Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations
Liberating Technologies, Inc.
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.
Description
This study will focus on investigating the tradeoffs between powered knees and mechanical knees to identify the prosthetic knee that is best suited for K2 users during different tasks. The investigators will assess measured, observed, and self-reported outcomes achieved through real-world use of these prosthetic knees. The results of this study will (1) provide initial evidence to guide clinical prescription and use of powered knee technologies for K2-level individuals with sound scientific data, (2) provide pilot data for a larger clinical trial to further inform the evidence-based prescript…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 an…
Interventions
- DeviceOssur Power Knee
Newest version of the commercially-available powered knee developed by Ossur.
- DeviceReboocon Intuy Knee
Commercially-available powered knee developed by Reboocon.
Location
- Hanger ClinicAustin, Texas