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

November 20, 2025 updated by: Zimmer Biomet

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Hôpital Ambroise-Paré
        • Principal Investigator:
          • Thomas Bauer, MD
        • Contact:
      • Marseille, France, 13915
        • Recruiting
        • Hôpitaux Universitaires de Marseille Nord
        • Contact:
        • Principal Investigator:
          • Xavier Flecher, MD
        • Principal Investigator:
          • Alexandre Fabre, MD
  • Germany
      • Leipzig, Germany, 04103
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Volker Alt, MD
        • Principal Investigator:
          • Volker Alt, MD
    • Hesse
      • Marburg, Hesse, Germany, 35039
        • Recruiting
        • Universitätsklinikum Marburg
        • Contact:
        • Principal Investigator:
          • Steffen Ruchholtz, MD
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • AOU Policlinico di Bari
        • Contact:
        • Principal Investigator:
          • Giovanni Vicenti, MD
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Massimo Sangiovanni, MD
  • South Africa
      • Cape Town, South Africa, 7505
        • Recruiting
        • Tygerberg hospital
        • Contact:
        • Principal Investigator:
          • Nando Ferreira, MD
      • Cape Town, South Africa, 7935
        • Recruiting
        • Groote Schuur Hospital
        • Contact:
        • Principal Investigator:
          • Maritz Laubscher, MD
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitario Valle de Hebron
        • Contact:
        • Principal Investigator:
          • Jordi Teixidor Serra, MD
  • Switzerland
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur
        • Contact:
        • Principal Investigator:
          • Christoph Meier, MD
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
        • Contact:
        • Principal Investigator:
          • Sam Molyneux, MD
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
        • Principal Investigator:
          • Peter Giannoudis, MD
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Aaron Saini, MD
      • London, United Kingdom, E1 1FR
        • Recruiting
        • The Royal London Hospital
        • Contact:
        • Principal Investigator:
          • Alexandros Vris, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Investigational group
Subjects that will be implanted with the ZNN Bactiguard tibia device.
Device: ZNN Bactiguard tibia
Tibia fracture fixation
Control group
Subjects 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture related infection (FRI) rate in investigational and control group
Time Frame: 12 months after fracture fixation
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.)
12 months after fracture fixation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tibia fracture healing assessed radiologically through Radiographic Union Scale in Tibial fractures (RUST) score
Time Frame: 12 months after fracture fixation
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).
12 months after fracture fixation
Tibia fracture healing assessed clinically through the Function IndeX for Trauma (FIX-IT) score
Time Frame: 12 months after fracture fixation
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.
12 months after fracture fixation
Limb functionality measured through the Oxford Knee Score
Time Frame: 12 months after fracture fixation
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.
12 months after fracture fixation
Quality of life of study participants assessed through the EQ-5D-5L questionnaire
Time Frame: 12 months after fracture fixation
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)
12 months after fracture fixation
Incidence and frequency of adverse events
Time Frame: 12 months after fracture fixation
Frequency and incidence of recorded AEs will be calculated
12 months after fracture fixation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Emilie Rohmer, Clin Ops Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMG2020-32T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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