The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- "Function" Subscale in the Koos Scale (area under the curve)
研究概览
简要总结
Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.
详细描述
Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.
The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.
The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 on
- •Previous total or subtotal meniscectomy
- •Medical insurance
- •Female patients have to be under contraceptive treatment
- •Sign consent form
排除标准
- •Age < 18 years
- •Pregnant or breast-feeding woman
- •Need of a simultaneous frontal osteotomy
- •Inflammatory disease
- •Septic background
- •Psychiatric background
- •Understanding difficulties or problems for follow-up
- •No consent
- •No medical insurance
结局指标
主要结局
"Function" Subscale in the Koos Scale (area under the curve)
时间窗: 2 years follow up
Koos Scale
次要结局
- Clinical criteria: pain, quality of life, professional activity(At 2 years follow-up)
- Post operative and late complications(At 2 years follow-up)