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临床试验/NCT04707404
NCT04707404已完成不适用

COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

RenJi Hospital0 个研究点目标入组 100 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Complications

研究概览

简要总结

Decompressive craniectomy is suggested as an effective surgical intervention for patients with high intracranial pressure. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK). The application of PEEK in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant. We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium.

详细描述

Decompressive craniectomy (DC) is suggested as an effective surgical intervention for patients with high intracranial pressure. For the skull defect after DC, cranioplasty could pro-vide protection, aesthetic and even functional improvements. The autologous bone flap (ABF) was once thought to be an optimal autograft for repairing [8]. While accumulated studies reported ABF related disadvantages. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK).

Titanium is a widely applied metal material for cranioplasty, attribute to its high strength, bio-compatibility and comparatively low material cost. Currently, pre-operative three dimensional (3D) reconstruction of titanium brings a customized implant for optimal shaping effect. However, titanium implant is still confronted with complications of infection, implant exposure, etc.

PEEK is a novel polymer used to rebuild the personalized construction. Through the precise computational reconstruction of high-resolution computed tomography (CT) scanning, the customized PEEK could more accurately rebuild the complex cranial and maxillofacial structure. The application of this material in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant.

We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium. The data of the patients implanted PEEK or titanium in four years in our institute were retrospectively collected and evaluated, in respects of the general information of patients, postoperative complications, shaping effects, and psychosocial improvements, to display a comprehensive evaluation for these two implants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients underwent cranioplasty with PEEK or Titanium.
  • Patients underwent cranioplasty and had complete data and 6-month follow-up records.

排除标准

  • Patients underwent cranioplasty with other material or ABF.
  • Patients had incomplete data or follow-up records.

结局指标

主要结局

Complications

时间窗: December 2016 to December 2020

Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.

次要结局

  • Postoperative cranial symmetry(December 2016 to July 2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junfeng Feng

Prof.

RenJi Hospital

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