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

Distal Radius Fracture Clinical Trial

Official title:
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study

Clinical Trial 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.

Clinical Trial Description

The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates. One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04653051
Study type Observational
Source Zimmer Biomet
Contact
Status Active, not recruiting
Phase
Start date March 12, 2021
Completion date October 30, 2022
View Details
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