Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Range of Motion Outcomes
研究概览
简要总结
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.
详细描述
All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function.
Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively.
Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty.
Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.
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 (Outcomes Assessor)
盲法说明
post operative assessor obtaining range of motion and performing physical exam will be blinded to participant's group.
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
- •A pre-operative plan for RTSA
排除标准
- •Active infection
- •Incompetent deltoid muscle
- •Unwillingness or inability to participate in a home exercise program
- •Medically unfit for operative intervention
- •Revision RTSA
- •RTSA for glenohumeral osteoarthritis or proximal humerus fracture
- •Unwillingness to participate in the study
- •Inability to read or comprehend written instructions
结局指标
主要结局
Range of Motion Outcomes
时间窗: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
次要结局
- Clinical Outcome Scores - Quality of Life(Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively)
- Clinical Outcome Scores - Functional(Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively)
- Clinical Outcome Scores - Pain(Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively)