Bilateral Upper Limb Amputation Observatory (ARMOBS)

July 15, 2016 updated by: Hospices Civils de Lyon

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon, Hôpital Edouard Herriot
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All incident case of bilateral upper limb amputation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: No intervention

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Lionel BADET, Pr, Hospices Civils de Lyon, Hôpital Edouard Herriot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL16_0465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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