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

NCT03567954 | Terminated DMC

• 1 other identifier: ProxHumUS
• Study Type: observational
• Target: 25
• Locations: 2 countries
• Sites: 2

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.

Conditions

Rotator Cuff Tear; Proximal Humeral Fracture

Keywords

Diagnostic ultrasound

Outcome Measures

Primary Outcomes (1)

• Full-thickness rotator cuff tear in the shoulder

  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 Outcomes (1)

• Partial-thickness rotator cuff tear in the shoulder

  Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)

Interventions

Ultrasound examination of the rotator cuff tendons DIAGNOSTIC_TEST

An ultrasound scan of the rotator cuff tendons will be performed to determine the presence of a rotator cuff tear or not

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Displaced proximal humeral fracture
• Referred to operative treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Viborg, Skive: collaborator
• Tampere University Hospital: collaborator

Study Sites (2)

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Fractures

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Fractures, Bone

Study Officials

• Helle Østergaard, MSc., PhD student

  Viborg Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 26, 2018
• Study Start: June 22, 2018
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: March 8, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); DK (1)