Ongoing Clinical Trials for Spondylolisthesis
Currently, there is 1 ongoing clinical trial investigating treatments for spondylolisthesis. This trial focuses on the long-term safety of a bone implant called NVDX3, which is being studied in patients with low-grade degenerative lumbar spondylolisthesis, a condition where one of the lower back bones slips over the one below it.
Clinical trial locations
Study on Long-term Safety of NVDX3 Implant for Patients with Distal Radius Fracture or Low-grade Degenerative Lumbar Spondylolisthesis
This trial is investigating the long-term safety of NVDX3, a bone implant designed to support bone growth and repair. The study includes patients with two different conditions: distal radius fractures (wrist fractures) and low-grade degenerative lumbar spondylolisthesis, a spine condition where one of the lower back vertebrae slips out of place.
Main inclusion criteria:
- Patients must have either a distal radius fracture or low-grade degenerative lumbar spondylolisthesis
- Patients must have already received the NVDX3 implant
- Participants must have previously taken part in one of the earlier NVDX3 clinical trials
- Patients must be willing to attend yearly follow-up safety visits for 10 additional years
- Both male and female patients can participate
- Patients must sign an informed consent form showing they understand and agree to participate in the long-term follow-up study
Main exclusion criteria:
- The exclusion criteria appear to focus on specific types of patients with distal radius fractures and those with low-grade degenerative lumbar spondylolisthesis treated by interbody spine fusion
Focus and goal:
The main goal of this study is to document the long-term safety of the NVDX3 implant over a 10-year period. Participants who have already received the implant in earlier trials will be monitored through yearly follow-up visits. During these visits, researchers will record any serious adverse events or other side effects related to the implant. The study aims to provide valuable information about how safe the implant remains over an extended period, contributing to our understanding of its long-term effects and potential benefits for patients with these bone-related conditions.
Investigational drug:
The study is testing NVDX3, an osteogenic implant made from human allogenic material. This means it is created from donor bone tissue and is designed to promote bone growth and healing. The implant is surgically placed and works by supporting the body’s natural bone regeneration processes. It is classified as a bone graft substitute and is being evaluated specifically for treating distal radius fractures and low-grade degenerative lumbar spondylolisthesis through interbody spine fusion.
Summary
There is currently one active clinical trial for spondylolisthesis, taking place in Luxembourg. This trial focuses on evaluating the long-term safety of the NVDX3 bone implant over a 10-year follow-up period. The study is unique in that it enrolls patients who have already received the implant in previous trials, allowing researchers to track safety outcomes over an extended timeframe. The trial addresses low-grade degenerative lumbar spondylolisthesis, a condition commonly seen in older adults where age-related changes in the spine cause one vertebra to slip forward over another. By monitoring participants through yearly safety visits, this research will help determine whether NVDX3 remains a safe option for bone repair and regeneration in the long term.