Recruiting

MagnetOs & Trinity Elite

Sponsor:

Kuros Biosurgery AG

Code:

NCT05037968

Conditions

Degenerative Disc Disease

Spine Fusion

Leg Pain and/or Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MagnetOs Flex Matrix

Trinity Elite

Study Details

Brief summary:

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.

Conditions

Degenerative Disc Disease

Spine Fusion

Leg Pain and/or Back Pain

Study ID

NCT05037968

Start date

Jun 10, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MagnetOs Flex Matrix

MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side

active comparator: Trinity Elite

Trinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft)

Interventions

MagnetOs Flex Matrix

Procedure: Instrumented Posterolateral Lumbar Fusion

Trinity Elite

Procedure: Instrumented Posterolateral Lumbar Fusion

Primary outcome measure

  • Radiographic Fusion by CT Scan [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Cesar Silva, MD

9702156793cesar.silva@kurosbio.com

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Cameron Kia, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Kern Singh, MD

MedStar Health Research Institute

Recruiting

Columbia, Maryland, United States, 21044

Principal Investigator:

Addisu Mesfin, MD

Michigan Orthopedic Surgeons

Recruiting

Bloomfield Hills, Michigan, United States, 48033

Principal Investigator:

Daniel Park, MD

Pinehurst Surgical Clinic

Recruiting

Pinehurst, North Carolina, United States, 28374

Principal Investigator:

Daniel Williams, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Stephanus Viljoen, MD

Huntsman Spinal Clinic

Recruiting

Salt Lake City, Utah, United States, 84124

Principal Investigator:

Kade Huntsman, MD

Inova Healthcare

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Andrew Fanous, MD

More Information

Sponsor

Kuros Biosurgery AG

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Degenerative Disc Disease
  • Spine Fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kuros Biosurgery AG on 2026-07-07.