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

NCT07370493 | Enrolling By Invitation FDA Device

• 1 other identifier: VAL-P-0190
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Cervical Disc Disease; Cervical Spine Degenerative Disc Disease; Degenerative Disc Disease; Cervical Spine Degenerative Disease

Keywords

Degenerative disc disease; cervical spine degenerative disc disease; Cervical Total Disc Arthroplasty; Symptomatic Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present

Secondary Outcomes (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

  10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present

Study Arms (2)

Retrospective chart review

Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels.

Device: Prodisc C Vivo

Prospective follow-up

Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels.

Device: Prodisc C Vivo

Interventions

Prodisc C Vivo DEVICE

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.

Prospective follow-up; Retrospective chart review

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients treated with prodisc® C Vivo implants at 2 levels in the cervical spine for the treatment of SCDD. Patients who underwent the initial surgery with the device, from 2010 until 2024 will be considered eligible for this study. Patients who are excluded from this study and their reason will be noted.

You may qualify if:

• 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).

Sponsors & Collaborators

• Centinel Spine: lead
• Avania: collaborator

Study Sites (1)

ONZ Spine

Recklinghausen, 45661, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• James Kuras, MS

  Centinel Spine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: January 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)