The Synergy Disc To Anterior Cervical Discectomy and Fusion (NCT04469231)
A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).
🩺 Plain-English Summary (8th-Grade Level)
A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.
Who can join: Review the eligibility criteria below.
Location: Barrow Brain and Spine — Phoenix, Arizona
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Barrow Brain and Spine — Phoenix, Arizona
- HonorHealth Research Institute/Barrow Brain and Spine — Scottsdale, Arizona
- Todd H. Lanman, M.D. — Beverly Hills, California
- Orthopedic Specialty Institute — Orange, California
- Institute of Neuro Innovation — Santa Monica, California
- Anschutz Medical Center — Aurora, Colorado
- Kennedy White Orthopaedic Center — Sarasota, Florida
- Indiana Spine Group — Carmel, Indiana
- Michigan Orthopedic Surgeons (2) — Southfield, Michigan
- Michigan Orthopedic Surgeons — Southfield, Michigan
- Upstate Medical University — East Syracuse, New York
- Hospital for Special Surgery — New York, New York
- Exiamia EquiHealth — Durham, North Carolina
- Summit Spine — Portland, Oregon
- Center for Sports Medicine and Orthopaedic Surgery (CSMO) — Chattanooga, Tennessee
- Central Texas Brain & Spine — Austin, Texas
- Austin Neurosurgeons — Austin, Texas
- Texas Spine Care Center — San Antonio, Texas
- The Disc Replacement Center — West Jordan, Utah
- Atlantic Brain & Spine — Reston, Virginia
💰 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 § 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.
More studies in Cervical Degenerative Disc Disease
- The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery — Scottsdale, Arizona
- M6-C Post Approval Study (PAS) — Phoenix, Arizona
Explore by condition: All Cervical Degenerative Disc Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.