Trauma Expectation Factor Trauma Outcome Measure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Aims:
- To develop a novel, psychometrically sound, trauma patient expectation instrument that:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ankle / dist. tibia fracture fixation
|
Procedure: ankle or distal tibia surgery
internal fixation for ankle or distal tibia fracture
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Clinician based outcomes [12 months post-op]
Bony union was assessed using X-Rays.
Eligibility Criteria
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
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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
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Subject is participating in other competing clinical research that may interfere with participation in this research
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Subject is unlikely to attend study related follow-up visits
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Subject has polytrauma (more than one organ system compromised)
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Subject has fracture(s) other than ankle fracture
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Subject is a prisoner
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Fracture occurred more than 4 weeks ago
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthopedic Trauma Service, University of Florida - Shands Jacksonville | Jacksonville | Florida | United States | 32207 |
| 2 | Department of Orthopaedic Surgery, Hospital for Special Surgery, New York | New York | New York | United States | 10021 |
| 3 | Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York | New York | New York | United States | 10021 |
| 4 | Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo | Ribeirao Preto | Sao Paulo | Brazil | 3900 |
| 5 | Department of Orthopaedic Trauma, Foothills Medical Center, Calgary | Calgary | Alberta | Canada | T2N2T9 |
Sponsors and Collaborators
- AO Clinical Investigation and Publishing Documentation
Investigators
- Principal Investigator: Michael Suk, Professor, Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TEFTOM