The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery (NCT05740176)
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 Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)
๐ฉบ Plain-English Summary (8th-Grade Level)
A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 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: HonorHealth โ Scottsdale, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (23 Sites)
- HonorHealth โ Scottsdale, Arizona
- Todd Lanman, MD โ Beverly Hills, California
- DOCS Health Management LLC โ Los Angeles, California
- Institute of Neuro Innovation โ Santa Monica, California
- Steamboat Orthopaedic and Spine Institute โ Steamboat Springs, Colorado
- Brain and Spine Center of South Florida โ Delray Beach, Florida
- Kennedy-White Orthopaedic Center โ Sarasota, Florida
- Indiana Spine Group โ Carmel, Indiana
- Orthopedics Northeast โ Fort Wayne, Indiana
- Precision Spine and Orthopaedic Associates, PA โ Overland Park, Kansas
- Bone and Joint Clinic of Baton Rouge โ Baton Rouge, Louisiana
- Louisiana Spine Institute โ Shreveport, Louisiana
- Michigan Orthopedic Surgeons โ Royal Oak, Michigan
- Carolina NeuroSurgery and Spine Associates, PA โ Charlotte, North Carolina
- M3 Emerging Medical Research โ Durham, North Carolina
- Pinehurst Surgical Clinic โ Pinehurst, North Carolina
- Summit Spine โ Portland, Oregon
- Oregon Spine Care โ Tualatin, Oregon
- Austin Neurosurgeons โ Austin, Texas
- DFW Center for Spinal Disorders โ Fort Worth, Texas
- Texas Spine Care Center โ San Antonio, Texas
- The Disc Replacement Center โ West Jordan, Utah
- Atlantic Brain and Spine โ Reston, Virginia
๐ฐ 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.
More studies in Cervical Degenerative Disc Disease
- The Synergy Disc To Anterior Cervical Discectomy and Fusion โ Phoenix, Arizona
- M6-C Post Approval Study (PAS) โ Phoenix, Arizona
Explore by condition: All Cervical Degenerative Disc Disease clinical trials
๐ก 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.