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โ† Trials
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ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Recruitingn/aAges 18 Years - anyAllZimmer Biomet
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In plain words

What the trial is, and whether it could suit you

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 instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • ZNN Bactiguard Retrograde Femoral Nail
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Where

4 sites
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Spain
Leeds General Infirmary
Leeds, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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