NIR Arthroscopic Fluorescence Angiography of Menisci
- Conditions
- Meniscus Rupture
- Interventions
- Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG
- Registration Number
- NCT05420974
- Lead Sponsor
- Isala
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NIR fluorescence NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG 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.
- Primary Outcome Measures
Name Time Method NIR fluorescence of the meniscus Fluorescence imaging will be performed from 0-10 minutes after injection of ICG Detection of fluorescence in the meniscus (yes/no), determined intra-operatively during the arthroscopy procedure using NIR fluorescence imaging and ICG.
- Secondary Outcome Measures
Name Time Method T start Fluorescence imaging will be performed from 0-10 minutes after injection of ICG Time between injection of ICG and initial detection of the fluorescence signal in the meniscus (T start).
I max Fluorescence imaging will be performed from 0-10 minutes after injection of ICG Maximum fluorescence intensity (Imax) in the meniscus. Fluorescence intensity will be measured in arbitrary units as a mean of three different region of interests.
T max 0-10 minutes Time to maximum intensity of the fluorescence signal
Baseline and End fluorescence intensity Fluorescence imaging will be performed from 0-10 minutes after injection of ICG Baseline fluorescence intensity of the meniscus and the end fluorescence intensity in the meniscus
The ration between the maximum fluorescence intensity in the meniscus and the background fluorecence intensity. Fluorescence imaging will be performed from 0-10 minutes after injection of ICG The fluorescence intensity is measured in arbitrary units as a mean of three region of interests.