Clinical Trial: Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)

Brief 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.

Detailed Summary:

Specific Aim 1: To test the reliability of the ProFit.

Patients enrolled in the TAOS trial returning for their eighteen month final visit will undergo radiographic, video, and photographic assessment. A blinded prosthetist panel (PP) will view these remotely and complete a 42 item assessment based on x-ray, photo and video. We will examine two aspects of reliability for the ProFit, inter-rater reliability and internal consistency.

Specific Aim 2: To examine the validity and responsiveness of the ProFit.

This study aims to examine the validity of the ProFit by specifically evaluating factor validity, construct validity and discriminant validity. This will be accomplished by correlating ProFit scores with measures of self-reported pain (Brief Pain Inventory), function (Short Musculoskeletal Functional Assessment), and satisfaction (Orthotics and Prosthetics User's Survey). Moreover, a subset of subjects will undergo quantitative measurement of fit and alignment using a novel prosthesis-mounted socket reaction moment sensor. Responsiveness of the ProFit will be based on repeated measurements at 6 and 18 months.

Specific Aim 3: To develop a shorter version of the ProFit.

Based on findings from Aim 1 and 2 at the individual item level, we will remove items that: 1) have poor inter-rater agreement; 2) demonstrate weak relationships with clinician and patient report of overall fit; or 3) exhibit strong ceiling or floor effects.

Study design: The ProFit study is a prospective validation study of an assessment of prosthetic fit and alignment among patients with a transtibial amputation.

Sponsor: Major Extremity Trauma Research Consortium

Current Primary Outcome: Prosthetic Fit and Alignment [ Time Frame: 18 months ]

A panel of CPOs will evaluate prosthetic fit and alignment using a 42 item assessment tool.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reliability of ProFit assessment tool [ Time Frame: 18 months ]
  • Validity of ProFit Assessment tool [ Time Frame: 18 months ]
  • Responsiveness of ProFit Assessment tool [ Time Frame: 18 months ]


Original Secondary Outcome: Same as current

Information By: Major Extremity Trauma Research Consortium

Dates:
Date Received: June 25, 2015
Date Started: January 2015
Date Completion: July 2022
Last Updated: April 25, 2017
Last Verified: March 2016