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

NCT05037968 | Recruiting FDA Device

• 1 other identifier: MAG-523-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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

Keywords

Degenerative Disc Disease; Spine Fusion

Outcome Measures

Primary Outcomes (1)

• Radiographic Fusion by CT Scan

  The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.

  Month 12

Secondary Outcomes (6)

• Radiographic Fusion by Plain Radiographs

  Month 6 and Month 12

• Radiographic Fusion by CT Scan

  Month 6

• Functional Outcome by Oswestry Disability Index

  Screening, Week 2, Week 6, Month 3, Month 6, Month 12

• Back and Leg Pain by Visual Analog Pain Scale (VAS)

  Screening, Week 2, Week 6, Month 3, Month 6, and Month 12

• Neurologic Status by Physical Exam

  Screening, Week 2, Week 6, Month 3, Month 6, and Month 12

Other Outcomes (8)

• Safety Endpoint - number of patients with Adverse Events

  Screening up to 12 Months post-op

• Safety Endpoint - number of patients with Serious Adverse Events

  Screening up to 12 Months post-op

• Safety Endpoint - number of patients with Adverse Device Effects

  12 Months

Study Arms (2)

MagnetOs Flex Matrix

EXPERIMENTAL

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

Device: MagnetOs Flex Matrix

Trinity Elite

ACTIVE COMPARATOR

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)

Device: Trinity Elite

Interventions

Trinity Elite DEVICE

Procedure: Instrumented Posterolateral Lumbar Fusion

Trinity Elite

MagnetOs Flex Matrix DEVICE

Procedure: Instrumented Posterolateral Lumbar Fusion

MagnetOs Flex Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Kuros BioSciences B.V.: collaborator

Study Sites (7)

Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

MedStar Health Research Institute

Columbia, Maryland, 21044, United States

RECRUITING

Michigan Orthopedic Surgeons

Bloomfield Hills, Michigan, 48033, United States

RECRUITING

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Huntsman Spinal Clinic

Salt Lake City, Utah, 84124, United States

RECRUITING

Inova Healthcare

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Cesar Silva, MD

CONTACT

9702156793; cesar.silva@kurosbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Intra-patient control. Each patient serves as their own control.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)