Trauma Expectation Factor Trauma Outcome Measure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-02-28

Brief Summary

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This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.

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Detailed Description

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Aims:

1. To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
2. To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).

Hypotheses:

H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).

H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.

H#3. Patient and surgeon expectations of final outcome status are different; however, the differences get smaller over time.

Conditions

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Ankle Fracture Pilon Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ankle / dist. tibia fracture fixation

ankle or distal tibia surgery

Intervention Type PROCEDURE

internal fixation for ankle or distal tibia fracture

Interventions

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ankle or distal tibia surgery

internal fixation for ankle or distal tibia fracture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Isolated ankle or distal tibia fracture
* Scheduled for and undergoing surgery for their fracture
* 18 years of age or older

Exclusion Criteria

* Subject has previously undergone internal fixation surgery for this ankle fracture
* Subject has disease entity, or condition that precludes likelihood of bony union (eg, metastatic cancer, metabolic bone disease)
* Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires
* Subject is participating in other competing clinical research that may interfere with participation in this research
* Subject is unlikely to attend study related follow-up visits
* Subject has polytrauma (more than one organ system compromised)
* Subject has fracture(s) other than ankle fracture
* Subject is a prisoner
* Fracture occurred more than 4 weeks ago

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No