Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- fMRI for evaluation of brain plasticity after transplant
研究概览
简要总结
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.
The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.
The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •double amputated patients
- •minimum of 3 months and maximum of 3 years interval between amputation and graft
- •adult aged 20 to 40 years
- •psychological maturity
- •written informed consent
排除标准
- •mono amputated patients
- •previous history of malignant tumor in remission for less than 5 years,
- •malignant tumor
- •previous psychiatric history
- •American Society of Anesthesiology (ASA) score >2
- •New York Heart Association (NYHA) >1
- •nenal insufficiency
- •severe hypertension
研究组 & 干预措施
hand allograft
干预措施: hand allograft (Procedure)
结局指标
主要结局
fMRI for evaluation of brain plasticity after transplant
时间窗: 1 year
Evaluation of brain plasticity after transplant
次要结局
- Adverse events(5 years)
- Rejection(Every 6 months following graft up to 5 years)