๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-28

Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (NCT04229017)

Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Providence Medical Technology, Inc.

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

This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.

Who can join: Review the eligibility criteria below.

Location: Barrow Neurological Institute โ€” Phoenix, Arizona

Age range: 18 Years to 80 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 (17 Sites)

  • Barrow Neurological Institute โ€” Phoenix, Arizona
  • Scripps โ€” Encinitas, California
  • OrthoNorCal โ€” Los Gatos, California
  • Spine Colorado โ€” Durango, Colorado
  • Rush University Medical Center โ€” Chicago, Illinois
  • The Orthopaedic Institute โ€” Paducah, Kentucky
  • Bone and Joint Clinic of Baton Rouge โ€” Baton Rouge, Louisiana
  • LSU Health โ€” New Orleans, Louisiana
  • Spine Institute of Louisiana โ€” Shreveport, Louisiana
  • LifeBridge Health - Sinai Hospital of Baltimore โ€” Baltimore, Maryland
  • Beaumont Health โ€” Royal Oak, Michigan
  • Inspira Health Network โ€” Vineland, New Jersey
  • The University of North Carolina at Chapel Hill โ€” Chapel Hill, North Carolina
  • Pinehurst Surgical Clinic โ€” Pinehurst, North Carolina
  • Atlantic Neurosurgical & Spine Specialists โ€” Wilmington, North Carolina
  • Thomas Jefferson University โ€” Philadelphia, Pennsylvania
  • Baylor College of Medicine โ€” Houston, Texas

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†—