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Chapter 4.4 Open versus Closed
If we want to answer the question of how to treat mandibular condyle fractures, the study design is probably the pivotal factor. As mentioned, a RCT - the golden standard for evaluating the effects of medical interventions - is challenging in terms of logistics, planning, and costs.5 A promising alternative to the conventional pragmatic RCT is the cohort multiple Randomized Controlled Trial (cm-RCT) approach, which is designed to facilitate randomized trials for the pragmatic evaluation of interventions.5,6 In a cm-RCT, all patients will undergo ‘standard treatment’. This group of patients will be named ‘the observational cohort’. Eligible patients within this observational cohort are identified, and some of them will be selected at random and offered the open intervention. The other eligible patients will not be approached and will undergo the standard treatment. In this way, two randomly compiled groups are formed and the two treatment modalities can be compared.
In conclusion, the answer to the question ‘open or closed?’ lies ahead, and by learning from each other’s difficulties during this journey, maybe someday we will be able to solve this major controversy.