Sikora Maciej, Chęciński Maciej, Nowak Zuzanna, Chęcińska Kamila, Olszowski Tomasz, Chlubek Dariusz
Department of Maxillofacial Surgery, Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland.
Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Powstańców Wielkopolskich 72, 70-111 Szczecin, Poland.
J Clin Med. 2021 Aug 16;10(16):3604. doi: 10.3390/jcm10163604.
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.
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.
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 ) respecting statistical significance (Student's -test > 0.05) and visualized using OriginLab.
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 ( = 0.53; = 0.015) and the total number of screw holes in the mini-plate ( = -0.45; = 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 ( = 0.79; = 0.001 for each study and = 0.99; = 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 ( = -0.27; = 0.000) and strong regarding individual mini-plate shape ( = -0.82; = 0.001). Three cases of 3D mini-plate fractures are noted, which account for 0.7% of all analyzed fixation cases.
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.
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.
由于手术入路困难以及骨碎片形状各异,下颌髁突基部和颈部骨折的固定颇具挑战性。传统的固定技术采用用于其他颅面骨骨折的直型微型钢板。三维微型钢板因其使用方便且机械性能不断改进,可能提供一种合理的替代方案。三维微型钢板众多不同的形状表明有必要对其进行评估。
本文旨在总结关于使用各种类型三维髁突微型钢板在再次手术需求以及骨合成材料松动和损坏发生率方面的临床试验。
根据PICOS标准和PRISMA方案进行系统评价。使用ROBINS - I和RoB 2 Cochrane方案评估偏倚风险。对获得的数据系列进行相关性分析(皮尔逊相关性分析),考虑统计显著性(学生t检验p>0.05),并使用OriginLab进行可视化。
综合纳入了13项关于6种形状三维微型钢板且总体偏倚风险较低的临床试验。再次手术的次数与固定次数(r = 0.53;p = 0.015)以及微型钢板上螺孔的总数(r = -0.45;p = 0.006)相关。骨合成螺钉松动的数量与用三维微型钢板治疗的骨折总数之间存在强相关性(每项研究r = 0.79;p = 0.001,每种微型钢板形状r = 0.99;p = 0.015)。就个体研究而言,丢失螺钉的百分比与远端螺孔数量之间的相关性较弱(r = -0.27;p = 0.000),而就个体微型钢板形状而言相关性较强(r = -0.82;p = 0.001)。记录到3例三维微型钢板骨折,占所有分析固定病例的0.7%。
分析文章的作者指出再次手术的原因有:骨碎片错位、骨碎片未愈合、继发性脱位和血肿。已知的螺钉松动因素有骨质不佳、双侧髁突骨折、由于手术入路限制导致骨合成材料正确定位困难、骨折线模式(包括存在中间碎片)以及机械过载。在参考文献文章中,固定下颌髁突的直型微型钢板骨折发生率高达16%。
没有令人信服的数据表明再次手术的次数取决于所使用的三维微型钢板的类型。骨合成螺钉松动的频率似乎不取决于三维微型钢板的形状。三维微型钢板的临床骨折极为罕见。