Clinical trial NCT05420974: NIR Arthroscopic Fluorescence Angiography of Menisci
Official title: Intraoperative Arthroscopic Near-infrared Fluorescence Imaging of the Vascular Perfusion of the Meniscus in Patients Treated With Meniscal Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus Rupture
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
name: Diagnostic Green GmbH
First posted: 2022-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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;

Primary outcomes:
measure: NIR fluorescence of the meniscus
timeFrame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Secondary outcomes:
measure: T start
timeFrame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
measure: I max
timeFrame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
measure: T max
timeFrame: 0-10 minutes
measure: Baseline and End fluorescence intensity
timeFrame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
measure: The ration between the maximum fluorescence intensity in the meniscus and the background fluorecence intensity.
timeFrame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.