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临床试验/NCT02107573
NCT02107573已完成不适用

Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?

University of Chicago4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
American Shoulder and Elbow Surgeons (ASES) Shoulder Score

研究概览

简要总结

The purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.

详细描述

The suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. Retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function.

This study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. Patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. They will be randomized into two arms: In one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. Post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.

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
Single (Participant)

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

  • Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction

排除标准

  • Patients less than 18 years of age
  • Irreparable rotator cuff tears

结局指标

主要结局

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

时间窗: one year

The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.

次要结局

  • Constant Shoulder Score(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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