Trials Sponsors Conditions Drugs Pricing

Conditions

Fracture Infection Tibial Fractures

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (16)

Tirolkliniken Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Rohit Arora, MDCONTACTrohit.arora@tirol-kliniken.at

Rohit Arora, MDPRINCIPAL INVESTIGATOR

Hôpital Ambroise-Paré

Boulogne-Billancourt, 92100, France

RECRUITING

Thomas Bauer, MDCONTACT0033149095575 thomas.bauer@aphp.fr

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 96 gemma.deramonfrancas@zimmerbiomet.com

Lisa To

CONTACT

+32 2 456 12 70

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

Actual (reported)

Primary Completion

July 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Investigational group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Investigational group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations