三维塑形钛板颞肌下修补颅骨缺损的安全及有效性:38例患者数据分析方案

Safety and efficacy of three-dimensional shaping of titanium plate in subtemporal repair of skull defects: study protocol for a data analysis of 38 patients

背景:去骨瓣减压治疗后需进行缺损颅骨的修补。既往使用的自体骨、异体骨、有机材料等存在塑形效果不理想、感染等风险,而钛网是一种较为理想的颅骨修补材料,数字化三维成型可以使其与颅骨缺损完好匹配,较好地还原患者缺损部位的解剖原貌。目的:探索三维塑形钛板颞肌下修补额颞区颅骨缺损修补的安全性及有效性。方法:对2015年1月至2016年12月在中国南通大学附属吴江医院(苏州市吴江区第一人民医院)神经外科进行治疗,应用三维塑形钛板颞肌下修补治疗的颅骨缺损患者38例的手术及随访资料进行回顾性分析。主要评价指标为术后12个月内并发症发生率,次要评价指标为修复后1,6,12,18,24个月时格拉斯哥预后分级评分、卡氏功能状态评分、NIHSS评分和头颅CT检查结果。试验方案已于2017-10-11在中国临床试验注册中心注册,注册号为Chi CTR-IOC-17012947。结果与结论:目前已完成的部分数据分析结果:38例患者已进行6-24个月不等的随访,未见并发症及不良反应发生,头颅CT结果均显示钛网及钛钉固定良好,颅骨形态对称,未见皮下积液及颅内出血。通过额颞区颅骨缺损患者并发症、神经功能及影像学的结果,为临床定制三维塑形钛板颞肌下修补额颞区颅骨缺损提供了试验依据。

BACKGROUND： Skull damage is necessary after decompressive craniectomy. Previously used autologousbone, allogeneic bone, and organic material are associated with the risk of an unsatisfactory cosmetic outcomeand infection. Titanium mesh is an ideal material for cranioplasty. Digital three-dimensional shaping of titaniummesh allows it to perfectly match the skull defect and can restore the anatomic appearance of the defective area.OBJECTIVE： To explore the safety and effectiveness of the three-dimensional shaping of titanium plate insubtemporal repair of skull defects.METHODS： We retrospectively analyzed the surgical and follow-up data of 38 patients with skull defects who underwent subtemporal repair using three-dimensional shaping of a titanium plate at the Department of Neurosurgery,Wujiang Hospital （The First People’s Hospital of Wujiang District）, Nantong University, China, from January 2015 toDecember 2016. The primary outcome measure was the incidence of complications within postoperative 12 months. Thesecondary outcome measures were the Glasgow outcome scale score, Karnofsky performance scale score, NationalInstitutes of Health stroke scale score, and skull computed tomography scan results at 1, 6, 12, 18, and 24 months afterrepair. This trial was registered in the Chinese Clinical Trial Registry （identifier： ChiCTR-IOC-17012947） at October 11th,2017.RESULTS AND CONCLUSION： Partial results have been obtained from 38 patients who have been followed up for 6 to24 months. No complications or adverse reactions occurred. Skull computed tomography scan results revealed that thetitanium mesh and nail were well fixed, the skull shape was symmetrical, and no subcutaneous effusion or intracranialhemorrhage occurred. Complications, neurological function, and imaging findings in patients with frontotemporal skulldefects provide an experimental basis for three-dimensional shaping of titanium plates in subtemporal repair offrontotemporal defects.