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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 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.

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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.

Conditions Studied

Degenerative Disc Disease Spine Fusion Leg Pain and/or Back Pain

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-06-10
Est. Completion 2026-12
Phase NA

Sponsor

Kuros Biosurgery

4 total trials

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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, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (40% lower). The listed sponsor is Kuros Biosurgery, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.