Status:
COMPLETED
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
Lead Sponsor:
Institution Nationale des Invalides
Collaborating Sponsors:
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Hopital d'instruction des armées Percy (HIA Percy)
Conditions:
Amputation
Lower Limb Amputation Above Knee (Injury)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual p...
Eligibility Criteria
Inclusion
- Amputee at or above knee level
- Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
- Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
- Person able to understand simple commands, to read and write, and to give their informed consent
- Person who has given informed consent
- Person affiliated to a social security scheme
Exclusion
- Minor
- Person of full age subject to a legal protection measure or unable to express consent
- Pregnant or breast-feeding women
- Persons with bilateral amputations
- Person with a neurological or orthopedic pathology with major repercussions on locomotion
- Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
- Persons weighing more than 125 kg
- Foot size less than 24 cm or greater than 30 cm
- Person with a hip disarticulation
- Person without an emergency walking solution
- Person with a suspension fitting with vacuum pump
- Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06522646
Start Date
July 9 2018
End Date
May 31 2023
Last Update
July 26 2024
Active Locations (4)
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1
Hôpital d'Instruction des Armées (HIA) Percy
Clamart, France, 92140
2
UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy
Nancy, France, 54000
3
Insitution Nationale des Invalides
Paris, France, 75007
4
Institut de Biomécanique Humaine Georges Charpak
Paris, France, 75013