Prosthetic Socket Design for Amputees
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo testing with unmodified and 8 modified socket designs in a randomized order
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trans-femoral prosthetic socket
Trans-femoral prosthetic socket is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Transfemoral amputations
- Transfemoral amputations
- Transfemoral amputations
- Transfemoral amputations
- Transfemoral amputations
- Transfemoral amputations
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
United States Department of Defense
Collaborator