University of Washington, Bioengineering Department
Seattle, Washington, 98195, United States
Completed
NCT Number: NCT01245504
Assessment of Socket Shapes Made by Central Fabrication Facilities
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- trans-tibial amputees who use a prosthesis and are ambulatory
Exclusion criteria
- do not have a prosthesis, cannot ambulate
Treatment and study plan
Assessed for socket fit
OtherSubjects are clinically assessed during standing to see how well computer manufactured sockets fit
Primary outcomes
-
Limb volume
Time frame: 1 day
Secondary outcomes
-
Limb shape
Time frame: 1 day
Sponsors and collaborators
Lead sponsor
University of Washington
Other
Registry information
Official study title
Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Nov 22, 2010
- Registry last updated
- Apr 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.