Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma



Status:Recruiting
Healthy:No
Age Range:18 - 60
Updated:6/28/2018
Start Date:January 2015
End Date:July 2022
Contact:Saam Morshed, MD
Email:Saam.Morshed@ucsf.edu

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

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.

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

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
We found this trial at
11
sites
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: William Obremskey, MD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Bosse, MD
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Charlotte, NC
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Patrick Bergin, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Anjan Shah, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Baltimore, Maryland 21201
Principal Investigator: Theodore Manson, MD
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Baltimore, MD
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Heather Vallier, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Houston, Texas 77030
Principal Investigator: Joshua Gary, MD
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Houston, TX
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Oklahoma City, OK
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San Antonio, Texas
Principal Investigator: Daniel Stinner, MD
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San Antonio, TX
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San Francisco, California 94143
Principal Investigator: Saam Morshed, MD
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San Francisco, CA
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Winston-Salem, North Carolina 27157
Principal Investigator: Eben Carroll, MD
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Winston-Salem, NC
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