NIR Arthroscopic Fluorescence Angiography of Menisci

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraoperative Arthroscopic Near-infrared Fluorescence Imaging of the Vascular Perfusion of the Meniscus in Patients Treated With Meniscal Repair

Conditions
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Meniscus Rupture

Intervention / Treatment
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* Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIR fluorescence<br>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. | Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG<br>* NIR fluorescence imaging of vascular perfusion using the Arthrex NIR fluorescence scope and Indocyanin Green<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIR fluorescence of the meniscus | Detection of fluorescence in the meniscus (yes/no), determined intra-operatively during the arthroscopy procedure using NIR fluorescence imaging and ICG. | Fluorescence imaging will be performed from 0-10 minutes after injection of ICG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T start | Time between injection of ICG and initial detection of the fluorescence signal in the meniscus (T start). | Fluorescence imaging will be performed from 0-10 minutes after injection of ICG | 
| I max | Maximum fluorescence intensity (Imax) in the meniscus. Fluorescence intensity will be measured in arbitrary units as a mean of three different region of interests. | Fluorescence imaging will be performed from 0-10 minutes after injection of ICG | 
| T max | Time to maximum intensity of the fluorescence signal | 0-10 minutes | 
| Baseline and End fluorescence intensity | Baseline fluorescence intensity of the meniscus and the end fluorescence intensity in the meniscus | 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. | The fluorescence intensity is measured in arbitrary units as a mean of three region of interests. | Fluorescence imaging will be performed from 0-10 minutes after injection of ICG |