CompletedNot Applicable

Early Weight Bearing for Ankle Fractures

19 participantsStarted 2016-05

Plain-language summary

The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.

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: * Men and women ages of 18 and up * Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures * Orthopaedic Trauma Association (OTA) classification of 44A and 44B * English speaking * Able and willing to consent Exclusion Criteria: * Open fractures * OTA classification of 43 and 44C * Patients with diabetes mellitus * No other lower extremity injuries that would affect functional outcomes * Previous use of walking aides * Patients with paralysis or hemiplegia * Ankle fractures requiring syndesmotic repair * Ankle fractures requiring fixation of the posterior malleolar * Associated neurovascular injury * Problems maintaining follow up (homeless or not willing to return for follow up) * Pathological fractures * Prisoners * Patients not allowed to bear weight before the 6 week post-operative follow up visit

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

Functional Outcome Scores

Timeframe: 12 months post operatively

Trial details

NCT IDNCT02736370

SponsorCorewell Health West

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02

View on ClinicalTrials.gov More Broken Ankle trials