Ankle Fracture (Isolated) Clinical Trial
Official title:
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?
| Status | Completed |
| Enrollment | 199 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Queen Mary Hospital | Hong Kong | |
| China | Shanghai Sixth People's Hospital | Shanghai | |
| Germany | Universitätsklinikum Köln | Köln | |
| India | HOSMAT Hospital | Bangalore | |
| Spain | Hospital Universitari de Girona Doctor Josep Trueta | Girona | |
| Switzerland | Kantonsspital Luzern | Luzern | |
| Switzerland | Stadtspital Triemli | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Documentation |
China, Germany, India, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Teftom Questionnaire | one year | No |