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 range18 Years – 65 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: * 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

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

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