Recruiting

Prosthetic Knees

Sponsor:

Liberating Technologies, Inc.

Code:

NCT06194838

Conditions

Amputation

Amputation; Traumatic, Leg, Lower

Limb; Absence, Congenital, Lower

Prosthesis User

Lower Limb Amputation Above Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ossur Power Knee

Reboocon Intuy Knee

Study Details

Brief summary:

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.

Conditions

Amputation

Amputation; Traumatic, Leg, Lower

Limb; Absence, Congenital, Lower

Prosthesis User

Lower Limb Amputation Above Knee (Injury)

Study ID

NCT06194838

Start date

Sep 12, 2023

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Comparator Baseline

The subject will wear the Ossur OFM-2, a passive mechanical knee which is the most commonly used knee for K2 users, for 3 months, as well as in the lab to complete outcome measures.

experimental: Ossur Power Knee

The subject will wear the Ossur Power Knee for 3 months, as well as in the lab to complete outcome measures.

experimental: Reboocon Intuy Knee

The subject will wear the Reboocon Intuy Knee for 3 months, as well as in the lab to complete outcome measures.

Interventions

Ossur Power Knee

Newest version of the commercially-available powered knee developed by Ossur.

Reboocon Intuy Knee

Commercially-available powered knee developed by Reboocon.

Primary outcome measure

  • Step count [ Time Frame: Monitored over entire study (9 months) ]
  • Activities-Specific Balance Confidence scale (ABC) - Measuring change from baseline [ Time Frame: Throughout study completion, an average of 9 months ]
  • Prosthesis Evaluation Questionnaire - Well Being (PEQ-WB) - Measuring change from baseline [ Time Frame: Throughout study completion, an average of 9 months ]

Central Contacts and Locations

Central contacts

Shane Wurdeman, PhD

402-290-8051swurdeman@hanger.com

Jennifer Johansson, MS

774-233-0874jen.johansson@liberatingtech.com

Locations

Hanger Clinic

Recruiting

Austin, Texas, United States, 78758

Contacts

Shane Wurdeman, PhD

402-290-8051swurdeman@hanger.com

Siya Asatkar

512-774-7105sasatkar@hanger.com

More Information

Sponsor

Liberating Technologies, Inc.

Last update posted

Sep 3, 2025

Last verified

Sep, 2025

Keywords

  • amputee
  • lower limb amputee
  • transfemoral amputee
  • prosthetic knee
  • power knee
  • mechanical knee
  • lower limb prosthesis user

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Liberating Technologies, Inc. on 2025-09-03.