Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- MRI
研究概览
简要总结
To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
- •The preoperative routine tests and examinations revealed no contraindications.
- •Revised sentence: "Informed consent of the patient
排除标准
- •The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
- •Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
- •In injection site or damage to the skin.
- •Patients with tumors or undergoing radiotherapy and chemotherapy.
- •Pregnant or breastfeeding women.
- •Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
- •Contraindications for MRI、Patients or their families do consent to participate in the study.
- •Other circumstances that render participation in the study unsuitable.
研究组 & 干预措施
postoperative (3 months)
The patients were injected with PRP.
干预措施: Sodium hyaluronate injection (Drug)
postoperative (6 weeks)
The patients were injected with PRP.
干预措施: Sodium hyaluronate injection (Drug)
结局指标
主要结局
MRI
时间窗: pre-operation,3 weeks after treatment, 6 months after treatment
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.
X-ray
时间窗: pre-operation,3 weeks after treatment, 6 months after treatment
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
CT
时间窗: pre-operation,3 weeks after treatment, 6 months after treatment
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
次要结局
未报告次要终点