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ENROLLING BY INVITATION
NCT05583448

MDR ExploR Radial Head System PMCF

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

93

Start Date

2022-08-16

Completion Date

2035-07-19

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

DEVICE

ExploR Radial Head

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

Locations (2)

Norton Healthcare

Louisville, Kentucky, United States

Akershus University Hospital

Lørenskog, Norway