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Bilateral Upper Limb Amputation Observatory

Observational Study of Bilateral Upper Limb Amputees in France

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02835378
Acronym
ARMOBS
Enrollment
40
Registered
2016-07-18
Start date
2015-12-31
Completion date
2020-12-31
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

bilateral upper limb amputation, prosthetic fitting, epidemiology, clinical practices, totally non-functional hand

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.

Interventions

OTHERNo intervention

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Etiology of amputationAt the time of the bilateral amputation (Day 0)Etiological characteristics of bilateral upper limb amputees
Amputation level on each sideAt the time of the bilateral amputation (Day 0)Epidemiological characteristics of bilateral upper limb amputees

Secondary

MeasureTime frame
Length of stay in the hospitalAt the time the stumps are healed (an average of 1 month)
Duration before entry into rehabilitation centreAt the time the stumps are healed (an average of 1 month)
Number and indication of surgical interventionsAt the time the stumps are healed (an average of 1 month)
Duration from surgical amputation to prosthesis fittingAt the time the stumps are healed (an average of 1 month)
Type of planned prosthesisAt the time the stumps are healed (an average of 1 month)
Duration from surgical amputation to healing of the stumpsAt the time the stumps are healed (an average of 1 month)
Number and type of surgical and medical complicationsAt the time the stumps are healed (an average of 1 month)

Countries

France

Contacts

Primary ContactLionel BADET, Pr
lionel.badet@chu-lyon.fr(0)4 72 11 91 91
Backup ContactMarie KOENIG
marie.koenig@chu-lyon.fr(0)4 72 11 57 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026