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Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma

NCT02540681 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2021-03-24

No results posted yet for this study

Summary

The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is investigating prosthesis fit, alignment and condition of the residual limb. As there are no validated measures of fit and alignment (factors known to impact comfort, function and performance among amputees) the TAOS study includes a provision in the protocol for acquisition of photographs, video and radiographs in order to help develop uniform assessments of the residual limb. The goal of the ProFit study is to validate and refine the prosthetic assessment tool (ProFit) that was developed by an expert panel of certified orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.

Conditions

  • Traumatic Amputation of Lower Extremity

Sponsors & Collaborators

Principal Investigators

  • Lisa Reider, PhD · Major Extremity Trauma Research Consortium

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540681 on ClinicalTrials.gov