 15 points in the Neck Disability Index (NDI) compared with baseline scores; 2. No secondary surgeries at the index level, including revisions, removals, reoperations or supplemental fixations; 3. No potentially (possibly or probably) device-related adverse events; 4. Maintenance or improvement in all components of neurologic status; and Neck pain Arm pain SF-12 Patient satisfaction Neurologic assessment Radiologic assessments for Investigational Arm: Heterotopic ossification Adjacent segment degeneration Device failure, including displacement or migration Radiographic outcomes (range of motion, disc height) Radiologic assessments for Control Arm: Adjacent segment degeneration Device failure