DRKS00017312招募中未知
Comparison of TriLock Bridging Plates with conventional Bridging plates in the context of complex mandibular reconstruction – a pilot study - TriLock Bridging plates for mandibular reconstruction
Department of Oral and Maxillofacial Surgery, Medical University of Graz0 个研究点目标入组 40 人开始时间: 2019年12月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •Male/female patients, requiring segmental mandibular reconstruction due to various inevitable medical reasons with the aid of mandibular reconstruction plates including:
- •- Severe mandibular trauma
- •- Osteonecrosis of the jaw
- •- Malignant tumorous disease involving the resection of the mandible
- •- Age range: 18-85y
- •- Written consent of the participant after being informed
排除标准
- •Non-compliant patients
- •Medical causes
- •- Contraindications according to the manufacturer’s IFU
- •- Severe mandibular trauma without segmental mandibular reconstruction
- •- Mandibular tumour resection, without segmental mandibular resection.
- •- Mandibular resection, due to osteonecrosis of the jaw, without segmental mandibular resection.
- •- Limited anaesthesiologic fitness, which does not allow for elaborate reconstructive mandibular procedures.
- •- Pregnancy
- •Informed Consent
- •- Patients, who meet the inclusion criteria, but do not wish to participate in the trial, cannot be enrolled to the study
研究者
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