Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- MRI T2 Mapping
研究概览
简要总结
This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.
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 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm
- •Signed patient informed consent.
- •Agree to adhere to rehabilitation protocol.
排除标准
- •Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
- •Total meniscectomy
- •Malalignment
- •Evidence of osteoarthritis
结局指标
主要结局
MRI T2 Mapping
时间窗: 24 months
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
次要结局
- Clinical evaluation(0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months)
研究者
Aldo Izaguirre
Dr./Study Director
Instituto Nacional de Rehabilitacion
