NCT00158613已完成4 期
A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 56
- 主要终点
- Mean change from baseline in the KOOS
研究概览
简要总结
This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided written informed consent
- •Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
- •Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
- •Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
- •patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure
排除标准
- •see above
结局指标
主要结局
Mean change from baseline in the KOOS
时间窗: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
次要结局
- Change from Baseline in the Modified Cincinnati Score(6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo)
- Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport(12mo, 24mo, 36mo, 48mo)
- Change from Baseline in the SF-36 Health Status Survey(12mo, 24mo, 36mo, 48mo)
研究者
研究点 (56)
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