Meniscus RuptureFLUORarthNCT05420974
NIR Arthroscopic Fluorescence Angiography of Menisci
A study testing NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG in people with Meniscus Rupture, run by Isala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Rupture
- What is being tested?
- NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intraoperative Arthroscopic Near-infrared Fluorescence Imaging of the Vascular Perfusion of the Meniscus in Patients Treated With Meniscal Repair
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.
Read the 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.
- Conditions
- Meniscus Rupture
- Being tested
- NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR fluorescence imaging of the vascular perfusion of the meniscus using ICGProcedure or surgery
NIR fluorescence imaging of vascular perfusion using the Arthrex NIR fluorescence scope and Indocyanin Green
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Secondary outcomes (5)
T start
Time between injection of ICG and initial detection of the fluorescence signal in the meniscus (T start).
Measured: 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.
Measured: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
T max
Time to maximum intensity of the fluorescence signal
Measured: 0-10 minutes
Baseline and End fluorescence intensity
Baseline fluorescence intensity of the meniscus and the end fluorescence intensity in the meniscus
Measured: 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.
Measured: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscus RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc., Diagnostic Green GmbH
- Responsible party
- Principal investigator, Pieter B.A.A. van Driel, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420974
- Sponsor's protocol ID
- NL81068.07522
- Acronym
- FLUORarth
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23881033Goncalves 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.
PubMed 34064948van 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.
PubMed 34347140
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Arthroscopic Near-infrared Fluorescence Imaging of the Vascular Perfusion of the Meniscus in Patients Treated With Meniscal Repair
- ClinicalTrials.gov ID
- NCT05420974
- Acronym / sponsor ID
- FLUORarth / NL81068.07522
- Conditions
- Meniscus Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Collaborators
- Arthrex, Inc., Diagnostic Green GmbH
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIR fluorescence | Experimental | Procedure: NIR fluorescence imaging of the vascular perfusion of the meniscus using ICGThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIR fluorescence imaging of the vascular perfusion of the meniscus using ICGNIR fluorescence imaging of vascular perfusion using the Arthrex NIR fluorescence scope and Indocyanin Green | Procedure or surgery | NIR fluorescence |
Primary outcome
NIR fluorescence of the meniscus
Time frame: 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.
5 secondary outcomes
T start
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
I max
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
T max
Time frame: 0-10 minutes
Baseline and End fluorescence intensity
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.
Time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Results publication: PubMed 23881033Vahrmeijer 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.
- Results publication: PubMed 34064948Goncalves 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.
- Results publication: PubMed 34347140van 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.
- Individual participant dataSharing planned: Undecided
Related trials for Meniscus Rupture
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NIR fluorescence imaging of the vascular perfusion of the meniscus using ICG in people with Meniscus Rupture, run by Isala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter B.A.A. van Driel, MD, PhD (003188 6245000, p.b.a.a.van.driel@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIR fluorescence of the meniscus (time frame: Fluorescence imaging will be performed from 0-10 minutes after injection of ICG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420974, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.