NU-FlexSIS Prosthetic Socket for Leg Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
The objective of this trial is to assess use and benefits of the subischial socket for persons with transfemoral amputation and lower mobility levels. Specifically, the investigators will evaluate whether the subischial socket improves comfort, socket wear time, mobility, participation, quality of life and satisfaction with device than the standard-of-care ischial containment socket.
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 safety data exists for the NU-FlexSIS Prosthetic Socket for Leg Amputation?
The provided research abstracts do not contain any specific safety data or evaluations related to the NU-FlexSIS Prosthetic Socket or its alternative names. Further research in relevant medical and prosthetic journals or clinical trial databases would be necessary to find safety data for this treatment.12345
Is the NU-FlexSIS Prosthetic Socket a promising treatment for leg amputation?
What makes the NU-FlexSIS prosthetic socket treatment unique for leg amputation?
The NU-FlexSIS prosthetic socket is unique because it is designed to improve comfort and hip motion by not interacting with the ischium (the lower part of the hip bone), unlike traditional ischial containment sockets. This design potentially reduces discomfort and enhances mobility for individuals with transfemoral amputation.678910
What data supports the idea that NU-FlexSIS Prosthetic Socket for Leg Amputation is an effective treatment?
The available research shows that the NU-FlexSIS Prosthetic Socket is effective because it improves comfort and allows for better hip movement compared to the traditional ischial containment sockets. This is important because many users of the traditional sockets experience discomfort and limited hip motion. The NU-FlexSIS design avoids these issues by not interacting with the ischium, which is a part of the pelvis. This leads to a more comfortable fit and potentially a better quality of life for people with leg amputations.678911
What data supports the effectiveness of the NU-FlexSIS Prosthetic Socket for Leg Amputation treatment?
Research suggests that the NU-FlexSIS socket, which is a type of subischial socket, may improve comfort and hip motion for people with leg amputations compared to traditional sockets. This design avoids contact with the ischium (a part of the pelvis), potentially reducing discomfort and enhancing quality of life.678911
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:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator