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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiberating Technologies, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ossur Power Knee
  • Reboocon Intuy Knee

Treatment groups

26 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Liberating Technologies, Inc.

Lead sponsor

Hanger Clinic: Prosthetics & Orthotics

Collaborator