ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Femoral fixation with intramedullary nails: Femoral fracture fixation Femoral Osteotomy
Study summary
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies.
This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.
Eligibility
Primary outcome measure(s)
- Performance of the study device — 12 months after fracture fixation
Analyzed as fracture healing 12 months after fracture fixation. Fracture healing will be analyzed radiographically and clinically. Radiographic healing is considered achieved when two or more cortices reach a score of two (2) on a version of the Radiographic Union-Scale in Tibial fractures (RUST) tool adapted for the femur, in A/P and lateral views. Clinical fracture healing will be assessed via the FiX-IT score.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Santa Cruz de Tenerife | Active Not Recruiting |
| Manchester Royal Infirmary | Manchester | Manchester | Recruiting |
More Zimmer Biomet trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05339360 on ClinicalTrials.gov ↗ ← All trials in Spain