Ultrasound to Predict the Prognosis of Rotator Cuff Tears

NCT04601623 | Completed

• 1 other identifier: MOST 109-2314-B-182A-171
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tears; surgery; ultrasound; elastography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Passive range of motions

  Baseline, 3 months, 6 months, 12 months

• Muscle strength

  Baseline, 3 months, 6 months, 12 months

• American Shoulder and Elbow Surgeons score (ASES score)

  Baseline, 3 months, 6 months, 12 months

• Western Ontario Rotator Cuff Index (WORC index)

  Baseline, 3 months, 6 months, 12 months

• WHOQOL-BREF (Taiwan version)

  Baseline, 3 months, 6 months, 12 months

Interventions

Sonoelastography OTHER

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Po-Cheng Chen, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 26, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

TW (1)