Post Marketing Study of MagnetOs Putty Compared to Demineralized Bone Matrix (DBM) Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion — PROOF

Degenerative Disc Disease Clinical Trial

Official title:
A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Putty Compared to Demineralized Bone Matrix Mixed With Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)

Status Not yet recruiting

Clinical Trial 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 or spinal trauma 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.

Clinical Trial Description

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to 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 demineralized bone matrix mixed with 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 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 up to two-level degenerative disc disease with up to grade 1 spondylolisthesis requiring treatment or spinal trauma 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, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04679844
Study type	Interventional
Source	Kuros Biosurgery AG
Contact	Katherine Sage, DO
Phone	617 285 2489
Email	Katherine.Sage@kurosbio.com
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2024
Completion date	March 2, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.