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Clinical Trials in the UK / NCT05276674
Recruiting Observational

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

NCT05276674 · tracked via the Priya Life Science UK tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2023-10-23
Last updated
2026-02-03

Condition(s) studied

Femoral Fracture

Investigational drug(s) / intervention(s)

ZNN Bactiguard Retrograde Femoral Nail

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients must be 18 years or older. * Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included. * Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail. * Patient must be able and willing to complete the protocol required follow-up. * Patient must have a signed EC approved consent. * Patients capable of understanding the surgeon's explanations and following his instructions. Exclusion Criteria: * Skeletally immature patients * A medullary canal obliterated by a previous fracture or tumor * Bone shaft having excessive bow or a deformity * Lack of bone substance or bone quality, which makes stable seating of the implant impossible * All concomitant diseases that can impair the operation, functioning or the success of the implant * Insufficient blood circulation * Infection * Patient is unwilling or unable to give consent. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding). * Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). * Not expected to survive the duration of the follow-up program

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
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 the UK

Official registry record

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 the UK