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

Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control

Observational Zimmer Biomet · NCT05022485

This study is testing whether a new type of tibia nail can reduce infection rates after a leg fracture compared to standard nails in up to 500 patients.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorZimmer Biomet Industry-sponsored
Locations16 sites (Innsbruck and 15 other locations)
Trial IDNCT05022485 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who have suffered a primary tibia fracture at high risk of infection and are eligible for intramedullary nailing.

Not a fit: Patients with low-risk tibial fractures or those not requiring surgical fixation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to reduced infection rates and improved healing outcomes for patients with tibial fractures.

How similar studies have performed: Other studies have shown promising results with similar infection prevention approaches, suggesting potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Innsbruck and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tibial FracturesFracture Infectionintramedullary tibia nailBactiguard
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.