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

肘部尺神经 (SUN) 手术的临床试验

• 批准号: 10925737
• 负责人: KEVIN C CHUNG
• 金额: $ 7.62万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10925737
• 关键词: Activities of Daily Living; Adult; Affect; Algorithms; Anterior; Blinded; Characteristics; Clinical Trials; Complication; Diagnosis; Dissection; Double-Blind Method; Economics; Elbow; Evidence based treatment; Fingers; Goals; Hand; Hand Strength; Hand functions; Healthcare; Hematoma; Heterogeneity; In Situ; Individual; Job loss; Left; Level of Evidence; Meta-Analysis; Multicenter Studies; Muscular Atrophy; Natural History; Nerve; Neuropathy; Numbness; Occupational; Operative Surgical Procedures; Outcome; Outcome Assessment; Pain; Paresthesia; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Physicians; Physiological; Positioning Attribute; Postoperative Complications; Postoperative Period; Prevalence; Procedures; Productivity; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Reporting; Research; Research Personnel; Sample Size; Second Look Surgery; Severities; Severity of illness; Site; Structure; Structure of ulnar nerve; Surgeon; Surgical Management; Symptoms; Techniques; Time; Training; Treatment Effectiveness; Ulnar Neuropathies; United States; Upper Extremity; Woman; arm; clinical research site; comorbidity; compare effectiveness; disability; effectiveness evaluation; evidence base; evidence based guidelines; experience; functional outcomes; illness length; improved outcome; individual patient; individualized medicine; irritation; men; novel; painful neuropathy; precision medicine; predictive modeling; preference; randomized, clinical trials; reduce symptoms; soft tissue; subcutaneous; surgery outcome; trend

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.

手肘尺神经病变（UNE）是一种常见的压迫性神经病变，如果不进行治疗，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治疗。两 最常见的外科手术是原位（简单）减压和皮下前路减压。 换位几项比较两种手术的研究，包括动力不足的随机对照研究， 随机对照试验（RCT）和荟萃分析，一直无法检测到结果的差异。确定最佳 由于UNE松解失败的翻修手术通常无效，因此必须对个别患者进行手术。 目前，手术类型的选择往往是基于医生的培训和偏好，因为缺乏 UNE手术的循证指南。 本拟定研究是一项双盲RCT，共有10家临床试验机构参与。诊断为UNE的受试者将 随机分为原位减压组和皮下前路移位组，随访1年。这 试验是新颖的，因为受试者将对他们的手术和研究人员进行盲态 功能评估也将设盲，以产生最客观的结局评估。具体 该研究的目的是比较两种手术的结果，使用功能性和经验证的患者- 报告结局、恢复趋势和并发症。我们的最终目标是建立一个基于证据的 治疗算法，以确定具有独特疾病严重程度的个体患者的最佳手术。