Evaluation of the Efficacy of Diprospan Injection to the Knee on Rehabilitation of Patients With Bilateral Knee Osteoarthritis After TKR of the Contralateral Knee.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual analogue pain score
研究概览
简要总结
This study is performed to assess the influence of intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into osteoarthritic knee in patients who undergo a total knee replacement of their contralateral knee.
The study population will include 50 patients with bilateral knee osteoarthritis, admitted for their first knee replacement surgery. Only patients with older than 50 years with primary osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6 weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score, Timed Up and Go Score and Functional Ambulatory Category Scale).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 50
- •Bilateral primary knee osteoarthritis
- •Undergoing knee arthroplasty
排除标准
- •Active infection
- •Allergy to medication compounds
- •Pregnancy
研究组 & 干预措施
1
干预措施: Betamethasone (Drug)
2
干预措施: Bupivocaine (Drug)
结局指标
主要结局
Visual analogue pain score
时间窗: 6 weeks
次要结局
- Timed Up and Go Score(6 weeks)
- Functional Ambulatory Category Scale(6 weeks)