Bilateral Upper Limb AmputationARMOBSNCT02835378
Bilateral Upper Limb Amputation Observatory
An observational study of Bilateral Upper Limb Amputation and Transverse Short Amputation of the Hand, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bilateral Upper Limb Amputation, Transverse Short Amputation of the Hand, Arm Amputation
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All incident case of bilateral upper limb amputation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, 69003
Lionel BADET, Pr, (0)4 72 11 91 91 ext. +33, lionel.badet@chu-lyon.fr
Marie KOENIG, (0)4 72 11 57 89 ext. +33, marie.koenig@chu-lyon.fr
About this study
Official title: 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.
Read more
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.
- Being tested
- No intervention
- Keywords
- bilateral upper limb amputation, prosthetic fitting, epidemiology, clinical practices, totally non-functional hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology of amputation
Etiological characteristics of bilateral upper limb amputees
Measured: At the time of the bilateral amputation (Day 0)
Amputation level on each side
Epidemiological characteristics of bilateral upper limb amputees
Measured: At the time of the bilateral amputation (Day 0)
Secondary outcomes (7)
Number and indication of surgical interventions
Measured: At the time the stumps are healed (an average of 1 month)
Number and type of surgical and medical complications
Measured: At the time the stumps are healed (an average of 1 month)
Length of stay in the hospital
Measured: At the time the stumps are healed (an average of 1 month)
Duration before entry into rehabilitation centre
Measured: At the time the stumps are healed (an average of 1 month)
Duration from surgical amputation to healing of the stumps
Measured: At the time the stumps are healed (an average of 1 month)
Duration from surgical amputation to prosthesis fitting
Measured: At the time the stumps are healed (an average of 1 month)
Type of planned prosthesis
Measured: At the time the stumps are healed (an average of 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Upper Limb AmputationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel BADET, Pr, Principal investigator, Hospices Civils de Lyon, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835378
- Sponsor's protocol ID
- 69HCL16_0465
- Acronym
- ARMOBS
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Bilateral Upper Limb Amputees in France
- ClinicalTrials.gov ID
- NCT02835378
- Acronym / sponsor ID
- ARMOBS / 69HCL16_0465
- Keywords
- bilateral upper limb amputation, prosthetic fitting, epidemiology, clinical practices, totally non-functional hand
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral upper limb amputation | – | Other: No interventionBilateral upper limb amputees, with amputation from the short transverse hand (hand completely non-functional) to complete arm, whatever their age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All incident case of bilateral upper limb amputation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Bilateral upper limb amputation |
Primary outcome
Etiology of amputation
Time frame: At the time of the bilateral amputation (Day 0)
Etiological characteristics of bilateral upper limb amputees
Amputation level on each side
Time frame: At the time of the bilateral amputation (Day 0)
Epidemiological characteristics of bilateral upper limb amputees
7 secondary outcomes
Number and indication of surgical interventions
Time frame: 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)
Length of stay in the hospital
Time frame: 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)
Duration from surgical amputation to healing of the stumps
Time frame: 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)
Type of planned prosthesis
Time frame: At the time the stumps are healed (an average of 1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
Related trials for Bilateral Upper Limb Amputation
Recruiting
Research on Wireless Brain Implant System for General Control of External Devices
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Recruiting
Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
Amputation
Recruiting
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Bilateral Traumatic Amputation of Upper Limbs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel BADET, Pr principal investigator
Hospices Civils de Lyon, Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Upper Limb Amputation and Transverse Short Amputation of the Hand, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel BADET, Pr ((0)4 72 11 91 91 ext. +33, lionel.badet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiology of amputation (time frame: At the time of the bilateral amputation (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.