NCT02540681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

July 1, 2019

Enrollment Period

6 years

First QC Date

June 25, 2015

Last Update Submit

March 23, 2021

Conditions

Traumatic Amputation of Lower Extremity

Keywords

Transtibial amputationProsthetic fitProsthetic alignment

Outcome Measures

Primary Outcomes (1)

  • Prosthetic Fit and Alignment

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

    18 months

Secondary Outcomes (3)

  • Reliability of ProFit assessment tool

    18 months

  • Validity of ProFit Assessment tool

    18 months

  • Responsiveness of ProFit Assessment tool

    18 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • Must be enrolled in the TAOS study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California at San Francisco

San Francisco, California, 94110, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 20742, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Wake Forest University Baptist Center

Winston-Salem, North Carolina, 27157, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

The University of Texas Health Science Center at Houston Medical School

Houston, Texas, 78229, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 37052578DERIVED

Study Officials

  • Lisa Reider, PhD

    Major Extremity Trauma Research Consortium

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

September 4, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 24, 2021

Record last verified: 2019-07

Locations

US(10)