Release/Relock Socket for Below Knee Amputation
Trial Summary
What is the purpose of this trial?
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Release/Relock Socket treatment for below-knee amputation?
The research on vacuum-assisted socket suspension systems shows that they can improve the fit and activity levels for lower extremity amputees compared to traditional pin suspension systems. This suggests that innovative socket designs, like the Release/Relock Socket, may also enhance comfort and functionality for below-knee amputees.12345
What makes the Release/Relock Socket treatment unique for below knee amputation?
The Release/Relock Socket treatment is unique because it involves a mechanism that allows for easy release and relocking of the prosthetic socket, which can be particularly beneficial for individuals with limited mobility or reach, such as those who are obese. This approach is different from standard prosthetic fittings as it focuses on enhancing user independence and comfort by modifying the release mechanism to be more accessible.678910
Research Team
Joan E Sanders, PhD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for individuals who have had a below-knee amputation at least 18 months ago, can walk continuously for at least 90 seconds, and regularly use a definitive prosthesis with a pin-lock system. Their residual limb should be at least 9 cm long. People using walking aids, those with elevated vacuum sockets or open wounds on their residual limb cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
In-Lab Testing
Participants operate the test socket in lab following a structured protocol to evaluate the release and relock mechanisms on limb volume.
Out-of-Lab Testing
Participants operate the test socket out of lab with no structured protocol to assess comfort and effectiveness of the release and relock mechanisms.
Follow-up
Participants are monitored for safety and effectiveness after testing, including assessments of socket comfort and limb volume changes.
Treatment Details
Interventions
- Release/Relock Socket & Control
- Release/Relock Socket - In Lab
- Release/Relock Socket - Out of Lab
Release/Relock Socket & Control is already approved in United States for the following indications:
- Management of daily residual limb fluid volume fluctuation in transtibial amputation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator