MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion (NCT05037968)
A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
🩺 Plain-English Summary (8th-Grade Level)
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
Who can join: Review the eligibility criteria below.
Location: Hartford Hospital — Hartford, Connecticut
Age range: 18 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 (8 Sites)
- Hartford Hospital — Hartford, Connecticut
- Rush University Medical Center — Chicago, Illinois
- MedStar Health Research Institute — Columbia, Maryland
- Michigan Orthopedic Surgeons — Bloomfield Hills, Michigan
- Pinehurst Surgical Clinic — Pinehurst, North Carolina
- The Ohio State University — Columbus, Ohio
- Huntsman Spinal Clinic — Salt Lake City, Utah
- Inova Healthcare — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (970) 215-6793
Email: cesar.silva@kurosbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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- Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain — Phoenix, Arizona
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Explore by condition: All Degenerative Disc Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.