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临床试验/NCT03218150
NCT03218150Unknown不适用

Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

Assiut University0 个研究点目标入组 1 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1
主要终点
safety : minimize incidence of infection

研究概览

简要总结

Prospective, comparative, observational study.

The project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety among the 3 types of treatment.

Eligibility to each treatment will respect the standard clinical practice.

Primary outcome: minimize post operative infection

Secondary outcomes: decrease operation time , clinical and psychological improvement of the patient, decrease the cost on the patient

详细描述

Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, ongoing researches on both biologic and non biologic substitutions continue aiming to develop the ideal reconstruction material.

Autologous bone grafts remain the best option for adult and pediatric patients with viable donor sites and small-to-medium defects. Large defects in the adult population can be reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use of computer-assisted design and manufacturing customization. Advances in alloplastic materials and custom manufacturing of implants will have an important influence on cranioplasty techniques in the years to come.

研究设计

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

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .
  • Age older than 10 and less than 60 years
  • Provided written informed consent

排除标准

  • Cases of cranial defects due to congenital anomalies or growing skull fractures .
  • Severe disease with limited life expectancy of less than one year

结局指标

主要结局

safety : minimize incidence of infection

时间窗: 360 days after surgery

incidence of adverse events ((infection, reabsorption))

次要结局

  • efficacy(60 , 120 , 360 days after surgery)

研究者

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

Alaeddin Mohamed Ali

resident doctor

Assiut University

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