Status:
ACTIVE_NOT_RECRUITING
ZNN Bactiguard Cephalomedullary Nails PMCF Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteotomy
Trochanteric Fractures
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, perf...
Detailed Description
This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Cephalomedullary Nails. The primary endpoint for this study is the assessment...
Eligibility Criteria
Inclusion
- Patients 18 years or older.
- Patient must have a signed EC approved informed consent.
- Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, or shaft fracture requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing.
- Patient has been or is scheduled to be treated with the ZNN Bactiguard System Cephalomedullary Nail.
- Patient must be able and willing to complete the protocol required 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 or unable to give consent.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subject with alcohol/drug addiction, known to be pregnant or breastfeeding).
- Patient anticipated to be non-compliant and/or likely to have problems complying with the follow-up program (e.g. patient with no fixed address, long-distance, plans to move during course of study).
Key Trial Info
Start Date :
January 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05362864
Start Date
January 23 2023
End Date
February 1 2026
Last Update
August 17 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier de Douai
Douai, France, France, 59507
2
Hospital Rio Hortega
Valladolid, Castille-La Mancha, Spain, 47012
3
Hospital Clinico de Valencia
Valencia, Valencia, Spain, 46010