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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Kuros Biosurgery AG
Study ID
NCT05037968
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MagnetOs Flex Matrix — DEVICE
    Procedure: Instrumented Posterolateral Lumbar Fusion
  • Trinity Elite — DEVICE
    Procedure: Instrumented Posterolateral Lumbar Fusion

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06106
Hanbing (Steve) Zhou, MD (PRINCIPAL_INVESTIGATOR)
MedStar Health Research InstituteColumbiaMaryland21044
Addisu Mesfin, MD (PRINCIPAL_INVESTIGATOR)
Michigan Orthopedic SurgeonsBloomfield HillsMichigan48033
Daniel Park, MD (PRINCIPAL_INVESTIGATOR)
Pinehurst Surgical ClinicPinehurstNorth Carolina28374
Daniel Williams, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Stephanus Viljoen, MD
[email protected]
Huntsman Spinal ClinicSalt Lake CityUtah84124
Principal Investigator Kade Huntsman, MD
Inova HealthcareFairfaxVirginia22031
Andrew Fanous, MD

Find similar trials in Hartford, CT

By research site
Hartford Hospital· Hartford, CTMedStar Health Research Institute· Columbia, MDMichigan Orthopedic Surgeons· Bloomfield Hills, MIPinehurst Surgical Clinic· Pinehurst, NCThe Ohio State University· Columbus, OHHuntsman Spinal Clinic· Salt Lake City, UT

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