Kolk Andreas, Köhnke Robert, Saely Christoph H, Ploder Oliver
Department of Oral- and Craniomaxillofacial Surgery, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Strasse 22, 81675 Munich, Germany.
Department for Oral- and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany ; Department of Oral- and Maxillofacial Surgery, Academic Teaching Hospital Feldkirch, Carinagasse 47, 6800 Feldkirch, Austria.
Biomed Res Int. 2015;2015:621481. doi: 10.1155/2015/621481. Epub 2015 Sep 27.
The aim was to evaluate three different biodegradable polylactic acid- (PLA-) based osteosynthesis materials (OM). These OM (BioSorb, LactoSorb, and Delta) were used in 64 patients of whom 55 (85.9%) had fractures of the zygoma, five (7.8%) in the LeFort II level, two of the frontal bone (3.1%), and two of the maxillary sinus wall (3.1%). In addition to routine follow-up (FU) at 3, 6, and 12 months (m) (T1, T2, and T3) all patients were finally evaluated at a mean FU after 14.1 m for minor (e.g., nerve disturbances, swelling, and pain) and major (e.g., infections and occlusal disturbances) complications. Out of all 64 patients 38 presented with complications; of these 28 were minor (43.8%) and 10 major (15.6%) resulting in an overall rate of 59.4%. Differences in minor complications regarding sensibility disturbance at T1 and T3 were statistically significant (P = 0.04). Differences between the OM were not statistically significant. Apart from sufficient mechanical stability for clinical use of all tested OM complications mostly involved pain and swelling probably mainly related to the initial bulk reaction attributable to the drop of pH value during the degradation process. This paper includes a review of the current aspects of biodegradable OM.
目的是评估三种不同的基于聚乳酸(PLA)的可生物降解骨合成材料(OM)。这些OM(BioSorb、LactoSorb和Delta)用于64例患者,其中55例(85.9%)为颧骨骨折,5例(7.8%)为LeFort II级骨折,2例(3.1%)为额骨骨折,2例(3.1%)为上颌窦壁骨折。除了在3、6和12个月(m)(T1、T2和T3)进行常规随访(FU)外,所有患者最终在平均随访14.1个月后接受评估,以检查轻微(如神经紊乱、肿胀和疼痛)和严重(如感染和咬合紊乱)并发症。在所有64例患者中,38例出现并发症;其中28例为轻微并发症(43.8%),10例为严重并发症(15.6%),总体发生率为59.4%。T1和T3时感觉障碍方面的轻微并发症差异具有统计学意义(P = 0.04)。OM之间的差异无统计学意义。除了所有测试的OM在临床使用中具有足够的机械稳定性外,并发症主要涉及疼痛和肿胀,这可能主要与降解过程中pH值下降引起的初始体积反应有关。本文包括对可生物降解OM当前各方面的综述。