EUCTR2016-000784-16-NO进行中（未招募）1 期
Focal cartilage defects in the knee – A randomized controlled trial comparing Autologous Chondrocyte Implantation with arthroscopic debridement - ACI
Akershus University Hospital0 个研究点开始时间: 2016年3月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age 18-50 years old
- •-Single symptomatic cartilage defect on medial or lateral femoral condyle or trochlea
- •-Defect size larger than 2 cm2
- •-Defect ICRS grade 3-4
- •-Ligamentous stable knee
- •-Acceptable range of motion (minimum 5-105 °)
- •- Lysholm score < 75
- •-Informed consent
- •-Meniscus > 50 % intact
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 82
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Osteoarthritis, rheumatoid or other systemic arthritis (asked)
- •-Malalignment > 5° measured on HKA x-rays
- •-No radiological osteoarthritis
- •-Obesity (Body mass index > 30)
- •-Comorbidities that may influence surgery or rehabilitation
- •-Pregnancy
- •-Inability to complete questionnaires or rehabilitation
- •-Serious alcohol or drug abuse
- •- Previous cartilage surgery to the chondral defect except OCD surgery
研究者
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