NCT02835378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

July 13, 2016

Last Update Submit

July 15, 2016

Conditions

Bilateral Upper Limb AmputationTransverse Short Amputation of the HandArm Amputation

Keywords

bilateral upper limb amputationprosthetic fittingepidemiologyclinical practicestotally non-functional hand

Outcome Measures

Primary Outcomes (2)

  • Etiology of amputation

    Etiological characteristics of bilateral upper limb amputees

    At the time of the bilateral amputation (Day 0)

  • Amputation level on each side

    Epidemiological characteristics of bilateral upper limb amputees

    At the time of the bilateral amputation (Day 0)

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

No interventionOTHER
Bilateral upper limb amputation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All incident case of bilateral upper limb amputation

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

Study Officials

  • Lionel BADET, Pr

    Hospices Civils de Lyon, Hôpital Edouard Herriot

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel BADET, Pr

CONTACT

(0)4 72 11 91 91lionel.badet@chu-lyon.fr

Marie KOENIG

CONTACT

(0)4 72 11 57 89marie.koenig@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 18, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

FR(1)