Autologous Conditioned Serum: Functional and Clinical Results Using a Novel Disease Modifying Agent for the Management of Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA).
详细描述
Fifteen patients with clinical and radiological signs of OA of the hip or knee were recruited for this study. Each patient received 4 injections of ACS (Orthokine®) at the site of OA once per week for 4 weeks. Clinical and functional evaluation were performed using VAS scale for pain, WOMAC scale and KSS functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. Statistical analysis was done with the Wilcoxon Signed-Rank Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee osteoarthritis >3 months in clinical and radiographic signs
- •VAS for pain >50mm
排除标准
- •Hepatitis B
- •Hepatitis C
- •pregnancy
- •drug abuse
- •other intra-articular injections <6 months
- •surgery on affected knee <12 months
研究组 & 干预措施
Autologous Conditioned Serum
Patients that were deemed admissible to the trial received 1 intra-articular injection of autologous conditioned serum (Orthokine®) for 4 consecutive weeks at the site of OA. These patients were then followed at 1 month and 6 months for clinical and functional evaluation using VAS for pain, WOMAC, and KSS.
干预措施: Autologous Conditioned Serum (Drug)
结局指标
主要结局
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 6 months
24 questions each scaled out of 100mm. 5 questions regarding pain. 2 questions regarding rigidity. 17 questions regarding difficulty in various activities. Total score out of 240 expressed as a percentage. Minimum score 0. Max score 100. Greater score implies worsening symptomatology.
Knee Society Score (KSS)
时间窗: 6 months
Clinical Score. Pain is measured out of 50 (no pain = 50, severe pain = 0). Range of motion (1 point for every 5 degress of flexion. Max points = 25). Stability; anteroposterior (\<5 degrees 10, 5-10 degrees 5, \>10 degrees 0); mediolateral (\<5 degrees = 10, 5-10 degrees = 5, \>10 degrees = 0); Flexion contracture (5-10 degrees = -2, 10-15 degrees = -5, 16-20 degrees = -10, \>20 degrees = -15); Extension lag (\<10 degrees = -5, 10-20 degrees = -10, 20 degrees = -15); Alignment (0-4 degrees = 0, 5-15 degrees = 3 points for each degree). Functional Score. Consists of walking score based on how many blocks (100m) patient can walk without stopping (unlimited = 100, \>10 blocks = 40, 5-10 blocks = 30, \<5 blocks = 20, housebound = 10, unable = 0); Stairs (normal = 50, normal up down with support = 40, up and down with support = 30, up with support down unable = 15, unable = 0); Functional deductions (cane = -5, two canes = -10, crutches or walker = -20)
Visual Analog Score for Pain
时间窗: 6 months
Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10
次要结局
未报告次要终点
研究者
Pierluigi Pironti
Doctor
Ospedale San Raffaele