Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05961956
Study type Interventional
Source Novadip Biosciences
Contact Denis Dufrane, MD
Phone 003210779220
Email clinical@novadip.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 12, 2023
Completion date November 15, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06407063 - Long-term Reoperations After Lumbar Spinal Stenosis Surgery
Active, not recruiting NCT03469791 - Degenerative Spondylolisthesis; Micro-decompression vs Decompression + Instrumented Fusion; Long Term Follow up N/A
Completed NCT00677950 - OP-1 Putty for Posterolateral Fusions N/A
Completed NCT00678353 - Study of OP-1 Putty in Uninstrumented Posterolateral Fusions N/A
Completed NCT00679107 - A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions N/A
Recruiting NCT02290314 - Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion N/A