Bilateral Upper Limb Amputation Observatory

NCT ID: NCT02835378

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Bilateral Upper Limb Amputation Transverse Short Amputation of the Hand Arm Amputation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lionel BADET, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, Hôpital Edouard Herriot

Locations

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Hospices Civils de Lyon, Hôpital Edouard Herriot

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lionel BADET, Pr

Role: CONTACT

(0)4 72 11 91 91 ext. +33

Marie KOENIG

Role: CONTACT

(0)4 72 11 57 89 ext. +33

Facility Contacts

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Lionel BADET, Pr

Role: primary

(0)4 72 11 91 91 ext. +33

Marie KOENIG

Role: backup

(0)4 72 11 57 89 ext. +33

Other Identifiers

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69HCL16_0465

Identifier Type: -

Identifier Source: org_study_id

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