NCT01697865已完成不适用
Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- ADLER Score
研究概览
简要总结
The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres minor dysfunction. The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group) and the second technique does not include a concomitant latissimus and teres major transfer (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without glenohumeral arthritis.
- •Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration.
- •Active forward elevation of less than 90 degrees
- •Teres minor dysfunction
- •Positive lag and hornblower sign
- •Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI
- •Able to attend scheduled office visits
- •Meet all criteria to have a latissimus and teres major transfer
排除标准
- •Revision arthroplasty
- •Previous shoulder infection
- •Neuro-muscular disorder (ie: Parkinson's)
- •Advanced dementia
结局指标
主要结局
ADLER Score
时间窗: 2 Year
Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
次要结局
- ASES score(1 Year, 2 Year)
- DASH Score(1 Year, 2 Year)
- SF-12 Score(1 Year, 2 Year)
- Range of Motion(1 Year, 2 Year)
- X-Ray Measurements(1 Year, 2 Year)
研究者
研究点 (2)
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