Evaluating the XtraFix® Small External Fixation System for treating wrist and proximal humerus fractures
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
This study is testing how well the XtraFix® Small External Fixation System works and its safety for people with wrist and shoulder fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Naples, Campania) |
| Trial ID | NCT05943574 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety, performance, and clinical benefits of the XtraFix® Small External Fixation System in treating long bone fractures, specifically wrist and proximal humerus fractures. It involves a retrospective analysis of data collected from patients who received the device at a single medical center in Naples, Italy, between 2019 and 2021. The study will evaluate fracture healing and monitor any complications or adverse events related to the device through medical records and follow-up questionnaires. A total of 91 consecutive cases will be included in the analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have received the XtraFix® Small External Fixation System for wrist or proximal humerus fractures.
Not a fit: Patients with active infections, inadequate skin or bone status, or those unable to comply with post-operative instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the XtraFix® system, potentially improving treatment outcomes for patients with wrist and proximal humerus fractures.
How similar studies have performed: While this study focuses on a specific device and patient population, similar observational studies have shown success in evaluating the safety and performance of medical devices in fracture treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Naples, Campania
- Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" — Naples, Campania, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Singer
- Email: andrea.singer@zimmerbiomet.com
- Phone: +41 79 318 06 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.