Recruiting

Biomechanical Evaluation

Sponsor:

VA Office of Research and Development

Code:

NCT06218238

Conditions

Transfemoral Amputation

Limb Loss

Limb Absence

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Powered prosthetic knee joint

Conventional prosthetic knee joint

Study Details

Brief summary:

Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.

Conditions

Transfemoral Amputation

Limb Loss

Limb Absence

Study ID

NCT06218238

Start date

Apr 1, 2024

Status verified date

Sep, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral, transfemoral amputation (any etiology).
  • Age from 45-75 years.
  • Residual limb length classified as standard (i.e., medium) to long.
  • Prosthesis user for at least 1 year prior to enrolling in the study.
  • K3 or K4 level ambulator.
  • Good sensation on their residual limb(s) (upon routine clinical examination).
  • Good skin integrity upon visual inspection.
  • Does not require the use of assistive devices to walk for short distances.
  • Not currently taking medications that are known to affect balance or gait.
  • Presents with good socket fit based upon a standard assessment by the study prosthetist.

Exclusion Criteria:

  • Bilateral amputations
  • Individuals with a knee disarticulation

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ossur Power Knee

Subjects will be fitted with the Ossur Power Knee, which has powered flexion and extension.

active comparator: Ossur Rheo XC Knee

Subjects will be fitted with the Ossur Rheo XC Knee, which is a conventional microprocessor-controlled knee joint that modulates the amount of damping during flexion and extension.

Interventions

Powered prosthetic knee joint

Subjects will be fitted and trained on the Ossur Power Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.

Conventional prosthetic knee joint

Subjects will be fitted and trained on the Ossur Rheo XC Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.

Primary outcome measure

  • Walking speed [ Time Frame: To be measured after the 1-month accommodation period of wearing each prosthetic knee component ]
  • Metabolic energy cost [ Time Frame: To be measured after the 1-month accommodation period of wearing each prosthetic knee component ]
  • Sit-to-stand/stand-to-sit symmetry [ Time Frame: To be measured after the 1-month accommodation period of wearing each prosthetic knee component ]

Central Contacts and Locations

Central contacts

Rebecca Stine, MS

(312) 503-5726rebecca.stine@va.gov

Steven A Gard, PhD

steven.gard@va.gov

Locations

Jesse Brown VA Medical Center, Chicago, IL

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Rebecca Stine, MS

312-503-5726rebecca.stine@va.gov

Steven A Gard, PhD

steven.gard@va.gov

Principal Investigator:

Steven A Gard, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • amputation
  • limb loss
  • limb deficiency
  • transfemoral
  • above-knee
  • prosthesis
  • knee joint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-09-09.