Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Amputation
  • Amputation, Traumatic
  • Amputation; Traumatic, Limb
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 95 years
Gender
Both males and females

Description

Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clinician training programs. The first step in fitting a prosthetic limb is to fabricate the socket, whi...

Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clinician training programs. The first step in fitting a prosthetic limb is to fabricate the socket, which fits over the residual limb and acts as the interface between the residual limb and the prosthesis. The socket is the most custom component of the prosthetic system and must be comfortable to wear, easy to clean, and durable enough to withstand years of day-to-day use. Simple and low-cost methods for socket fabrication and fitting would improve access to prosthetic care and could give many people in need their first opportunity to use a prosthesis. We have developed an easy-to-follow method that allows us to cast the limb in less than 30 minutes and finish the socket in 90 minutes, making it a practical choice for socket fitting in busy clinical settings, and where users are unable to return for multiple fittings. We have submitted a provisional US patent for our socket fabrication method. We hypothesize that our novel method of fabrication for a low cost prosthesis can produce a device that has appropriate suspension, a comfortable interface, and requires little long term follow-up.

Tracking Information

NCT #
NCT04725461
Collaborators
Not Provided
Investigators
Not Provided