NCT01134354

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Conditions

• Tibia Fracture (Isolated)
• Ankle Fracture (Isolated)

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2010-06-02
• Last updated: 2014-06-19

Locations

7 sites across 5 countries: China, Germany, India, Spain, Switzerland