Status:
TERMINATED
Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients
Lead Sponsor:
University Hospital, Angers
Conditions:
Amputation
Adult Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volum...
Detailed Description
With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.
Eligibility Criteria
Inclusion
- Patients aged 18 years old and above
- Above knee or below knee amputation (irrespective of etiology and time from amputation)
- Residual limb pain
- Prosthetic with classic fitting
- Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting …)
- Recipients or registered with a social security scheme
- Informed consent form signed beforehand
Exclusion
- Patient with peripheral neuropathies contraindicating the use of Revofit system
- Pregnant woman, nursing mother or parturiant
- Patient in detention by judicial or administrative decision
- Patient undergoing psychiatric compulsory care
- Patient in a health or social institution for purposes other than research
- Legally protected person
- Patient unable to express their consent
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04276714
Start Date
February 22 2021
End Date
March 10 2021
Last Update
July 6 2022
Active Locations (1)
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1
DIMONAIS
Angers, France, 49100