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NCT05037968 · ClinicalTrials.gov registry record · NA
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
A NA study of Degenerative Disc Disease and Spine Fusion, sponsored by Kuros Biosurgery.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 7
- Study locations
NCT05037968: Recruiting NA study of Degenerative Disc Disease and Spine Fusion, sponsored by Kuros Biosurgery.
NCT05037968 is a NA study of Degenerative Disc Disease and Spine Fusion that is actively recruiting participants, run by Kuros Biosurgery. The registered enrollment target is 100 participants, below the 166-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (40% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05037968, a NA study of Degenerative Disc Disease and Spine Fusion, is actively recruiting participants, sponsored by Kuros Biosurgery.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
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.
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 |
What NCT05037968 shows while recruiting
NCT05037968 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 166-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (40% lower).
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.
NCT05037968 lists 7 locations in 7 states (Connecticut, Maryland, Michigan).
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.
What interventions are being tested in trial NCT05037968?
The interventions under investigation include: MagnetOs Flex Matrix (DEVICE), Trinity Elite (DEVICE).
Who is sponsoring clinical trial NCT05037968?
This trial is sponsored by Kuros Biosurgery, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05037968's enrollment target sits among peer trials
100 20th of 42 higher than 21 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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