Comparing two bone graft extenders for spinal fusion surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• Central CT Neurosurgery & Spine
  New Britain, Connecticut, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, 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

Study contacts

• Study coordinator: Cesar Silva
• Email: cesar.silva@kurosbio.com
• Phone: 9702156793

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.