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