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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01134354
First received: May 28, 2010
Last updated: February 26, 2013
Last verified: February 2013
History of Changes

May 28, 2010
February 26, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
Teftom Questionnaire [ Time Frame: one year ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01134354 on ClinicalTrials.gov Archive Site
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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

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?
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Observational
Time Perspective: Prospective
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Non-Probability Sample

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)
  • Tibia Fracture (Isolated)
  • Ankle Fracture (Isolated)
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TEFTOM
Patient outcome measure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Germany,   India,   Spain,   Switzerland
 
NCT01134354
TEFTOM EURASIA
No
AO Clinical Investigation and Documentation
AO Clinical Investigation and Documentation
Not Provided
Principal Investigator: Reto Babst, MD Luzerner Kantonsspital
AO Clinical Investigation and Documentation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP