Repair of Articular Osteochondral Defect
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
- 否
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
