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.
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.
Study Type
OBSERVATIONAL
Enrollment
204
internal fixation for ankle or distal tibia fracture
Orthopedic Trauma Service, University of Florida - Shands Jacksonville
Jacksonville, Florida, United States
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
New York, New York, United States
Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York
New York, New York, United States
Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
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.
Time frame: 12 months post-op
Clinician based outcomes
Bony union was assessed using X-Rays.
Time frame: 12 months post-op
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Ribeirão Preto, São Paulo, Brazil
Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
Calgary, Alberta, Canada