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NCT02540681 · ClinicalTrials.gov registry record

Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma

A clinical trial, sponsored by Major Extremity Trauma Research Consortium.

Completed
Registry status
33
Enrollment target

NCT02540681: Completed study, sponsored by Major Extremity Trauma Research Consortium.

NCT02540681 is a clinical trial that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02540681 has completed, sponsored by Major Extremity Trauma Research Consortium.

COMPLETED
Registry status
33 participants
Enrollment target

Study 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.

Primary Outcome

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

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2015-01
Est. Completion 2021-01

What the finished NCT02540681 record still lists

NCT02540681 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02540681 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02540681 about?

NCT02540681 is a clinical study titled "Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma". 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...

What is the current status of trial NCT02540681?

This trial is currently completed. The enrollment target is 33 participants. The study started on 2015-01. Estimated completion is 2021-01.

Who is sponsoring clinical trial NCT02540681?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02540681, the US trial registry maintained by the National Library of Medicine. NCT02540681 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.