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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02540681
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : June 26, 2018
University of California, San Francisco
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

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.

Condition or disease
Traumatic Amputation of Lower Extremity

Detailed Description:

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.

Study duration: 3 years Sample size: 120 TAOS patients will provide adequate power to detect important differences in fit and alignment 18 months following amputation. A subset of 60 patients is necessary to detect significant differences in alignment using the Smart Pyramid.

Number of study sites: Up to 35 centers including 24 Core METRC sites, 4 MTFs, and 7 METRC satellite sites.

Study population: Patients enrolled in the METRC TAOS study.

Outcome measure: This ancillary project to the TAOS trial is designed to study the validity reliability and validity of the ProFit, a 42-item tool for assessing prosthetic fit and alignment among patients with a transtibial amputation.

Statistical analysis: Inter-rater reliability and internal consistency will be examined to test the reliability of the ProFit. The validity of this assessment will be evaluated using a variety of construct validity tests. Based on findings from the reliability and validity analysis, a shorter version of the ProFit will be developed. The performance of the shorter version will be determined based on correlation with the original assessment.

Randomization: Not applicable

Safety monitoring: Not applicable

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)
Study Start Date : January 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prosthetic Fit and Alignment [ Time Frame: 18 months ]
    A panel of CPOs will evaluate prosthetic fit and alignment using a 42 item assessment tool.

Secondary Outcome Measures :
  1. Reliability of ProFit assessment tool [ Time Frame: 18 months ]
  2. Validity of ProFit Assessment tool [ Time Frame: 18 months ]
  3. Responsiveness of ProFit Assessment tool [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be drawn from the TAOS study which enrolls patients with below the knee amputations from trauma centers participating in the Major Extremity Research Consortium (METRC).

Inclusion Criteria:

  • Must be enrolled in the TAOS study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02540681

Contact: Saam Morshed, MD

United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Saam Morshed, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Principal Investigator: Anjan Shah, MD         
United States, Maryland
University of Maryland, R Adams Cowley Shock Trauma Center Not yet recruiting
Baltimore, Maryland, United States, 20742
Principal Investigator: Theodore Manson, MD         
United States, Mississippi
University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Principal Investigator: Patrick Bergin, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Principal Investigator: Michael Bosse, MD         
Wake Forest University Baptist Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Eben Carroll, MD         
United States, Ohio
MetroHealth Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Heather Vallier, MD         
United States, Oklahoma
University of Oklahoma Withdrawn
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: William Obremskey, MD         
United States, Texas
The University of Texas Health Science Center at Houston Medical School Not yet recruiting
Houston, Texas, United States, 78229
Principal Investigator: Joshua Gary, MD         
San Antonio Military Medical Center Recruiting
San Antonio, Texas, United States, 78234
Principal Investigator: Daniel Stinner, MD         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
University of California, San Francisco
Study Director: Lisa Reider, PhD Major Extremity Trauma Research Consortium

Responsible Party: Major Extremity Trauma Research Consortium Identifier: NCT02540681     History of Changes
Other Study ID Numbers: OR130357
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Major Extremity Trauma Research Consortium:
Transtibial amputation
Prosthetic fit
Prosthetic alignment

Additional relevant MeSH terms:
Amputation, Traumatic
Leg Injuries
Wounds and Injuries