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

Institution Nationale des Invalides

Status

Completed

Conditions

Amputation

Lower Limb Amputation Above Knee (Injury)

Treatments

Device: SPCM

Device: Usual Prothesis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06522646

SPCM

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.