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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Austin

Hanger Clinic, Austin, Texas, United States, 78758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 and 1.95m (47.2in and 76.8in)
  • * Has a phone to answer periodic study calls
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Liberating Technologies, Inc.,

Jennifer Johansson, MS, PRINCIPAL_INVESTIGATOR, Liberating Technologies, Inc.

Study Record Dates

2025-08-31