跳至主要内容
临床试验/DRKS00017312
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

发起方
Department of Oral and Maxillofacial Surgery, Medical University of Graz

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