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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.
Aims:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle / dist. tibia fracture fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ankle or distal tibia surgery | Procedure | internal fixation for ankle or distal tibia fracture |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician based outcomes | Bony union was assessed using X-Rays. | 12 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who expericenced an ankle or pilon fracture presenting to the emergency room or orthopedic department were asked to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Suk, Professor | Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Trauma Service, University of Florida - Shands Jacksonville | Jacksonville | Florida | 32207 | United States | ||
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| Department of Orthopaedic Surgery, Hospital for Special Surgery, New York |
| New York |
| New York |
| 10021 |
| United States |
| Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York | New York | New York | 10021 | United States |
| Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo | Ribeirão Preto | São Paulo | 3900 | Brazil |
| Department of Orthopaedic Trauma, Foothills Medical Center, Calgary | Calgary | Alberta | T2N2T9 | Canada |