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
  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:


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 April 15, 2014