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临床试验/NCT01409447
NCT01409447Unknown不适用

Repair of Articular Osteochondral Defect

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Knee injury and Osteoarthritis Outcome Score

研究概览

简要总结

Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

详细描述

Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

研究设计

研究类型
Interventional
分配方式
Na
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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 ~ 60 years
  • Articular cartilage defect of the knee
  • Diagnosis by X-ray and/or MRI, Arthroscopy
  • Confined area: diameter < 3 cm
  • Full layer cartilage damage

排除标准

  • Pregnancy
  • Nonunion of fracture around the knee
  • Diffuse degenerative arthropathy of the knee
  • Diffuse cartilage pathology due to
  • Rheumatism: rheumatoid, psoriatic, ...
  • Metabolic disorder: gouty, hemorrhagic, ...
  • Stiff knee from any reason
  • Flexion < 130˚
  • Extension loss > 20˚

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Score

时间窗: 1 Year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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Repair of Articular Osteochondral Defect | 临床试验