Intraoperative Arthroscopic Near-infrared Fluorescence Imaging of the Vascular Perfusion of the Meniscus in Patients Treated With Meniscal Repair
试验速览
- 阶段
- 不适用
- 发起方
- Isala
- 入组人数
- 20
- 主要终点
- NIR fluorescence of the meniscus
研究概览
简要总结
This trial is an explorative single center, single-arm study to assess whether vascularization of the meniscus can be visualized intraoperatively using arthroscopic near-infrared (NIR) fluorescence using ICG during standard of care meniscal repair treatment.
详细描述
The meniscal healing process is based on two fundamental principles: a solid primary fixation, and a well-functioning biological process of cicatrization, where the presence of vascularization is thought to play a major role. Intra-operative near infrared fluorescence angiography using Indocyanine Green (ICG) is a widely used method for operative assessment of vascularization. Fluorescence guided detection of the vascularity surrounding a meniscal tear could be of great value to predict meniscal healing after repair.
This pilot study will explore the technical feasibility of intraoperative near-infrared fluorescence angiography of the meniscus in patients undergoing arthroscopic meniscal repair. Technical challenges for NIR fluorescence arthroscopy are the visibility of the vascular perfusion in microvessels in the dense meniscus, motion artifacts encountered with arthroscopy and wash in of ICG using a fluid irrigation system.
The included patients will be subdivided in four equal subgroups in order to evaluate alteration of NIR fluorescence signal during arthroscopy in combination with a tourniquet and/or irrigation pump system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years or older;
- •Patients with on MRI confirmed Zone 1 meniscal tear
- •Patients with a clinical indication for arthroscopic meniscal repair
- •Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.
排除标准
- •Prior operative treatment of the ruptured meniscus
- •Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. In specific, these conditions concern smoking, diabetes and being overweight.
- •Pregnancy
- •allergy to iodine, shellfish or ICG;
- •Psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
研究组 & 干预措施
NIR fluorescence
The included patients will be subdivided in four equal subgroups in order to evaluate alteration of NIR fluorescence signal during arthroscopy in combination with a (temporary) tourniquet and irrigation pump system.
干预措施: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG (Procedure)
结局指标
主要结局
NIR fluorescence of the meniscus
时间窗: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Detection of fluorescence in the meniscus (yes/no), determined intra-operatively during the arthroscopy procedure using NIR fluorescence imaging and ICG.
次要结局
- Baseline and End fluorescence intensity(Fluorescence imaging will be performed from 0-10 minutes after injection of ICG)
- The ration between the maximum fluorescence intensity in the meniscus and the background fluorecence intensity.(Fluorescence imaging will be performed from 0-10 minutes after injection of ICG)
- T max(0-10 minutes)
- T start(Fluorescence imaging will be performed from 0-10 minutes after injection of ICG)
- I max(Fluorescence imaging will be performed from 0-10 minutes after injection of ICG)
研究者
Pieter B.A.A. van Driel
P.B.A.A. van Driel, MD, PhD
Isala