An interventional study of NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG in Meniscus Rupture, sponsored by Isala. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Isala · Not applicable, Interventional, and Treatment
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.
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
T start
Time between injection of ICG and initial detection of the fluorescence signal in the meniscus (T start).
Time frame: 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.
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
T max
Time to maximum intensity of the fluorescence signal
Time frame: 0-10 minutes
Baseline and End fluorescence intensity
Baseline fluorescence intensity of the meniscus and the end fluorescence intensity in the meniscus
Time frame: 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.
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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