A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
研究概览
简要总结
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
详细描述
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 50 years
- •a diagnosis of primary knee osteoarthritis
- •Kellgren-Lawrence (K-L) grading scale smaller than 3
- •both male and female.
排除标准
- •patients younger than 50 years of age
- •K-L grade 3 or more
- •history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
- •generalized OA
- •the detection of rapidly progressive OA before the start of the trial
- •underwent any previous lower extremity surgery
- •excessive mechanical axis deviation (varus > 5°, valgus > 5°)
- •body mass index larger than 30
- •history or presence of malignant disorders
- •systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
- •systematic or intra-articular corticosteroid therapy in the previous 3 months
- •prior treatment with HA in the past 6 months
- •anticoagulants or antiaggregants therapy in the preceding 30 days
- •non-steroidal anti-inflammatory medications in the preceding 7 days
- •platelet count less than 150,000/ml of blood
- •hemoglobin values less than 12g/dL of blood.
结局指标
主要结局
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
时间窗: Baseline and 1-month, 3-month, 6-month after injection
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
次要结局
- The change of Knee Cartilage strain ratio from baseline(Baseline and 1-month, 3-month, 6-month after injection)
- The change of Knee Cartilage Grading System from baseline(Baseline and 1-month, 3-month, 6-month after injection)
- The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline(Baseline and 6-month after injection)