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

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation Above Knee (Injury); Amputation
• Intervention / Treatment: Device: SPCM; Device: Usual Prothesis

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Hôpital d'Instruction des Armées (HIA) Percy
  • Nancy, France, 54000
    • UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy
  • Paris, France, 75007
    • Insitution Nationale des Invalides
  • Paris, France, 75013
    • Institut de Biomécanique Humaine Georges Charpak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPCM; Patients will be fitted with the SPCM prothesis	Device: SPCM; During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis
Active Comparator: Usual Prosthesis; Patients will be fitted with their usual microprocessor prosthesis	Device: Usual Prothesis; During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.	The aim is to compare the adaptation of the prosthetic system to the constraints of everyday life. SPCM adapts the ankle's behavior to the walking situation, and should make it possible to restore the time during which the foot remains flat during the stance phase, in different situations	Evaluation after 4 weeks' wear of each of the 2 prostheses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contralateral ankle power	Contralateral ankle power is a locomotor compensation device used by transfemoral amputees. It is a biomechanical parameter usually measured by quantified motion analysis (AQM). The SPCM prosthetic system is expected to reduce these power.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Pelvis elevation	Pelvis elevation is a locomotor compensation device used by transfemoral amputees. It is a biomechanical parameter usually measured by quantified motion analysis (AQM). The SPCM prosthetic system is expected to reduce these Pelvis elevation.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Toe clearance	Toe clearance is the distance between the toe of the foot and the ground during the swing phase. The greater this distance, the safer the patient. With SPCM, the toe clearance should increase, providing greater safety during pitch change in the swing phase.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Prosthesis evaluation	The PEQ is composed of 9 validated scales that are each comprised of multiple questions, and there are a number of additional individual questions. Each question is rated between 0 and 100. Higher number will correspond with a more positive response.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Locomotor abilities	It is composed of 14 questions about different locomotor activities. A 4-level ordinal scale (0-3 points; ranging from "not able" to "able to accomplish the activity alone") scores the degree of a person's perceived independence in performing each of the 14 activities while wearing the prosthesis. The higher the total score, the greater the patient's abilities.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Mobility	The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M provide a T-score that ranges from 17.5 to 76.6.A higher PLUS-M™ T-score corresponds to greater mobility.	Evaluation after 4 weeks' wear of each of the 2 prostheses
SF-36 Questionnaire	Socre of the SF-36 questionnaire, evaluation of the quality of life. The score range from 0 to 100. A higher score mean a better outcome.	Evaluation after 4 weeks' wear of each of the 2 prostheses
Number of steps	Quantifying real-life activity. The aim is to check whether the improvements observed during the laboratory motion analysis test are reflected in real life. Comparison of the number of steps recorded by the prosthesis sensors and those obtained during the laboratory gait analysis. Equivalence between the systems is expected.	Evaluation after 4 weeks' wear of SPCM
Cadence	Quantifying real-life activity. The aim is to check whether the improvements observed during the laboratory motion analysis test are reflected in real life. Comparison of the cadence recorded by the prosthesis sensors and those obtained during the laboratory gait analysis. Equivalence between the systems is expected.	Evaluation after 4 weeks' wear of SPCM

Collaborators and Investigators

• Sponsor: Institution Nationale des Invalides
• Collaborators: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est; Proteor Group; Hopital d'instruction des armées Percy (HIA Percy); Direction Générale de l'Armement

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SPCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No