Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
brief summary
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
detailed description
This is a prospective, single arm, single-center PoC study in adult patients, suffering from a degenerative lumbar (L1-S1) spondylolisthesis, treated by spondylodesis in which NVDX3, an osteogenic implant from human allogeneic origin is used. The screening and implant surgery visits will be used as the reference timepoint respectively for the clinical and the radiological efficacy outcome evaluations.
As per standard of care, patients with DLS are followed up to 12 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 24 months post-implant surgery.
official title
A Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Spine Fusion in Adults.