Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score
研究概览
简要总结
The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.
详细描述
Autologous osteo-periosteal cylinder graft surface is a periosteal structure, with the ability of repairment to cartilage, periosteum is closely connected to the cortical bone, then the deep loose cancellous bone.The objective of the study is to evaluate the clinical efficacy of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus by randomized controlled trial. 70 patients with clinically diagnosed Hepple V talus osteochondral lesions according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with autologous osteo-periosteal cylinder graft transplantation under arthroscopy. The control group will be treated with autologous osteochondral graft under arthroscopy. The patients will be treated by the same surgeon in this study group. Postoperative MRI MOCART evaluation, clinical AOFAS score, VAS score, Tegner score, and the secondary arthroscopy ICRS score will be selected as the measures of outcome. The incidence of adverse events will be recorded.
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
- None
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
- •18-50 years old, male or female
- •Chronic pain in the ankle, confirmed by ankle joint MRI as Hepple V osteo-chondral lesions of the talus
- •Using rest/external use/oral non-steroidal anti-inflammatory drugs and other conservative treatment for more than 3 months ineffective
- •Patients voluntarily participated in clinical trials, signed informed consent, with clinical follow-up
排除标准
- •In the last 6 months patients participated in other drug or medical device clinical trials
- •Line of force in ankle is not correct (varus or valgus> 5 degrees)
- •Grade III ankle collateral ligament injury
- •Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
- •Joint fibrosis, ankylosis, activity was significantly limited
- •Moderate and severe osteoarthritis
- •There are MRI contraindications
- •Hemophilia patients
- •The general condition of patients can not tolerate surgery
- •Pregnant or planned pregnant women and lactating women
- •Abnormal mental capacity without autonomy
- •Other conditions in which the doctor can not decide to participate in the trial
结局指标
主要结局
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score
时间窗: 4 years
American Orthopaedic Foot \& Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.
次要结局
- Tegner activity level score(4 years)
- International Cartilage Repair Society(ICRS) score(4 years)
- Magnetic Resonance Observation of cartilage repair tissue(MOCART) score(4 years)
- Visual analogue scale(4 years)
研究者
Guo Qinwei
Principal Investigator, Clinical Associate Professor and Chief Orthopedist of Orthopedic Sports Medicine
Peking University Third Hospital