NU-FlexSIS Prosthetic Socket for Leg Amputation

Recruiting at 2 trial locations

Overseen By Stefania Fatone, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Femoral length <5 inches, Silicone allergy, Active malignancy, Pregnancy, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

115 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

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. ^{1 2 3 4 11}

Research Team

Stefania Fatone, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

Exclusion Criteria

Have a known silicone allergy

Are unable to don or tolerate wearing a compressive liner

I currently have cancer.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will be assessed for 12 weeks in their usual ischial containment socket before receiving a subischial socket to be worn and assessed for 24 weeks.

Group II: Reference Group Active Control 1 Intervention

Participants will be assessed for 40 weeks in their usual ischial containment socket. No intervention will be provided.

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:

• Transfemoral amputation and lower mobility levels

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The development of a passive suction version of the Northwestern University Flexible Sub-Ischial Vacuum socket allows for a broader application of this technology to more individuals with transfemoral amputations, especially in situations where active vacuum suspension is not feasible.

From January 2015 to March 2018, 266 of these passive suction sockets were successfully fitted, demonstrating the effectiveness of the technique modifications required for casting and fabricating this new socket design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique modifications for a suction suspension version of the Northwestern University Flexible Sub-Ischial Vacuum socket: The Northwestern University Flexible Sub-Ischial Suction socket. Caldwell, R., Fatone, S.[2022]

The new subischial socket design improved comfort for both transfemoral prosthesis users compared to traditional ischial containment sockets, as evaluated through comfort scores.

Functional performance, measured by gait analysis and clinical outcome tests, was generally comparable between the subischial socket and ischial containment sockets, indicating that while comfort improved, overall function remained similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: Part 2 Description and Preliminary evaluation. Fatone, S., Caldwell, R.[2022]

The Ilisi® database, created by the IPASVI Rome Nursing Board, provides free access to over 2700 abstracts from Italian nursing and health-related journals, promoting nursing scholarship and lifelong learning for students and professionals.

The project aims to enhance the visibility of Italian nursing literature and encourage scientific production among Italian nurses, with plans to translate the content into English for broader accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ILISI® digital index of the Italian scientific literature of nursing. Stievano, A., Bonfigli, A., Fanfera, E., et al.[2019]

Nursing and allied health libraries in Norway have faced challenges in literature searching due to the use of uncontrolled indexing terms, leading to confusion and inefficiency in finding relevant resources.

To address this issue, a working group was formed to recommend a controlled vocabulary for nursing and health literature, suggesting the development of a Norwegian thesaurus based on translations of established thesauri like MeSH and CINAHL, which could improve search quality in the BIBSYS library system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled vocabulary for nursing and allied health in Norway. Flor, P., Jakobsson, A., Mogset, I., et al.[2019]

The ILISI database, launched in July 2008, provides access to approximately 3000 articles and 30 nursing journals, enhancing the availability of Italian nursing literature for bibliographic research.

In its first year, the database saw significant usage, with 9000 consultations, indicating a growing interest and need for accessible nursing resources among professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new resource for the bibliography research: project experience ILISI® Index of Italian Literature on Nursing Sciences]. Rocco, G., Bonfigli, A., Bruno, E., et al.[2011]

A new computerized index correlates five biomedical library classification schemes with MeSH terms in both English and Spanish, facilitating easier access to medical information for bilingual users.

This index serves multiple purposes, including aiding in the reclassification of library collections and providing a foundation for future applications like automatic classification and translations into other languages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized English-Spanish correlation index to five biomedical library classification schemes based on MeSH. Muench, EV.[2019]

A novel transformation-based auditing method was developed to identify missing hierarchical IS-A relations in biomedical terminologies, successfully detecting 39,359 potential missing relations across 13 source terminologies in the UMLS.

Domain experts confirmed a high precision rate of 86.5% for the SNOMED CT and 63% for Gene Ontology, demonstrating the effectiveness of this method in improving the accuracy of biomedical information systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transformation-based method for auditing the IS-A hierarchy of biomedical terminologies in the Unified Medical Language System. Zheng, F., Shi, J., Yang, Y., et al.[2021]

The ISNY above-knee prosthetic socket significantly enhances comfort, function, and appearance for juvenile amputees, thanks to its flexible polyethylene design that adapts to limb growth.

In a review of 10 subjects, all participants who previously used rigid sockets with pelvic band suspension were able to effectively use total or partial suction for the ISNY sockets, indicating good compatibility and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Icelandic-Swedish-New York above-knee prosthetic sockets: pediatric experience. Fishman, S., Edelstein, JE., Krebs, DE.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of NU-FlexSIV Socket Performance for Military Service Members with Transfemoral Amputation. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

The Hybrid Subischial Socket for Persons With Transfemoral Amputation: Gait Parameters and Clinical Assessment of a Case Series. [2023]

4. France pubmed.ncbi.nlm.nih.gov

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]

5. France pubmed.ncbi.nlm.nih.gov

Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: Part 2 Description and Preliminary evaluation. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

ILISI® digital index of the Italian scientific literature of nursing. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A controlled vocabulary for nursing and allied health in Norway. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[A new resource for the bibliography research: project experience ILISI® Index of Italian Literature on Nursing Sciences]. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

A computerized English-Spanish correlation index to five biomedical library classification schemes based on MeSH. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A transformation-based method for auditing the IS-A hierarchy of biomedical terminologies in the Unified Medical Language System. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Icelandic-Swedish-New York above-knee prosthetic sockets: pediatric experience. [2019]