跳至主要内容
临床试验/NCT01781494
NCT01781494撤回不适用

Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity

Mayo Clinic0 个研究点开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
Change in the distance between the ligaclips on lateral elbow radiographs

研究概览

简要总结

The goal of this study is to test the hypothesis that immediate elbow motion is safe after anterior submuscular ulnar nerve transposition, and will not result in disruption of the repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate elbow motion after submuscular ulnar nerve transposition for performing activities of daily living and self-care are evident, however theoretical advantages include early "gliding" of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve function.

A group of 44 consecutive patients that are determined to be candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing will be prospectively randomized to either immediate motion or long arm cast immobilization after surgery. All patients will be counseled about the two postoperative treatment options (immobilization followed by protected range of motion versus immediate range of motion), risks involved with each treatment protocol, postoperative follow-up and need for radiographs. If they choose not to participate, they will be treated by the same postoperative protocol currently used by the principal investigator: arm sling at rest for six weeks with intermittent active assisted range of motion exercises.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona
  • Exclusion criteria:
  • Pregnancy
  • Patients who have had prior ulnar nerve surgery
  • Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome)
  • Workman's compensation patients
  • Subluxing ulnar nerve
  • Elbow contracture or stiffness
  • Negative electrodiagnostic studies

排除标准

  • 未提供

结局指标

主要结局

Change in the distance between the ligaclips on lateral elbow radiographs

时间窗: Baseline to 3 months post-operatively

次要结局

  • Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion(Baseline to 3 months post-operatively)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin J. Renfree

Assistant Professor of Orthopedics, College of Medicine

Mayo Clinic

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