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PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System

NCT04653051 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2024-11-20

Study results available
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Summary

The study is a single-center, 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 DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.

Conditions

  • Distal Radius Fracture
  • Distal Ulna Fracture
  • Osteotomy

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hassan Achakri · Zimmer Biomet

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2021-10-03
Completion
2022-11-15

Countries

  • United Kingdom

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 NCT04653051 on ClinicalTrials.gov