Quantitatively-informed Socket Design Process

  • End date
    Sep 17, 2024
  • participants needed
  • sponsor
    University of Pittsburgh
Updated on 7 October 2022


This study will investigate the effects of specific standardized modifications to trans-femoral prosthetic sockets in a randomized within-subject design. This is in preparation for a subsequently planned clinical trial to validate the findings by implementing them into a fitting method for individual sockets.


Background: Lower limb amputees experience chronic health challenges such as residual limb skin problems, low back pain, and osteoarthritis. These problems are exacerbated by high physical activity levels and by poor prosthetic socket fit. Prosthetists believe that limiting residual femur and skin motion will improve force coupling and thereby address these problems. However, there are no data demonstrating how changes in socket design affect residual femur and skin motion, and, by extension, lead to improved patient-reported outcomes.

Objective/Hypothesis: Goal of this research is to improve the current socket design optimization process that involves trial and error and relies heavily on the prosthetist's experience and intuition by using a quantitatively informed optimization process. The hypothesis is that modifiable in-socket mechanics, i.e. residual femur motion, skin strain, and pressure within the socket, are related to socket design and patient outcomes, and can be estimated using readily available clinical measurements.

Specific Aims: First aim is to identify the key characteristics of in-socket mechanics that are related to physical function and patient-reported comfort and function. The second aim is to identify readily available clinical measurements that are associated with the in-socket mechanical characteristics that are related to outcomes. The purpose of this aim is to correlate our laboratory findings from Aim 1 with more conventional modalities for clinical assessment.

Research Strategy: Preliminary data demonstrates the feasibility of the proposed research plan and will progress to a pilot clinical trial. The two aims will involve 30 transfemoral amputees. A highspeed biplane radiography system is used to image the residual limb while participants walk on a dual-belt instrumented treadmill both in their current socket and in sockets with purposely altered volume, brim height, cross-sectional geometry, and stiffness. Three-dimensional (3D) skin motion within the socket will be determined by tracking the motion of 40 to 50 small metal beads placed in a grid pattern on the skin of the residual limb before donning the socket. Residual femur motion within the socket will be determined with submillimeter accuracy using a validated tracking process that matches subject-specific bone models obtained from CT to the biplane radiographs. Discrete in-socket pressure will be recorded at four locations using pressure sensing pads. Readily available clinical measurements will be collected as well, including gait analysis, foot loading patterns, ground reaction forces, residual limb tissue stiffness, and hip range of motion hip strength. Each participant will complete clinical questionnaires to qualitatively evaluate comfort, fit, and overall satisfaction after wearing each socket. The different socket modifications are intended to affect the in-socket mechanics of the residual limb, physical function and patient-reported outcomes (Aim 1). These relationships will be assessed using a generalized linear model. Correlation between the research grade measurements and accessible clinical measures (Aim 2) will be evaluated using bivariate correlation analyses. The information gained in Aims 1 and 2 will be used to develop a quantitatively-informed socket optimization process, wherein the clinical measurements associated with in-socket mechanics will be used to inform socket design optimizations.

Condition Artificial Limbs
Treatment Trans-femoral prosthetic socket
Clinical Study IdentifierNCT05041998
SponsorUniversity of Pittsburgh
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Transfemoral prosthesis user
-80 years of age
Body weight less than 125 kg
Able to walk unassisted on a treadmill

Exclusion Criteria

Pregnant females
Clinically diagnosed osteoporosis
Previous high exposure to radiation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note