Page 152 - Open versus closed Mandibular condyle fractures

Problems in starting a randomized controlled trial
This letter concerns a major controversy in maxillofacial trauma care: whether to perform open or closed treatment of a mandibular condyle fracture. A Randomized Clinical Trial (RCT) on this subject has been underway since 2013 at the Academic Medical Center in Amsterdam, University Medical Center in Groningen, Erasmus Medical Center in Rotterdam, Spaarne Hospital in Haarlem, and Isala Clinics in Zwolle. Other researchers have tried to do this before.1,2 Until now, no research group has succeeded in executing a RCT with sufficient power to answer the question as to whether one should perform surgery on a mandibular condyle fracture or not. During the 4 years of research to date, we have met many challenges, as outlined below:
1. A multicenter trial was designed in order to include an adequate number of patients and to have a study with sufficient power. However, due to the inadequate existing definitions of the separate treatment modalities, setting up a uniform study protocol that every center could agree on was the first obstacle.3,4
2. Following the implementation of the study, coordination and planning of the protocol at the different centers, with many different consultants involved, turned out to be difficult.
3. The inclusion of patients was the next hurdle. First, for ethical reasons, the inclusion criteria for this study were strict, e.g. fracture with dislocation confirmed radiographically, no other fractures interfering with the occlusion and malocclusion present. The reported number of dislocated fractures with a malocclusion were very small. Second, patients now like to make their own decision on which treatment they wish to receive. Therefore, convincing them to take part in a RCT, in which the treatment is determined by randomization, is difficult, and this is not acceptable in most patients.
4. Furthermore, good results are achieved with closed treatment and this raises the question of what the necessity of the surgical treatment procedure would be. During night and weekend shifts, the temptation to select the relatively simple closed treatment option and not follow the study protocol has appeared to be a reality.
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