Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion

  • STATUS
    Recruiting
  • End date
    Aug 18, 2023
  • participants needed
    30
  • sponsor
    Kuros Biosurgery AG
Updated on 18 July 2021
Investigator
Pascal Longlade, MD
Primary Contact
Henry Ford Hospital System (4.8 mi away) Contact

Summary

This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty 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 Putty 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.

Description

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo a two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, Month 9, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.

In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with two-level degenerative disc disease with up to grade 1 spondylolisthesis requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.

Radiographs will be obtained at Screening, Day 0, Week 6, Month 3, and Month 9. CT scans will only be obtained at Month 6 and Month 12.

Details
Condition Intervertebral Disc Degeneration, Spine Fusion, degenerative disc disease
Treatment MagnetOs Putty, Autograft Bone
Clinical Study IdentifierNCT04679844
SponsorKuros Biosurgery AG
Last Modified on18 July 2021

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