Evaluation of Bactiguard Cephalomedullary Nails for Fracture Fixation
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
This study is testing if a new type of nail used in surgery can help heal femur fractures safely and reduce the risk of infections over the year after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 3 sites (Douai and 2 other locations) |
| Trial ID | NCT05362864 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective study aims to collect data on the safety and performance of the ZNN Bactiguard Cephalomedullary Nails used for the internal fixation of femoral fractures and osteotomies. The primary focus is on assessing fracture healing within 12 months post-surgery, while secondary endpoints include evaluating safety and the incidence of postoperative infections. Data will be gathered through patient-reported outcomes and radiological assessments at multiple follow-up points. The study will involve 150 patients across up to 10 sites in the EMEA region.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific types of femoral fractures requiring surgical intervention.
Not a fit: Patients with skeletal immaturity, significant bone deformities, or other conditions that could impair surgery or healing 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 Bactiguard nails, potentially leading to improved patient outcomes in fracture management.
How similar studies have performed: While this study builds on existing knowledge of fracture fixation devices, the specific use of Bactiguard technology in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 years or older. * Patient must have a signed EC approved informed consent. * Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, or shaft fracture requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing. * Patient has been or is scheduled to be treated with the ZNN Bactiguard System Cephalomedullary Nail. * Patient must be able and willing to complete the protocol required 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 or unable to give consent. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subject with alcohol/drug addiction, known to be pregnant or breastfeeding). * Patient anticipated to be non-compliant and/or likely to have problems complying with the follow-up program (e.g. patient with no fixed address, long-distance, plans to move during course of study).
Where this trial is running
Douai and 2 other locations
- Centre Hospitalier de Douai — Douai, France (Active_not_recruiting)
- Hospital Rio Hortega — Valladolid, Castilla-La Mancha, Spain (Recruiting)
- Hospital Clinico de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Miguel Correa-Tapia
- Email: Miguel.CorreaTapia@zimmerbiomet.com
- Phone: +41791522905
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.