Introduction: Fixing fractures of the base and neck of mandibular condyles is demanding due to the difficulties in surgical access and the various shapes of bone fragments. Classic fixation techniques assume the use of straight mini-plates, utilized for other craniofacial bone fractures. Three dimensional mini-plates may provide a reasonable alternative due to their ease of use and steadily improved mechanical properties. The multitude of different shapes of 3D mini-plates proves the need for their evaluation.
Aim: This paper aims to summarize the clinical trials regarding the use of various types of 3D condylar mini-plates in terms of need for reoperation and the incidence of loosening and damage to the osteosynthetic material.
Materials and methods: A systematic review was conducted in accordance with PICOS criteria and PRISMA protocol. The risk of bias was assessed using ROBINS-I and RoB 2 Cochrane protocols. The obtained data series was analyzed for correlations (Pearson's r) respecting statistical significance (Student's t-test p > 0.05) and visualized using OriginLab.
Results: 13 clinical trials with low overall risk of bias regarding 6 shapes of 3D mini-plates were included in the synthesis. The number of reoperations correlates with the number of fixations (r = 0.53; p = 0.015) and the total number of screw holes in the mini-plate (r = -0.45; p = 0.006). There is a strong correlation between the number of loosened osteosynthetic screws and the total number of fractures treated with 3D mini-plates (r = 0.79; p = 0.001 for each study and r = 0.99; p = 0.015 for each mini-plate shape). A correlation between the percentage of lost screws and the number of distal screw holes is weak regarding individual studies (r = -0.27; p = 0.000) and strong regarding individual mini-plate shape (r = -0.82; p = 0.001). Three cases of 3D mini-plate fractures are noted, which account for 0.7% of all analyzed fixation cases.
Discussion: The reasons for reoperations indicated by the authors of the analyzed articles were: mispositioning of the bone fragments, lack of bone fragment union, secondary dislocation, and hematoma. The known screw loosening factors were poor bone quality, bilateral condylar fractures, difficulties in the correct positioning of the osteosynthetic material due to the limitations of the surgical approach, fracture line pattern, including the presence of intermediate fragments, and mechanical overload. Fractures of the straight mini-plates fixing the mandibular condyles amounts for up to 16% of cases in the reference articles.
Conclusions: There is no convincing data that the number of reoperations depends on the type of 3D mini-plate used. The frequency of osteosynthetic screw loosening does not seem to depend on the 3D mini-plate's shape. Clinical fractures of 3D mini-plates are extremely rare.
Keywords: fracture fixation; mandibular condyle fracture; miniplate; open reduction and internal fixation; osteosynthesis; three-dimensional plate.