RecruitingNot ApplicableNCT06194838

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations

Sponsor

Liberating Technologies, Inc.

Enrollment

26 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

Amputation Lower Limb Amputation Above Knee (Injury)Amputation; Traumatic, Leg, Lower Limb; Absence, Congenital, Lower Prosthesis User Amputation; Traumatic, Leg: Thigh, Between Hip and Knee

Summary

The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

Are at least 18 years old
Transfemoral prosthesis user (limb absence between the knee and hip)
Current user of a mechanical knee
Regularly wears prosthesis at least 5 days per week
Have adequate clearance between distal end and ground for necessary knee and foot components
Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team
Socket-Comfort Score: 6 or above to ensure adequate socket fit
Six months or more experience on a prosthesis
Body weight between 50kg and 116kg (110lbs - 256lbs)
Height between 1.2m and 1.95m (47.2in and 76.8in)
Has a phone to answer periodic study calls

Exclusion Criteria8

Present injuries to residual limb or contralateral leg affecting functional ability
Contralateral amputation proximal to MTP (metatarsophalangeal) joint
Socket issues/changes in the last 6 weeks
Users with bone-anchored implants
Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and/or completing the study
Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).
If subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.
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.

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