NCT00823888已完成不适用
Mechanics of Knee Bracing
The New England Baptist Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment.
研究概览
简要总结
The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.
详细描述
This study is closed to enrollment and in the data analysis phase
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •knee pain, aching or stiffness on most of the past 30 days
- •x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA)
- •overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions)
- •ambulatory persons
排除标准
- •use of a crutch, walker, or wheelchair or cane more than 50% of the time
- •history of Deep Vein Thrombosis
- •Pain emanating more from back or hip than from knee
- •Low pain score on WOMAC
- •predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain.
- •Planning to move from area within 1 month of study screening.
- •Unable to fit the brace properly
- •BMI greater than 35
- •corticosteriod injections in the past month
- •Bilateral total knee replacements or plan for TKR
- •Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout.
- •woman who are pregnant (due to x-rays taken to determine eligibility)
结局指标
主要结局
To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment.
时间窗: At study visit
次要结局
- To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a lower pain score and improved function during the time of this treatment than during the use of a control treatment.(During study visit)
研究者
研究点 (2)
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