RecruitingNCT05022485

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

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

Sponsor

Zimmer Biomet

Enrollment

500 participants

Start Date

Apr 11, 2022

Study Type

OBSERVATIONAL

Conditions

Tibial Fractures Fracture Infection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ZNN Bactiguard tibia for people with fracture infection and tibial fractures. The study is currently recruiting participants at 16 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEZNN Bactiguard tibia

Tibia fracture fixation

Locations(16)

Tirolkliniken Innsbruck

Innsbruck, Austria

Hôpital Ambroise-Paré

Boulogne-Billancourt, France

Hôpitaux Universitaires de Marseille Nord

Marseille, France

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

AOU Policlinico di Bari

Bari, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Tygerberg Hospital

Cape Town, South Africa

Groote Schuur Hospital

Cape Town, South Africa

Hospital Universitario Valle de Hebrón

Barcelona, Catalonia, Spain

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

The Royal London Hospital

London, United Kingdom

King's College Hospital NHS Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05022485

Related Trials

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

NCT0542174114 locations

Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures

NCT07733271

OCT in Open Fracture and Infected Fracture

NCT057851821 location

Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

NCT066790491 location

Intramedullary Calcium Sulfate Antibiotic Depot

NCT0576667010 locations