Clinical trial NCT02835378: Bilateral Upper Limb Amputation Observatory
Official title: Observational Study of Bilateral Upper Limb Amputees in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bilateral Upper Limb Amputation
Transverse Short Amputation of the Hand
Arm Amputation
Keywords: bilateral upper limb amputation
prosthetic fitting
epidemiology
clinical practices
totally non-functional hand
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All incident case of bilateral upper limb amputation

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.


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

Primary outcomes:
measure: Etiology of amputation
timeFrame: At the time of the bilateral amputation (Day 0)
measure: Amputation level on each side
timeFrame: At the time of the bilateral amputation (Day 0)
Secondary outcomes:
measure: Number and indication of surgical interventions
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Number and type of surgical and medical complications
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Length of stay in the hospital
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Duration before entry into rehabilitation centre
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Duration from surgical amputation to healing of the stumps
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Duration from surgical amputation to prosthesis fitting
timeFrame: At the time the stumps are healed (an average of 1 month)
measure: Type of planned prosthesis
timeFrame: At the time the stumps are healed (an average of 1 month)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital Edouard Herriot
name: Lionel BADET, Pr
role: PRINCIPAL_INVESTIGATOR
References: