NIR Arthroscopic Fluorescence Angiography of Menisci

NCT05420974 | Unknown DMC

• 1 other identifier: NL81068.07522
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meniscus Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• T start

  Fluorescence imaging will be performed from 0-10 minutes after injection of ICG

• I max

  Fluorescence imaging will be performed from 0-10 minutes after injection of ICG

• T max

  0-10 minutes

• Baseline and End fluorescence intensity

  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.

  Fluorescence imaging will be performed from 0-10 minutes after injection of ICG

Study Arms (1)

NIR fluorescence

EXPERIMENTAL

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

Interventions

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

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

NIR fluorescence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Isala: lead
• Arthrex, Inc.: collaborator
• Diagnostic Green GmbH: collaborator

Related Publications (3)

• 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.

  PMID: 23881033 RESULT

• 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.

  PMID: 34064948 RESULT

• 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.

  PMID: 34347140 RESULT

Central Study Contacts

Pieter B.A.A. van Driel, MD, PhD

CONTACT

003188 6245000; p.b.a.a.van.driel@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.B.A.A. van Driel, MD, PhD

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 16, 2022

Record last verified: 2022-06