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2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
NCT04012996 · View on ClinicalTrials.gov ↗
Study Summary
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Conditions Studied
Interventions
- DEVICE prodisc C SK and/or Vivo
- DEVICE Mobi-C Cervical Disc
Study Locations (20)
California
- Todd Lanman, MD, Inc. — Beverly Hills
- Doctors Outpatient Center for Surgery — Los Angeles
- Sutter Health - Palo Alto Medical Foundation — Palo Alto
- Sutter Health — Sacramento
Florida
- St. Vincent's Neurosurgery — Jacksonville
- Kennedy-White Orthopaedic Center — Sarasota
- University of South Florida — Tampa
- Florida Orthopaedic Institute — Temple Terrace
Colorado
- HCA Healthcare — Lone Tree
- Sky Ridge Medical Center Campus — Lone Tree
- Center for Spine and Orthopedics, Scientific Education and Research Foundation — Thornton
Arizona
- Flagstaff Bone and Joint — Flagstaff
District of Columbia
- Georgetown University Hospital — Washington D.C.
Indiana
- Indiana Spine Group — Carmel
Kentucky
- Orthopaedic Institute of Western Kentucky — Paducah
Louisiana
- Spine Institute of Louisiana — Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2028-05-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04012996
The ClinicalTrials.gov registry entry for NCT04012996 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centinel Spine, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Symptomatic Cervical Disc Disease appearing as the primary indexed condition, and to 2 interventions — of which prodisc C SK and/or Vivo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04012996 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04012996 about?
NCT04012996 is a clinical study titled "2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C". A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
What is the current status of trial NCT04012996?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 390 participants. The study started on 2019-08-05. Estimated completion is 2028-05-13.
What conditions does trial NCT04012996 study?
This clinical trial studies the following conditions: Symptomatic Cervical Disc Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04012996?
The interventions under investigation include: prodisc C SK and/or Vivo (DEVICE), Mobi-C Cervical Disc (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04012996?
This trial is sponsored by Centinel Spine, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04012996 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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