Comparing two bone graft extenders for spinal fusion surgery

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

This study is testing whether a new bone graft extender called MagnetOs Flex Matrix works better than Trinity Elite for helping patients with degenerative disc disease heal after spinal fusion surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kuros Biosurgery AG (Industry-sponsored)
• Locations: 7 sites (Hartford, Connecticut and 6 other locations)
• Trial ID: NCT05037968 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of MagnetOs Flex Matrix compared to Trinity Elite when used as bone graft extenders in patients undergoing up to four-level instrumented posterolateral fusion due to degenerative disc disease. A total of 100 patients will be randomized to receive either MagnetOs Flex Matrix or Trinity Elite at the surgical site, with follow-up assessments at various intervals up to one year post-surgery. The primary endpoint will focus on the success of spinal fusion as determined by radiographic analysis. This study aims to provide insights into the optimal use of these graft extenders in spinal surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with leg and/or back pain requiring spinal fusion after failing conservative treatments for at least three months.

Not a fit: Patients requiring more than four-level fusion or those with prior surgeries at the involved levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients undergoing spinal fusion.

How similar studies have performed: Other studies have shown promising results with similar bone graft extenders, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Hartford, Connecticut and 6 other locations

• Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
• MedStar Health Research Institute — Columbia, Maryland, United States (Recruiting)
• Michigan Orthopedic Surgeons — Bloomfield Hills, Michigan, United States (Recruiting)
• Pinehurst Surgical Clinic — Pinehurst, North Carolina, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Huntsman Spinal Clinic — Salt Lake City, Utah, United States (Recruiting)
• Inova Healthcare — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Cesar Silva, MD

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