MedTrace Logo

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

NCT05943574 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Wrist Fracture
  • Proximal Humerus Fracture

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hassan Achakri · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2025-11-14
Completion
2025-11-14

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943574 on ClinicalTrials.gov