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

This study has been completed.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation Identifier:
First received: May 28, 2010
Last updated: June 18, 2014
Last verified: June 2014


Prediction trial, up to 10 sites in Asia and Europe


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?

Tibia Fracture (Isolated)
Ankle Fracture (Isolated)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Teftom Questionnaire [ Time Frame: one year ]

Enrollment: 199
Study Start Date: June 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Patient outcome measure


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient 18 years of age or older with an 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) or EF followed by ORIF)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01134354

Queen Mary Hospital
Hong Kong, China
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Universitätsklinikum Köln
Köln, Germany, 50931
HOSMAT Hospital
Bangalore, India, 560025
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain, 17007
Kantonsspital Luzern
Luzern, Switzerland, 6000
Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Principal Investigator: Reto Babst, MD Luzerner Kantonsspital
  More Information

Responsible Party: AO Clinical Investigation and Documentation Identifier: NCT01134354     History of Changes
Other Study ID Numbers: TEFTOM EURASIA
Study First Received: May 28, 2010
Last Updated: June 18, 2014

Keywords provided by AO Clinical Investigation and Documentation:
Validation study
Outcome Measures
Patient Outcomes Assessment
Patient expectations
Physician patient relationship

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Ankle Fractures
Wounds and Injuries
Leg Injuries processed this record on May 25, 2017