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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03567954
• Other study ID #: ProxHumUS
• Status: Terminated
• Start date: June 22, 2018
• Est. completion date: March 5, 2024

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Fractures

Intervention

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

Locations

Country	Name	City	State
Denmark	Viborg Regional Hospital	Viborg
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Viborg, Skive, Tampere University Hospital

Countries where clinical trial is conducted

Denmark,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Partial-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)