‘An excellent randomized controlled trial of a common fracture’
Bilateral mandibular fracture—How much fixation is necessary?
17 September 2020
AO CMF has recently funded and concluded, with AO ITC support, a prospective randomized controlled trial (RCT) on the fixation of bilateral mandibular fractures. This study provided high-quality clinical evidence and demonstrated that a combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture (DMFx) has similar outcomes in comparison to nonrigid fixation for both fractures.
The manuscript was submitted to the Journal of Oral and Maxillofacial Surgery (JOMS), peer-reviewed, and recommend for publication without revision. In the reviewers' and the section editor's own words, this is a "perfect example of a high caliber investigation", "a true multi-center study of common a fracture", and "an excellent RCT". The principal coordinating investigators, Ed Ellis and Risto Kontio, as well as all the coauthors all share in this success.
The conclusion of the study is clinically significant and answered a long-standing debate on the best fixation method in DMFx. As Ed Ellis explains, surgeons may now be reassured that a minimum use of devices, such as mini-plates and monocortical screws, can provide sufficient fixation. This will provide savings on materials and time, and therefore, healthcare costs. Risto Kontio agrees and added that, minimum uses of devices also mean smaller incisions, smaller operations, and faster recuperation for the patients.
Ed Ellis said, "The previous evidence came from (my own) retrospective studies…the current study is a prospective study. And, with the randomized design, it is methodologically much more robust and provided the best kinds of scientific evidence, so we must accept it."
“…saves materials and time, smaller incisions, smaller operations, and faster recuperation for the patients…”
RCT is the gold standard in the world of clinical trials. It is nevertheless relatively rare in orthopedic research. We asked Risto Kontio why this is the case; he explained that a high-quality RCT requires a large sample size (over 300 patients for this particular study), which most clinics cannot achieve on their own. The AO, with its network of surgeons and in-house clinical research unit, provided not only the funding but also the expertise in coordinating and conducting the multi-center studies according to a strict study protocol.
This was the first time that Vivesh Rughubar (South Africa), a longstanding AO member, has participated in an AO study. His clinic enrolled the largest number of cases, and he is eager to put the study results to practice. Vivesh Rughubar suggests that, with the current results, it may eventually be possible to treat these patients with local instead of general anesthesia, which could lead to the elimination of a hospital stay. Aside from disseminating the current results locally in South Africa, Vivesh Rughubar has received ethics clearance for several new AO studies. This is an outstanding example of the vital role the AO CMF global network plays in delivering high-quality clinical evidence.