Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measurement of meniscal blood supply using Indocyanine green (ICG)
研究概览
简要总结
Single-center pilot prospective observational study to determine feasibility of assessing meniscal tissue vascularity using dynamic contrast-enhanced fluorescence arthroscopy
详细描述
The purpose of this pilot study is to determine whether it is possible to translate the dynamic contrast-enhanced fluorescence imaging methods we have been using to assess bone perfusion in orthopaedic trauma patients to the field of arthroscopic surgery. In other words, it is the development of dynamic contrast-enhanced fluorescence arthroscopy.
While fluorescence arthroscopes are available, there are several challenges associated with minimally invasive procedures compared with wide field imaging, and this pilot study will help determine whether these can be overcome. They are mainly to do with motion artifacts caused by the non-fixed position of the scope during wash-in/wash-out of the dye, and the use of an arthroscopic pump to pressurize the fluid in the surgical cavity.
The long-term goal of this work is to use dynamic contrast-enhanced fluorescence arthroscopy for the assessment of vascularity of meniscal tissue arthroscopically to determine potential healing capacity using dynamic contrast-enhanced fluorescence imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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.
- •Meniscal tear based on MRI or preoperative assessment
- •Provision of informed consent.
排除标准
- •Inability of patient to provide informed consent
- •Iodine allergy.
- •Evidence of septic arthritis of the proposed surgical joint.
- •Incarceration.
- •Expected survival of less than 90 days.
- •Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- •Pregnant or Breastfeeding Women
结局指标
主要结局
Measurement of meniscal blood supply using Indocyanine green (ICG)
时间窗: Baseline, up to 20 minutes
The primary study outcome is to measure meniscal blood flow in patients during surgery.
次要结局
- Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.(Baseline, up to 20 minutes)
研究者
Michael B. Sparks
Associate Professor of Orthopaedics
Dartmouth-Hitchcock Medical Center