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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03567954
Enrollment
25
Registered
2018-06-26
Start date
2018-06-22
Completion date
2024-03-05
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fracture, Rotator Cuff Tear

Keywords

Diagnostic ultrasound

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.

Interventions

DIAGNOSTIC_TESTUltrasound 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

Sponsors

Regionshospitalet Viborg, Skive
CollaboratorOTHER
Tampere University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Full-thickness rotator cuff tear in the shoulderUltrasound 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

MeasureTime frameDescription
Partial-thickness rotator cuff tear in the shoulderUltrasound 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

Countries

Denmark, Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026