A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Foot and Ankle Outcome Score (FAOS)
研究概览
简要总结
The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are:
Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications?
Participants will:
Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 Lesions of the Talus (OLT);
- •Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
- •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
Foot and Ankle Outcome Score (FAOS)
时间窗: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
次要结局
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)(12 and 24 months after surgery)
- Visual Analogue Scale (VAS)(Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery)
- International Cartilage Repair Society (ICRS)(12 months after surgery)
- Complications(Final follow-up (48 months after surgery))
- American Orthopedic Foot and Ankle Society Score (AOFAS)(Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery)
- Ankle Activity Score (AAS)(Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery)