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Assessment of Socket Shapes Made by Central Fabrication Facilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245504
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):
Joan Sanders, University of Washington

Brief Summary:

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.

Condition or disease Intervention/treatment
People With Lower Limb Amputation That Are Ambulatory Other: Assessed for socket fit

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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

Primary Outcome Measures :
  1. Limb volume [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Limb shape [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people with lower limb amputation that are ambulatory

Inclusion Criteria:

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

Exclusion Criteria:

  • do not have a prosthesis, cannot ambulate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245504

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United States, Washington
University of Washington, Bioengineering Department
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington

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Responsible Party: Joan Sanders, Professor, University of Washington Identifier: NCT01245504     History of Changes
Other Study ID Numbers: 31673 E/B
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014