NCT07329361招募中不适用
Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial
MiKS Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月16日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- KOOS - Knee Injury and Osteoarthritis Outcome Score
研究概览
简要总结
Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes.
- •Aged between 40 and 85 years old.
- •Diagnosed with osteoarthritis through clinical radiological examination.
- •Joint pain equal to or less than 75 points on the KOOS (pain).
- •Radiological severity grades 1, 2, and 3 according to the Ahlbäck scale.
- •Indication for intra-articular PRP infiltration.
- •Body Mass Index values between 20 and
- •Negative serological tests for syphilis, HIV, HBV, and HCV.
- •Possibility of observation during the follow-up period.
- •Signature of informed consent.
排除标准
- •Body mass index >35
- •Diagnosed polyarticular disease.
- •Previous arthroscopy in the last year.
- •Severe mechanical deformity.
- •Intra-articular hyaluronic acid injection in the last 12 months.
- •Intra-articular corticosteroid or PRP injection in the last 6 months.
- •Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
- •Anemia or other hematological disorders.
- •Positive serological tests for SYPHILIS, HIV, HBV, and HCV.
- •Undergoing immunosuppressive treatments.
- •Poorly controlled diabetes mellitus.
- •Patients allergic to paracetamol.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Frozen Platelet-Rich Plasma
Experimental
干预措施: Platelet Rich Plasma (Other)
Platelet-Rich Plasma
Active Comparator
干预措施: Platelet Rich Plasma (Other)
结局指标
主要结局
KOOS - Knee Injury and Osteoarthritis Outcome Score
时间窗: 6 months
From 0 (worst outcome) to 100 (best outcome)
次要结局
- KOOS - Knee Injury and Osteoarthritis Outcome Score(2 months)
- VAS - Visual Analog Scale(6 months)
- Lequesne Index(6 months)
- VAS - Visual Analog Scale(2 months)
- Lequesne Index(2 months)
研究者
研究点 (1)
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