Rotator Cuff Tear Clinical Trial
Official title:
The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture
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 |
Verified date | December 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Viborg Regional Hospital | Viborg | |
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Regionshospitalet Viborg, Skive, Tampere University Hospital |
Denmark, Finland,
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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