Assessment of Socket Shapes Made by Central Fabrication Facilities

NCT ID: NCT01245504

Last Updated: 2014-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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People With Lower Limb Amputation That Are Ambulatory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lower-limb amputee

Subjects with at least one lower limb amputated at teh trans-tibial level

Assessed for socket fit

Intervention Type OTHER

Subjects are clinically assessed during standing to see how well computer manufactured sockets fit

Interventions

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Assessed for socket fit

Subjects are clinically assessed during standing to see how well computer manufactured sockets fit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* do not have a prosthesis, cannot ambulate
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Joan Sanders

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Washington, Bioengineering Department

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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31673 E/B

Identifier Type: -

Identifier Source: org_study_id

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