PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System (Implants and Instrumentation) - A Retrospective Consecutive Series Study
Zimmer Biomet
91 participants
Jun 10, 2024
OBSERVATIONAL
Conditions
Summary
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the XtraFix® Small External Fixation System (implants and instrumentation) when used to treat long bone fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
Eligibility
Inclusion Criteria4
- -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 Criteria4
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05943574