Status:
RECRUITING
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Femoral Fracture
Eligibility:
All Genders
18+ years
Brief 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 ...
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 i...
Eligibility Criteria
Inclusion
- Patients must be 18 years or older.
- Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention 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 Retrograde Femoral Nail.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must have a signed EC approved consent.
- Patients capable of understanding the surgeon's explanations and following his instructions.
Exclusion
- Skeletally immature patients
- A 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 or unable to give consent.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, 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 course of study).
- Not expected to survive the duration of the follow-up program
Key Trial Info
Start Date :
October 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05276674
Start Date
October 23 2023
End Date
December 1 2027
Last Update
December 4 2024
Active Locations (4)
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1
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain, 38010
2
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
3
Manchester Royal Infirmary
Manchester, United Kingdom
4
Stepping Hill Hospital
Stockport, United Kingdom