20 Participants Needed

Powered vs Conventional Prosthetic Knees for Amputation

(OPKTFA Trial)

SA
RS
Overseen ByRebecca Stine, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking medications that affect balance or walking.

Is the powered prosthetic knee generally safe for humans?

Research shows that powered prosthetic knees, like the Ossur Power Knee, are designed to improve mobility and control for amputees, but specific safety data is not detailed in the available studies. However, microprocessor-controlled prosthetic knees have been found to offer safety benefits in community settings, suggesting that powered knees may also be safe.12345

How does the Ossur Power Knee treatment differ from conventional prosthetic knees for amputees?

The Ossur Power Knee is unique because it is a powered prosthetic knee that uses motors to provide active support, making movements like sitting down more controlled and less difficult for above-knee amputees. Unlike conventional passive prosthetic knees, which rely on resistive damper systems, the Power Knee can generate positive power, potentially improving mobility and reducing the need for over-compensation with other body parts.25678

What data supports the effectiveness of powered prosthetic knees for amputation?

Research shows that powered prosthetic knees, like the Ossur Power Knee, can improve mobility and reduce the strain on the hip muscles for people with above-knee amputations. They provide better control and support during movements like sitting down, compared to passive prosthetic knees, which can enhance overall functional mobility.12457

Who Is on the Research Team?

SA

Steven A Gard, PhD

Principal Investigator

Jesse Brown VA Medical Center, Chicago, IL

Are You a Good Fit for This Trial?

This trial is for individuals with a transfemoral amputation, meaning they have had an amputation above the knee. Participants should be current users of a conventional prosthetic knee joint and willing to try out a powered prosthetic knee joint.

Inclusion Criteria

I can walk short distances without help from devices.
My skin is healthy and intact.
I have had one leg amputated above the knee.
See 7 more

Exclusion Criteria

I have had both of my limbs amputated.
I have had a knee disarticulation surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Accommodation

Participants undergo a 1-month accommodation period with each prosthetic knee component

4 weeks

Biomechanical Evaluation

Participants are evaluated for gait, stairs, slopes, and sit-to-stand activities using the Ossur Power Knee and Ossur Rheo XC

4 weeks
Multiple visits for data collection

Follow-up

Participants are monitored for safety and effectiveness after the evaluation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional prosthetic knee joint
  • Ossur Power Knee
Trial Overview The study is testing the Ossur Power Knee, which uses motors to help in walking and other activities, against the Ossur Rheo XC, which does not use motors but adjusts automatically during movement. The comparison will look at how each affects mobility.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Ossur Power KneeExperimental Treatment1 Intervention
Subjects will be fitted with the Ossur Power Knee, which has powered flexion and extension.
Group II: Ossur Rheo XC KneeActive Control1 Intervention
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.

Conventional prosthetic knee joint is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Conventional prosthetic knee joint for:
  • Transfemoral amputation
  • Lower limb amputation
🇪🇺
Approved in European Union as Conventional prosthetic knee joint for:
  • Transfemoral amputation
  • Lower limb amputation
🇨🇦
Approved in Canada as Conventional prosthetic knee joint for:
  • Transfemoral amputation
  • Lower limb amputation

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

The use of an active powered microprocessor-controlled prosthetic knee (A-MPK) resulted in greater knee range of motion and reduced hip torque during walking compared to a passive microprocessor-controlled prosthetic knee (P-MPK) in four transfemoral amputees, suggesting improved gait mechanics.
A follow-up case study indicated that using the A-MPK for four weeks increased the amputee's confidence and highlighted the importance of adaptation time for optimizing the benefits of the A-MPK.
Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking.Creylman, V., Knippels, I., Janssen, P., et al.[2018]
The development of a passive polycentric knee joint for trans-femoral amputees led to a significant increase in health-related quality of life (HRQL), with physical and mental scores improving by 49% and 46% respectively after 6 months of use.
The prosthetic device demonstrated enhanced performance, achieving a global score of 63, indicating that this affordable knee joint could greatly benefit trans-femoral amputees and should be considered for wider use.
Rehabilitation evaluation of the newly developed polymeric based passive polycentric knee joint.Arun, S., Marbaniang, B., Borgohain, B., et al.[2021]
In a study comparing prosthetic knee systems for U.S. military service members with transfemoral amputations, the Power Knee™ (PK) showed greater peak knee power in the amputated limb during sit-to-stand tasks compared to the C-Leg, suggesting enhanced performance for PK users.
Despite the differences in knee power, both prosthetic systems resulted in greater forces on the intact limb, indicating that while PK may improve certain tasks, it does not significantly reduce impact on the remaining joints compared to the C-Leg.
Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks.Wolf, EJ., Everding, VQ., Linberg, AA., et al.[2022]

Citations

Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking. [2018]
Rehabilitation evaluation of the newly developed polymeric based passive polycentric knee joint. [2021]
Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks. [2022]
Can a powered knee-ankle prosthesis improve weight-bearing symmetry during stand-to-sit transitions in individuals with above-knee amputations? [2023]
The effect of microprocessor controlled exo-prosthetic knees on limited community ambulators: systematic review and meta-analysis. [2023]
Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. [2022]
Biomechanical responses of young adults with unilateral transfemoral amputation using two types of mechanical stance control prosthetic knee joints. [2022]
Gait asymmetry of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. [2022]
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