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

NCT06415123 | Enrolling By Invitation FDA Device

• 1 other identifier: CT-003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Posterolateral lumbar/thoraco-lumbar fusion

  6 months post surgery

• Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI)

  12 months post-surgery

• Secondary Surgical Interventions (SSI's)

  12 months post-surgery

• Clinical outcome via neck visual analog scale (VAS)

  12 months post-surgery

Interventions

MagnetOs Flex Matrix DEVICE

MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
• Male or female patient ≥ 18 years old.
• Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1).
• 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.

You may not qualify if:

• Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery.
• Had prior PLF fusion or attempted PLF fusion at the involved levels.
• Had previous decompression at the involved levels.
• Women who are or intend to become pregnant within the next 12 months.
• To treat conditions in which general bone grafting is not advisable.
• 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).
• In case of significant vascular impairment proximal to the graft site.
• In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
• In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
• When intraoperative soft tissue coverage is not planned or possible.
• Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
• Receiving treatment with medication interfering with calcium metabolism.
• Has leg pain, and/or back pain related to benign or malignant tumor.
• Has history or presence of active malignancy.
• 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.

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: June 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)