ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Launched by ZIMMER BIOMET · Mar 2, 2022

Keywords

ClinConnect Summary

The ZNN Bactiguard Retrograde Femoral Nails PMCF Study is a clinical trial designed to check how safe and effective a specific type of device, called the Zimmer Natural Nail (ZNN) Bactiguard, is for treating femoral fractures (breaks in the thigh bone). This study aims to confirm the benefits of using this device for stabilizing and fixing these types of fractures after surgery. Currently, the study is looking for participants who are at least 18 years old and have a femoral fracture that needs surgical treatment, and who are scheduled to receive the ZNN Bactiguard device.

If you or a loved one qualifies for this trial, you can expect to receive the ZNN Bactiguard treatment and will be asked to attend follow-up appointments to monitor your recovery. It’s important to note that certain conditions may exclude individuals from participation, such as having a previous injury that affects the bone or not being able to understand the study details. This study is an opportunity to contribute to important research that may help improve treatment options for femoral fractures in the future.

Gender

ALL

Eligibility criteria

• 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