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

肘部尺神经病变是一种常见的压迫性神经病变，如不及时治疗可导致 残疾和失业。60%的病例保守治疗失败，大多数患者需要手术。两个人 最常见的外科手术是原位(简单)减压和皮下前路减压。 换位。几项比较这两种程序的研究，包括动力不足的随机对照 试验(RCT)和荟萃分析一直无法检测到结果的差异。确定最好的 对个别患者进行手术是势在必行的，因为对于UNE释放失败的翻修手术通常无效。 目前，由于缺乏，手术类型的选择往往基于医生的培训和偏好 关于UNE手术的循证指南。 这项拟议的研究是一项双盲随机对照试验，共有10个临床站点。被诊断为UNE的受试者将被 随机接受原位减压术或皮下前路移位术，并随访一年。这 试验是新颖的，因为受试者在手术过程中将是盲目的，而进行 功能评估也将是盲目的，以便对结果进行最客观的评估。具体的 这项研究的目的是比较两种程序之间的结果，使用功能和有效的患者- 报告的结果、恢复趋势和并发症。我们的最终目标是开发一种基于证据的 治疗算法，以确定针对个别患者的最佳治疗程序，具有独特的疾病严重性。

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.