Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
研究概览
简要总结
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.
详细描述
Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skull defects without the possibility to be covered with the missing own bone
- •Size of the defect ≥ 16 cm2
- •Written informed consent of the patient
排除标准
- •Active tumor
- •ASA 4 classification
- •Allergic disposition to ceramic or titanium
- •Concomitant participation in other clinical trials
- •Pregnant or nursing women
- •Expected low compliance
- •HIV positive
- •Active drug abuses
结局指标
主要结局
Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
时间窗: 6 months
次要结局
- Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.(6 months)
- Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.(6 months)
- Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.(6 months)
- Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms.(48 hours post-operative)
- Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.(6 months)
- Description of osteointegration with CT and bone scan six months post-operative in both groups(6 months)
研究者
Dirk Lindner
Dr.
University of Leipzig