ZNN Bactiguard Antegrade Femoral Nails PMCF Study

Launched by ZIMMER BIOMET · Apr 20, 2022

Keywords

ClinConnect Summary

The ZNN Bactiguard Antegrade Femoral Nails PMCF Study is a clinical trial aimed at evaluating the safety and effectiveness of a specific medical device used to treat femur fractures and perform surgical procedures called osteotomies. This device, known as the ZNN Bactiguard Antegrade Femoral Nail, is already approved for use and on the market. The study will collect information to ensure it continues to meet safety standards and provides clinical benefits to patients undergoing surgery for femur fractures.

To participate in this trial, you must be at least 18 years old and have a femur fracture or require an osteotomy, which is a surgical procedure that reshapes bones. You also need to be able to understand and follow the doctor's instructions. If you join the study, you can expect to receive the treatment with the Bactiguard device and participate in follow-up assessments to monitor your progress. It's important to note that some people may not be eligible to participate, such as those with certain medical conditions or who are unable to provide informed consent.

Gender

ALL

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