Here is the design of a clinical trial:

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'

Included conditions:
- Ankle Fracture - Medial Malleolus

Study Armgroups:
- {'label': 'FIXATION', 'type': 'ACTIVE_COMPARATOR', 'description': 'Medial malleolus fixation, with the method of fixation left to the surgeons discretion.', 'interventionNames': ['Procedure: Fixation']}
- {'label': 'NON-FIXATION', 'type': 'ACTIVE_COMPARATOR', 'description': 'A well reduced medial malleolus fracture is then left without fixation ie, non-operative management.', 'interventionNames': ['Procedure: Non-fixation']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Fixation', 'description': "A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise", 'armGroupLabels': ['FIXATION']}
- {'type': 'PROCEDURE', 'name': 'Non-fixation', 'description': 'A well reduced medial malleolus fracture will be left without fixation', 'armGroupLabels': ['NON-FIXATION']}

Primary Outcomes:
- {'measure': 'Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period', 'description': "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.", 'timeFrame': '6 week, 3 months, 6 months and one year.'}

Please estimate the sample size based on the assumption: 
80% power, 5% (two-sided) significance level, 20% increase to account for loss to follow-up.
Sample size
        The primary outcome measure will be the OMAS. In total, 154 patients (77 per arm) will be required with 80% power and 5% (two-sided) significance to detect a clinically meaningful difference of 10 points on the OMAS scale at 12âmonths between the two groups [24â26]. This assumes a standard deviation of 20 [27]. The sample size has been increased by 20% to account for any loss to follow-up.