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New coated nail aims to stop bone infections after leg fractures

NCT ID NCT05022485

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of metal nail coated with a noble metal alloy to fix broken shin bones (tibia fractures). The goal is to see if it reduces the chance of infection compared to standard uncoated nails. About 500 adults with high-risk fractures will be followed for 12 months to check infection rates and bone healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
noble metal alloy-coated intramedullary nail
What this could lead to
If it works, this could reduce the risk of serious bone infections after tibia fracture surgery, leading to faster healing and fewer complications.
What could go wrong
This is a mid-stage trial with a retrospective control group, which may introduce bias. The coating might not significantly lower infection rates, and there could be unknown risks with the new material.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

18-year-old patients or older with tibia fractures at high risk for infection (as defined in the inclusion criteria) treated with a titanium-alloy intramedullary nail.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture infection Tibial fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Policlinico di Bari

    RECRUITING

    Bari, 70124, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Groote Schuur Hospital

    RECRUITING

    Cape Town, 7935, South Africa

  • Hospital Universitario Valle de Hebrón

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hôpital Ambroise-Paré

    RECRUITING

    Boulogne-Billancourt, 92100, France

  • Hôpitaux Universitaires de Marseille Nord

    RECRUITING

    Marseille, 13915, France

  • Kantonsspital Winterthur

    RECRUITING

    Winterthur, Canton of Zurich, 8400, Switzerland

  • King's College Hospital NHS Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • The Royal London Hospital

    RECRUITING

    London, E1 1FR, United Kingdom

  • Tirolkliniken Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Tygerberg Hospital

    RECRUITING

    Cape Town, 7505, South Africa

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Marburg

    RECRUITING

    Marburg, Hesse, 35039, Germany

  • Universitätsklinikum Regensburg

    RECRUITING

    Regensburg, 93053, Germany

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