Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical evaluation scoring system: IKDC
研究概览
简要总结
CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:
- Arthroscopy to collect cartilage;
- Implantation following arthrotomy about 6 weeks following arthroscopy.
Both groups will follow the same rehabilitation program.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated femoral osteochondral lesion
- •aged 18 to 45
- •grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
- •lesion depth under 10mm
- •IKDC score below 55
- •no prior surgical treatment
排除标准
- •pregnancy or breastfeeding
- •arthrosis
- •varus or valgus angle greater than 6°
- •kissing lesion
- •affection of the patella
- •excessive laxity
- •meniscal pathology history
- •severe chronic disease
- •BMI > 30
- •HIV, Hepatitis B, C, HTLV, Syphilis
结局指标
主要结局
Clinical evaluation scoring system: IKDC
时间窗: 18 months
次要结局
未报告次要终点