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New coated nail aims to prevent infections in broken thighs

NCT ID NCT05339360

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 100 adults who need surgery for a broken thigh bone or a bone cut (osteotomy). They will receive a special nail with an infection-fighting coating. The goal is to see how well the bone heals and if the nail is safe over 12 months. The nail is already on the market, so this is a routine check on its real-world performance.

What this could mean

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

Active substance
ZNN Bactiguard Antegrade Femoral Nail (a medical device with an infection-fighting coating)
What this could lead to
If successful, this could confirm that the nail is safe and works well for healing thigh bone fractures, reducing infection risks.
What could go wrong
This is a post-market study, not a test for a new cure. The nail is already approved, so the study mainly checks real-world performance. Results may not apply to all patients.

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 100 people

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

Started

Jan 2024

Expected to finish

Dec 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

Consecutive series of patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Bactiguard Antegrade Femoral Nail according to the approved/cleared indications.

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 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

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Conditions

The condition(s) this trial relates to.

Femoral Fractures femoral neck fracture

As listed by the trial registrant

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

Femur fracture Osteotomy

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Universitario Nuestra Señora de Candelaria

    ACTIVE_NOT_RECRUITING

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, Manchester, M13 9WL, United Kingdom

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