Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower
About this trial
This is an interventional other trial for Amputation focused on measuring amputee, lower limb amputee, transfemoral amputee, prosthetic knee, power knee, microprocessor knee, MPK, Ossur, lower limb prosthesis user
Eligibility Criteria
Inclusion Criteria:
- Are at least 18 years old
- Unilateral transfemoral prosthesis user (limb absence between the knee and hip)
- Current user of a microprocessor-controlled knee (MPK)
- Have adequate clearance between distal end and ground for necessary knee and foot components
- Medicare Functional Classification Level (K-Level): 4
- Socket-Comfort Score: 6 or above to ensure adequate socket fit
- PLUS-M T-score of 55 or above
- Six months or more experience on a prosthesis
- Body weight between 50kg and 116kg (110lbs - 256lbs)
Exclusion Criteria:
- Present injuries to residual limb or contralateral leg affecting functional ability
- Socket issues/changes in the last 6 weeks
- Users with bone-anchored implants
Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.). Subjects in this study will not be discriminated by sex/gender or race/ethnicity.
Using a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
Sites / Locations
- Liberating Technologies, Inc.
- Hanger ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Comparator Baseline
Power Knee
The subject will wear their usual Microprocessor Knee (MPK) for 3 months, as well as in the lab to complete outcome measures.
The subject will wear the Ossur PK in place of their usual MPK for 3 months, as well as in the lab to complete outcome measures.