Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma

Completed

Conditions studied: Traumatic Amputation of Lower Extremity

In brief

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.

Key facts

Study ID

NCT02540681

Run by

Major Extremity Trauma Research Consortium

People needed

33

Starts

2015-01-01

Expected to finish

2021-01-01

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be enrolled in the TAOS study

You may not qualify if…

• Patients weighing <300 lbs.
• Patient requires an LAR
• Women who are breastfeeding or pregnant

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest University Baptist Center — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• The University of Texas Health Science Center at Houston Medical School — Houston, Texas, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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