Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
试验速览
- 阶段
- 不适用
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Functional outcome (a composition of following measures)
研究概览
简要总结
Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects.
Functional and aesthetic outcome is assessed by patient and doctor.
详细描述
Development phase: Clinical trial Objectives: Assessment of functional and aesthetic outcome Methodology: Intervention study Sample size: 35+20+25 Main criteria for inclusion: Skull bone defect OR orbital floor fracture
Investigational drug/treatment, dose and mode of administration: FRC implant Comparative drug(s)/placebo/treatment, dose and mode of administration: -
Duration of treatment: 2 years of follow-up
Assessments:
Clinical outcome and radiologic assesment Functional and aesthetic outcome with Visual Analog Scale (VAS). Pain assessment with VAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study arm 1:
- •patients with skull bone defect
- •reconstruction indications fullfilled
- •Study arm 2:
- •patients with orbital floor defect
- •reconstruction indication fullfilled
排除标准
- •if informed consent cannot be obtained
结局指标
主要结局
Functional outcome (a composition of following measures)
时间窗: 2 year follow-up
After reconstruction, patient follow-up protocol follows to assess functional outcome, including safety. Follow-up is done at timepoints of 1 week, 1 month, 3 months, 6 months and after that every 6 month up to 2 years post-operatively. After this the follow-up is continued yearly, if necessary. Visual and manual assessment is done by a doctor. Lateral and PA skull rtg is obtained to assess the fixation and position of the implant. C-reactive protein level and leukocyte level is measured to assess the possible inflammation.
次要结局
- Aesthetic outcome (a composition of following measures)(2 years post-operatively)