NCT01147315已完成不适用
10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- The cure of ORN
研究概览
简要总结
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated
- •Presence maximum of 2 outbreaks of ORN
- •Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site
- •ECOG performance status 0, 1 or 2
- •ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar
- •Signed informed consent
排除标准
- •Oncological treatment
- •Haematologic background
- •Current bone necrosis consecutive or concurrent to taking bisphosphonates
- •Extension of ORN does not allow the retention of a mandibular rod (bicortical form)
- •Presence of fracture complicating ORN
- •Bisphosphonates during the last year
- •Contraindications to the removal of iliac or sternum bone marrow
- •Contraindication for general anesthesia
结局指标
主要结局
The cure of ORN
时间窗: 12 months
次要结局
- Quality of life
- Number of hospital days
- CT semiology description of the treated area
- Bone regeneration
- Safety of hybrid bone substitution
- Evaluation of post operative pain at mandibular and bone marrow sampling site
- Possibility of secondary dental prosthetic devices
研究者
研究点 (4)
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