100 Participants Needed

Release/Relock Socket for Below Knee Amputation

JE
Overseen ByJoan E Sanders, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JE

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

Participants involved remotely will have to meet the following inclusion criteria: Have a spare prosthesis, No cognitive issues, Good hand dexterity and strength (not frail), Capable of communication over a video Zoom conference call.
K2 or higher MFCL
I had a below-the-knee amputation over 18 months ago.
See 4 more

Exclusion Criteria

Unable to satisfy inclusion criteria
I currently have open sores on my skin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-Lab Testing

Participants operate the test socket in lab following a structured protocol to evaluate the release and relock mechanisms on limb volume.

1-2 weeks
Multiple visits (in-person)

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.

At least 2 days
Continuous monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after testing, including assessments of socket comfort and limb volume changes.

4 weeks

Treatment Details

Interventions

  • Release/Relock Socket & Control
  • Release/Relock Socket - In Lab
  • Release/Relock Socket - Out of Lab
Trial OverviewThe study is testing a new socket technology designed to adjust to daily changes in limb volume. Participants will try the Release/Relock Socket both in lab settings and during regular activities outside the lab compared to their usual control socket.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Release/Relock Socket - Out of LabExperimental Treatment1 Intervention
The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the effects of the re-lock panel and pin mechanisms on participant comfort.
Group II: Release/Relock Socket - In LabExperimental Treatment1 Intervention
The test socket will be operated by the participant in lab, following a structured protocol. This arm focuses on the order effects on the re-lock panel and pin mechanisms on limb volume.
Group III: Release/Relock Socket & ControlExperimental Treatment2 Interventions
The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the comparing participant experience using the novel mechanism versus traditional socket mechanisms.

Release/Relock Socket & Control is already approved in United States for the following indications:

🇺🇸
Approved in United States as Release/Relock Socket for:
  • 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

Trials
1,858
Recruited
2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

In a study involving eight unilateral below-knee amputees, CAD-CAM prosthetic sockets required more adjustments (one change for all but one socket) compared to hand-made sockets (only two changes), indicating potential challenges in initial fit.
Despite differences in design and configuration, both CAD-CAM and hand-made sockets were similarly accepted by patients in terms of comfort, with no significant differences reported in pressure or pain levels.
Comparison of CAD-CAM and hand made sockets for PTB prostheses.Köhler, P., Lindh, L., Netz, P.[2017]
The study involved five unilateral trans-tibial amputees who assessed their socket comfort and satisfaction using questionnaires, but the results showed no statistically significant differences in interface pressure between comfortable and uncomfortable socket conditions, except in specific areas.
Despite the lack of clear findings, the study suggests that larger sample sizes and longer acclimation periods are necessary to better understand the relationship between socket pressure and patient-reported comfort and satisfaction outcomes.
Socket Interface Pressure and Amputee Reported Outcomes for Comfortable and Uncomfortable Conditions of Patellar Tendon Bearing Socket: A Pilot Study.Safari, MR., Tafti, N., Aminian, G.[2015]
The Rapidform process represents a significant advancement in the manufacturing of prostheses, allowing for complete control over the production process, which enhances the precision and customization of prosthetic devices.
Clinical and laboratory results indicate that Rapidform is not only swift and accurate but also economical, making it a practical solution for producing various types of prosthetic sockets without the need for specialized services.
The Rapidform process for automated thermoplastic socket production.Davies, RM., Lawrence, RB., Routledge, PE., et al.[2017]

References

Comparison of CAD-CAM and hand made sockets for PTB prostheses. [2017]
Socket Interface Pressure and Amputee Reported Outcomes for Comfortable and Uncomfortable Conditions of Patellar Tendon Bearing Socket: A Pilot Study. [2015]
The Rapidform process for automated thermoplastic socket production. [2017]
The Compress® transcutaneous implant for rehabilitation following limb amputation. [2022]
Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. [2015]
Soft tissue balancing in varus total knee arthroplasty: an algorithmic approach. [2022]
Total knee arthroplasty for severe valgus deformity. Five to fourteen-year follow-up. [2022]
Shuttle lock release modification of a trans-tibial prosthesis with an obese client. [2007]
Soft Tissue Releases in Total Knee Arthroplasty for Valgus Deformities. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Selective Medial Release Technique Using the Pie-Crusting Method for Medial Tightness During Primary Total Knee Arthroplasty. [2018]