Clinical trial NCT03682679: Sonoelastography to Predict Rotator Cuff Tears
Official title: Use Sonoelastography to Predict the Reparability of Large-to-massive Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: large-to-massive rotator cuff tears
reparability
sonoelastography
magnetic resonance imaging
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-09-25
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: CROSS_SECTIONAL
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: Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These problems can be solved by surgeries, but only part of them can be completely repaired. The prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. More and more recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. However, the availability of MRI is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. Because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. This aim of this study is to:

1. check the reliability of sonoelastography.
2. associate the findings of sonoelastography to the results of MRI.
3. build a predictive model for the reparability of large-to-massive rotator cuff tears.


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: Sonoelastography
timeFrame: Baseline
Secondary outcomes:
measure: Passive range of motions
timeFrame: Baseline
measure: Muscle strength
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeons score.
timeFrame: Baseline
measure: MRI
timeFrame: Baseline
measure: Surgical outcome
timeFrame: Baseline
measure: B-mode ultrasound
timeFrame: Baseline
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:
citation: Tseng YH, Chou WY, Wu KT, Chang CD, Chen YC, Huang YC, Lin WC, Chen PC. Use sonoelastography to predict the reparability of large-to-massive rotator cuff tears. Medicine (Baltimore). 2020 Jul 2;99(27):e21139. doi: 10.1097/MD.0000000000021139.