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Clinical Trials/NCT03567954
NCT03567954
Terminated
N/A

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

University of Aarhus2 sites in 2 countries25 target enrollmentJune 22, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
University of Aarhus
Enrollment
25
Locations
2
Primary Endpoint
Full-thickness rotator cuff tear in the shoulder
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 22, 2018
End Date
March 5, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Displaced proximal humeral fracture
  • Referred to operative treatment

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Full-thickness rotator cuff tear in the shoulder

Time Frame: 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

Secondary Outcomes

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

Study Sites (2)

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