NCT05276674

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

Detailed description

The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures. The primary endpoint is the assessment of performance by analyzing fracture healing. The secondary endpoints are the assessment of safety, clinical benefit and post-op 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.

Conditions

• Femoral Fracture

Interventions

Type	Name	Description
DEVICE	ZNN Bactiguard Retrograde Femoral Nail	Femoral fracture internal fixation.

Timeline

• Start date: 2023-10-23
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-03-11
• Last updated: 2026-02-03

Locations

4 sites across 2 countries: Spain, United Kingdom