The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA
NCT ID: NCT01134354
Last Updated: 2014-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
199 participants
OBSERVATIONAL
2010-06-30
2014-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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TEFTOM
Patient outcome measure
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Reto Babst, MD
Role: PRINCIPAL_INVESTIGATOR
Luzerner Kantonsspital
Locations
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Queen Mary Hospital
Hong Kong, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Universitätsklinikum Köln
Cologne, , Germany
HOSMAT Hospital
Bangalore, , India
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Kantonsspital Luzern
Lucerne, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Countries
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Other Identifiers
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TEFTOM EURASIA
Identifier Type: -
Identifier Source: org_study_id
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