Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Appraise of magnetic reasonance imaging
研究概览
简要总结
The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with microfracture, while the other will only receive microfracture as a control group.
详细描述
Decalcification bone scaffold is a tissue engineering scaffold with the closest biomechanics and structure of normal cartilage. The objective of the study is to evaluate the clinical efficacy of arthroscopic decalcification bone scaffold combined with microfracture in the repairment of articular cartilage defects by randomized controlled trial. Sixty patients with clinically diagnosed knee cartilage injury according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with decalcification bone scaffold combined with microfracture .The control group will be treated with microfracture . The patients will be treated by the same surgeon in this study group. MRI evaluation, Lysholm score, IKDC score, Tegner score, VAS score are selected as the measures of outcome, while the blood routine, blood biochemistry, urine, CRP, ECG and other laboratory tests will be recorded inclduing the incidence of adverse events.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-50 years old, male or female
- •Cartilage defect 2-8 cm²
- •Subjects have the surgical indication of microfracture and no contradiction
- •Subjects participate the clinical trial voluntarily, and sign informed consent
- •Subjects could comply with follow-up
排除标准
- •Participated in other drug or medical device clinical trials in the last 6 months.
- •Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
- •Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
- •Complex multi-ligament injury
- •Suffered from systemic immune disease or systemic, locally infected
- •Joint fibrosis, joint rigidity, mobility was significantly limited
- •Moderate and severe osteoarthritis
- •With contraindications to MRI
- •Hemophilia
- •General condition can not tolerate surgery
- •Pregnant or planned pregnant women and lactating women
- •With abnormal spirit and selfless ability
- •Other circumstances judged by doctors that can not participate in the trial
结局指标
主要结局
Appraise of magnetic reasonance imaging
时间窗: 5 years
Evaluate the articular cartilage postoperatively by MRI.
次要结局
- International Knee Documentation Committee (IKDC) 2000(5 years)
- Visual analogue scale(5 years)
- Lysholm score(5 years)
- Tegner activity level score(5 years)
研究者
Ao Yingfang
Director of the Institute of Sports Medicine , Principal Investigator, Clinical Professor of Orthopedic Sports Medicine
Peking University Third Hospital