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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnetOs Flex Matrix | Device | MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Posterolateral lumbar/thoraco-lumbar fusion | Posterolateral lumbar/thoraco-lumbar fusion at Month 6 post-surgery assessed by CT-scans | 6 months post surgery |
| Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with leg pain and/or back pain requiring treatment with up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (PLF) and who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the MagnetOs Flex Matrix during the surgical procedure. If the surgeon decides intra-operatively not to utilize the MagnetOs Flex Matrix, the patient will be considered a screen failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Orthopaedic Surgeons | Southfield | Michigan | 48033 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
| 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. | 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. | 12 months post-surgery |