NCT01243814已完成不适用
A Double-blind, Randomized, Placebo-controlled Study of the Relative Efficacy of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- AOFAS score, difference from mean at 6 weeks and 12 weeks
研究概览
简要总结
To compare the therapeutic effect of single intra-articular injection of hyaluronate with a single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.
详细描述
This study is a randomized, prospective, double-blind (blinded observer) , saline solution-controlled, parallel experimental design. The study device is SUPARTZ (Seikagaku Corporation, Tokyo, Japan) a brand of sodium hyaluronate.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •To be eligible, subjects had to be at least 18 years old, not pregnant, and have pain and osteoarthritis of the ankle of at least stage 2 on the Kellgren and Lawrence scale.
- •Their AOFAS score had to be 90 points or less out of a possible 100 points.
- •Eligible subjects had to be willing to discontinue all pain medications and NSAIDs other than the rescue pain medications provided in the study.
排除标准
- •Persons with systemic inflammatory condition or infection of the ankle or nearby soft tissues,
- •an injection of steroid or surgery on the involved joint within 6 months,
- •local cellulitis, rash, skin condition
- •diabetic or neuropathic Charcot arthropathy,
- •significant vascular insufficiency,
- •current treatment with anticoagulants,
- •lower extremity pain syndromes, sciatica, sprains, plantar fasciitis,
- •significant ankle instability or malalignment,
- •any known allergy to any of the components of either injection, known or suspected allergy to birds or bird products,
- •disabling degenerative joint disease of the ipsilateral hip, knee or foot were ineligible for the study.
结局指标
主要结局
AOFAS score, difference from mean at 6 weeks and 12 weeks
时间窗: 6 weeks 12 weeks
American Orthopaedic Foot and Ankle score
次要结局
未报告次要终点
研究者
研究点 (2)
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