MDR ExploR Radial Head System PMCF

• Conditions: Elbow Injury
• Interventions: Device: ExploR Radial Head

• Registration Number: NCT05583448
• Lead Sponsor: Zimmer Biomet

Brief 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.

Study Timeline

• Study Start: 2022-08-16
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-08-16
• Study Completion: 2035-07-19

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment

• Primary replacement after fracture of the radial head
• Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.

Exclusion Criteria

• Infection
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurological disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Patient is a prisoner.
• Patient is a current alcohol or drug abuser.
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Patient is known to be pregnant or breastfeeding.
• Patient is unwilling to sign informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ExploR Radial Head	ExploR Radial Head	Subjects who have received the ExploR Radial Head Device.

Primary Outcome Measures

Name	Time	Method
Device Survivorship	10 years	Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.
Device Safety	10 years	Assessed by recording frequency of adverse events during the length of the study.

Secondary Outcome Measures

Name	Time	Method
QuickDASH	1, 3, 5, 7, and 10 years	QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability.

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States