Neurosurgery department, Hôpital de Bretonneau, Tours, France.
Clinical research department, Finceramica Faenza S.p.A, Ravenna, Italy.
Neurochirurgie. 2021 Jul;67(4):301-309. doi: 10.1016/j.neuchi.2021.02.007. Epub 2021 Mar 2.
Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis.
To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years.
Mean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection.
Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.
颅骨切除术产生的骨缺损的修复，无论是在骨整合方面，还是在功能和认知恢复方面，都是一项重大的治疗挑战。此外，这些手术程序通常会伴有感染、破裂、移位和排斥等并发症，导致假体失效和植入物被取出。
评估采用多孔羟基磷灰石定制颅骨修复假体 CUSTOMBONE 植入后的累积取出和感染率。2012 年 12 月至 2014 年 7 月，在 21 个中心组成的多中心研究中，前瞻性纳入了 110 例连续需要颅骨重建的骨缺损患者。随访时间为 2 年。
研究中患者的平均年龄为 42±15 岁（y.o），主要由男性（57.27%）组成。13/110（11.8%）名患者进行了 CUSTOMBONE 假体取出，主要原因是感染：9/13（69.2%）（p<0.0001），其中 2 例（15.4%）假体骨折，1 例（7.7%）皮肤缺损，1 例（7.7%）为植入物移位。累积取出率分别为 4.6%（SD 2.0）、7.4%（SD 2.5）、9.4%（SD 2.8）和 11.8%（SD 2.9%），分别在术后 2、6、12 和 24 个月。110 例患者中有 16 例（14.5%）发生感染：8 例（50%）为浅表感染，8 例（50%）为深部感染。无论是人口统计学特征、适应证、植入物大小、位置、再次手术、合并症还是病史，都没有被确定为假体取出或感染的危险因素。
本研究为颅骨手术中 CUSTOMBONE 假体的性能和安全性提供了相关的临床证据。主要并发症发生在术后 6 个月内，但也可能在后期（>1 年）出现。因此，需要进行认真、定期和长期的监测。
