Degenerative Disc DiseaseNCT07370493
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
An observational study of Degenerative Disc Disease and Cervical Spine Degenerative Disease, run by Centinel Spine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease
- What is being tested?
- Prodisc C Vivo
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2025to Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- -There are no additional exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
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.
Read the 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
- Being tested
- Prodisc C Vivo
- Keywords
- Degenerative disc disease, cervical spine degenerative disc disease, Cervical Total Disc Arthroplasty, Symptomatic Cervical Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prodisc C VivoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective chart review | Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels. Receives: Device: Prodisc C Vivo | |
| Prospective follow-up | Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels. Receives: Device: Prodisc C Vivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Nov 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centinel Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- James Kuras, MS, Study director, Centinel Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370493
- Sponsor's protocol ID
- VAL-P-0190
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07370493
- Acronym / sponsor ID
- VAL-P-0190
- Conditions
- Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease, Cervical Spine Degenerative Disc Disease
- Keywords
- Degenerative disc disease, cervical spine degenerative disc disease, Cervical Total Disc Arthroplasty, Symptomatic Cervical Disc Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centinel SpineIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective chart review | – | Device: Prodisc C VivoRetrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels. |
| Prospective follow-up | – | Device: Prodisc C VivoProspective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- -There are no additional exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prodisc C VivoThe 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. | Device | Prospective follow-up, Retrospective chart review |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Kuras, MS study director
Centinel Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Cervical Spine Degenerative Disease, run by Centinel Spine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.