MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Condition(s) studied
Investigational drug(s) / intervention(s)
MagnetOs Flex Matrix: Procedure: Instrumented Posterolateral Lumbar Fusion
Trinity Elite: Procedure: Instrumented Posterolateral Lumbar Fusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Radiographic Fusion by CT Scan — Month 12
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | Recruiting |
| Central CT Neurosurgery & Spine | New Britain | Connecticut | Recruiting |
| Rush University Medical Center | Chicago | Illinois | Recruiting |
| MedStar Health Research Institute | Columbia | Maryland | Recruiting |
| Michigan Orthopedic Surgeons | Bloomfield Hills | Michigan | Recruiting |
| Pinehurst Surgical Clinic | Pinehurst | North Carolina | Recruiting |
| The Ohio State University | Columbus | Ohio | Recruiting |
| Huntsman Spinal Clinic | Salt Lake City | Utah | Recruiting |
| Inova Healthcare | Fairfax | Virginia | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05037968 on ClinicalTrials.gov ↗ ← All trials in the USA