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MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
NCT05037968 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DEVICE MagnetOs Flex Matrix
- DEVICE Trinity Elite
Study Locations (7)
Connecticut
- Hartford Hospital — Hartford
Maryland
- MedStar Health Research Institute — Columbia
Michigan
- Michigan Orthopedic Surgeons — Bloomfield Hills
North Carolina
- Pinehurst Surgical Clinic — Pinehurst
Ohio
- The Ohio State University — Columbus
Utah
- Huntsman Spinal Clinic — Salt Lake City
Virginia
- Inova Healthcare — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05037968
The ClinicalTrials.gov registry entry for NCT05037968 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kuros Biosurgery, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions — of which MagnetOs Flex Matrix is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05037968 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Connecticut, Maryland, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05037968 about?
NCT05037968 is a clinical study titled "MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion". 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 w...
What is the current status of trial NCT05037968?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-06-10. Estimated completion is 2026-12.
What conditions does trial NCT05037968 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05037968?
The interventions under investigation include: MagnetOs Flex Matrix (DEVICE), Trinity Elite (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05037968?
This trial is sponsored by Kuros Biosurgery, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05037968 being conducted?
This trial has 7 study locations across Connecticut, Maryland, Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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