Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)

Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)

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 prosthesis".

The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people.

This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.

Inclusion Criteria:

• 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 Criteria:

• 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.