Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Spine Fusion
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel Assignment Intra-patient control. Each patient serves as their own control.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-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 local autograft bone...
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-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 local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, 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 with with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar 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. CT scans will only be obtained at Month 6 and Month 12.
Tracking Information
- NCT #
- NCT04679896
- Collaborators
- Orthopaedic Institute of Western Kentucky
- Simplified Clinical Data Systems, LLC
- Investigators
- Study Director: Pascal Longlade, MD Kuros BioSciences B.V.