Long-Term Safety Study of NVDX3, a Human Bone Implant, Following Previous Treatment for Bone Conditions

What this Trial Is About

Researchers are evaluating the long-term safety of patients who have previously been treated with NVDX3, an osteogenic implant derived from human allogenic origin. This study focuses on individuals who participated in earlier core NVDX3 trials for conditions such as distal radius fractures and degenerative lumbar spondylolisthesis. It aims to monitor safety outcomes over an extended period to gather comprehensive data on the implants long-term effects. The study involves patients who received the NVDX3 implant during a single surgical procedure in prior core trials. The amount of NVDX3 implanted depends on the size of the bone defect or intervertebral disc space. Participants enter this long-term follow-up study after signing informed consent and are expected to attend yearly safety visits for up to 10 years following their initial treatment. Participants will be involved in annual follow-up visits focusing on safety assessments over a 10-year period after the core study. Researchers will monitor the long-term safety of the NVDX3 implant from the screening visit through 120 months post-core study. This ongoing observation includes safety evaluations to ensure continuous monitoring of participant health throughout the study duration, which may last until March 2036.

Long-term Safety Trial with NVDX3