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Clinical Trial 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?


Clinical Trial Description

n/a


Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01134354
Study type Observational
Source AO Clinical Investigation and Documentation
Contact
Status Completed
Phase N/A
Start date June 2010
Completion date February 2014