Ankle Fracture, Pilon Fracture
Conditions
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: 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.
Interventions
internal fixation for ankle or distal tibia fracture
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient reported outcomes | 12 months post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician based outcomes | 12 months post-op | Bony union was assessed using X-Rays. |
Countries
Brazil, Canada, United States