Assessment of Socket Shapes Made by Central Fabrication Facilities

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by University of Washington.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT01245504

First received: November 18, 2010

Last updated: November 19, 2010

Last verified: November 2010

History of Changes

Purpose

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	Intervention
People With Lower Limb Amputation That Are Ambulatory	Other: Assessed for socket fit

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss

U.S. FDA Resources

Further study details as provided by University of Washington:

Estimated Enrollment:	50
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

people with lower limb amputation that are ambulatory

Criteria

Inclusion Criteria:

trans-tibial amputees who use a prosthesis and are ambulatory

Exclusion Criteria:

do not have a prosthesis, cannot ambulate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245504

Locations

United States, Washington
University of Washington, Bioengineering Department	Recruiting
Seattle, Washington, United States, 98195
Contact: Joan E Sanders, PhD 206-221-5872 jsanders@u.washington.edu

Sponsors and Collaborators

University of Washington

More Information

No publications provided

Responsible Party:	Joan Sanders, Associate Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT01245504 History of Changes
Other Study ID Numbers:	31673 E/B
Study First Received:	November 18, 2010
Last Updated:	November 19, 2010
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013

To Top