NCT05362864

ZNN Bactiguard Cephalomedullary Nails PMCF Study

Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of trochanteric, sub-trochanteric or shaft femoral fractures and osteotomies. This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.

Detailed description

This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Cephalomedullary Nails. The primary endpoint for this study is the assessment of performance by analyzing fracture/osteotomy healing within 12 months after fracture fixation. Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP and lateral radiographs and clinically as full weight-bearing without pain. The secondary endpoint is the assessment of safety, clinical benefit, and postop fracture-related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group. Data will be collected at 6 weeks, 3 months, 6 months and 1 year after fracture fixation. The study will enroll patients implanted with the Zimmer Natural Nail Bactiguard Cephalomedullary Nail according to the approved/cleared indications. The sample size for this study is 150 study cases, and up to 10 sites in EMEA will participate.

Conditions

• Osteotomy
• Trochanteric Fractures
• Sub-trochanteric Fractures
• Femoral Shaft Fracture

Interventions

Type	Name	Description
PROCEDURE	Fracture fixation via Intramedullary Nailing	Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.

Timeline

• Start date: 2023-01-23
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2022-05-05
• Last updated: 2025-08-17

Locations

3 sites across 2 countries: France, Spain