MDR ExploR Radial Head System PMCF

Elbow Injury Clinical Trial

Official title: Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study

Status Enrolling by invitation

Clinical Trial Summary

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.

Clinical Trial Description

This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 89 subjects will be enrolled into the study. ;

Related Conditions & MeSH terms

• Elbow Injuries
• Elbow Injury

• NCT number: NCT05583448
• Study type: Observational
• Source: Zimmer Biomet
• Status: Enrolling by invitation
• Start date: August 16, 2022
• Completion date: July 19, 2035