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Tibial FracturesNCT05022485

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

An observational study of Tibial Fractures and Fracture Infection, run by Zimmer Biomet at 16 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibial Fractures, Fracture Infection
What is being tested?
ZNN Bactiguard tibia
Type of treatment
Medical device
How many people
500 participants
Where
16 sitesin 8 countries
Study dates
11 Apr 2022to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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;

Who cannot join

  • 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.
Show all 28Show fewer
  • 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:
  • demographic information
  • injury classification
  • FRI information
  • operative report and device information
  • 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

Trial locations and contacts

16 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Gemma de Ramon Francas contact

+41 79 377 11 96

gemma.deramonfrancas@zimmerbiomet.com

Lisa To contact

+32 2 456 12 70

Lisa.To@zimmerbiomet.com

16 sites in 8 countries

United Kingdom4 sites, 4 recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

    Sam Molyneux, MD, sgmolyneux@gmail.com

    Sam Molyneux, MD

    Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX

    Nik Kanakaris, MD, n.kanakaris@nhs.net

    Peter Giannoudis, MD

    Recruiting

  • The Royal London Hospital

    London, E1 1FR

    Alexandros Vris, MD, avris@nhs.net

    Alexandros Vris, MD

    Recruiting

  • King's College Hospital NHS Trust

    London, SE5 9RS

    Aaron Saini, MD, +44 (0)20 3299 1919, aaronsaini@nhs.net

    Aaron Saini, MD

    Recruiting

Other trials in United Kingdom

Germany3 sites, 3 recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103

    Georg Osterhoff, MD, Georg.Osterhoff@medizin.uni-leipzig.de

    Georg Osterhoff, MD

    Recruiting

  • Universitätsklinikum Marburg

    Marburg, Hesse, 35039

    Antonius Korschinsky, MD, +49 6421 58-64904, korschin@med.uni-marburg.de

    Steffen Ruchholtz, MD

    Recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93053

    Volker Alt, MD

    Volker Alt, MD

    Recruiting

Other trials in Germany

France2 sites, 2 recruiting

  • Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100

    Thomas Bauer, MD, 0033149095575, thomas.bauer@aphp.fr

    Thomas Bauer, MD

    Recruiting

  • Hôpitaux Universitaires de Marseille Nord

    Marseille, 13915

    Xavier Flecher, MD, 0033 4 91 96 86 94, Xavier.FLECHER@ap-hm.fr

    Xavier Flecher, MD

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • AOU Policlinico di Bari

    Bari, 70124

    Giovanni Vicenti, MD, dott.gvicenti@gmail.com

    Giovanni Vicenti, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

    Massimo Sangiovanni, MD, sangiomas@virgilio.it

    Massimo Sangiovanni, MD

    Recruiting

Other trials in Italy

South Africa2 sites, 2 recruiting

  • Tygerberg Hospital

    Cape Town, 7505

    Nando Ferreira, MD, +27 83 324 5585, nferreira@sun.ac.za

    Nando Ferreira, MD

    Recruiting

  • Groote Schuur Hospital

    Cape Town, 7935

    Maritz Laubscher, MD, +27(0)83 3841191, maritz.laubscher@uct.ac.za

    Maritz Laubscher, MD

    Recruiting

Other trials in South Africa

Austria1 site, 1 recruiting

  • Tirolkliniken Innsbruck

    Innsbruck, 6020

    Rohit Arora, MD, rohit.arora@tirol-kliniken.at

    Rohit Arora, MD

    Recruiting

Other trials in Austria

Spain1 site, 1 recruiting

  • Hospital Universitario Valle de Hebrón

    Barcelona, Catalonia, 08035

    Yaiza Garcia, yaiza.garcia@vhir.org

    Jordi Teixidor Serra, MD

    Recruiting

Other trials in Spain

Switzerland1 site, 1 recruiting

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8400

    Christoph Meier, MD, christoph.meier@ksw.ch

    Christoph Meier, MD

    Recruiting

Other trials in Switzerland

About this study

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

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.

The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

Read the detailed description

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls.

The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails.

500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an:

  • investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia)
  • a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure).

The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation.

The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems:

  • Radiologic (RUST) \& clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance).
  • Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits).
  • EQ5D-5L (patients' quality of life).
  • Incidence and frequency of adverse events (safety).

Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.

Being tested
ZNN Bactiguard tibia
Keywords
intramedullary tibia nail, Bactiguard
Medical subject headings
Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZNN Bactiguard tibiaDevice

    Tibia fracture fixation

Study groups in NCT05022485
Study groupRoleWhat they receive
Investigational groupSubjects that will be implanted with the ZNN Bactiguard tibia device.
Receives: Device: ZNN Bactiguard tibia
Control groupSubjects that have received an uncoated titanium-alloy tibia nail in the past (data collection is retrospective; patients will not have to undergo any study-related procedure).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fracture related infection (FRI) rate in investigational and control group

    FRI diagnosed according to the updated diagnostic algorithm drafted by the Fracture-Related Infection Consensus Group (Definition and diagnosis of fracture-related infection, M McNally,G Govaert, M Dudareva, M Morgenstern, W J Metsemakers, EFORT Open Rev 2020;5:614-619.)

    Measured: 12 months after fracture fixation

Secondary outcomes (5)

  1. Tibia fracture healing assessed radiologically through Radiographic Union Scale in Tibial fractures (RUST) score

    The RUST score assigns each tibial cortex (anterior, posterior, medial and lateral) a score from 1 to 3, based on the appearance on the X-ray. The scores of all cortices combined will give a minimum score of 4 (definitely not healed) up to a maximum of 12 (completely healed).

    Measured: 12 months after fracture fixation

  2. Tibia fracture healing assessed clinically through the Function IndeX for Trauma (FIX-IT) score

    The FIX-IT score assesses the subject's pain and ability to bear weight on lower extremity fractures. It ranges from 0 to 12 points, with 12 points representing the highest level of limb function.

    Measured: 12 months after fracture fixation

  3. Limb functionality measured through the Oxford Knee Score

    The Oxford Knee Score consists of twelve questions regarding knee functionality and pain. The score ranges from 12 to 60 points, with 12 points indicating the best outcome.

    Measured: 12 months after fracture fixation

  4. Quality of life of study participants assessed through the EQ-5D-5L questionnaire

    The EQ-5D is a self-reported descriptive questionnaire about the patient's quality of life composed of 5 questions referring to mobility, self-care, daily activities, pain and anxiety/depression. Each question has 3 possible answers, which define the level of perceived problems (none, moderate,extreme problem)

    Measured: 12 months after fracture fixation

  5. Incidence and frequency of adverse events

    Frequency and incidence of recorded AEs will be calculated

    Measured: 12 months after fracture fixation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start11 Apr 2022
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022485
Sponsor's protocol ID
CMG2020-32T
Status last verified
Nov 2025
First submitted
16 Jul 2021
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tibial Fractures and Fracture Infection, run by Zimmer Biomet at 16 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, Germany, France, Italy, South Africa and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gemma de Ramon Francas (+41 79 377 11 96, gemma.deramonfrancas@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fracture related infection (FRI) rate in investigational and control group (time frame: 12 months after fracture fixation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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