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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation Lower Limb Amputation Above Knee (Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPCM

Patients will be fitted with the SPCM prothesis

Group Type EXPERIMENTAL

SPCM

Intervention Type DEVICE

During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis

Usual Prosthesis

Patients will be fitted with their usual microprocessor prosthesis

Group Type ACTIVE_COMPARATOR

Usual Prothesis

Intervention Type DEVICE

During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis

Interventions

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SPCM

During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis

Intervention Type DEVICE

Usual Prothesis

During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No