Evaluation of a new implant for fixing femoral 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Leeds General Infirmary
  Leeds, Leeds, United Kingdom Recruiting
• Manchester Royal Infirmary
  Manchester, United Kingdom Recruiting
• Hospital Universitario Ntra. Sra. de Candelaria
  Santa Cruz de Tenerife, Tenerife, Spain Active not 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

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.