Comparing powered and mechanical prosthetic knees for K2-level amputees

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.

  This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.

  Recruiting Hanger Institute for Clinical Research and Education, LLC · Austin, Texas · NCT06937242

• Effect of EMG sensor number and placement on control of below-elbow prosthetic arms

  This project will test whether changing the number and placement of myoelectric sensors helps adults with below-elbow limb absence control a prosthetic arm better while wearing a real device.

  Recruiting Liberating Technologies, Inc. · Chicago, Illinois and 1 other locations · NCT07011420

• Assessment of patients with transfemoral amputation using osseointegrated implants

  This study is testing if a new type of implant that attaches directly to the bone can help people with transfemoral amputation move better and feel more comfortable than traditional prosthetic sockets.

  Recruiting Istituto Ortopedico Rizzoli · Bologna, Bologna · NCT06737770

• Osseointegrated (bone-anchored) prosthesis for below-knee (transtibial) amputation

  This trial tests whether the OPRA bone-anchored implant helps people aged 22–65 with transtibial (below-knee) amputations who cannot use or do not benefit from socket prostheses.

  Recruiting at 2 sites Walter Reed National Military Medical Center · Bethesda, Maryland and 1 other locations · NCT06636136

• Understanding the impact of powered prosthetics on walking for transfemoral amputees

  This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.

  Recruiting Shirley Ryan AbilityLab · Chicago, Illinois · NCT06433648

• Improving walking skills for lower limb prosthesis users on uneven terrain

  This study tests a walking program for people using lower limb prostheses to see if training on uneven surfaces helps them walk better and feel more confident.

  Recruiting University of Nevada, Las Vegas · Las Vegas, Nevada · NCT06419920

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.