A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
Kuros Biosurgery AG
Summary
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.
Description
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 30 patients have completed their Month 6 visit and have measurements for the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent. * Male or female patient ≥ 18 years old. * Patients with segmental mechanical spinal instability requiring arthrodesis surgery. Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of…
Interventions
- DeviceMagnetOs Easypack Putty
MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.
- DeviceDemineralized Bone Matrix or Fibers mixed with local autograft bone
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.
Locations (6)
- The Regents of the University of California- Irvine CampusIrvine, California
- Corewell HealthGrand Rapids, Michigan
- The Washington UniversitySt Louis, Missouri
- Rothman Orthopaedic InstitutePhiladelphia, Pennsylvania
- Tennessee Orthopaedic AllianceNashville, Tennessee
- University of WashingtonSeattle, Washington