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临床试验/NCT02466841
NCT02466841撤回不适用

Prospective Comparison of Techniques for Cubital Tunnel Release

University of Pittsburgh0 个研究点开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Patient rated ulnar nerve evaluation (PRUNE) score

研究概览

简要总结

Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve at the elbow, but the ideal release has not been determined. These techniques vary from simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition), and removing part of the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential complications. Simple in-situ release has the benefit of shorter operative times and less surgical dissection, however, the nerve may subluxate post-operatively and cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition) prevent subluxation and take tension off the nerve, however, they require more dissection, larger incisions, and also partially devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a prolonged recovery and persistent pain from removing part of the bone.

The purpose of this study is to prospective evaluate patients undergoing cubital tunnel release according to the standard practice and preference of their surgeon. The investigators plan to compare the different techniques at standard post-operative intervals.

详细描述

Objective:

The purpose of this study is to compare different techniques for cubital tunnel release.

Specific Aims:

  1. Determine if there are differences in patient-directed outcomes scores between different techniques used for cubital tunnel release.
  2. Determine if there are differences in post-operative pain scores between different techniques used for cubital tunnel release.
  3. Determine if there are differences in objective measurements such as range of motion and grip strength scores between different techniques used for cubital tunnel release.
  4. Determine if there are differences in complications between different techniques used for cubital tunnel release.

Background:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients indicated to surgery by attending surgeon

排除标准

  • previous cubital tunnel release on ipsilateral side
  • unable/unwilling to provide consent
  • pregnant women
  • prisoners
  • < 18 years of age

结局指标

主要结局

Patient rated ulnar nerve evaluation (PRUNE) score

时间窗: 1 year

The PRUNE is a validated patient rated outcome measurement to assess pain, symptoms and functional disability in patients with ulnar nerve compression at the elbow.

次要结局

  • 2 Point Discrimination Test(1 year)
  • Elbow Range of Motion(1 year)
  • Number of subjects with post-surgical complications(1 year)
  • Visual Analog Scale (VAS) for Pain(1 year)
  • Hand Dynamometer to measure Grip Strength(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Fowler

MD

University of Pittsburgh

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