Sonoelastography to Predict Rotator Cuff Tears

NCT03682679 | Completed

• 1 other identifier: CMRPG8H0811
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.check the reliability of sonoelastography.
2. 2.associate the findings of sonoelastography to the results of MRI.
3. 3.build a predictive model for the reparability of large-to-massive rotator cuff tears.

Conditions

Rotator Cuff Tear

Keywords

large-to-massive rotator cuff tears; reparability; sonoelastography; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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. While assessing, the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity for wight times at the center point of each quadrant.

  Baseline

Secondary Outcomes (6)

• Passive range of motions

  Baseline

• Muscle strength

  Baseline

• American Shoulder and Elbow Surgeons score.

  Baseline

• MRI

  Baseline

• Surgical outcome

  Baseline

Interventions

Sonoelastography DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigator will enroll participants with diagnosis of large-to-massive rotator cuff tears who will receive surgical repairs later, and sonoelastography and MRI are necessary for preoperative evaluation.

You may qualify if:

• Patients who are diagnosed with rotator cuff tear by an orthopedist.
• 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.
• Being willing to cooperated with the arranged examinations before the operation.

You may not qualify if:

• Patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears.
• Patients who have acromioclavicular arthritis that needs distal clavicle resection.
• Patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32629749 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Po-Cheng Chen, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 25, 2018
• Study Start: October 22, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 3, 2021

Record last verified: 2020-02

Locations

TW (1)