Evaluation of Bactiguard Antegrade Femoral Nails for treating femur fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Manchester Royal Infirmary
  Manchester, Manchester, United Kingdom Recruiting
• Hospital Universitario Nuestra Señora de Candelaria
  Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain Active not recruiting

Study contacts

• Study coordinator: Gemma de Ramon Francàs
• Email: gemma.deramonfrancas@zimmerbiomet.com
• Phone: +41 79 377 11 96

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.