115 Participants Needed

NU-FlexSIS Prosthetic Socket for Leg Amputation

Recruiting at 2 trial locations
RS
KG
SF
Overseen ByStefania Fatone, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Yes, the NU-FlexSIS Prosthetic Socket is a promising treatment for leg amputation. It offers improved comfort and allows for better hip movement compared to traditional sockets. This can lead to a better quality of life for users.678910

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?

SF

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

Provision of signed and dated informed consent form
Be a Veteran (VA site only)
Speak and read English
See 9 more

Exclusion Criteria

Have a known silicone allergy
Are unable to don or tolerate wearing a compressive liner
I currently have cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Participants are assessed in their usual ischial containment socket

12 weeks
Multiple visits (in-person and remote)

Intervention

Participants receive and are assessed with the subischial socket

24 weeks
8 visits (in-person), 11 remote survey assessments

Monitoring

Reference group participants are monitored with their usual socket

40 weeks
8 remote survey assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS)
Trial Overview The study is testing the NU-FlexSIS, which is a new type of socket for leg prostheses designed to improve comfort and mobility compared to the standard socket used after thigh-level leg amputations. The goal is to see if this new design enhances quality of life, increases how long the prosthesis can be worn daily, and improves overall satisfaction.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Reference GroupActive Control1 Intervention

Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) is already approved in United States for the following indications:

🇺🇸
Approved in United States as NU-FlexSIV for:

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Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Published Research Related to This Trial

The Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket was found to be significantly more comfortable than the ischial containment (IC) socket after 7 weeks of use, with a mean Socket Comfort Score of 8.4 compared to 7.0 for the IC socket.
Participants using the NU-FlexSIV Socket reported greater satisfaction with their device, although other functional performance measures showed no significant differences between the two socket types.
Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial.Fatone, S., Caldwell, R., Angelico, J., et al.[2022]
The Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket technique allows for greater hip motion in military service members with transfemoral amputation compared to traditional ischial containment sockets, which may enhance mobility during activities like stair ascent.
While the NU-FlexSIV Socket improved hip motion, it did not consistently increase overall comfort for walking and running, indicating that while it is a viable alternative, individual experiences may vary based on socket fit and materials.
Evaluation of NU-FlexSIV Socket Performance for Military Service Members with Transfemoral Amputation.Brown, SE., Russell Esposito, E., Ikeda, AJ., et al.[2022]
The Hybrid Subischial Socket (HySS) significantly improved comfort and various gait parameters in three participants with transfemoral amputation after one month of use, compared to their usual Ischial Containment Socket (ICS).
Participants experienced enhanced hip range-of-motion, increased walking speed and distance, and greater satisfaction with the prosthesis, indicating that HySS may be a beneficial alternative for prosthetic users.
The Hybrid Subischial Socket for Persons With Transfemoral Amputation: Gait Parameters and Clinical Assessment of a Case Series.Pellegrini, R., Denza, G., Brunelli, S., et al.[2023]

Citations

Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial. [2022]
Evaluation of NU-FlexSIV Socket Performance for Military Service Members with Transfemoral Amputation. [2022]
The Hybrid Subischial Socket for Persons With Transfemoral Amputation: Gait Parameters and Clinical Assessment of a Case Series. [2023]
Technique modifications for a suction suspension version of the Northwestern University Flexible Sub-Ischial Vacuum socket: The Northwestern University Flexible Sub-Ischial Suction socket. [2022]
Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: Part 2 Description and Preliminary evaluation. [2022]
ILISI® digital index of the Italian scientific literature of nursing. [2019]
A controlled vocabulary for nursing and allied health in Norway. [2019]
[A new resource for the bibliography research: project experience ILISI® Index of Italian Literature on Nursing Sciences]. [2011]
A computerized English-Spanish correlation index to five biomedical library classification schemes based on MeSH. [2019]
A transformation-based method for auditing the IS-A hierarchy of biomedical terminologies in the Unified Medical Language System. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Icelandic-Swedish-New York above-knee prosthetic sockets: pediatric experience. [2019]
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