An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
研究概览
简要总结
An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.
详细描述
This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult men and women over 15 and less than 65 years of age
- •applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
- •patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
- •patients which surrounding cartilage are normal
- •patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form
排除标准
- •patients hypersensitive to bovine protein
- •patients hypersensitive to gentamicin antibiotics
- •patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
- •patients with arthritis related to autoimmune disease
- •pregnant, breast-feeding patients or those who have a possibility of pregnancy
- •patients with accompanying diseases other than articular cartilage defects, including tumors
- •patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
- •patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
- •patients who are administering antibiotics and antimicrobial agents due to infection
- •patients who receive steroid hormone therapy
- •Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
结局指标
主要结局
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
时间窗: baseline(preoperative stage),12months post-surgery
AOFAS scores(best score-100,worst score- 0 ) 1. pain-none:40/Strong and Always present:O 2. Function * activities-without support activities:10/need restrain, clutch , walker or wheelchair:0 * Maximum gait distance- more than 6:5/ less than 1:0 * gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0 * Gait abnormality-none:8/marked:0 * saggital mobidity- normal or minimal restrain:6/strong restraint:0 * hindfoot mobidity -normal minimal restrain:6/strong restrain:0 * ankle and hindfoot stability - stable:8/unstable:0 3. alignment- good:10/bad:0
次要结局
- Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery(baseline(preoperative stage),12months post-surgery)
- Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery(baseline(preoperative stage),12months post-surgery)