The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.
The primary objective of the study is to evaluate (estimate) the post-operative performance of prodisc® C Vivo overall, after implantation. Post-operative device performance will be estimated using Patient Reported Outcomes (PROs) and radiographic data derived from the patient's surgical charts and medical history. The secondary objectives of this study are to assess: * patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s) * the rates of ADEs inclusive of intraoperative and post-operative complications * Patient Reported Outcomes (PROs) * Outcome self-assessment of Health Survey (SF 12 or 36 as available)
Study Type
OBSERVATIONAL
Enrollment
200
The prodisc® C Vivo device is a non-keeled cervical disc replacement prosthesis. The device is modular intervertebral disc prostheses designed to replace a diseased and/or a degenerated disc of the cervical spine in SCDD patients, thereby restoring disc height, biomechanical stability and allowing the potential for motion at the affected vertebral segment.
ONZ Spine
Recklinghausen, Germany
Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels
The primary objective of the study is to evaluate the post-operative performance of the prodisc® C Vivo after implantation by the occurrence of secondary surgical interventions in patients treated with prodisc® C Vivo at 2 levels. The State of the Art (SOTA) will be used as the comparison data collected in this study.
Time frame: 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present
Assessment to demonstrate the continuous clinical and radiographic status of the prodisc C Vivo implants allowing characterization of performance of the device by nominal variables (percentages) based on ADEs, SSIs, PROs, and SF 12 data collection
Nominal variables will be presented as count (percent). For numerical variables, the results will be presented as minimum, 25th percentile, mean, standard deviation, median, 75th percentile and maximum. Frequency tables for system organ class and preferred terms will be compiled based on participants experiencing an ADE (Adverse Device Event), and on the number of ADEs (from initial surgery to present, including intraoperative and post-operative complications). These percentage variables will include multiple data collection factors, such as the number and proportions of patients with no secondary surgical interventions (SSIs) (revision, removal, re-operation, supplemental fixation) at the index level(s) from initial surgery to present, Patient Reported Outcome (PRO) assessments, and self-assessment of Health Surveys (SF 12).
Time frame: 10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present
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