Ultrasound Shear Wave Elastography to Predict the Treatment Effect and Risk of Re-tear in Patients With Large-to-massive Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline finding of sonoelastography
研究概览
简要总结
To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound elastography.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline finding of sonoelastography
时间窗: Baseline, 3 months, 6 months, 12 months
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.
次要结局
- American Shoulder and Elbow Surgeons score (ASES score)(Baseline, 3 months, 6 months, 12 months)
- MRI(Baseline, 6 months)
- Passive range of motions(Baseline, 3 months, 6 months, 12 months)
- Muscle strength(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)
- EQ-5D-3L(Baseline, 3 months, 6 months, 12 months)