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

NCT01134354 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199

Last updated 2014-06-19

No results posted yet for this study

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)

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Reto Babst, MD · Luzerner Kantonsspital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • China
  • Germany
  • India
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134354 on ClinicalTrials.gov