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

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ClinicalTrials.gov Identifier: NCT03567954
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : May 20, 2021
Sponsor:
Collaborators:
Regionshospitalet Viborg, Skive
Tampere University Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment
Rotator Cuff Tear Proximal Humeral Fracture 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 Design
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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567954


Contacts
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Contact: Helle Østergaard, MSc., PhD stud. +45 61718026 helle.oestergaard@viborg.rm.com

Locations
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Denmark
Viborg Regional Hospital Recruiting
Viborg, Denmark, 8800
Contact: Helle Østergaard, PhD student    61718026    helle.oestergaard@viborg.rm.dk   
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Antti Launoenen, DM, PhD    +358405508210    antti@loosi.ee   
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Viborg, Skive
Tampere University Hospital
Investigators
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Principal Investigator: Helle Østergaard, MSc., PhD student Viborg Regional Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03567954    
Other Study ID Numbers: ProxHumUS
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Diagnostic ultrasound
Additional relevant MeSH terms:
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Fractures, Bone
Rotator Cuff Injuries
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
 Rupture
Shoulder Injuries
Tendon Injuries
Arm Injuries