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

Overview

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.

Full Title of Study: “The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 5, 2024

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 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Partial-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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Regionshospitalet Viborg, Skive
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helle Østergaard, MSc., PhD student, Principal Investigator, Viborg Regional Hospital

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