Ankle Fracture (Isolated), Tibia Fracture (Isolated)
Conditions
Keywords
Validation study, Outcome Measures, Patient Outcomes Assessment, Patient expectations, Physician patient relationship
Brief 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?
Interventions
None listed
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Teftom Questionnaire | one year |
Countries
China, Germany, India, Spain, Switzerland
Outcome results
None listed