THE APPLICATION OF PLASMA RICH IN GROWTH FACTORS FOR KNEE OSTEOARTHRITIS IMPROVES THE QUALITY OF LIFE AND FUNCTIONAL CAPACITY COMPARED WITH CONVENCIONAL TREATMENT WITH VISCOSUPLEMENTATION
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Effectiveness after 6 months of treatment with PRGF with an improvement in the reference tests of more than 15% compared to treatment with hyaluronic acid.
研究概览
简要总结
HYPOTHESIS:
The application of plasma rich in growth factors (PRGF) will improve the quality of life and functional capacity of patients diagnosed with knee osteoarthritis, providing better functional results than conventional treatment with viscosupplementation.
OPERATING ASSUMPTIONS
Following the initial administration of three doses of PRGF interspersed every 15 days, applied via intraarticular, patients will present an improvement in functional test (WOMAC and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with patients treated with hyaluronic acid.
详细描述
OBJECTIVES
The overall objective of the study is to assess the effectiveness of the treatment with PRGF in the osteoarthritis of the knee.
Main objective:
- To show more effectiveness after 6 months of the treatment with PRGF, with an improvement in the reference test (WOMAC and Lequesne) of 15 % or more compared to the treatment with hyaluronic acid in patients with osteoarthritis of the knee.
Secondary objectives:
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
- 55 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above
- •Moderate to severe symptoms according to the WOMAC pain score of more than 6 months of evolution.
- •Grade II - III knee osteoarthritis radiographic criteria for the classification of Kellgren and Lawrence.
- •BMI Index below 35 which is considered Morbid Obesity according to WHO.
- •Absence of treatments for osteoarthritis in the last 6 months.
排除标准
- •Patients who have previously received medical treatment through viscosupplementation in the last 6 months.
- •Patients who have allergies to some of the components of DUROLANE ® either hyaluronic acid itself or any of its excipients.
- •Patients with severe angular changes and joint instability.
- •Patients on anticoagulants or antiplatelet treatment that may not temporarily reversed for infiltrations.
- •Polyarticular disease
- •Infectious Diseases
- •Tumor processes on treatment or medical care.
- •Immunosuppressive therapy or immunosuppressive processes.
- •Inability to understand the health questionnaires and / or adequately complete.
研究组 & 干预措施
Plasma rich in growth factors (PRGF)
Patients in this group will receive one cycle of three intra-articular injections of PRGF every 15 days.
Procedure for the application of the treatment:
- Study Group or PRGF group
-
Blood sample :
-
Taken minimum after 4 hours of fasting and drinking only water in order to maintain low levels of glucose.
-
20 cc of peripheral blood will be taken by sterile systems with Sodium Citrate buffer to avoid hemolysis.
-
Spinning of the sample:
-
8 minutes at 1800 rpm .
-
getting the blood fraction containing the PRGF
-
activation of PRGF with 50 ul of 10% CaCl2 per ml of plasma.
-
the application of PRGF should not exceed 90 minutes after the blood sample extraction in order to avoid risk of contamination.
干预措施: Plasma rich in growth factors (Biological)
Hyaluronic acid (Durolane®)
Patients in this group will receive a single intra-articular injection at visit 1.
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Effectiveness after 6 months of treatment with PRGF with an improvement in the reference tests of more than 15% compared to treatment with hyaluronic acid.
时间窗: 6 months
Measured by WOMAC and Lequesne reference scales score for osteoarthritis of the knee.
次要结局
- Effectiveness of the treatment with PRGF compared to treatment with hyaluronic acid after 12 months of follow-up.(12 months)
- Effectiveness of the two-cycles-treatment-based with PRGF in the second phase compared to one-cycle-treatment-based in the first phase after 12 months of the second phase(12 months of follow-up in the second phase)
- Blood platelet quantification and its correlation with the effect(12 months (main stage) and 12 months (extension stage))