NIR Arthroscopic Fluorescence Angiography of Menisci (FLUORarth)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Meniscus Rupture
• Intervention / Treatment: Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pieter B.A.A. van Driel, MD, PhD; Phone Number: 003188 6245000; Email: p.b.a.a.van.driel@isala.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Isala
• Collaborators: Arthrex, Inc.; Diagnostic Green GmbH

Publications and helpful links

General Publications

• Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23.
• Goncalves LN, van den Hoven P, van Schaik J, Leeuwenburgh L, Hendricks CHF, Verduijn PS, van der Bogt KEA, van Rijswijk CSP, Schepers A, Vahrmeijer AL, Hamming JF, van der Vorst JR. Perfusion Parameters in Near-Infrared Fluorescence Imaging with Indocyanine Green: A Systematic Review of the Literature. Life (Basel). 2021 May 11;11(5):433. doi: 10.3390/life11050433.
• van Schie P, van der Lelij TJN, Gerritsen M, Meijer RPJ, van Arkel ERA, Fiocco M, Swen JA, Vahrmeijer AL, Hazelbag HM, Keereweer S, van Driel PBAA. Intra-operative assessment of the vascularisation of a cross section of the meniscus using near-infrared fluorescence imaging. Knee Surg Sports Traumatol Arthrosc. 2022 May;30(5):1629-1638. doi: 10.1007/s00167-021-06690-w. Epub 2021 Aug 4.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: NL81068.07522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No