- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601623
Ultrasound to Predict the Prognosis of Rotator Cuff Tears
March 11, 2022 updated by: Chang Gung Memorial Hospital
Ultrasound Shear Wave Elastography to Predict the Treatment Effect and Risk of Re-tear in Patients With Large-to-massive Rotator Cuff Tears
To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound elastography.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline finding of sonoelastography
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Passive range of motions
Time Frame: Baseline, 3 months, 6 months, 12 months
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Passive range of motions of internal and external rotation, abduction, extension, and flexion, which are assessed by a goniometer.
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Baseline, 3 months, 6 months, 12 months
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Muscle strength
Time Frame: Baseline, 3 months, 6 months, 12 months
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Muscle strength assessment include the following motions, which are internal and external rotation, abduction, extension, and flexion.
They are measured by a manual dynamometer
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Baseline, 3 months, 6 months, 12 months
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American Shoulder and Elbow Surgeons score (ASES score)
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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Western Ontario Rotator Cuff Index (WORC index)
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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WHOQOL-BREF (Taiwan version)
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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EQ-5D-3L
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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MRI
Time Frame: Baseline, 6 months
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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.
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Baseline, 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Po-Cheng Chen, MD, Chang Gung Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
October 16, 2020
First Submitted That Met QC Criteria
October 23, 2020
First Posted (Actual)
October 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 14, 2022
Last Update Submitted That Met QC Criteria
March 11, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST 109-2314-B-182A-171
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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