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Prosthetic Device

Ossur Power Knee for Amputation (OPKTFA Trial)

N/A

Recruiting

Led By Steven A Gard, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Does not require the use of assistive devices to walk for short distances

Good skin integrity upon visual inspection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be measured after the 1-month accommodation period of wearing each prosthetic knee component

Awards & highlights

OPKTFA Trial Summary

This trial aims to compare two types of prosthetic knees - the Ossur Power Knee and the Ossur Rheo XC. The Power Knee uses a motor to provide active power during walking,

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed for this type of device trial, participants may experience discomfort or require time to adjust when switching between different types of prosthetic knees.

OPKTFA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk short distances without help from devices.

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My skin is healthy and intact.

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I have had one leg amputated above the knee.

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I am between 45 and 75 years old.

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My residual limb is of medium to long length.

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I can walk with some assistance or devices.

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I have been using a prosthesis for at least one year.

OPKTFA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be measured after the 1-month accommodation period of wearing each prosthetic knee component

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be measured after the 1-month accommodation period of wearing each prosthetic knee component

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be measured after the 1-month accommodation period of wearing each prosthetic knee component for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metabolic energy cost

Sit-to-stand/stand-to-sit symmetry

Walking speed

Secondary outcome measures

Kinematics of pelvic motion

Sound leg loading rate

Step length

+1 more

OPKTFA Trial Design

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,273 Total Patients Enrolled

Steven A Gard, PhDPrincipal InvestigatorJesse Brown VA Medical Center, Chicago, IL

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific goals and objectives of this research study?

"The primary goal of this trial is to assess the symmetry between sit-to-stand and stand-to-sit movements after a one-month accommodation period with each prosthetic knee component. Secondary objectives include measuring step length during walking at different speeds on level ground, toe clearance during swing phase on the prosthetic side while walking at various speeds, and sound leg loading rate during walking on level ground at slow, normal, and fast speeds."

Answered by AI

Do I meet the necessary criteria to participate in this research trial?

"To be deemed eligible for this clinical trial, potential participants must have undergone leg amputation and fall within the age range of 45 to 75. The study aims to enroll approximately 20 individuals."

Answered by AI

Is the enrollment process currently ongoing for individuals interested in participating in this trial?

"As per the information available on clinicaltrials.gov, this particular study is not currently accepting new participants. It was first posted on April 1st, 2024 and last updated on January 11th, 2024. However, it's important to note that there are still other ongoing clinical trials actively seeking volunteers at this time. In fact, there are currently one additional clinical trial in search of eligible participants."

Answered by AI