Trauma Expectation Factor Trauma Outcome Measure
Completed
Conditions studied: Ankle Fracture, Pilon Fracture
In brief
This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.
Key facts
- Study ID
- NCT01126398
- Run by
- AO Clinical Investigation and Publishing Documentation
- People needed
- 204
- Starts
- 2007-02-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2021-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Isolated ankle or distal tibia fracture
- Scheduled for and undergoing surgery for their fracture
- 18 years of age or older
You may not qualify if…
- Subject has previously undergone internal fixation surgery for this ankle fracture
- Subject has disease entity, or condition that precludes likelihood of bony union (eg, 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 polytrauma (more than one organ system compromised)
- Subject has fracture(s) other than ankle fracture
- Subject is a prisoner
- Fracture occurred more than 4 weeks ago
Where it is running
- Orthopedic Trauma Service, University of Florida - Shands Jacksonville — Jacksonville, Florida, United States
- Department of Orthopaedic Surgery, Hospital for Special Surgery, New York — New York, New York, United States
- Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York — New York, New York, United States
- Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo — Ribeirão Preto, São Paulo, Brazil
- Department of Orthopaedic Trauma, Foothills Medical Center, Calgary — Calgary, Alberta, Canada
Full record on ClinicalTrials.gov
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