Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Knee joint function
研究概览
简要总结
The goal of this clinical trial is to learn if vitamin D supplementation affects postoperative rehabilitation in osteoarthritis patients who underwent joint arthroplasty. The main questions it aims to answer are:
Does oral vitamin D supplementation for a period of time after joint arthroplasty affect the postoperative recovery speed in patients who have vitamin D deficiency? Does oral vitamin D supplementation after joint arthroplasty affect the long-term recovery of joint functions in patients who have vitamin D deficiency?
Participants will:
Take vitamin D oral supplement every day for 3 months. Visit the clinic in 1, 3, 6, 12 months after joint replacement surgery for checkups and tests.
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 (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vitamin D deficiency (blood 25-hydroxyvitamin D value < 20ng/ml);
- •Meeting the diagnostic criteria for hip or knee osteoarthritis;
- •Planning to undergo hip or knee arthroplasty after clinical assessment;
排除标准
- •Having other diseases that could cause damage to the bone or cartilage structure of the hip or knee, such as trauma, joint infection, congenital joint malformation, and systemic diseases such as rheumatoid arthritis and gout.
研究组 & 干预措施
Vitamin D oral supplement
Using vitamin D oral supplement that has been widely used in clinic
干预措施: Vitamin D (Drug)
结局指标
主要结局
Knee joint function
时间窗: From enrollment to the end of treatment at 1 year
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Hip joint function
时间窗: From enrollment to the end of treatment at 1 year
Harris Hip Score. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Muscle strength
时间窗: From enrollment to the end of treatment at 1 year
Using portable muscle strength tester to measure flexor and extensor muscle strength of knee or hip joint
次要结局
未报告次要终点