Prosthetic Socket Design for Amputees

No longer recruiting at 1 trial location
GF
WA
Overseen ByWilliam Anderst, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various modifications to prosthetic sockets affect comfort and performance for individuals with a transfemoral (above-knee) amputation. Participants will try several socket designs, each during a brief 10-minute walk, while researchers collect data. The goal is to identify the best modifications for future improvements in socket fitting for amputees. This trial suits those who use a prosthetic leg above the knee and can walk on a treadmill unaided. As an unphased trial, it offers participants the chance to directly contribute to advancements in prosthetic technology and enhance future socket designs.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these prosthetic socket modifications are safe for amputees?

Research shows that different designs of above-knee prosthetic sockets affect comfort and mobility. For example, one study found that the NU-FlexSIV socket was more comfortable and satisfying than traditional designs after seven weeks. This indicates that changes in socket design can enhance user comfort.

While new technologies for prosthetic sockets are under development, existing designs remain reliable. Thus, any new changes likely build on designs that are already safe and comfortable.

In summary, although specific data on side effects for the new changes is unavailable, research and the use of similar sockets suggest these designs are generally safe and comfortable for people with amputations.12345

Why are researchers excited about this trial?

Researchers are excited about the prosthetic socket design trial because it explores how different socket modifications can improve comfort and mobility for amputees. Unlike current options, which often involve a one-size-fits-all approach, this study tests a personalized method by trying eight different socket versions in random sequences for each participant. This approach aims to find the best fit and function for individuals, potentially leading to more comfortable and effective prosthetic solutions tailored to each user's unique needs.

What evidence suggests that these prosthetic socket modifications are effective for amputees?

This trial will compare the effectiveness of different designs of above-knee prosthetic sockets. Studies have shown that changes in socket design can significantly impact their functionality for people with amputations. For example, modifications can help individuals walk more smoothly and move their hips more easily. Research indicates that certain socket designs can also enhance comfort and stability when moving. One study found that improved socket designs reduce awkward movement between the leg stump and the prosthetic, making walking more efficient. Overall, these findings suggest that better socket designs can lead to improved mobility and comfort for prosthetic leg users.12678

Who Is on the Research Team?

WA

William Anderst, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 who use a transfemoral prosthesis, can walk unassisted on a treadmill, and weigh less than 125 kg. It's not suitable for those with high radiation exposure, pregnant women, or anyone clinically diagnosed with osteoporosis.

Inclusion Criteria

I use a prosthetic leg that attaches at the thigh.
I can walk by myself on a treadmill.
Body weight less than 125 kg
See 3 more

Exclusion Criteria

I have been exposed to high levels of radiation in the past.
I have been diagnosed with osteoporosis.
You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo testing with unmodified and 8 modified socket designs in a randomized order

8-10 weeks
9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Trans-femoral prosthetic socket
Trial Overview The study is testing specific standardized changes to the design of transfemoral prosthetic sockets. Participants will experience different socket modifications in a randomized order to prepare for future trials on individual fitting methods.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Unmodified Socket + 8 Socket Modifications in Random OrderExperimental Treatment1 Intervention

Trans-femoral prosthetic socket is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Transfemoral Prosthetic Socket for:
🇺🇸
Approved in United States as Transfemoral Prosthetic Socket for:
🇨🇦
Approved in Canada as Transfemoral Prosthetic Socket for:
🇯🇵
Approved in Japan as Transfemoral Prosthetic Socket for:
🇨🇳
Approved in China as Transfemoral Prosthetic Socket for:
🇨🇭
Approved in Switzerland as Transfemoral Prosthetic Socket for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Published Research Related to This Trial

The transfemoral socket is essential for ensuring comfort and functionality in prosthetic limbs, regardless of the technology used in other components like knees and feet.
The article reviews different socket designs, specifically quadrilateral and ischial containment, and discusses various suspension options to optimize the fit and performance of the prosthesis.
Transfemoral socket design and suspension options.Kapp, SL.[2013]
In a study of 12 transfemoral amputees, those using the ischial-ramal containment (IRC) socket reported significantly better comfort and stability compared to those using the quadrilateral (QL) socket, particularly in sitting comfort and lumbar support.
Despite the IRC socket providing a more comfortable experience and better femur positioning, it did not show superior metabolic efficiency in gait compared to the QL socket, indicating that while the IRC socket may enhance comfort, it does not improve oxygen consumption during walking.
Subjective evaluations and objective measurements of the ischial-ramal containment prosthesis.Hachisuka, K., Umezu, Y., Ogata, H., et al.[2019]
A study involving 47 transfemoral prosthetic users showed that the Direct Socket interface significantly improved quality of life, comfort, and mobility compared to their previous prostheses, with 36 subjects completing the 6-month follow-up.
Participants reported enhanced stability, suspension, and overall comfort with the Direct Socket, along with improved mobility as indicated by reduced reliance on assistive devices, suggesting this method is a promising alternative to traditional prosthetic fittings.
Clinical Outcome of Transfemoral Direct Socket Interface (Part 2).Walker, J., Marable, WR., Smith, C., et al.[2023]

Citations

The Hybrid Subischial Socket for Persons With ...This report describes the differences in terms of gait parameters, hip RoM and satisfaction with the prosthesis following the change of the socket (from ICS to ...
2.strathprints.strath.ac.ukstrathprints.strath.ac.uk/79766/
Transfemoral prosthetic socket designs : a review of the ...The review purpose is to assess the quality of scientific evidence and compare this for a variety of available transfemoral socket designs.
Influence of different types of sockets on the range ...To compare the individual influence of different types of socket designs on the hip's range of motion in transfemoral amputees.
Effects of Prosthetic Socket Design on Residual Femur ...Individuals with transfemoral amputation experience relative motion between their residual limb and prosthetic socket, which can cause inefficient dynamic load ...
Critical Transfemoral Socket Design Features and VariationsThe effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: A randomized clinical trial.
The Newest TechnologyNew prosthetic socket interface technology offers the potential of improving your use of an above-knee prosthesis. To learn more about each of these ...
Comparison of Ischial Containment and Subischial Sockets ...The results suggest that after 7 weeks' accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket ...
Transfemoral Socket Fabrication Method Using Direct ...Direct Socket for transfemoral (DS-TF) prosthetic user is a novel method of fabricating a laminated interface on to the residual limb but requires ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security