Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

Part of paid clinical trials in Irvine, California.

Sponsor
Kuros Biosurgery AG
Study ID
NCT04679844
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • MagnetOs Easypack Putty — DEVICE
    MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.
  • Demineralized Bone Matrix or Fibers mixed with local autograft bone — DEVICE
    Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.

Study Details

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

Key Dates

Start date
Dec 6, 2024
Status verified
Nov 2025
Primary completion
Jun 2, 2027
Completion
Aug 30, 2027

Study Design

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

Arms

  • Experimental: MagnetOs Easypack Putty
    Interventions * Procedure: Instrumented posterolateral spine fusion * Device; MagnetOs Easypack Putty
  • Active Comparator: Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone
    Interventions * Procedure: Instrumented posterolateral spine fusion * Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
The Regents of the University of California- Irvine CampusIrvineCalifornia92697
Michael Oh, MD
[email protected]
Corewell HealthGrand RapidsMichigan49503
Jason Squires, M
[email protected]
The Washington UniversitySt LouisMissouri63130
Principal Investigator, Mark Lambrechts, MD
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107
Principal Investigator, Jose Canseco, MD
Tennessee Orthopaedic AllianceNashvilleTennessee37209
Ryan Snowden, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98104
Christoph Hofstetter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
The Regents of the University of California- Irvine Campus· Irvine, CACorewell Health· Grand Rapids, MIThe Washington University· St Louis, MORothman Orthopaedic Institute· Philadelphia, PATennessee Orthopaedic Alliance· Nashville, TNUniversity of Washington· Seattle, WA

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