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

NCT ID: NCT03567954

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-22

Study Completion Date

2024-03-05

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tear Proximal Humeral Fracture

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helle Østergaard, MSc., PhD student

Role: PRINCIPAL_INVESTIGATOR

Viborg Regional Hospital

Locations

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Viborg Regional Hospital

Viborg, , Denmark

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Denmark Finland

Other Identifiers

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ProxHumUS

Identifier Type: -

Identifier Source: org_study_id

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