An observational study in Rotator Cuff Tear, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by Chang Gung Memorial Hospital · Observational
To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound elastography.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: Baseline, 3 months, 6 months, 12 months
Passive range of motions
Passive range of motions of internal and external rotation, abduction, extension, and flexion, which are assessed by a goniometer.
Time frame: Baseline, 3 months, 6 months, 12 months
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
Time frame: Baseline, 3 months, 6 months, 12 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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.
Time frame: Baseline, 6 months
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital