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MagnetOs Flex Matrix vs. Trinity Elite for Spinal Fusion

This study is looking at two different bone graft materials, MagnetOs Flex Matrix and Trinity Elite, used during spinal fusion surgery. Spinal fusion is a procedure to join two or more vertebrae (bones in your spine) to treat conditions like degenerative disc disease, which can cause leg and/or back pain. Researchers want to see which material is better at helping the bones fuse together. You might be able to join if you are at least 18 years old, have leg and/or back pain requiring up to a four-level spinal fusion, and have tried other treatments without success. The main goal is to see how well the bones have fused by looking at CT scans after 12 months. The study is currently recruiting 100 participants.

Study design
This study will involve 100 participants who will be randomly assigned to receive MagnetOs Flex Matrix on one side of their spine and Trinity Elite on the other during surgery.
What's involved
You will have follow-up visits at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12, including X-rays and CT scans at certain points.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 months after your surgery, with the primary outcome measured at the 12-month mark.

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NCT05037968

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Recruiting
NAAges 18+InterventionalTreatment
Kuros Biosurgery AG
~100 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:MagnetOs Flex MatrixTrinity Elite

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Fusion by CT Scan
Measured over Month 12

Conditions

Degenerative Disc Disease
Spine Fusion
Leg Pain and/or Back Pain

Explore related trials

Intervertebral Disc Degenerative DisorderSpine fusion

Where it's being run

8 sites across 8 states
Connecticut1
Illinois1
Maryland1
Michigan1
North Carolina1
Ohio1
Utah1
Virginia1

Who to contact

Cesar Silva, MD
[email protected]
9702156793
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (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

Requires \> 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.
Receiving treatment with medication interfering with calcium metabolism.
Had leg pain, and/or back pain related to a benign or malignant tumor.
Had history or presence of active malignancy.
Has known substance abuse, psychiatric disorder, or 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.

What this trial measures

  • Radiographic Fusion by CT ScanMonth 12

    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.