ZNN Bactiguard Antegrade Femoral Nails PMCF Study

Recruiting now

Conditions studied: Femur Fracture, Osteotomy

In brief

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.

Key facts

Study ID

NCT05339360

Run by

Zimmer Biomet

People needed

100

Starts

2024-01-16

Expected to finish

2027-12-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Manchester Royal Infirmary — Manchester, Manchester, United Kingdom (enrolling)
• Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Full record on ClinicalTrials.gov

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