Zanetti Diego, Nassif Nader
Otorhinolaryngology Department, University of Brescia, Brescia, Italy.
Skull Base. 2003 Feb;13(1):1-11. doi: 10.1055/s-2003-820552.
This prospective open pilot study was designed to assess the suitability of flexible composite sheets of polymer and hydroxyapatite (HA) for the reconstruction of limited lateral skull base defects through a conservative transmastoid approach.Seven patients with a petrous bone dehiscence less than 3 cm in diameter, either iatrogenic or caused by chronic otitis media or temporal bone trauma, underwent a mastoidectomy. The defect was repaired with the new material and a connective tissue graft. All bone defects were detected by computed tomography (CT) of the temporal bone except one that was found at surgery in an asymptomatic patient.Outcome was evaluated in terms of anatomical integrity of the tegmina, absence of cerebrospinal fluid leaks, side effects, and extrusion and complication rates. None of the patients suffered from immediate side effects related to the implant or the operation. With a minimum follow-up of 18 months (maximum, 62 months), neither extrusion nor a foreign body reaction occurred. Postoperative CT confirmed a satisfactory anatomic contour. Although the number of patients is limited, these preliminary results are encouraging and indicate a need for further clinical trials with a material that allows a minimally invasive approach to selected skull base defects.
这项前瞻性开放性试点研究旨在评估聚合物与羟基磷灰石(HA)的柔性复合片材通过保守经乳突入路修复局限性外侧颅底缺损的适用性。7例因医源性因素、慢性中耳炎或颞骨外伤导致岩骨缺损直径小于3 cm的患者接受了乳突切除术。使用新材料和结缔组织移植物修复缺损。除1例在手术中发现的无症状患者的骨缺损外,所有骨缺损均通过颞骨计算机断层扫描(CT)检测到。根据骨盖的解剖完整性、脑脊液漏的有无、副作用以及材料挤出和并发症发生率对结果进行评估。所有患者均未出现与植入物或手术相关的即刻副作用。在至少18个月(最长62个月)的随访中,既未发生材料挤出,也未出现异物反应。术后CT显示解剖轮廓令人满意。尽管患者数量有限,但这些初步结果令人鼓舞,表明需要对这种允许以微创方式治疗特定颅底缺损的材料进行进一步的临床试验。