Intra-articular Injections of Platelet-rich Plasma in Patients With Knee Pain of Articular Cartilage Origin (Degenerative Chondropathy and Early OA).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for increasing the rate of cure in bone and soft-tissue regeneration, although there are very few clinical studies regarding the treatment of articular cartilage damage. Therefore, our study proposes non-surgical intervention for patients with articular cartilage damage and who are experiencing knee pain caused by this damage.
This study was conducted as a single medical center. It was an uncontrolled, prospective clinical trial, and the study subjects included 44 patients who were suffering from early osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and were included in the study irregardless their sex. PRP was injected twice intraarticulary within an interval of four weeks. The pain scores and functional scores were compared two months, four months, and six months following the second injection was completed, using the VAS, the Lysholm knee scale, and the Cincinnati knee rating system.
详细描述
Patients between 18 and 65 years of age with early osteoarthritis and degenerative chondropathy who had previously taken medication for more than six months and without physical improvement, were assessed in an open clinical trial. The 44 patients who met the experiment criteria and who voluntarily gave written consent to PRP treatment, were finally selected. The knee joint had to be stable and without a severe deformity greater than 5 degrees in the valgus or varus.
The exclusion criteria included advanced osteoarthritis (Kellgren-Lawrence Grading Scale >2) and inflammatory arthritis with severe deformity exceeding the above range. Patellofemoral instability, a history of drug abuse, and/or psychological problems were also patient exclusion criteria.
In addition, patients with positive HIV, HBV, HCV, HTLV, CMV, EBV, Syphilis test, severe anemia, severe heart disease or with the history of cardiac surgeries, active tuberculosis, pneumonia, pregnant women or women who were planning pregnancy within six months, women who were breast-feeding, patients with a history of drug abuse within the past six months, patients with uncontrolled infections, those who had taken anti-inflammatory drugs within the past five days, and patients who were judged to be inappropriate to participate in a clinical trial by the doctors of the experiment due to their psychiatric problems, were excluded from this study.
A total of 44 patients received the treatment, and there were 19 male patients (43%) and 25 female patients (57%). The mean age of the study subjects was 43 years (range: 19-63 years old), and their mean BMI was 24.9 (20.1-31.2). Fifteen of them had left knee pain, five of them had right knee pain, and 14 of them had pain in both knees.
This clinical study was in accord with the 'ethical principles of medical research with human beings' based on the declaration of Helsinki and with Korean good clinical practice standards (GCP, The Ministry of Food and Drug Administration 2009-211) and was conducted after being reviewed by Institutional review board (Catholic University of Korea).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 65 years of age with early osteoarthritis and degenerative chondropathy who had previously taken medication for more than six months and without physical improvement
排除标准
- •advanced osteoarthritis (Kellgren-Lawrence Grading Scale > 2) and inflammatory arthritis with severe deformity exceeding the above range.
- •patellofemoral instability,
- •a history of drug abuse, and/or
- •psychological problems
结局指标
主要结局
Visual Analogue Scale
时间窗: 6 month follow up
The study subjects followed the instructions given by the doctors during the experiment and the second PRP injection was administered four weeks after the first injection. The pain score and the functional score were measured two months, four months, and six months after the second injection using the Visual Analogue Scale (VAS), the Cincinnati knee rating system (CKRS), and the Lysholm knee scale (LKS). The clinical score was calculated after determining the times of evaluation as level 1 (before the injection), level 2 (the second injection), level 3 (two months after the second injection), level 4 (in four months after the second injection), and level 5 (in six months after the second injection).
次要结局
- Cincinnati knee rating system(6 month follow up)
研究者
Seok-Jung Kim
Vice-dean , catholic medical college
The Catholic University of Korea