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Enrolling by Invitation

NCT Number: NCT07370493

Retrospective Analysis of 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.

Enrolling by Invitation

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Cervical Spine Degenerative Disc Disease Cervical Spine Degenerative Disease Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Symptomatic Cervical Disc Disease

Sex eligibility

All sexes

Study type

Observational

Primary location

ONZ Spine

Recklinghausen, 45661, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

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

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

    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).

Sponsors and collaborators

Lead sponsor

Centinel Spine

Industry

Collaborators

  • Avania

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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