Comparing powered and mechanical prosthetic knees for K2-level amputees
Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations
This study is testing whether powered prosthetic knees work better than mechanical ones for K2-level amputees to help improve their mobility and make better choices for future prosthetic designs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liberating Technologies, Inc. Industry-sponsored |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06194838 on ClinicalTrials.gov |
What this trial studies
This project aims to collect community-based data from K2-level transfemoral amputees to determine the most effective prosthetic knee options. The study will compare powered prosthetic knees with mechanical ones to assess their performance in real-world settings. Participants will be involved in a pilot longitudinal randomized crossover study, testing different knee types to gather evidence that can guide clinical prescriptions and improve future prosthetic designs. The findings will also help optimize the use of healthcare resources by ensuring that powered knees are prescribed only to those who will benefit from them.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are transfemoral prosthesis users with a K-Level of 2 and regularly wear their prosthesis.
Not a fit: Patients with current injuries to their residual limb or those with specific medical conditions affecting their functional ability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized prosthetic knee prescriptions for K2-level amputees, enhancing their mobility and quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving prosthetic outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Austin, Texas
- Hanger Clinic — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Johansson, MS — Liberating Technologies, Inc.
- Study coordinator: Shane Wurdeman, PhD
- Email: swurdeman@hanger.com
- Phone: 402-290-8051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.