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

March 6, 2024 updated by: University of Aarhus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Diagnostic test: Ultrasound examination of the rotator cuff tendons

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Viborg, Denmark, 8800
    - Viborg Regional Hospital
Finland
- - Tampere, Finland
    - Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The study population consists of adults referred to Viborg Regional Hospital and Tampere University Hospital, Finland, under suspicion of a proximal humerus fracture.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Tampere University Hospital

Regionshospitalet Viborg, Skive

Investigators

Principal Investigator: Helle Østergaard, MSc., PhD student, Viborg Regional Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2018

Primary Completion (Actual)

March 5, 2024

Study Completion (Actual)

March 5, 2024

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria