MDR ExploR Radial Head System PMCF

NCT05583448 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Elbow Injury

Interventions

DEVICE

ExploR Radial Head

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

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2026-08-16
Completion
2035-07-19
FDA Device
Yes

Countries

  • United States
  • Norway

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 NCT05583448 on ClinicalTrials.gov