Degenerative Disc Disease
Conditions
Brief summary
The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.
Detailed description
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.
Interventions
DEVICEMagnetOs Flex Matrix
MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects.
Sponsors
Research Source
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent. 2. Male or female patient ≥ 18 years old. 3. Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1). 4. 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.
Exclusion criteria
1. Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery. 2. Had prior PLF fusion or attempted PLF fusion at the involved levels. 3. Had previous decompression at the involved levels. 4. Women who are or intend to become pregnant within the next 12 months. 5. To treat conditions in which general bone grafting is not advisable. 6. In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible). 7. In case of significant vascular impairment proximal to the graft site. 8. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing. 9. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). 10. When intraoperative soft tissue coverage is not planned or possible. 11. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space. 12. Receiving treatment with medication interfering with calcium metabolism. 13. Has leg pain, and/or back pain related to benign or malignant tumor. 14. Has history or presence of active malignancy. 15. Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements. 16. Is involved in active litigation relating to his/her spinal condition. 17. Has participated in an investigational study within 30 days prior to surgery for study devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterolateral side fusion | 12 months post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posterolateral lumbar/thoraco-lumbar fusion | 6 months post surgery | Posterolateral lumbar/thoraco-lumbar fusion at Month 6 post-surgery assessed by CT-scans |
| Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI) | 12 months post-surgery | 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. |
| Secondary Surgical Interventions (SSI's) | 12 months post-surgery | 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. |
| Clinical outcome via neck visual analog scale (VAS) | 12 months post-surgery | 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. |
Countries
United States
Outcome results
None listed