NCT05583448

MDR ExploR Radial Head System PMCF

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
• Phase: —
• Study type: Observational
• Enrollment: 93 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 93 subjects will be enrolled into the study.

Conditions

• Elbow Injury

Interventions

Type	Name	Description
DEVICE	ExploR Radial Head	Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.

Timeline

• Start date: 2022-08-16
• Primary completion: 2026-08-16
• Completion: 2035-07-19
• First posted: 2022-10-17
• Last updated: 2026-02-04

Locations

2 sites across 2 countries: United States, Norway

Regulatory

• FDA-regulated device study