Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prodisc C Vivo.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease, Cervical Spine Degenerative Disc Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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)
Interventions
- Device Prodisc C Vivo
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.
Primary outcome measures
- Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels [Time frame: 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present]
Secondary outcome measures (1)
- 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 [Time frame: 10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present]
Eligibility criteria
Inclusion criteria
- In order for a patient's data to be included in this study, he/she has to meet the indications and not possess any of the specific or general contraindications listed in the Instructions For Use (IFU).
- They must provide written informed consent with appropriate documentation noted in source documentation (prospective cohort only).
Exclusion criteria
-There are no additional exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- ONZ Spine — Recklinghausen
Identifiers
NCT: NCT07370493 · VAL-P-0190