Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees (NCT06194838)
Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (6 items).
Location: Hanger Clinic — Austin, Texas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hanger Clinic — Austin, Texas
📞 Contact the Study Coordinator
Phone: (402) 290-8051
Email: swurdeman@hanger.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: At a minimum, each subject will receive three training sessions to learn how to properly use each device for a variety of daily activities and a fourth session to demonstrate retention of the learn...
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.