Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Total Bone Blood Flow (TBBF)-Post Osteotomy
研究概览
简要总结
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
详细描述
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
- •Provision of informed consent
排除标准
- •Iodine allergy
- •Pregnant women
结局指标
主要结局
Total Bone Blood Flow (TBBF)-Post Osteotomy
时间窗: 4 hours
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.
Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping
时间窗: 4 hours
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.
次要结局
未报告次要终点
研究者
Ida Leah Gitajn
Staff Physician
Dartmouth-Hitchcock Medical Center