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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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