NCT05022485

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
8 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Apr 2022Jul 2027

First Submitted

Initial submission to the registry

July 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

4.2 years

First QC Date

July 16, 2021

Last Update Submit

November 20, 2025

Conditions

Tibial FracturesFracture Infection

Keywords

intramedullary tibia nailBactiguard

Outcome Measures

Primary Outcomes (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.)

    12 months after fracture fixation

Secondary Outcomes (5)

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

    12 months after fracture fixation

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

    12 months after fracture fixation

  • Limb functionality measured through the Oxford Knee Score

    12 months after fracture fixation

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

    12 months after fracture fixation

  • Incidence and frequency of adverse events

    12 months after fracture fixation

Study Arms (2)

Investigational group

Subjects that will be implanted with the ZNN Bactiguard tibia device.

Device: ZNN Bactiguard tibia

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).

Interventions

ZNN Bactiguard tibiaDEVICE

Tibia fracture fixation

Investigational group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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:

You may not qualify if:

  • 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:
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Tirolkliniken Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Hôpital Ambroise-Paré

Boulogne-Billancourt, 92100, France

RECRUITING

Hôpitaux Universitaires de Marseille Nord

Marseille, 13915, France

RECRUITING

Universitätsklinikum Marburg

Marburg, Hesse, 35039, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

AOU Policlinico di Bari

Bari, 70124, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Tygerberg Hospital

Cape Town, 7505, South Africa

RECRUITING

Groote Schuur Hospital

Cape Town, 7935, South Africa

RECRUITING

Hospital Universitario Valle de Hebrón

Barcelona, Catalonia, 08035, Spain

RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

RECRUITING

The Royal London Hospital

London, E1 1FR, United Kingdom

RECRUITING

King's College Hospital NHS Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Emilie Rohmer

    Clin Ops Director

    STUDY DIRECTOR

Central Study Contacts

Gemma de Ramon Francas

CONTACT

+41 79 377 11 96gemma.deramonfrancas@zimmerbiomet.com

Lisa To

CONTACT

+32 2 456 12 70Lisa.To@zimmerbiomet.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 26, 2021

Study Start

April 11, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

FR(2)DE(3)AU(1)ES(1)CH(1)GB(4)IT(2)ZA(2)