To investigate the possibility of NIR fluorescence intra-operative angiography of the meniscus using ICG in patients undergoing arthroscopic meniscal repair.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of Near Infra Red fluorescence
Secondary outcome
• The time between injection of ICG and initial detection of the fluorescence
signal with arthroscopic NIR fluorescence intra-operative angiography,
expressed in seconds (Tstart).
• The maximum fluorescence intensity of ICG (Imax) in the meniscus during
intra-operative arthroscopic NIR fluorescence angiography. Fluorescence
intensity, in arbitrary units (a.u.), will be calculated as a mean of three
different regions of interest (ROI).
• The time between injection and the maximum fluorescence intensity of ICG in
the meniscus during intra-operative arthroscopic NIR fluorescence angiography
(Tmax).
• The ratio between the intensity of the fluorescence signal in the vascular
zone 1 and the background in the avascular zone 3, determined with
intra-operative arthroscopic NIR fluorescence angiographyThe ratio between the
intensity of the fluorescence signal and the background signal, determined with
arthroscopic NIR fluorescence intra-operative angiography, expressed as
percentile scores.
• The baseline- and end-fluorescence intensity of ICG in the meniscus during
intra-operative arthroscopic NIR fluorescence angiography. Fluorescence
intensity, in arbitrary units (a.u.), will be calculated as a mean of three
different regions of interest (ROI) in the vascular zone 1 of the meniscus.
• Percentage of patients where fluorescence is detected in the meniscus using
NIR fluorescence angiography per subgroup. Four different subgroups are the
arthroscopy procedure with/without the use of a tourniquet or irrigation pump
system. Comparison will be expressed as percentile scores. Differences in
presence of fluorescence between the subgroups will be determined using
Chi-squared tests.
Background summary
The menisci act as a shock absorbers within the knee and are therefore of
paramount importance for the preservation of cartilage. Further, they play an
important role in the stability of the knee. A meniscal tear is one of the most
frequent pathologies treated by orthopaedic surgeons. Whenever possible, a
meniscal tear will be repaired with sutures to ensure its critical role within
the knee joint. However, such meniscal repair is only feasible when the tear is
localized within the vascularized region of the meniscus. Despite careful
patient selection, improved surgical techniques and postoperative
rehabilitation, failure rates of meniscal repair of up to 30% have been
documented. One of the potential reasons for failure of meniscal repair is the
current inability to visualize whether the meniscal repair sutures are placed
within viable, vascularized meniscal tissue. Intra-operative near infrared
fluorescence angiography of the meniscus using ICG could guide the orthopaedic
surgeon in the decision which meniscal tear could be repaired. This pilot study
will explore the possibility of near-infrared fluorescence angiography of the
meniscus in patients undergoing a meniscal repair.
Study objective
To investigate the possibility of NIR fluorescence intra-operative angiography
of the meniscus using ICG in patients undergoing arthroscopic meniscal repair.
Study design
This trial is a singlecenter, single-arm pilot study to assess the possibility
of NIR fluorescence intra-operative angiography of the meniscus using ICG in
patients undergoing total knee arthroplasty. All patients will undergo
standard-of-care. This includes a pre-operative MRI of the knee. In addition to
the standard-of-care, during the total knee arthroplasty patients receive a
single intravenous (IV) dose of 0.1 mg/kg ICG. NIR fluorescence imaging will be
performed prior to the routine arthroscopic meniscal repair . Through the same
incisions made for the arthroscopic mensical repair, a NIR fluorescence scope
will be inserted into the knee joint. In the 10 minutes following the ICG
injection, imaging recordings will be made of the meniscus, in order to assess
vascularity of the meniscus. Following this, standard of care will proceed.
Study burden and risks
ICG is a registered product, therefore information regarding chapter 12.1 can
be found in the Summary of Product Characteristics [24].
This study is embedded in standard treatment for arthroscopic meniscal repair,
and expands standard-of-care with arthroscopic NIR fluorescence imaging using
an intra-venous injection of ICG and NIR fluorescence scope. The injection of
ICG is safe and widely used, adverse reactions have been reported in less than
1 in 40,000 patients. (5) In order to reduce the risk of adverse reactions,
patients with prior history of allergy to iodine, shellfish or ICG will be
excluded. Furthermore, during surgery the anesthesiologist will closely watch
for any allergic reaction. An allergic reaction can be treated with adrenalin,
hydrocortisone or an antihistaminic and oxygen if needed.
The Arthrex NIR fluorescence scope is CE marked and therefore meeting the
safety, health and environmental protection requirement in the European Union.
As the scope is registered for endoscopy, the scope is used in-label in this
arthroscopic study. No risks are expected using the NIR fluorescence scope for
arthroscopic surgery.
Surgical time will be extended by 10 minutes which, in case of arthroscopic
surgery, is not likely to result in any complications. Patients will not
experience more pain because of NIR fluorescence imaging procedure and will not
have any extra psychological burden.
Besides injection of ICG, the use of a NIR fluorescence scope and a prolonged
surgical time of 10 minutes, all applied interventions are standard treatment
for patients undergoing meniscal repair. Therefore extra risks and possible
burdens are negligible as compared to the standard clinical treatment.
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
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 teared meniscus;
• history of allergy to iodine, shellfish or ICG;
• Any condition that in the opinion of the investigator could potentially
jeopardize the health status of the patient. In specific, these conditions
concern smoking, renal insufficiency, diabetes, thyroid disorder and overweight.
• Pregnancy
• Presence of any 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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05420974 |
| CCMO | NL81068.075.22 |