RECRUITING

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

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Conditions

Degenerative Disc DiseaseSpine FusionLeg Pain And/or Back Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-06-10
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05037968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
  2. * Male or female patient ≥ 18 years old.
  3. * Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
  4. * 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.
  1. * Requires \> four-level fusion or expected to need secondary intervention within one year following surgery.
  2. * Had prior PLF fusion or attempted PLF fusion at the involved levels
  3. * Had previous decompression at the involved levels.
  4. * Women who are or intend to become pregnant within the next 12 months
  5. * To treat conditions in which general bone grafting is not advisable.
  6. * 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).
  7. * In case of significant vascular impairment proximal to the graft site.
  8. * In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
  9. * In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  10. * When intraoperative soft tissue coverage is not planned or possible.
  11. * Receiving treatment with medication interfering with calcium metabolism.
  12. * Had leg pain, and/or back pain related to a benign or malignant tumor.
  13. * Had history or presence of active malignancy.
  14. * 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.
  15. * Is involved in active litigation relating to his/her spinal condition.
  16. * Has participated in an investigational study within 30 days prior to surgery for study devices.

Contacts and Locations

Study Contact

Katherine Sage, DO
CONTACT
617 285 2489
katherine.sage@kurosbio.com
Cesar Silva, MD
CONTACT
cesar.silva@kurosbio.com

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06106
United States
MedStar Health Research Institute
Columbia, Maryland, 21044
United States
Michigan Orthopedic Surgeons
Bloomfield Hills, Michigan, 48033
United States

Collaborators and Investigators

Sponsor: Kuros Biosurgery AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Degenerative Disc Disease
  • Spine Fusion

Additional Relevant MeSH Terms

  • Degenerative Disc Disease
  • Spine Fusion
  • Leg Pain And/or Back Pain