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.
Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
Male or female patient ≥ 18 years old.
Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.
Requires > four-level fusion or expected to need secondary intervention within one year following surgery.
Had prior PLF fusion or attempted PLF fusion at the involved levels
Had previous decompression at the involved levels.
Women who are or intend to become pregnant within the next 12 months
Parallel
MagnetOs Flex Matrix
DeviceProcedure: Instrumented Posterolateral Lumbar Fusion
Trinity Elite
DeviceProcedure: Instrumented Posterolateral Lumbar Fusion
Radiographic Fusion by CT Scan
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.
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Functional Outcome by Oswestry Disability Index
Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.
Back and Leg Pain by Visual Analog Pain Scale (VAS)
Change in back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
Safety Endpoint - number of patients with Adverse Events
The number of patients with Adverse Events from Screening up to Month 12 after surgery.
Safety Endpoint - number of patients with Serious Adverse Events
The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
Safety Endpoint - number of patients with Adverse Device Effects
The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
Safety Endpoint - number of patients with Device Related Complications
The number of patients with any complications considered to device related with 12 months after surgery.
Click on the lead sponsor to view all of their trials.
Kuros Biosurgery AG
Lead sponsor
Kuros BioSciences B.V.
Collaborator
