NCT06358807招募中不适用
Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- American Orthopedic Foot and Ankle Society Score (AOFAS)
研究概览
简要总结
The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:
- Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
- Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.
Participants will:
- Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
- Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
- Take MRI preoperatively and 6, 12 and 24 months after surgery
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
- •Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
- •Conservative treatment of at least 3 months fails to relieve symptoms;
- •Willingness to voluntarily participate in the trial and to sign informed consent.
排除标准
- •Varus or valgus deformity of the ankle of more than 5 degrees;
- •Grade III injury of the lateral collateral ligament of ankle;
- •Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
- •Joint fibrosis, stiffness, and significantly restricted range of motion;
- •Evidence of moderate to severe knee osteoarthritis on plain radiographs;
- •Failure to complete the rehabilitation protocol as required;
- •Patient medically not fit for surgery, radiographs or MRI;
- •For women, pregnant, planning to be pregnant or lactating.
结局指标
主要结局
American Orthopedic Foot and Ankle Society Score (AOFAS)
时间窗: Pre-surgery and 3, 6, 12 and 24 months after surgery
The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery.
次要结局
- Patient Satisfaction(Final follow-up (24 months after surgery))
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)(Twelve and 24 months after surgery)
- Return-to-Sport Rate(Final follow-up (24 months after surgery))
- Foot and Ankle Outcome Score (FAOS)(Pre-surgery and 3, 6, 12 and 24 months after surgery)
- Ankle Activity Score (AAS)(Pre-surgery and 3, 6, 12 and 24 months after surgery)
- Visual Analogue Scale (VAS)(Pre-surgery and 3, 6, 12 and 24 months after surgery)
- Complications(Final follow-up (24 months after surgery))
研究者
研究点 (1)
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