The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients

Terminated

• Conditions: Rotator Cuff Tear; Proximal Humeral Fracture

• Registration Number: NCT03567954
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study Start: 2018-06-22
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Status Verified: 2022-12
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Displaced proximal humeral fracture
• Referred to operative treatment

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Full-thickness rotator cuff tear in the shoulder	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 Outcome Measures

Name	Time	Method
Partial-thickness rotator cuff tear in the shoulder	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

Trial Locations

Locations (2)

Viborg Regional Hospital; 🇩🇰 Viborg, Denmark

Tampere University Hospital; 🇫🇮 Tampere, Finland