跳至主要内容
临床试验/NCT02725320
NCT02725320Unknown不适用

Rotator Cuff Surgical Outcomes in Women

University of Calgary1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
192
试验地点
1
主要终点
Western Ontario Rotator Cuff score (WORC)

研究概览

简要总结

The overall purpose of this work is to use a prospective cohort study to examine patient-specific but shoulder-extrinsic factors and how they influence the results of rotator cuff surgery. There are undoubtedly many factors that play a role in patient outcome, however, this project will focus on three: the effect of gender on outcome, the effect of mood disorders and coping style on outcome, and the effect of patient height and reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have a significant influence over outcomes.

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
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred for surgical treatment of predominantly unilateral rotator cuff syndrome

排除标准

  • unable to speak or read English
  • unable to complete 12 month follow-up
  • significant cervicogenic arm and shoulder pain in the affected arm
  • significant chronic pain diagnoses felt at least as likely to be the cause of the symptoms as the rotator cuff condition as evaluated by the surgeon

结局指标

主要结局

Western Ontario Rotator Cuff score (WORC)

时间窗: 1 year

WORC scores will be compared at 12 months between the groups (males versus females)

次要结局

  • WORC score correlated to gender, PCS, HADS(1 year)
  • Height (males versus females)(baseline)
  • Rate of change in visual analogue scale (VAS) (male versus female)(1 year)
  • Change in reach over time(1 year)
  • Overall change in WORC (male versus female)(1 year)
  • Rate of change in WORC (male versus female)(1 year)
  • Prevalence of anxiety and depression at baseline(Baseline data)
  • Prevalence of catastrophizing at baseline(Baseline data)
  • Improvement in HADS(1 year)
  • Rate of change in SF-36 (short-form 36) response scores (male versus female)(1 year)
  • Rate of change of satisfaction with surgical outcome (male versus female)(1 year)
  • WORC score by HADS score(1 year)
  • WORC score by PCS score(1 year)
  • WORC score by forward reach(1 year)

研究者

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

Marlis Sabo

Clinical Assistant Professor

University of Calgary

研究点 (1)

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