Clinical Trial

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Study acronym: PRECISE

Recruiting

Summary

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix 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. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Protocol Amendment History 11 amendments

This ClinicalTrials.gov record has been amended 11 times since 2021-08-31; most recent amendment 2026-07-06.

Status change: Not Yet Recruiting → Recruiting 2024-12-04

Trial Details

NCT Number	NCT05037968
Lead Sponsor	Kuros Biosurgery AG Collaborators: Kuros BioSciences B.V.
Conditions	Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
Enrollment	100 participants
Start Date	2024-06-10
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-07