Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

点击翻译按钮获取中文摘要

Ulnar neuropathy at the elbow (UNE) is a common compressive neuropathy that if left untreated can lead to disability and job loss. Conservative treatment fails in 60% of cases and most patients require surgery. The two most common surgical procedures are in-situ (simple) decompression and subcutaneous anterior transposition. Several studies comparing the two procedures, including underpowered randomized controlled trials (RCTs) and meta-analyses, have been unable to detect a difference in outcomes. Determining the best surgery for individual patients is imperative because revision surgery for failed UNE release is often ineffective. Currently, the choice of procedure type is often based on physician training and preferences owing to the lack of evidence-based guidelines for UNE surgery. This proposed study is a double-blind RCT with 10 clinical sites. Subjects diagnosed with UNE will be randomized to in-situ decompression or subcutaneous anterior transposition and followed for one year. This trial is novel because subjects will be blinded regarding their surgery and the researchers performing the functional assessments will also be blinded to yield the most objective assessment of outcomes. The specific aims of the study are to compare outcomes between the two procedures using functional and validated patient- reported outcomes, recovery trends, and complications. Our ultimate goal is to develop an evidence-based treatment algorithm to determine the best procedure for individual patients with unique disease severity.