A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT06218238
Status
Recruiting
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Conditions

  • Limb Absence
  • Limb Loss
  • Transfemoral Amputation

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Powered prosthetic knee joint — OTHER
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Walking speed [ Time Frame: To be measured after the 1-month accommodation period of wearing each prosthetic knee component ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jesse Brown VA Medical Center, Chicago, ILChicagoIllinois60612
Rebecca Stine, MS
[email protected]
312-503-5726
Steven A Gard, PhD
[email protected]
Steven A Gard, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Jesse Brown VA Medical Center, Chicago, IL· Chicago, IL

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