New Microprocessor-Controlled Prosthetic Knee Evaluation

NCT06017024 | Completed FDA Device

• 1 other identifier: 2022-A01266-37
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

Micro-processor controlled knee; Lower Limb prosthesis; Patient-specific Functional Scale

Outcome Measures

Primary Outcomes (1)

• Personal goal achievement

  Patient-specific Functional Scale - PSFS - \[0-10\], the higher the better

  test sessions 1 and 2 (20 minutes)

Secondary Outcomes (8)

• Functional walking test - mobility capacity

  test sessions 1 and 2 (8 minutes)

• Functional walking test - fast walking speed

  test sessions 1 and 2 (1 minute)

• Functional test - ability to walk downhill

  test sessions 1 and 2 (3 minutes)

• Functional test - ability to walk downstairs

  test sessions 1 and 2 (3 minutes)

• Questionnaire to assess comfort in the socket

  test sessions 1 and 2 (1 minute)

Study Arms (2)

Current microprocessor-controlled knee (MPK) then New MPK

EXPERIMENTAL

Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks

Device: microprocessor-controlled knee (MPK) assessment

New MPK then Current MPK

EXPERIMENTAL

Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks

Device: microprocessor-controlled knee (MPK) assessment

Interventions

microprocessor-controlled knee (MPK) assessment DEVICE

The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests

Current microprocessor-controlled knee (MPK) then New MPK; New MPK then Current MPK

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteor Group: lead

Study Sites (5)

Hôpital Léon Bérard

Hyères, France

Location

Clinique du Dr Ster

Lamalou-les-Bains, France

Location

UGECAM Nord-Est IRR

Nancy, France

Location

Centre Mutualiste de Kerpape

Ploemeur, France

Location

UGECAM La Tourmaline

Saint-Herblain, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 30, 2023
• Study Start: June 7, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)