The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA

Study Overview
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Brief Summary
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Design: Prediction trial, up to 10 sites in Asia and Europe Goal: To better understand the success or failure after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly baseline questionnaire - capable of predicting success or failure based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM). Primary aim: To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population. Secondary aim: To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population. Key questions related to patient and surgeon expectations: How different, or similar, are patient and surgeon expectations? Do expectations change over time? Do patient expectations predict outcomes in validated measures use today?

Official Title
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The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA

Conditions
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Tibia Fracture (Isolated), Ankle Fracture (Isolated)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated ankle or distal tibia fracture Scheduled for and undergoing one of the following surgeries for their fracture: Open fracture and internal fixation (ORIF) external fixation (EF) EF followed by ORIF 18 years of age or older Understand and read country national language at elementary level Able to understand the purpose of the clinical trial, Able and willing to conduct all follow-up visits Signed informed consent Exclusion Criteria: Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture. Subject has disease entity, or condition that precludes likelihood of bony union (e.g., 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 poly-trauma (more than one organ system compromised) Subject has additional fracture(s) other than ankle fracture Subject is a prisoner Fracture occurred more than 28 days before surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEFTOM<br>Patient outcome measure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teftom Questionnaire |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Validation study, Outcome Measures, Patient Outcomes Assessment, Patient expectations, Physician patient relationship