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临床试验/NCT00560664
NCT00560664已完成3 期

Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

University Hospital, Brest24 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
58
试验地点
24
主要终点
Clinical evaluation scoring system

研究概览

简要总结

Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • isolated femoral osteochondral lesion
  • aged 18 to 50
  • grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm
  • IKDC score below 55

排除标准

  • pregnancy
  • arthrosis
  • varus or valgus angle greater than 10°
  • ACL laxity
  • Severe chronic disease
  • BMI > 30 Kg/m2
  • HIV, B or C Hepatitis

结局指标

主要结局

Clinical evaluation scoring system

时间窗: IKDC

次要结局

  • MRI(at 2 years)
  • Arthroscopy with biopsy(at 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (24)

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