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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Symptomatic Cervical Disc Disease; Cervical Spine Degenerative Disc Disease; Cervical Spine Degenerative Disease
• Intervention / Treatment: Device: Prodisc C Vivo

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)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Germany
  • Recklinghausen, Germany, 45661
    • ONZ Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective chart review; Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels.	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.
Prospective follow-up; Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Nominal variables will be presented as count (percent). For numerical variables, the results will be presented as minimum, 25th percentile, mean, standard deviation, median, 75th percentile and maximum. Frequency tables for system organ class and preferred terms will be compiled based on participants experiencing an ADE (Adverse Device Event), and on the number of ADEs (from initial surgery to present, including intraoperative and post-operative complications). These percentage variables will include multiple data collection factors, such as the number and proportions of patients with no secondary surgical interventions (SSIs) (revision, removal, re-operation, supplemental fixation) at the index level(s) from initial surgery to present, Patient Reported Outcome (PRO) assessments, and self-assessment of Health Surveys (SF 12).	10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present

Collaborators and Investigators

• Sponsor: Centinel Spine
• Collaborators: Avania
• Investigators: Study Director: James Kuras, MS, Centinel Spine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Degenerative disc disease; Symptomatic Cervical Disc Disease; cervical spine degenerative disc disease; Cervical Total Disc Arthroplasty
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: VAL-P-0190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No