Bilateral Upper Limb Amputation Observatory (ARMOBS)
Observational Study of Bilateral Upper Limb Amputees in France
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Recruiting
- Hospices Civils de Lyon, Hôpital Edouard Herriot
-
Contact:
- Lionel BADET, Pr
- Phone Number: +33 (0)4 72 11 91 91
- Email: lionel.badet@chu-lyon.fr
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Contact:
- Marie KOENIG
- Phone Number: +33 (0)4 72 11 57 89
- Email: marie.koenig@chu-lyon.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bilateral upper limb amputation
Bilateral upper limb amputees, with amputation from the short transverse hand (hand completely non-functional) to complete arm, whatever their age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Etiology of amputation
Time Frame: At the time of the bilateral amputation (Day 0)
|
Etiological characteristics of bilateral upper limb amputees
|
At the time of the bilateral amputation (Day 0)
|
|
Amputation level on each side
Time Frame: At the time of the bilateral amputation (Day 0)
|
Epidemiological characteristics of bilateral upper limb amputees
|
At the time of the bilateral amputation (Day 0)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number and indication of surgical interventions
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Number and type of surgical and medical complications
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Length of stay in the hospital
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Duration before entry into rehabilitation centre
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Duration from surgical amputation to healing of the stumps
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Duration from surgical amputation to prosthesis fitting
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
|
Type of planned prosthesis
Time Frame: At the time the stumps are healed (an average of 1 month)
|
At the time the stumps are healed (an average of 1 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lionel BADET, Pr, Hospices Civils de Lyon, Hôpital Edouard Herriot
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL16_0465
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