RecruitingNot ApplicableNCT05037968

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

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)


Sponsor

Kuros Biosurgery AG

Enrollment

100 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares MagnetOs Flex Matrix (a synthetic bone graft substitute) with a traditional bone graft in patients undergoing lumbar spinal fusion surgery at up to four vertebral levels, to evaluate which promotes better bone fusion and recovery. You may be eligible if: - You are 18 years of age or older - You have leg and/or back pain requiring spinal fusion surgery in up to four lumbar levels (T11–S1) - You have tried conservative treatments (physical therapy, injections, etc.) for at least 3 months without adequate relief - You are able to provide informed consent You may NOT be eligible if: - You need more than four spinal levels fused - You have had prior fusion surgery at the levels being treated - You are pregnant or plan to become pregnant within 12 months - You have an active infection, cancer, or severe metabolic bone disease (like Paget's disease) - You have a history of active malignancy - You have a substance abuse issue or psychiatric disorder that could affect healing - You are involved in spinal-related litigation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetOs Flex Matrix

Procedure: Instrumented Posterolateral Lumbar Fusion

DEVICETrinity Elite

Procedure: Instrumented Posterolateral Lumbar Fusion


Locations(7)

Hartford Hospital

Hartford, Connecticut, United States

MedStar Health Research Institute

Columbia, Maryland, United States

Michigan Orthopedic Surgeons

Bloomfield Hills, Michigan, United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Huntsman Spinal Clinic

Salt Lake City, Utah, United States

Inova Healthcare

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05037968


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