Sonoelastography to Predict Rotator Cuff Tears

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Diagnostic test: Sonoelastography

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passive range of motions	Passive range of motions of internal and external rotation, abduction, extension, and flexion, which are assessed by a goniometer.	Baseline
Muscle strength	Muscle strength assessment include the following motions, which are internal and external rotation, abduction, extension, and flexion. They are measured by a manual dynamometer.	Baseline
American Shoulder and Elbow Surgeons score.	Shoulder function that are scaled by using American Shoulder and Elbow Surgeons score.	Baseline
MRI	MRI was performed on a 1.5T system (Signa Horizon LX, GE Healthcare) equipped with a standard shoulder surface coil. The shoulder MRI protocol was identical for all patients and consisted of axial proton-density-weighted fast spin-echo with fat suppression sequence, the sequences was performed above the level o f the acromioclavicular joint down to below the axillary pouch with the following parameters: Coronal oblique proton-density-weighted with and without fat suppression, with axis parallel to the supraspinatus tendon, and sagittal oblique proton-density--weighted with and without fat suppression, with axis perpendicular to the coronal oblique axis, the ast spin-echo sequences were performed with the following parameters: TR msec/TE msec, 2700-4800 /25-40, echo-train length, 6; matrix, 256 × 256; field of view, 180 mm; section thickness, 2.5 mm with 2-mm gap. No IV or intraarticular gadolinium was administered.	Baseline
Surgical outcome	The investigator will discuss the surgical outcome with the orthopedist to define whether the tear side is repaired partially or completely. If the tendon can be repaired using simple side-to-side tendon repair, horizontal mattress transosseous repair via the bone trough and reduced into an anatomic position, or via the rough area of greater tuberosity (marginal converging repair), it is defined as complete repair of the tendon. If the tendon cannot be reduced to the anatomic footprint and the orthopedist only secures re-attachment of the infraspinatus to the posterior side of greater tuberosity and/or the subscapularis of lesser tuberosity, it is defined as partial repair of the tendon.	Baseline
B-mode ultrasound	The ultrasound machine will be calibrated similarly using the musculoskeletal (MSK) preset and B-mode with autogain. The dynamic range will be set at 70 dB for all participants. The examiners will apply adequate transducer pressure to obtain optimal images for comparisons of muscle and bone echo. The Heckmatt scale will be used to grade the muscle echogenicity within each ROI of supraspinatus and infraspinatus muscles. The grading rule is as follows: Grade 1: Normal; Grade 2: Increased muscle echo intensity with distinct bone echo; Grade 3: Marked increased muscle echo with reduced bone echo; Grade 4: Very strong muscle echo and complete loss of bone echo	Baseline

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Po-Cheng Chen, MD, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; large-to-massive rotator cuff tears; reparability; sonoelastography
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CMRPG8H0811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No