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

Launched by LIBERATING TECHNOLOGIES, INC. · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to understand how powered prosthetic knees compare to traditional non-powered prosthetic knees for individuals with transfemoral (above-the-knee) amputations who are classified as K2-level users. The goal is to collect real-world data from users in the community to help healthcare providers make better decisions about which type of knee prosthesis will work best for each patient. By gathering this information, the researchers aim to ensure that veterans and others receiving healthcare can get the most effective devices, while also making the best use of available resources.

To be eligible for the study, participants need to be at least 18 years old, use a transfemoral prosthesis regularly (at least 5 days a week), and have been using a prosthesis for at least six months. They should also have a functional level determined to be K2 by a healthcare team. Participants will be expected to answer periodic study phone calls and share their experiences with the prosthetic knees. It's also important to know that individuals with certain injuries or conditions, or who have had recent changes to their prosthesis, may not be eligible for the study. Overall, this trial aims to improve the lives of prosthesis users by identifying the most beneficial features and guiding future device development.

Gender

ALL

Eligibility criteria

• 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 and 1.95m (47.2in and 76.8in)
• • Has a phone to answer periodic study calls
• Exclusion Criteria:
• • 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.