Trauma Expectation Factor Trauma Outcome Measure

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Aims: 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). 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.

Official Title
-----------------
The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)

Conditions
-----------------
Ankle Fracture, Pilon Fracture

Intervention / Treatment
-----------------
* Procedure: ankle or distal tibia surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ankle / dist. tibia fracture fixation<br> | Procedure: ankle or distal tibia surgery<br>* internal fixation for ankle or distal tibia fracture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient reported outcomes | The patient reported outcome includes the Trauma Outcome Measure (TOM), the AAOS Foot and Ankle Core Score, the Foot and Ankle Outcome Scores (FAOS), a 10mm visual analogue scale (VAS), and the SF-36. | 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician based outcomes | Bony union was assessed using X-Rays. | 12 months post-op |