Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
brief summary
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.
detailed description
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)
official title
A Multicenter, Retrospective Analysis to Evaluate Radiographic Outcomes and Safety Profiles Along Prospective Follow-Up Periods for Patients Implanted With 2 Levels of Prodisc® C Vivo Devices.