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PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

NCT05215613 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2025-02-25

Study results available
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Summary

The study is a monocentric, retro- and prospective, 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 Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia 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

  • Proximal Humeral Fracture
  • Proximal Tibia Fractures
  • Diaphyseal 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
2023-03-15
Primary Completion
2024-03-27
Completion
2024-03-27

Countries

  • Italy

Study Locations

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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 NCT05215613 on ClinicalTrials.gov