MDR ExploR Radial Head System PMCF

NCT05583448 | Enrolling By Invitation FDA Device

• 1 other identifier: MDRG2017-89MS-77E
• Study Type: observational
• Target: 93
• Locations: 2 countries
• Sites: 2

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.

Conditions

Elbow Injury

Outcome Measures

Primary Outcomes (2)

• Device Survivorship

  Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.

  10 years

• Device Safety

  Assessed by recording frequency of adverse events during the length of the study.

  10 years

Secondary Outcomes (1)

• QuickDASH

  1, 3, 5, 7, and 10 years

Study Arms (1)

ExploR Radial Head

Subjects who have received the ExploR Radial Head Device.

Device: ExploR Radial Head

Interventions

ExploR Radial Head DEVICE

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

ExploR Radial Head

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population should be a consecutive series of subjects implanted with the ExploR Radial Head System. The aim is to include 93 radial head arthroplasty procedures in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

MeSH Terms

Conditions

Elbow Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: August 16, 2022
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): July 19, 2035
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NO (1)