CompletedNot Applicable

Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

Australia160 participantsStarted 2010-08

Plain-language summary

This study will determine whether operative management confers improved short and long-term outcomes for patients with isolated AO type 44-B1 distal fibula fractures when compared with non-operative management.

Who can participate

Age range

18 Years – 65 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: * Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture * Patients aged between 18 and 65 inclusive. * No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle. * Closed injury * No concurrent fractures/dislocations * Mobilising unaided/independently pre-injury * Willingness to be followed up for 12 months * Able to provide informed written consent Exclusion Criteria: * Medically fit for general anaesthesia/surgery * Dislocation on presentation * Skeletally immature patients * Previous trauma or surgery to the affected ankle * Pregnancy * Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation * Non-English speaking

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

American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire

Timeframe: 12 months

PCS of Short Form (SF)-12v2

Timeframe: 12 months

Trial details

NCT IDNCT01134094

SponsorThe University of New South Wales

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Ankle Fractures trials

Who can participate

Age range

18 Years – 65 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.