Bilateral Upper Limb Amputation Observatory

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Observational Study of Bilateral Upper Limb Amputees in France

Conditions
-----------------
Bilateral Upper Limb Amputation, Transverse Short Amputation of the Hand, Arm Amputation

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral upper limb amputation<br>Bilateral upper limb amputees, with amputation from the short transverse hand (hand completely non-functional) to complete arm, whatever their age | Other: No intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etiology of amputation | Etiological characteristics of bilateral upper limb amputees | At the time of the bilateral amputation (Day 0) | 
| Amputation level on each side | Epidemiological characteristics of bilateral upper limb amputees | At the time of the bilateral amputation (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bilateral upper limb amputation, prosthetic fitting, epidemiology, clinical practices, totally non-functional hand