NCT00144820Unknown4 期
Intra-Articular Injections of Hyaluronan Versus 20 Ml NaCl Versus Placebo in Treatment of Knee Osteoarthritis: a Randomised, Double-Blind, Placebo Controlled Single Centre Trial.
Glostrup University Hospital, Copenhagen2 个研究点 分布在 1 个国家目标入组 251 人开始时间: 1999年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Pain measured on a visual scale on movement (VAS-movement)
研究概览
简要总结
251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline).
They all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics.
Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.
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
- Double
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, men/women age > 60 years with clinical,
- •Radiological and possible arthroscopical verified knee osteoarthritis.
- •Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline.
排除标准
- •Age below 60
- •Unconsciousness
- •Psychosis
- •Ingestion of drugs that may influence the results of the clinical examinations
- •Inflammatory diseases of the joints
- •Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria
- •Contraindication to hyalgan treatment
- •Previous intraarticular fracture of a knee joint
- •Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids.
- •Any other condition that might interfere with the efficacy assessment or completion of the trial.
结局指标
主要结局
Pain measured on a visual scale on movement (VAS-movement)
At rest (VAS-rest)
During the night (VAS-night)
次要结局
- Daily consumption of analgetics
- Cartilage and bone degradation markers
- KOOS scores (knee injury and osteoarthritis outcome score)
- The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
- Global assessment patient
- Global assessment investigator
研究者
研究点 (2)
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