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.
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 Type
OBSERVATIONAL
Enrollment
93
Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.
Norton Healthcare
Louisville, Kentucky, United States
Akershus University Hospital
Lørenskog, Norway
Device Survivorship
Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.
Time frame: 10 years
Device Safety
Assessed by recording frequency of adverse events during the length of the study.
Time frame: 10 years
QuickDASH
QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability.
Time frame: 1, 3, 5, 7, and 10 years
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