ZNN Bactiguard Antegrade Femur
Research type
Research Study
Full title
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation) - A Multicenter, Prospective, Consecutive series
IRAS ID
308279
Contact name
Joseph Alsousou
Contact email
Sponsor organisation
Zimmer Biomet
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
This is a multicenter, prospective, observational, post-market clinical follow-up study involving patients implanted with the Zimmer Natural Nail (ZNN) Bactiguard Antegrade Femoral Nails. The device is CE-marked and commercially available.
The objective of this study is to collect data confirming the safety, performance and clinical benefits of the ZNN Bactiguard Antegrade Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies.
The primary endpoint is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation.
The secondary endpoint is 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.
The sample size for this study is 100 study cases, and up to 10 sites in EMEA will participate.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0193
Date of REC Opinion
28 Oct 2022
REC opinion
Further Information Favourable Opinion