The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.
This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery.
Study Type
OBSERVATIONAL
Enrollment
30
MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects.
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States
Posterolateral side fusion
The percentage of the posterolateral sides with bridging bone for the MagnetOs Flex Matrix and control treatments using CT-scans and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior transverse processes.
Time frame: 12 months post surgery
Posterolateral lumbar/thoraco-lumbar fusion
Posterolateral lumbar/thoraco-lumbar fusion at Month 6 post-surgery assessed by CT-scans
Time frame: 6 months post surgery
Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI)
Standard of care patient reported Oswestry Low Back Pain Disability Questionnaire (ODI) will be used to evaluate patient pain. On a scale of 0 to 6 with a score of 0 being no pain and a score of 5 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.
Time frame: 12 months post-surgery
Secondary Surgical Interventions (SSI's)
Number of patients with revisions, re-operations, removals, supplemental fixations, and any other procedure that adjust or in any way remove part of the original implant configuration with or without replacement of the components within 12 months post-surgery. A low score (numbers of revisions, reoperations, etc.) means better safety outcome. A high score (numbers of revisions, reoperations, etc.) means a worse safety outcome.
Time frame: 12 months post-surgery
Clinical outcome via neck visual analog scale (VAS)
Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months post-surgery