Sonoelastography to Predict Rotator Cuff Tears

NCT ID: NCT03682679

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2020-12-31

Brief 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

Rotator Cuff Tear

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Sonoelastography

This 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients who are diagnosed with rotator cuff tear by an orthopedist.

2. The large-to-massive rotator cuff tears need to be confirmed by magnetic resonance imaging or ultrasound. The definitions of this diagnosis include a tear over 3 cm or any full-thickness of tears in more than two rotator cuff muscles.

3. Being willing to cooperated with the arranged examinations before the operation.

Exclusion Criteria

1. Patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears.

2. Patients who have acromioclavicular arthritis that needs distal clavicle resection.

3. Patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Po-Cheng Chen, MD

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Tseng YH, Chou WY, Wu KT, Chang CD, Chen YC, Huang YC, Lin WC, Chen PC. Use sonoelastography to predict the reparability of large-to-massive rotator cuff tears. Medicine (Baltimore). 2020 Jul 2;99(27):e21139. doi: 10.1097/MD.0000000000021139.

Reference Type: DERIVED

PMID: 32629749 (View on PubMed)

Other Identifiers

CMRPG8H0811

Identifier Type: -

Identifier Source: org_study_id