跳至主要内容
临床试验/NCT02192073
NCT02192073撤回不适用

Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up

Rush University Medical Center2 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
American Shoulder and Elbow Surgeons (ASES) Shoulder Score

研究概览

简要总结

Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder).

Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better 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
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

  • Scheduled to undergo biceps tenodesis
  • Pain at intertubercular groove
  • Anterior Humeral pain
  • Patient agrees to follow up and consent

排除标准

  • Biceps Tenotomy
  • Revision biceps procedure
  • Prior SLAP or labral repair
  • Concomitant subscapularis repair
  • More than 1 rotator cuff repair at time of surgery
  • Concomitant arthroplasty
  • Prior infection

结局指标

主要结局

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

时间窗: 1 year

Validated outcome score assessing pain and function of shoulder

次要结局

  • Constant Score(1 year)

研究者

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

Carla Edwards

Clinical Research Manger

Rush University Medical Center

研究点 (2)

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