Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT05339360
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral 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 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.
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 Antegrade Femoral Nails.
The primary endpoint for this study is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation. Fracture healing will be analyzed radiologically by the RUSH score adapted to the femur and clinically by the Fix-IT score.
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.
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 Antegrade Femoral Nail according to the approved/cleared indications. The sample size for this study is 100 study cases, and up to 10 sites in EMEA will participate.
The primary endpoint for this study is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation. Fracture healing will be analyzed radiologically by the RUSH score adapted to the femur and clinically by the Fix-IT score.
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.
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 Antegrade Femoral Nail according to the approved/cleared indications. The sample size for this study is 100 study cases, and up to 10 sites in EMEA will participate.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: