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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Procedure: Instrumented Posterolateral Lumbar Fusion
Procedure: Instrumented Posterolateral Lumbar Fusion
Hartford Hospital
Hartford, Connecticut, United States
RECRUITINGMedStar Health Research Institute
Columbia, Maryland, United States
RECRUITINGMichigan Orthopedic Surgeons
Bloomfield Hills, Michigan, United States
RECRUITINGPinehurst Surgical Clinic
Pinehurst, North Carolina, United States
RECRUITINGHuntsman Spinal Clinic
Salt Lake City, Utah, United States
RECRUITINGInova Healthcare
Fairfax, Virginia, United States
RECRUITINGRadiographic 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.
Time frame: Month 12
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
Time frame: Month 6 and Month 12
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.
Time frame: Month 6
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.
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, Month 12
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.
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
Neurologic Status by Physical Exam
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
Success Rate
Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.
Time frame: Week 2, Week 6, Month 3, Month 6, and Month12
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