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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

Kuros Biosurgery AG · with Kuros BioSciences B.V. · NCT05037968

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
9
Study start
June 10, 2024
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: MagnetOs Flex Matrix; Trinity Elite

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Hartford Hospital

    Hartford, CT 06106

    Site contact: Cameron Kia, MD

  • Central CT Neurosurgery & Spine

    New Britain, CT 06051

    Site contact: Ahmed Khan, MD

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Kern Singh, MD

  • MedStar Health Research Institute

    Columbia, MD 21044

    Site contact: Addisu Mesfin, MD

  • Michigan Orthopedic Surgeons

    Bloomfield Hills, MI 48033

    Site contact: Daniel Park, MD

  • Pinehurst Surgical Clinic

    Pinehurst, NC 28374

    Site contact: Daniel Williams, MD

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Stephanus Viljoen, MD

  • Huntsman Spinal Clinic

    Salt Lake City, UT 84124

    Site contact: Kade Huntsman, MD

  • Inova Healthcare

    Fairfax, VA 22031

    Site contact: Andrew Fanous, MD

Study contacts (from the official record)

  • Cesar Silva · 9702156793 · cesar.silva@kurosbio.com
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MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local… (NCT05037968) | Bored Studies