NCT01442571Unknown1 期
Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 主要终点
- IKDC (the International Knee Documentation Committee)
研究概览
简要总结
The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).
排除标准
- •Patients with known rheumatic disorders.
- •Known hypersensitivity to HA.
- •Synovial diseases like PVNS, under 18y old.
研究组 & 干预措施
Hyaluronic Acid Injection, pain, function
Experimental
干预措施: Hyaluronic Acid Injection (Device)
Saline Injection
Placebo Comparator
干预措施: Saline Injection (Drug)
结局指标
主要结局
IKDC (the International Knee Documentation Committee)
次要结局
未报告次要终点
研究者
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