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

RecruitingNAAges 18 Years - anyAllKuros Biosurgery AG
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In plain words

What the trial is, and whether it could suit you

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • MagnetOs Flex Matrix
  • Trinity Elite
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Where

9 sites
Hartford Hospital
Hartford, United States
Central CT Neurosurgery & Spine
New Britain, United States
Rush University Medical Center
Chicago, United States
MedStar Health Research Institute
Columbia, United States
Michigan Orthopedic Surgeons
Bloomfield Hills, United States
Pinehurst Surgical Clinic
Pinehurst, United States
The Ohio State University
Columbus, United States
Huntsman Spinal Clinic
Salt Lake City, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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