Status:
COMPLETED
New Microprocessor-Controlled Prosthetic Knee Evaluation
Lead Sponsor:
Proteor Group
Conditions:
Lower Limb Amputation Above Knee (Injury)
Eligibility:
All Genders
18-85 years
Phase:
NA
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06017024
Start Date
June 7 2023
End Date
December 11 2024
Last Update
December 13 2024
Active Locations (5)
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1
Hôpital Léon Bérard
Hyères, France
2
Clinique du Dr Ster
Lamalou-les-Bains, France
3
UGECAM Nord-Est IRR
Nancy, France
4
Centre Mutualiste de Kerpape
Ploemeur, France