NCT01899807Unknown不适用
Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series
Karolinska University Hospital3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Rate of adverse events
研究概览
简要总结
The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. The frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. In addition, the quality of life before and after implantation will be evaluated as well as the bone regeneration around implant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtained informed consent.
- •Males or females, ≥18 years of age
- •Subject with cranial defect size > 25 cm
- •History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
- •Willing and able to comply with all study procedures and restrictions.
- •The 5 subjects participating in bone regeneration analysis (PET/CT scans) has to be 50 years or older
排除标准
- •Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
- •Pregnant or nursing women.
- •Exclusion criteria during surgery, if applicable:
- •Perioperative appearance of previously not identified tumor or infection in the reconstruction area.
结局指标
主要结局
Rate of adverse events
时间窗: From the date of intervention up to 12 months post intervention
The primary endpoint, rate of adverse events, will be measured by clinical evidence of infection and/or manifested rupture of skin around the implant, within 12 months, that necessitates explantation.
次要结局
- Quality of life scores(Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention)
- PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area(The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention)
- Percentage subjects with an adverse event(From the date of intervention up to 14 days, 3 months, 6 months follow-up)
- Subject mean MOCA(3 months and 12 months follow-up compared to baseline)
研究者
Dr. Kalle Lundgren
MD, PhD
Karolinska University Hospital
研究点 (3)
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