Evaluation of a new implant for fixing femoral fractures
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
This study is testing a new implant to see if it helps people with femoral fractures heal safely and effectively after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 4 sites (Santa Cruz de Tenerife, Tenerife and 3 other locations) |
| Trial ID | NCT05276674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the safety, performance, and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail for the internal fixation and stabilization of femoral fractures. It will collect data on fracture healing as the primary endpoint, while also assessing safety and clinical benefits through patient-reported outcomes and monitoring for post-operative fracture-related infections. The study involves patients who are undergoing surgical intervention for femoral fractures and will follow them through the required protocol follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a femoral fracture requiring surgical intervention eligible for intramedullary nailing.
Not a fit: Patients who are skeletally immature or have significant bone quality issues that prevent stable implant seating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the treatment outcomes for patients with femoral fractures by providing a safer and more effective fixation method.
How similar studies have performed: Other studies have shown promising results with similar intramedullary nailing approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Santa Cruz de Tenerife, Tenerife and 3 other locations
- Hospital Universitario Ntra. Sra. de Candelaria — Santa Cruz de Tenerife, Tenerife, Spain (Active_not_recruiting)
- Leeds General Infirmary — Leeds, Leeds, United Kingdom (Recruiting)
- Manchester Royal Infirmary — Manchester, United Kingdom (Recruiting)
- Stepping Hill Hospital — Stockport, United Kingdom (Active_not_recruiting)
Study contacts
- Study coordinator: Gemma de Ramon Francàs
- Email: gemma.deramonfrancas@zimmerbiomet.com
- Phone: +41 79 377 11 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.