Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
研究概览
简要总结
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
详细描述
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.
The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 55 years old;
- •Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree;
- •Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;
- •Normal lower limb mechanical force line (varus or valgum < 5°);
- •Skeletal mature;
- •18Kg/M2 ≤ BMI ≤ 30Kg/M2;
- •Agree to sign the informed consent form;
- •Can cooperate in a post-operative rehabilitation program.
排除标准
- •Superficial cartilage defects;
- •Concomitant with subchondral bone defect;
- •Varus or valgum > 5°;
- •Serious meniscus injury;
- •Fractures around the knee;
- •Cannot join in the post-operative rehabilitation program;
- •The contralateral lower-limb cannot stand weight-bearing;
- •A history of knee surgery within 6 months;
- •Secondary arthritis affecting cartilage;
- •Serious arthrocleisis;
- •Undergoing clinical trial;
- •Serious illness of the heart, lung, and other vital organs;
- •Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit;
- •Have a contagious disease;
- •Allergic to the agents;
- •Lactating or pregnant women;
- •Serious neuropathy or mental disease;
- •Be addicted with drug or alcohol.
研究组 & 干预措施
CaReS-1S
干预措施: CaReSR-1S (Device)
Microfracture
干预措施: Microfracture (Device)
结局指标
主要结局
Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
时间窗: 12 months
次要结局
- Difference of Lysholm score change from baseline between groups(12 months)
- Difference of MOCART score change from baseline between groups(12 months)
- "Good""Moderate""Poor" rates according to Lysholm score(12 months)
- Effective rate according to Lysholm score(12 months)
- Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups(12 months)
- Incidence of treatment-related adverse events(12 months)
- Total efficiency according to Lysholm score(12 months)