MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Start Date
6/10/2024
Completion Date
12/1/2026
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.
Detailed Description
In this study, following a screening period of a maximum of 30 days, 100 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 Trinity Elite 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. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MagnetOs Flex Matrix
Trinity Elite
Conditions
Locations
Hartford Hospital
Hartford, Connecticut 06106
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
MedStar Health Research Institute
Columbia, Maryland 21044
United States
Michigan Orthopedic Surgeons
Bloomfield Hills, Michigan 48033
United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina 28374
United States
The Ohio State University
Columbus, Ohio 43210
United States
Huntsman Spinal Clinic
Salt Lake City, Utah 84124
United States
Inova Healthcare
Fairfax, Virginia 22031
United States