Status:
RECRUITING
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Femur Fracture
Osteotomy
Eligibility:
All Genders
18+ years
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, per...
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 assessme...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05339360
Start Date
January 16 2024
End Date
December 1 2027
Last Update
November 25 2025
Active Locations (2)
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1
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
2
Manchester Royal Infirmary
Manchester, Manchester, United Kingdom, M13 9WL