Bilateral Upper Limb Amputation Observatory

• Conditions: Bilateral Upper Limb Amputation; Transverse Short Amputation of the Hand; Arm Amputation
• Interventions: Other: No intervention

• Registration Number: NCT02835378
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral upper limb amputation	No intervention	Bilateral upper limb amputees, with amputation from the short transverse hand (hand completely non-functional) to complete arm, whatever their age

Primary Outcome Measures

Name	Time	Method
Etiology of amputation	At the time of the bilateral amputation (Day 0)	Etiological characteristics of bilateral upper limb amputees
Amputation level on each side	At the time of the bilateral amputation (Day 0)	Epidemiological characteristics of bilateral upper limb amputees

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospices Civils de Lyon, Hôpital Edouard Herriot; 🇫🇷 Lyon, France