Vascular CT Assessment of Structural Autograft and Allograft Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in intramedullary vascular volume and new bone growth based on CBCT
研究概览
简要总结
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.
详细描述
The purpose of this study is to investigate quantitative vascular cone beam CT(CBCT) in a clinical pilot of patients that have received a structural allograft for bone cancer or a vascularized structural autograft for bone cancer or traumatic injury. Development of a minimally invasive, longitudinal outcome measure to quantify intramedullary vascular volume and cortical bone volume of structural allografts in patients is required to translate "revitalizing" structural allograft in clinical trials. Our novel vascular CBCT will be able to demonstrate the significant differences between vascularized fibular autografts vs. structural allografts in patients that will undergo structural grafting. These data will be used to devise a power calculation for a definitive clinical trial to evaluate the efficacy of the revitalizing allograft.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •all races will be included
- •autograft or allograft of long bone as part of treatment for bone tumor
排除标准
- •pregnancy
- •patients with a history of IV contrast reactions
- •contraindication to use of epinephrine or diphenhydramine
- •hypertyroidism or history of sensitivity to iodine
- •kidney disease (abnormal urinalysis or calculaged GFR) or poor hydration due to poor intake or other causes
结局指标
主要结局
Change in intramedullary vascular volume and new bone growth based on CBCT
时间窗: 2, 8 & 18 months
次要结局
未报告次要终点
研究者
Eddie Schwarz
Professor
University of Rochester