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MagnetOs Flex Matrix Compared to Cell Based Allografts in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion — PRECISE  

Degenerative Disc Disease Clinical Trial

Official title:
A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOsTM Flex Matrix Compared to Cell Based Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)

Clinical Trial 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. A cellular based allograft will also be used according to its latest IFU approved in the US. Specifically, the cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Clinical Trial Description

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Flex Matrix on the assigned side of the spine and a Cell Based Allograft on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Week 2, Week 6, Month 3, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05037968
Study type Interventional
Source Kuros Biosurgery AG
Contact Katherine Sage, DO
Phone 617 285 2489
Email katherine.sage@kurosbio.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date July 2025
View Details
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