跳至主要内容
临床试验/NCT03567954
NCT03567954终止不适用

The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture

University of Aarhus2 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2018年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Full-thickness rotator cuff tear in the shoulder

研究概览

简要总结

The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.

详细描述

Although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. Ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. It is a user-dependent modality and health professionals must possess the competence and training before using it. To the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Displaced proximal humeral fracture
  • Referred to operative treatment

排除标准

  • Younger than 18 years old
  • Non-independent
  • Does no understand written and spoken guidance in local language, Danish, Swedish or Finnish
  • Open fracture
  • Isolated tuberculum fracture

结局指标

主要结局

Full-thickness rotator cuff tear in the shoulder

时间窗: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)

The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value

次要结局

  • Partial-thickness rotator cuff tear in the shoulder(Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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