Medial malleolus: Operative Or Non-operative (MOON study) Ankle fractures are a common Orthopaedic trauma presentation, accounting for approximately 10% of the workload. There has been debate regarding the significance of the contribution of the medial malleolus to ankle stability. Some deem the lateral malleolus as the key stabiliser. With this anatomically aligned the ankle joint should be stable. Operating on the medial malleolus fracture often requires a second generous skin incision, soft tissue stripping and insertion of metalwork. This carries with it the risk of wound complications, infection and increased operation time. High risk patients including the elderly, diabetics and those with significant swelling following injury are particularly vulnerable. The study will include adult patients (≥16 years) with capacity to consent and complete post-operative questionnaires, presenting to a single Orthopaedic trauma unit. Participants will be randomised to fixation or non-fixation of associated medial malleolus fractures at the same time as fixation of the lateral malleolar fracture to assess if this impacts on validated patient outcomes, failure, operative time and complications over a one-year follow-up. Only one trial has been published, showing no significant difference between failure rates or outcomes, but reduced operative time. Participants will be enrolled into the trial following informed consent. The final decision on whether a participant is eligible can only be made during surgery when the medial malleolus fracture has reduced with no more than 2mm displacement. If this is confirmed the participant will be randomised to receive either fixation or non-fixation of the medial malleolus. Randomisation therefore occurs at the time of surgery. Participants will be reviewed at set post-operative checkpoints, with X-rays and patient reported outcome scores. Trial data will hopefully enable surgeons to make better informed decisions when managing patients with ankle fracture dislocations.
Age range
16 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period
Timeframe: 6 week, 3 months, 6 months and one year.