Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft

A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)

The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: MagnetOs Flex Matrix

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Southfield, Michigan, United States, 48033
      • Michigan Orthopaedic Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Research Source

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CT-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No