MDR ExploR Radial Head System PMCF

Study Overview
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Brief Summary
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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
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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. 89 subjects will be enrolled into the study.

Official Title
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Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study

Conditions
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Elbow Injury

Intervention / Treatment
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* Device: ExploR Radial Head


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have undergone primary or revision 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 Revision following failed radial head arthroplasty 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ExploR Radial Head<br>Subjects who have received the ExploR Radial Head Device. | Device: ExploR Radial Head<br>* Patient must have undergone primary or revision elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH | QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability. | 1, 3, 5, 7, and 10 years |