NCT05420974

NIR Arthroscopic Fluorescence Angiography of Menisci

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Isala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Meniscus Rupture

Interventions

Type	Name	Description
PROCEDURE	NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG	NIR fluorescence imaging of vascular perfusion using the Arthrex NIR fluorescence scope and Indocyanin Green

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2022-06-16
• Last updated: 2022-06-16