Clinical Trial

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

Study acronym: PROOF
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2020-12-18; most recent amendment 2026-03-18.
Status change: Not Yet Recruiting → Recruiting 2025-02-14
Status change: Recruiting → Not Yet Recruiting 2023-11-15
Status change: Not Yet Recruiting → Recruiting 2021-07-08
Trial Details
NCT Number NCT04679844
Lead Sponsor Kuros Biosurgery AG
Collaborators: Simplified Clinical Data Systems, LLC, Kuros BioSciences B.V.
Conditions Degenerative Disc Disease, Spine Fusion, Back Pain
Enrollment 60 participants
Start Date 2024-12-06
Primary Completion 2027-06-02 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-20