NCT05022485

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tibial Fractures
• Fracture Infection

Interventions

Type	Name	Description
DEVICE	ZNN Bactiguard tibia	Tibia fracture fixation

Timeline

• Start date: 2022-04-11
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2021-08-26
• Last updated: 2025-11-25

Locations

16 sites across 8 countries: Austria, France, Germany, Italy, South Africa, Spain, Switzerland, United Kingdom