๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-28

2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C (NCT04012996)

A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodiscยฎ C SK and Prodiscยฎ C Vivo to Mobi-Cยฎ Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Centinel Spine

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Flagstaff Bone and Joint โ€” Flagstaff, Arizona

Age range: 18 Years to 69 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • Flagstaff Bone and Joint โ€” Flagstaff, Arizona
  • Todd Lanman, MD, Inc. โ€” Beverly Hills, California
  • Doctors Outpatient Center for Surgery โ€” Los Angeles, California
  • Sutter Health - Palo Alto Medical Foundation โ€” Palo Alto, California
  • Sutter Health โ€” Sacramento, California
  • HCA Healthcare โ€” Lone Tree, Colorado
  • Sky Ridge Medical Center Campus โ€” Lone Tree, Colorado
  • Center for Spine and Orthopedics, Scientific Education and Research Foundation โ€” Thornton, Colorado
  • Georgetown University Hospital โ€” Washington D.C., District of Columbia
  • St. Vincent's Neurosurgery โ€” Jacksonville, Florida
  • Kennedy-White Orthopaedic Center โ€” Sarasota, Florida
  • University of South Florida โ€” Tampa, Florida
  • Florida Orthopaedic Institute โ€” Temple Terrace, Florida
  • Indiana Spine Group โ€” Carmel, Indiana
  • Orthopaedic Institute of Western Kentucky โ€” Paducah, Kentucky
  • Spine Institute of Louisiana โ€” Shreveport, Louisiana
  • University of Maryland Medical Center โ€” Baltimore, Maryland
  • William Beaumont Hospital โ€” Royal Oak, Michigan
  • University Spine Center โ€” Wayne, New Jersey
  • NYU Langone Orthopedic Hospital โ€” New York, New York
  • Hospital for Special Surgery โ€” New York, New York
  • Northwell Health, Lenox Hill Hospital โ€” New York, New York
  • Axis Neurosurgery and Spine โ€” Williamsville, New York
  • M3-Emerging Medical Resarch โ€” Durham, North Carolina
  • SVCMC Solon Medical - Northern Ohio Surgery Center โ€” Beachwood, Ohio

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—