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New treatment option for Amputation
Official title Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
ClinicalTrials.gov ID: NCT06194838
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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 people can be excluded...
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.