NIR Arthroscopic Fluorescence Angiography of Menisci (FLUORarth)

Isala

Status: Not yet enrolling

Conditions: Meniscus Rupture

Treatments: Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05420974

NL81068.07522

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

NIR fluorescence

Experimental group

Description:

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.

Treatment:

Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG