NCT00925509终止不适用
Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Accuracy of implants insertion, radio-surgical guidance.
研究概览
简要总结
Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.
详细描述
- Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps
- Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps)
- Investigate the delay of mucous healing
- Estimate the prosthetic function
- Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation
- Estimate the implant rate due to minimally invasive flaps
- Estimate the implant rate due to pure trans mucosa way
- Estimate the post surgical therapeutic success after 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •age over 18
- •Performance status over 70
- •Histological evidence of upper digestive tract cancer
- •History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer.
- •Bone volume sufficient to support an implant.
- •Mandatory affiliation with a social security system
- •Written, voluntary, informed consent
排除标准
- •Patient with evolutive malignant disease
- •Contraindication to general anesthesia
- •Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia...)
- •Patient enrolled in another clinical trial including chemotherapy
- •Pregnant or lactating woman
- •Anticipation of an impossible follow-up
- •Patient deprived of freedom
结局指标
主要结局
Accuracy of implants insertion, radio-surgical guidance.
时间窗: 8 months after inclusion
次要结局
- Accuracy of inserting implants(16 months after inclusion)
- Delay of mucous healing(16 months after inclusion)
- Estimation of the prosthetic function(16 months after inclusion)
- Osteonecrosis rate after radiation with traumatic etiology due to implantation(16 months after inclusion)
- Implant rate(16 months after inclusion)
- Post surgical therapeutic success after 1 year(after 1 year)
研究者
研究点 (8)
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