CompletedNot Applicable

Trauma Expectation Factor Trauma Outcome Measure

United States, Brazil, Canada204 participantsStarted 2007-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Isolated ankle or distal tibia fracture * Scheduled for and undergoing surgery for their fracture * 18 years of age or older Exclusion Criteria: * 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

What they're measuring

patient reported outcomes

Timeframe: 12 months post-op

Trial details

NCT IDNCT01126398

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-02

View on ClinicalTrials.gov More Ankle Fracture trials