ZNN Bactiguard Retrograde Femoral Nails PMCF Study (NCT05276674) | Clinical Trial Compass
RecruitingNot Applicable
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Spain, United Kingdom100 participantsStarted 2023-10-23
Plain-language 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 instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pro…
What they're measuring
1
Rate of fracture healing 12 months after fracture fixation
Timeframe: 3, 6, and 12 months after fracture fixation