ACTRN12623001092684尚未招募1 期
Safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction. A Pilot Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •18 years and older
- •Head and neck cancer
- •Undergoing fibula free flap reconstruction of the mandible where there is a > 10 mm deficit in the mandible contour that would normally (without the PAEK implant) result in asymmetry
- •Willingness to give informed consent
排除标准
- •Active soft tissue infection or osteomyelitis
- •Less than 18 years of age
- •Previously undergone renal or any other allogeneic transplantation and on high dose immunosuppressive therapy
- •Unable to give informed medical consent due to cognitive impairment of psychiatric illness
- •Current or recent drug and/or alcohol abusers
- •On high dose immunosuppressive therapy including high dose steroids and methotrexate
- •A history of an endocrine, connective tissue, or metabolic disorder known to severely affect osteogenesis (e.g., Paget’s Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta)
- •On other clinical trials who have received treatment with an investigational therapy within 28 days prior to reconstructive surgery or where treatment is planned during or after the follow up period
研究者
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