A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair
研究概览
简要总结
66 articular cartilage injury diseases patients were divided into two groups as 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence of adverse events.
详细描述
In this study, 66 patients who were clinically diagnosed as articular cartilage injury diseases were divided into test group and control group according to the ratio of 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence 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
- Single (Outcomes Assessor)
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 years old and ≤50 years old, male or female patients
- •Patients with knee articular cartilage defect area ≥2cm2 and ≤8cm2, who can undergo microfracture surgery, no surgical contraindications
- •Patients voluntarily participate in clinical trials, sign an informed consent form, and be able to cooperate with clinical follow-up
排除标准
- •Participants in clinical trials of other drugs or medical devices in the past 6 months
- •Unable to accept autologous fat glue due to religion, ethnicity, etc.
- •Injury area <2 cm2 or >8cm2 or lack of normal cartilage tissue surrounding the injury
- •Those with compound multiple ligament injuries
- •Those with systemic immune diseases or systemic or local infections
- •Those with joint fibrosis, joint ankylosis, and obvious limitation of movement
- •People with moderate to severe osteoarthritis
- •Those who have contraindications to MRI examination
- •Patients with hemophilia
- •People whose general condition cannot tolerate surgery
- •Women who are pregnant or planning to become pregnant and women who are breastfeeding
- •Mental abnormalities and no behavioral autonomy
- •Other circumstances in which the doctor judges that he cannot participate in the trial
结局指标
主要结局
Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair
时间窗: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of postoperative MRI evaluation with autologous fat glue combined with micro-fracture treatment or micro-fracture treatment articular cartilage injury
次要结局
- IKDC score(IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.)
- VAS score(VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.)
- Lysholm score(Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.)
- Tegner score(Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.)