Ultrasound to Predict the Prognosis of Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

Official title:

Ultrasound Shear Wave Elastography to Predict the Treatment Effect and Risk of Re-tear in Patients With Large-to-massive Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601623
• Other study ID #: MOST 109-2314-B-182A-171
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound elastography.

Description:

Most symptomatic large-to-massiverotator cuff tears (RCTs) should be operated, but the prognosis and postoperative risk of re-tear depended on the quality of rotator cuff muscles. Preoperative evaluations were usually done by magnetic resonance imaging (MRI). MRI was used in recent studies to predict the surgical outcome of large-to-massive RCTs and postoperative re-tear, but the clinical availability was not as good as ultrasound. The investigators hypothesize that ultrasound elastography can predict the prognosis of large-to-massive RCTs and risk of re-tear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline finding of 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.	Baseline, 3 months, 6 months, 12 months
Secondary	Passive range of motions	Passive range of motions of internal and external rotation, abduction, extension, and flexion, which are assessed by a goniometer.	Baseline, 3 months, 6 months, 12 months
Secondary	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, 3 months, 6 months, 12 months
Secondary	American Shoulder and Elbow Surgeons score (ASES score)	Shoulder function is evaluated using American Shoulder and Elbow Surgeons score, which includes one item for pain (VAS) and 10 items for shoulder function. The ASES score ranges from 0 to 100, and the outcome is better when ASES score is higher.	Baseline, 3 months, 6 months, 12 months
Secondary	Western Ontario Rotator Cuff Index (WORC index)	Shoulder function is evaluated using Western Ontario Rotator Cuff Index, which includes physical symptoms (10 items), sport/recreation/work function (4 items), lifestyle function (4 items), and emotional function (3 items). The WORC index ranges from 0 to 2100 or can be converted to 0 to 100 scale, and the outcome is better when WORC index is lower.	Baseline, 3 months, 6 months, 12 months
Secondary	WHOQOL-BREF (Taiwan version)	The WHOQOL-BREF (Taiwan version) instrument comprises 28 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF (Taiwan version) is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The total score WHOQOL-BREF (Taiwan version) can be transformed to a 0-100 scale, and the quality of life is better when the score is higher.	Baseline, 3 months, 6 months, 12 months
Secondary	EQ-5D-3L	The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Baseline, 3 months, 6 months, 12 months
Secondary	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 spinecho 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, 6 months