Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma

NCT ID: NCT02540681

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2021-01-31

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 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

Conditions

Traumatic Amputation of Lower Extremity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Major Extremity Trauma Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Reider, PhD

Role: STUDY_DIRECTOR

Major Extremity Trauma Research Consortium

Locations

University of California at San Francisco

San Francisco, California, United States

Tampa General Hospital

Tampa, Florida, United States

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Wake Forest University Baptist Center

Winston-Salem, North Carolina, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

The University of Texas Health Science Center at Houston Medical School

Houston, Texas, United States

San Antonio Military Medical Center

San Antonio, Texas, United States

Countries

United States

References

Major Extremity Trauma Research Consortium (METRC). Development of a prosthetic fit and alignment assessment (ProFit) in persons with post-traumatic transtibial amputation. Prosthet Orthot Int. 2023 Dec 1;47(6):599-606. doi: 10.1097/PXR.0000000000000237. Epub 2023 Apr 4.

Reference Type: DERIVED

PMID: 37052578 (View on PubMed)

Other Identifiers

OR130357

Identifier Type: -

Identifier Source: org_study_id