Clinical Trials Directory

Trials / Completed

CompletedNCT03682679

Sonoelastography to Predict Rotator Cuff Tears

Use Sonoelastography to Predict the Reparability of Large-to-massive Rotator Cuff Tears

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These problems can be solved by surgeries, but only part of them can be completely repaired. The prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. More and more recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. However, the availability of MRI is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. Because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. This aim of this study is to: 1. check the reliability of sonoelastography. 2. associate the findings of sonoelastography to the results of MRI. 3. build a predictive model for the reparability of large-to-massive rotator cuff tears.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSonoelastographyThis diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly. Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography and the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity at the center point of each quadrant.

Timeline

Start date
2018-10-22
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2018-09-25
Last updated
2021-03-03

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03682679. Inclusion in this directory is not an endorsement.