Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Lower extremity swelling
研究概览
简要总结
The goal of this clinical trial is to find out the efficacy of diosmin and hesperidin on postoperative early rehabilitation after primary total knee arthroplasty. The main questions it aims to answer are:
Does diosmin and hesperidin combined drug decreases the lower extremity swelling, pain and increases the range of motion after primary total knee arthroplasty surgery compared to standard therapy group? Does diosmin and hesperidin combined drug decreases inflammation after total knee arthroplasty surgery.
Participants will take diosmin and hesperidin in addition to standard therapy for 14 days after total knee arthroplasty surgery. Lower extremity swelling, pain and range of motion of the patients will be recorded in every visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent unilateral primary total knee replacement surgery
- •Patients who are functionally ASA 1, ASA 2 or ASA 3.
排除标准
- •Patients >80 years or <18 years of age
- •Patients with liver insufficiency
- •Patients with allergy to diosmin or hesperidin
- •Patients which are not capable to communicate
研究组 & 干预措施
Study group
Participants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery.
干预措施: Diosmin and Hesperidin Combination (Drug)
结局指标
主要结局
Lower extremity swelling
时间窗: From enrollment to the end of the treatment at 2 weeks
Lower extremity swelling is measured by measuring extremity diameters from 3 points (below patella, patella and above patella) and noted. Then percentage of increment or decrement of diameters is measured.
次要结局
- Pain(From enrollment to the end of the treatment at 2 weeks)
- Range of motion(From enrollment to the end of the treatment at 2 weeks)
- Blood C-reactive protein value as an inflammotory marker(From enrollment to the end of the treatment at 2 weeks)
- Blood erythrocyte sedimentation rate as an inflammotory marker(From enrollment to the end of the treatment at 2 weeks)
- Blood neutrophil/lymphocyte rate as an inflammatory marker(From enrollment to the end of the treatment at 2 weeks)
- Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker(From enrollment to the end of the treatment at 2 weeks)
- The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker(From enrollment to the end of the treatment at 2 weeks)
研究者
Ahmet Berkay Girgin
Principal Investigator
Ankara Etlik City Hospital