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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03567954
Other study ID # ProxHumUS
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 22, 2018
Est. completion date March 5, 2024

Study information

Verified date December 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date March 5, 2024
Est. primary completion date March 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Ultrasound examination of the rotator cuff tendons
An ultrasound scan of the rotator cuff tendons will be performed to determine the presence of a rotator cuff tear or not

Locations

Country Name City State
Denmark Viborg Regional Hospital Viborg
Finland Tampere University Hospital Tampere

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Regionshospitalet Viborg, Skive, Tampere University Hospital

Countries where clinical trial is conducted

Denmark,  Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Full-thickness rotator cuff tear in the shoulder The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Secondary Partial-thickness rotator cuff tear in the shoulder The outcome is dichotomous; yes/no and will be used to estimate the sensitivity, specificity, the negative predictive value and the positive predictive value Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
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