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

Launched by KUROS BIOSURGERY AG · Aug 31, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a product called MagnetOs Flex Matrix, which is used as a bone graft extender during spinal fusion surgery for patients with degenerative disc disease. The trial compares MagnetOs Flex Matrix mixed with the patient's own bone (autograft) to another product called Trinity Elite, which is a type of bone graft made from donated tissue. The goal is to see how well these treatments help reduce leg and back pain in patients who have already tried other treatments without success.

To be eligible for the study, participants must be at least 18 years old and have been experiencing leg or back pain that requires surgery to fuse up to four levels of the spine. They should also have tried other treatments, like physical therapy or medications, for at least three months without relief. Participants will receive the assigned treatment during their surgery and will be monitored for their recovery. It's important to note that certain individuals, such as those with specific health conditions or who are pregnant, may not qualify for the study.

Gender

ALL

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.