Piitulainen Jaakko M, Posti Jussi P, Aitasalo Kalle M J, Vuorinen Ville, Vallittu Pekka K, Serlo Willy
Division of Surgery and Cancer Diseases, Department of Otorhinolaryngology - Head and Neck Surgery, Turku University Hospital, PO Box 52, 20521, Turku, Finland,
Acta Neurochir (Wien). 2015 Apr;157(4):681-7. doi: 10.1007/s00701-015-2363-2. Epub 2015 Feb 10.
In children, approximately half of cryopreserved allograft bone flaps fail due to infection and resorption. Synthetic materials offer a solution for allograft bone flap resorption. Fibre-reinforced composite with a bioactive glass particulate filling is a new synthetic material for bone reconstruction. Bioactive glass is capable of chemically bonding with bone and is osteoinductive, osteoconductive and bacteriostatic. Fibre-reinforced composite allows for fabricating thin (0.8 mm) margins for implant, which are designed as onlays on the existing bone. Bioactive glass is dissolved over time, whereas the fibre-reinforced composite serves as a biostable part of the implant, and these have been tested in preclinical and adult clinical trials. In this study, we tested the safety and other required properties of this composite material in large skull bone reconstruction with children.
Eight cranioplasties were performed on seven patients, aged 2.5-16 years and having large (>16 cm(2)) skull bone defects. The implant used in this study was a patient-specific, glass-fibre-reinforced composite, which contained a bioactive glass particulate compound, S53P4.
During follow-up (average 35.1 months), one minor complication was observed and three patients needed revision surgery. Two surgical site infections were observed. After treatment of complications, a good functional and cosmetic outcome was observed in all patients. The implants had an onlay design and fitted the defect well. In clinical and imaging examinations, the implants were in the original position with no signs of implant migration, degradation or mechanical breakage.
Here, we found that early cranioplasty outcomes with the fibre-reinforced composite implant were promising. However, a longer follow-up time and a larger group of patients are needed to draw firmer conclusions regarding the long-term benefits of the proposed novel biomaterial and implant design. The glass-fibre-reinforced composite implant incorporated by particles of bioactive glass may offer an original, non-metallic and bioactive alternative for reconstruction of large skull bone defects in a paediatric population.
在儿童中，约一半的冷冻同种异体骨瓣因感染和吸收而失败。合成材料为同种异体骨瓣吸收提供了一种解决方案。具有生物活性玻璃颗粒填充物的纤维增强复合材料是一种用于骨重建的新型合成材料。生物活性玻璃能够与骨进行化学键合，具有骨诱导性、骨传导性和抑菌性。纤维增强复合材料可制造出薄（0.8毫米）的植入边缘，设计为覆盖在现有骨上。生物活性玻璃会随着时间溶解，而纤维增强复合材料作为植入物的生物稳定部分，这些已在临床前和成人临床试验中得到测试。在本研究中，我们在儿童大型颅骨重建中测试了这种复合材料的安全性和其他所需特性。
对7名年龄在2.5至16岁、患有大型（>16平方厘米）颅骨缺损的患者进行了8次颅骨成形术。本研究中使用的植入物是定制的玻璃纤维增强复合材料，其中含有生物活性玻璃颗粒化合物S53P4。
在随访期间（平均35.1个月），观察到1例轻微并发症，3例患者需要翻修手术。观察到2例手术部位感染。在并发症得到治疗后，所有患者均获得了良好的功能和美容效果。植入物采用覆盖设计，与缺损贴合良好。在临床和影像学检查中，植入物处于原始位置，没有植入物迁移、降解或机械破损的迹象。
在此，我们发现纤维增强复合材料植入物的早期颅骨成形术结果很有前景。然而，需要更长的随访时间和更大规模的患者群体，才能就所提出的新型生物材料和植入物设计的长期益处得出更确凿的结论。由生物活性玻璃颗粒组成的玻璃纤维增强复合材料植入物可能为儿科人群中大型颅骨缺损的重建提供一种原始性、非金属且具有生物活性的替代方案。
