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临床试验/NCT02444962
NCT02444962Unknown不适用

Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Changes in implant stability as measured by the Osstell implant stability meter at one year

研究概览

简要总结

At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life.

Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions.

Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient.

The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In need of an auricular, nasal or orbital episthesis
  • Be able to maintain a good personal hygiene

排除标准

  • Contraindications for general anesthesia
  • DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene
  • Poor personal hygiene
  • Pregnancy
  • Acute infection
  • Immunosuppression
  • Compromised by medication
  • Local irradiation >50Gray

研究组 & 干预措施

HAVD implant

Experimental

干预措施: HAVD-implant (Device)

结局指标

主要结局

Changes in implant stability as measured by the Osstell implant stability meter at one year

时间窗: one year

次要结局

  • Clinical ease of use(Directly after implant placement (0))
  • redness/irritation of the skin(52 weeks after implant placement)
  • Implant survival(52 weeks after implant placement)
  • Patient satisfaction as measured by a VAS scoring system(52 weeks after implant placement)
  • Quality of life a measured by a VAS scoring system(52 weeks after implant placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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