ClinicalTrials.gov identifier: NCT02540681
Purpose: 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 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 orthopedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.
Study type: Observational
Study design: Cohort, prospective study
Estimated enrollment: 60
Eligibility criteria: Both genders are eligible; ages 18 years to 60 years. Patients must be enrolled in the TAOS study which enrolls patients with below-the-knee amputations from trauma centers participating in the METRC. Excludes patients weighing less than 300 pounds, patients requiring a LAR, and women who are breastfeeding or pregnant.
Study start date: January 2015
Estimated study completion date: July 2022
Estimated primary completion date: The final collection date for primary outcome measures will be January 2021.
Primary outcome measures: Prosthetic fit and alignment. Time frame is 18 months. A panel of CPOs will evaluate prosthetic fit and alignment using a 42-item assessment tool.
Secondary outcome measures: Reliability, validity, responsiveness of ProFit assessment tool. Time frame is 18 months.
Sponsors and collaborators: Sponsored by the METRC with collaboration from University of California, San Francisco
Contact: Saam Morshed, MD, Saam_Morshed@ucsf.edu
Information acquired from: METRC, via clinicaltrials.gov
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