Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)
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|ClinicalTrials.gov Identifier: NCT02540681|
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : April 26, 2017
|Condition or disease|
|Traumatic Amputation of Lower Extremity|
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|
|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|
- Prosthetic Fit and Alignment [ Time Frame: 18 months ]A panel of CPOs will evaluate prosthetic fit and alignment using a 42 item assessment tool.
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02540681
|Contact: Saam Morshed, MD||Saam.Morshed@ucsf.edu|
|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|
|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|
|Study Director:||Lisa Reider, PhD||Major Extremity Trauma Research Consortium|