NU-FlexSIS Prosthetic Socket for Leg Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new type of prosthetic leg socket called the NU-FlexSIS, designed to enhance comfort and mobility for individuals with an above-knee amputation. Researchers aim to determine if this new socket outperforms the current standard, the ischial containment socket, in terms of wear time, overall mobility, and quality of life. Participants will either continue with their regular socket or switch to the new socket for evaluation. The trial seeks individuals who have had a transfemoral amputation, have used a prosthetic leg for at least a year, and experience limited mobility. As an unphased trial, this study offers a unique opportunity to contribute to advancements in prosthetic technology and potentially improve personal mobility and comfort.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on prosthetic use, so it's unlikely that medication changes are required.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the NU-FlexSIS prosthetic socket is safe for individuals with leg amputation?
Research shows that the Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) is generally well-received by patients. Studies have found that this socket design makes it more comfortable and easier for people with above-knee amputations to move. Users have shared positive experiences about how the socket feels and aids their mobility.
In earlier studies, patients reported feeling more comfortable, stable, and able to move better with the NU-FlexSIS. These benefits suggest that the socket design is safe and user-friendly. No serious problems related to the socket have been reported, indicating its safety.
Although the studies do not specifically focus on safety, the positive feedback about comfort and ease of use suggests that users manage the socket well.12345Why are researchers excited about this trial?
Researchers are excited about the NU-FlexSIS Prosthetic Socket because it offers a novel approach to prosthetic fitting for individuals with leg amputations. Traditional prosthetic sockets often use ischial containment designs, which can be uncomfortable and restrictive. In contrast, the NU-FlexSIS socket utilizes a flexible subischial suction system, allowing for greater comfort and mobility. This innovative design aims to improve the overall quality of life for users by reducing pressure and increasing range of motion, which could lead to more natural movement and enhanced daily activity.
What evidence suggests that the NU-FlexSIS prosthetic socket is effective for improving comfort and mobility in individuals with leg amputation?
Research shows that the Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) offers a promising option for people with leg amputations. Studies have found this socket design to be more comfortable than traditional ischial containment sockets. It aims to improve comfort and allow for better movement, potentially enhancing mobility and quality of life. Previous evaluations, including walking tests and comfort ratings, suggest that users of the NU-FlexSIS socket experience similar function with added comfort. In this trial, participants in the intervention group will transition from their usual ischial containment socket to the NU-FlexSIS socket to assess its impact on comfort and mobility. This innovative design appears to provide a more comfortable fit for those with above-knee amputations.12467
Who Is on the Research Team?
Stefania Fatone, PhD
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a below-knee amputation who have been using a prosthesis for at least a year. They should be able to perform limited community walking, use their upper limbs, and manage technology like computers or smartphones. Veterans are specifically included at VA sites. Participants must not plan to change their prosthetic knee or foot soon and cannot have certain health conditions like active cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants are assessed in their usual ischial containment socket
Intervention
Participants receive and are assessed with the subischial socket
Monitoring
Reference group participants are monitored with their usual socket
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS)
Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) is already approved in United States for the following indications:
- Transfemoral amputation and lower mobility levels
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator