Assessment of Socket Shapes Made by Central Fabrication Facilities

April 24, 2014 updated by: Joan Sanders, University of Washington

Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities

Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.

Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington, Bioengineering Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

people with lower limb amputation that are ambulatory

Description

Inclusion Criteria:

  • trans-tibial amputees who use a prosthesis and are ambulatory

Exclusion Criteria:

  • do not have a prosthesis, cannot ambulate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower-limb amputee
Subjects with at least one lower limb amputated at teh trans-tibial level
Other: Assessed for socket fit
Subjects are clinically assessed during standing to see how well computer manufactured sockets fit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Limb volume
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Limb shape
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 31673 E/B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on People With Lower Limb Amputation That Are Ambulatory

  • Shirley Ryan AbilityLab
    Coapt, LLC
    Active, not recruiting
    VR to Evaluate Phantom Limb Pain
    Lower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Upper Limb Amputation Below Elbow (Injury) | Phantom Pain Following Amputation of Lower Limb | Upper Limb Amputation Above... and other conditions
    United States

Clinical Trials on Assessed for socket fit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe