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

NCT04679896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-13

No results posted yet for this study

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 leg pain and/or back pain 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.

Conditions

  • Degenerative Disc Disease
  • Spine Fusion

Interventions

DEVICE

MagnetOs Putty

Procedure: Instrumented posterolateral spine fusion

Sponsors & Collaborators

  • Orthopaedic Institute of Western Kentucky

    collaborator UNKNOWN

  • Simplified Clinical Data Systems, LLC

    collaborator INDUSTRY

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Pascal Longlade, MD · Kuros BioSciences B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2023-08-02
Completion
2023-12-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679896 on ClinicalTrials.gov