ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Condition(s) studied
Investigational drug(s) / intervention(s)
ZNN Bactiguard Retrograde Femoral Nail: Femoral fracture internal fixation.
Study summary
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
Eligibility
Primary outcome measure(s)
- Rate of fracture healing 12 months after fracture fixation — 3, 6, and 12 months after fracture fixation
Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario Ntra. Sra. de Candelaria | Santa Cruz de Tenerife | Tenerife | Active Not Recruiting |
| Leeds General Infirmary | Leeds | LEEDS | Recruiting |
| Manchester Royal Infirmary | Manchester | United Kingdom | Recruiting |
| Stepping Hill Hospital | Stockport | United Kingdom | Active Not 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 NCT05276674 on ClinicalTrials.gov ↗ ← All trials in Spain