Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- MRI evaluation of articular cartilage injury 730 days (2 years) after repair
研究概览
简要总结
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
详细描述
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
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 years old and ≤50 years old, regardless of gender
- •2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
- •Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
排除标准
- •Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
- •Those with stage III or above degeneration of bone and joint
- •Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
- •Those who are sensitive to collagen, foreign protein or pig-derived materials
- •Repair the damaged area> 8 cm2 or <2 cm2, lack of normal cartilage tissue around the injury
- •Severe heart, liver and kidney insufficiency are defined as:
- •Heart function: NYHA grade III or above; ALT, AST> 2.5 times the upper limit of normal value; Serum creatinine> 1.5 times the upper limit of normal value;
- •People with systemic immune diseases or systemic or local infections
- •Joint fibrosis, joint stiffness, and obviously restricted movement
- •Those with moderate or severe osteoarthritis
- •People with contraindications for MRI examination
- •Patients with hemophilia
- •Those who cannot tolerate surgery
- •Women who are pregnant or plan to become pregnant and breastfeeding women
- •Persons with mental abnormalities and incapacity to act autonomously
- •Other conditions that the doctor judges cannot participate in the trial
研究组 & 干预措施
Cartilage membrane surgery
The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery.
干预措施: Guided cartilage regeneration membrane (Combination Product)
Cartilage membrane surgery
The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery.
干预措施: Microfracture (Procedure)
Microfracture
The control group was treated with microfractures widely recognized at home and abroad.
干预措施: Microfracture (Procedure)
结局指标
主要结局
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
时间窗: End of surgery to 730 days after surgery
The nuclear magnetic evaluation indicators are as follows: 1. Cartilage defect repair filling degree; 2. Fusion of repair tissue and adjacent normal cartilage; 3. Repair tissue surface structure; 4. Repair the internal structure of the organization. The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
次要结局
- Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value(At 24 months after surgery)
- Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value(At 24 months after surgery)