NCT01814033Unknown不适用
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Range of Motion
研究概览
简要总结
The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.
详细描述
- Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.
- Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.
- •Exclusion criteria:
- •bilateral total knee arthroplasties
- •revision total knee arthroplasties
- •unexpected decline in medical or mental status
- •Subjects will range from 30 years of age to 80 years of age
- •primary diagnosis of rheumatoid arthritis
排除标准
- 未提供
结局指标
主要结局
Range of Motion
时间窗: 3 Days
Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.
次要结局
- Pain(3 Days)
研究者
Theresa J. Gustus
Rehabilitation Services Manager
Newton-Wellesley Hospital
研究点 (2)
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