Study to Confirm Safety and Benefits of the Zimmer Natural Nail Bactiguard Retrograde Femoral Nail for Femoral Fracture Fixation and Stabilization

What this Trial Is About

Researchers are evaluating the Zimmer Natural Nail ZNN Bactiguard Retrograde Femoral Nail system in a post-market clinical follow-up study to confirm its safety, performance, and clinical benefits for patients with femoral fractures. This observational study focuses on how well the device helps with temporary internal fixation and stabilization of these fractures, with particular attention to fracture healing as the main outcome. Participants will receive the ZNN Bactiguard Retrograde Femoral Nail implanted to fix and stabilize their femoral fracture. The study tracks their recovery over time without testing other treatments or placebos. The device is used during surgery, and the study observes how it performs in real-world medical use. During the study, participants will be monitored at 3, 6, and 12 months after surgery. Researchers will assess fracture healing rates, limb function using the Oxford Knee Score, and quality of life with the EQ-5D-5L questionnaire. They will also record any complications or adverse events, including infections related to the fracture. The total participation duration is up to 12 months, with careful follow-up to gather patient-reported outcomes and safety data.

ZNN Bactiguard Retrograde Femoral Nails PMCF Study