Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices

Centinel Spine

Status

Invitation-only

Conditions

Symptomatic Cervical Disc Disease

Degenerative Disc Disease

Cervical Spine Degenerative Disc Disease

Cervical Spine Degenerative Disease

Treatments

Device: Prodisc C Vivo

Study type

Observational

Funder types

Industry

Identifiers

NCT07370493

VAL-P-0190

Details and patient eligibility

About

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.

Full 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)

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.