MOON study - Medial malleolus: Operative Or Non-operative
Research type
Research Study
Full title
Medial Malleolus: Operative Or Non-operative. A prospective randomized controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fracture dislocations of the ankle joint
IRAS ID
222034
Contact name
Thomas H Carter
Contact email
Sponsor organisation
NHS Lothian Research and Development
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
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 (inner aspect of ankle joint) to ankle stability. Some deem the lateral malleolus (outer aspect) 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.
We 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.
REC name
South East Scotland REC 02
REC reference
17/SS/0124
Date of REC Opinion
15 Sep 2017
REC opinion
Favourable Opinion