NCT07370493

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

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.

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Centinel Spine · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Degenerative Disc Disease
• Cervical Spine Degenerative Disease
• Symptomatic Cervical Disc Disease
• Cervical Spine Degenerative Disc Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study