Enrolling by invitationNCT06415123Updated Aug 22, 2025

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

An observational study in Degenerative Disc Disease, sponsored by Research Source. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Research Source · Observational

From the registry’s dates

Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as enrolling by invitation.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

Degenerative Disc Disease

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Intervertebral Disc Degeneration 464

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's planned enrollment of 30 is below the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Research Source is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
Is involved in active litigation relating to his/her spinal condition.
Has participated in an investigational study within 30 days prior to surgery for study devices

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 30 participants (estimated)
Patient registry: No

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
Time frame: 12 months post-surgery

Study locations

1 site

Michigan Orthopaedic Surgeons
Southfield, Michigan 48033, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06415123
Lead sponsor: Research Source
Responsible party: Sponsor
First posted: May 16, 2024
Start date: Jun 11, 2024
Primary completion: May 2026 (estimated)
Completion: May 2027 (estimated)
Last update: Aug 22, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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Discussion

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