NCT05339360 ZNN Bactiguard Antegrade Femoral Nails PMCF Study
| NCT ID | NCT05339360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Femur Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-16 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: 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
Contact & Investigator
Emilie Rohmer
STUDY DIRECTOR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT05339360 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Femur Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05339360 currently recruiting?
Yes, NCT05339360 is actively recruiting participants. Contact the research team at gemma.deramonfrancas@zimmerbiomet.com for enrollment information.
Where is the NCT05339360 trial being conducted?
This trial is being conducted at Santa Cruz de Tenerife, Spain, Manchester, United Kingdom.
Who is sponsoring the NCT05339360 clinical trial?
NCT05339360 is sponsored by Zimmer Biomet. The principal investigator is Emilie Rohmer at Zimmer Biomet. The trial plans to enroll 100 participants.