Observational Study of Bilateral Upper Limb Amputees in France
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Etiology of amputation
研究概览
简要总结
In France, there is currently no data to directly estimate the number of bilateral upper limb amputations, their characteristics and therapeutic care.
By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR) Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of amputees patients referred by orthopaedic centres in the United Kingdom , whose population's characteristics are similar to France) identified 395 incident cases of upper limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or related to diabetes. The population was relatively young, aged between 15 and 54 year old.
On this basis, the estimated number of new cases of bilateral upper limb amputations throughout France should therefore be about 40 incident cases over a 5-year period.
This observational study is aimed at collecting comprehensive and high quality data to describe the French population of bilateral upper limb amputees.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All French patients :
- •presenting bilateral upper limb amputation, from short transverse amputation of the hand (hand not fully functional) to arm amputation;
- •affiliated with a social security scheme or assimilated;
- •who have given their non-opposition to participate in the study.
排除标准
- •Patients with finger amputation only;
- •Patients already having prosthesis of one upper limb (first amputation) and willing to receive prosthesis fitting after a contralateral amputation
结局指标
主要结局
Etiology of amputation
时间窗: At the time of the bilateral amputation (Day 0)
Etiological characteristics of bilateral upper limb amputees
Amputation level on each side
时间窗: At the time of the bilateral amputation (Day 0)
Epidemiological characteristics of bilateral upper limb amputees
次要结局
- Number and indication of surgical interventions(At the time the stumps are healed (an average of 1 month))
- Number and type of surgical and medical complications(At the time the stumps are healed (an average of 1 month))
- Length of stay in the hospital(At the time the stumps are healed (an average of 1 month))
- Duration before entry into rehabilitation centre(At the time the stumps are healed (an average of 1 month))
- Duration from surgical amputation to healing of the stumps(At the time the stumps are healed (an average of 1 month))
- Duration from surgical amputation to prosthesis fitting(At the time the stumps are healed (an average of 1 month))
- Type of planned prosthesis(At the time the stumps are healed (an average of 1 month))