Clinical trial NCT04601623: Ultrasound to Predict the Prognosis of Rotator Cuff Tears
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tears
surgery
ultrasound
elastography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline finding of sonoelastography
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Passive range of motions
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Muscle strength
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: American Shoulder and Elbow Surgeons score (ASES score)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Western Ontario Rotator Cuff Index (WORC index)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: WHOQOL-BREF (Taiwan version)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: EQ-5D-3L
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: MRI
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Po-Cheng Chen, MD
role: STUDY_CHAIR
References: