Medial Malleolus: Operative Or Non-operative (MOON)
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|ClinicalTrials.gov Identifier: NCT03362229|
Recruitment Status : Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : October 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fracture - Medial Malleolus||Procedure: Fixation Procedure: Non-fixation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial with 50:50 randomisation into one of 2 groups. Randomisation will also be stratified be age of patient (>= 65 and <65 years).|
|Masking:||None (Open Label)|
|Masking Description:||There is no blinding possible in this trial as the presence or absence of medial sided surgery is obvious to both the surgeon and the patient due to the presence or absence of a skin incision.|
|Official 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'|
|Actual Study Start Date :||October 24, 2017|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
Active Comparator: FIXATION
Medial malleolus fixation, with the method of fixation left to the surgeons discretion.
A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise
Active Comparator: NON-FIXATION
A well reduced medial malleolus fracture is then left without fixation ie, non-operative management.
A well reduced medial malleolus fracture will be left without fixation
- Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]The OMAS is a functional rating scale developed in 1984, which has been used extensively as a research tool in foot and ankle surgery. It includes nine parameters: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The sub-score parameters are summated to generate a final score from 0 - 100, with '100' representing an excellent functional outcome and '0' being the worse possible outcome.
- Change in Euroqol-5D over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]A standardised instrument for use as a measure of health outcome. A score of '+1.0' represents an excellent state of general health and a score of '-1.0' represents a very poor state of general health.
- Change in Manchester-Oxford Foot Questionnaire (MOXFQ) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]A validated and reliable PROM for surgery of the foot and ankle, it consists of 16-items from three domains: walking/standing (7 items), pain (5 items) and social interaction (4 items). Each item is scored on a 5-point Likert scale ranging from no limitation to maximum limitation (0,1,2,3,4). The sub-scales are summated to generate a raw score out of 64 is then converted to a 0 - 100 metric score, with '100' being awarded for the most severe limitation and a score of '0' for no limitation whatsoever.
- Tourniquet time [ Time Frame: Immediately post-operatively ]Length of time tourniquet inflated for during surgery
- Change in Visual analogue pain scale (VAS) over a one-year post-operative period [ Time Frame: 6 week, 3 months, 6 months and one year. ]Assessment of pain with '100' being no pain and '0' being extreme pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362229
|Edinburgh Orthopaedic Trauma Unit, Edinburgh Royal Infirmary|
|Edinburgh, United Kingdom, EH16 4SA|