Ultrasound to Predict the Prognosis of Rotator Cuff Tears

NCT ID: NCT04601623

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Po-Cheng Chen, MD

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOST 109-2314-B-182A-171

Identifier Type: -

Identifier Source: org_study_id

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