Actively Recruiting
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Led by Zimmer Biomet · Updated on 2025-11-25
100
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 or older
- Patient must have a signed EC-approved informed consent.
- Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
- Patient has been or is scheduled to be treated with the ZNN Bactiguard System Antegrade Femoral Nail
- Patient must be able and willing to complete the protocol required for follow-up
- Patients capable of understanding the surgeon's explanations and following his instructions
You will not qualify if you...
- Skeletally immature patients
- Medullary canal obliterated by a previous fracture or tumor
- Bone shaft having excessive bow or a deformity
- Lack of bone substance or bone quality, which makes stable seating of the implant impossible
- All concomitant diseases that can impair the operation, functioning or the success of the implant
- Insufficient blood circulation
- Infection
- Patient is unwilling to give consent.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with alcohol/drug addiction, known to be pregnant or breast feeding)
- Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long-distance, plans to move during the course of study)
- Patients not expected to survive the duration of the follow-up program
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
Active, Not Recruiting
2
Manchester Royal Infirmary
Manchester, Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
G
Gemma de Ramon Francàs
CONTACT
L
Lisa To
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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