Evaluation of Bactiguard Antegrade Femoral Nails for treating femur fractures
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
This study is testing a new type of nail used in surgery to fix femur fractures to see how safe and effective it is for helping patients heal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 2 sites (Santa Cruz de Tenerife, Santa Cruz de Tenerife and 1 other locations) |
| Trial ID | NCT05339360 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective study focuses on the ZNN Bactiguard Antegrade Femoral Nails, which are used for the internal fixation and stabilization of femoral fractures and osteotomies. The study aims to collect data on the safety, performance, and clinical benefits of this CE-marked device, already available on the market. Key endpoints include assessing fracture healing through radiological and clinical evaluations, as well as monitoring safety and post-operative complications. Data will be collected at multiple time points over a year to ensure comprehensive follow-up.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with femoral fractures or osteotomies requiring surgical intervention eligible for fixation with intramedullary nails.
Not a fit: Patients who are skeletally immature or have significant bone quality issues or previous obstructions in the medullary canal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the effectiveness and safety of the Bactiguard system in treating femoral fractures.
How similar studies have performed: While this study builds on existing knowledge of intramedullary nails, it specifically evaluates a novel device with a focus on post-market surveillance, making it a unique contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be 18 or older * Patient must have a signed EC-approved informed consent. * Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy 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 Antegrade Femoral Nail * Patient must be able and willing to complete the protocol required for follow-up * Patients capable of understanding the surgeon's explanations and following his instructions Exclusion Criteria: Skeletally immature patients * 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 to give consent. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with 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 the course of study) * Patients not expected to survive the duration of the follow-up program
Where this trial is running
Santa Cruz de Tenerife, Santa Cruz de Tenerife and 1 other locations
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Active_not_recruiting)
- Manchester Royal Infirmary — Manchester, Manchester, United Kingdom (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.