New Microprocessor-Controlled Prosthetic Knee Evaluation

Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial

The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Amputation Above Knee (Injury)
• Intervention / Treatment: Device: microprocessor-controlled knee (MPK) assessment

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurine Calistri, MS; Phone Number: +33779825147; Email: laurine.calistri@proteor.com
• Study Contact Backup: Name: Victoria Spartacus, PhD; Email: victoria.spartacus@proteor.com

Study Locations

• France
  • Hyères, France
    • Recruiting
    • Hôpital Léon Bérard
  • Lamalou-les-Bains, France
    • Recruiting
    • Clinique du Dr Ster
  • Nancy, France
    • Recruiting
    • UGECAM Nord-Est IRR
  • Ploemeur, France
    • Recruiting
    • Centre Mutualiste de Kerpape
  • Saint-Herblain, France
    • Recruiting
    • UGECAM La Tourmaline

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Able to understand and give informed consent
• Man or woman, more than 18 y.o
• Lower limb amputee KD or AKA, unilateral or bilateral
• K3/K4 activity level
• Already fitted with FR-reimbursed MPK
• Being comfortable in their socket (SCS>=5)

Exclusion Criteria:

• Protected person
• Pregnant or breast feeding lady
• Person having pathologies affecting their sensitivity
• Using walking aids
• Weighting more than 136kg
• Insufficient hip joint or pelvic voluntary muscle control
• Insufficient cognitive ability to charge the knee and care for the device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Current microprocessor-controlled knee (MPK) then New MPK; Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks	Device: microprocessor-controlled knee (MPK) assessment; The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
Experimental: New MPK then Current MPK; Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks	Device: microprocessor-controlled knee (MPK) assessment; The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal goal achievement	Patient-specific Functional Scale - PSFS - [0-10], the higher the better	test sessions 1 and 2 (20 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional walking test - mobility capacity	6-minute walk test (6MWT)	test sessions 1 and 2 (8 minutes)
Functional walking test - fast walking speed	10-meter walk test (10mWT)	test sessions 1 and 2 (1 minute)
Functional test - ability to walk downhill	Hill assessment index (HAI) [0-11], the higher the better	test sessions 1 and 2 (3 minutes)
Functional test - ability to walk downstairs	Stairs assessment index (SAI) [0-13], the higher the better	test sessions 1 and 2 (3 minutes)
Questionnaire to assess comfort in the socket	Socket comfort score (SCS) [0-10], the higher the better	test sessions 1 and 2 (1 minute)
Questionnaire to assess satisfaction	Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better	test sessions 1 and 2 (5 minutes)
Questionnaires to assess quality of life	Short Form (36) health survey (SF-36); the higher the better	test sessions 1 and 2 (5 minutes)
Prosthesis Evaluation Questionnaire	PEQ, 8 sub-scales [0-100], the higher the better	test sessions 1 and 2 (29 minutes)

Collaborators and Investigators

• Sponsor: Proteor Group

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Micro-processor controlled knee; Lower Limb prosthesis; Patient-specific Functional Scale
• Other Study ID Numbers: 2022-A01266-37

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: Yes
• product manufactured in and exported from the U.S.: Yes