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Assessment of Socket Shapes Made by Central Fabrication Facilities

Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01245504
Enrollment
24
Registered
2010-11-22
Start date
2008-11-30
Completion date
2011-12-31
Last updated
2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People With Lower Limb Amputation That Are Ambulatory

Brief summary

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.

Interventions

OTHERAssessed for socket fit

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

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* do not have a prosthesis, cannot ambulate

Design outcomes

Primary

MeasureTime frame
Limb volume1 day

Secondary

MeasureTime frame
Limb shape1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026