Assessment of Socket Shapes Made by Central Fabrication Facilities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joan Sanders, University of Washington
ClinicalTrials.gov Identifier:
NCT01245504
First received: November 18, 2010
Last updated: April 24, 2014
Last verified: April 2014
  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:

Primary Outcome Measures:
  • Limb volume [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Limb shape [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: December 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Joan Sanders, 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: April 24, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014