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临床试验/NCT03148184
NCT03148184已完成不适用

Reverse Shoulder Arthroplasty in Patients 60 Years Old and Younger: Short-term Clinical and Radiographic Results

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Assess functional change from before surgery to two years post surgery

研究概览

简要总结

The purpose of this study is to assess the early outcomes following Reverse Shoulder Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these patients, evaluating their clinical outcomes and radiographic appearance.The investigators would like to know how quickly they are healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a better defined and study supported understanding of the post-operative recovery timeline in the younger population.

详细描述

This study is looking at patients who are sixty years or younger at the time of they undergo a reverse total shoulder replacement. This is an important population to look at their functional and clinical outcomes as they are often still employed and have more physical demands upon their shoulder in everyday life than the older replacement population for which there are more outcome data available. The investigators would like to determine how the younger population is healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a study supported understanding of the post-operative recovery timeline in the younger population. The investigators will review x-rays to evaluate healing at two years. Functional surveys are given pre and post operatively (1 & 2 years) and these will be reviewed as well. A physical exam is also performed to determine range of motion pre and post operatively (1 & 2 years).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years old or younger at the time of surgery
  • reverse shoulder arthroplasty with a single implant system by one of our four surgeons

排除标准

  • unable to complete imaging portion of the two-year follow-up due to health safety/exposure concerns
  • unwilling/unable to return for follow up
  • Revision procedure

结局指标

主要结局

Assess functional change from before surgery to two years post surgery

时间窗: 2 years post op

Assess changes in range of motion as part of the overall clinical outcome function scores. ASES (American Shoulder and Elbow Questionnaire)

次要结局

  • Radiographic Outcomes(2 years post op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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