NIR Arthroscopic Fluorescence Angiography of Menisci

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-31

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.

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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.

Conditions

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Meniscus Rupture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

NIR fluorescence imaging of vascular perfusion using the Arthrex NIR fluorescence scope and Indocyanin Green

Interventions

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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

Intervention Type PROCEDURE

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No