PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System

Launched by ZIMMER BIOMET · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the XtraFix® Small External Fixation System, which is used to treat fractures in bones, specifically wrist and upper arm fractures. The main goal of the study is to see how well this system helps bones heal after an injury. Researchers will also look at any complications or problems that might arise during treatment to ensure the device is safe for patients.

To be eligible for the study, participants must be at least 18 years old and have received the XtraFix® system for their long bone fractures. This includes people who have had recent fractures or revision surgeries. However, individuals with infections, certain medical conditions, or those who may struggle to follow healing instructions will not be included. Participants can expect to share their experiences and any issues they face during recovery, which will help researchers gather important information about the device's performance and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-year-old or older patients having received the XtraFix® Small External Fixation System for the treatment of long bone fractures.
• • Specifically, the system is intended for temporary stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
• • Revision surgeries will also be included in the study.
• • In this study we will only collect data on wrist and proximal humerus fractures.
• Exclusion Criteria:
• • Off-label use
• • Active or suspected infection
• • Conditions that limit the patient's ability and/or willingness to follow instructions during the healing process
• • Inadequate skin, bone, or neurovascular status