Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04679896
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2020-12-18
Brief Title:
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Sponsor:
Kuros Biosurgery AG
Organization:
Kuros Biosurgery AG
Study Overview
Official Title:
A Prospective Randomized Single-center Study to Assess the Performance of MagnetOs Putty Compared to Local Autograft in Patients Undergoing up to Three-level Instrumented Posterolateral Lumbar Fusion PLF
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARTNER
Brief 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 andor back pain and undergoing spinal fusion surgery
In this study MagnetOs Putty will be used according to the latest US Instructions For Use specifically as a bone graft extender mixed with autograft in a 11 vol in the posterolateral spine
In this study MagnetOs Putty will be used according to the latest US Instructions For Use specifically as a bone graft extender mixed with autograft in a 11 vol in the posterolateral spine
Detailed 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 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 11 vol in patients with with leg pain andor back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure The fusion procedure PLF will be left to the surgeons 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
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 11 vol in patients with with leg pain andor back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure The fusion procedure PLF will be left to the surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None