Comparing infection rates of a new tibia nail to standard nails after fracture fixation

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 compare the rates of fracture-related infections (FRI) between the Zimmer Natural Nail Bactiguard Tibia and conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. It will enroll up to 500 patients across 15 sites, with 250 receiving the Bactiguard device and 250 serving as retrospective controls. The study will assess safety, performance, and clinical benefits through various measures, including radiologic and clinical outcomes, as well as patient-reported quality of life. Data will be collected at multiple time points over the course of a year.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must be 18 or older.
* Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements).
* Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions:

  * Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.
  * Delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail).
  * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).
  * Closed fractures with severe tissue damage: Tscherne grade C2 and C3.
* Patient:

  * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);
  * was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;

Exclusion Criteria:

* Patient is unwilling or unable to give consent.
* Patient is not expected to survive follow-up schedule.
* Patient is anticipated to be non-compliant to the study protocol.
* Patient has a mental or neurological condition or alcohol/drug addiction that will not allow for proper informed consent and/or participation in follow-up program.
* Patient is a prisoner.
* Patient is known to be pregnant and/or breastfeeding.
* Patient suffered tibia fracture that meets any of the following conditions:

  * Pathologic fracture.
  * Gustilo Type IIIC open fracture.
  * Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.
  * Patients with wound closure more than 10 days after injury.
  * Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and/or fibula plate fixation are allowed).
  * Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.
* For control group:

  * patient doesn't have all the minimum required data available:

    1. demographic information
    2. injury classification
    3. FRI information
    4. operative report and device information
    5. radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)
* Tibia medullary canal is obliterated by a previous fracture or tumor\*
* Tibia bone shaft having excessive bow or a deformity\*
* Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\*
* All concomitant diseases that can impair the operation, functioning or the success of the nail implant\*
* Insufficient blood circulation\*
* Skeletally immature patients\*
* Infection\*

  * ZNN Bactiguard tibia contraindication

Where it's running

• Tirolkliniken Innsbruck
  Innsbruck, Austria Recruiting
• Hôpital Ambroise-Paré
  Boulogne-Billancourt, France Recruiting
• Hôpitaux Universitaires de Marseille Nord
  Marseille, France Recruiting
• Universitätsklinikum Marburg
  Marburg, Hesse, Germany Recruiting
• Universitätsklinikum Leipzig
  Leipzig, Germany Recruiting
• Universitätsklinikum Regensburg
  Regensburg, Germany Recruiting

Study contacts

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

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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.