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Distal FemoralICGNCT02918383

Subchondral Perfusion Mapping Using Indocyanin Green Laser

A study testing Indocyanin Green Dye (ICG) in people with Distal Femoral and Proximal Tibial, run by Loma Linda University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been utilized to assess the viability of soft tissue, most prominently in the general surgery and plastic surgery literature. This technique has been used for prediction of soft tissue viability by assessing the perfusion status. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Distal Femoral, Proximal Tibial, Knee Surgery
What is being tested?
Indocyanin Green Dye (ICG)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jun 2016to Dec 2017
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 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective orthopedic intervention in which the distal femoral or proximal tibial articular surface is visualized through arthroscopic or open technique
  • Patients not meeting exclusion criteria

Who cannot join

  • Iodine allergy
  • Intolerance to indocyanine green dye
  • Active infection at surgical site
  • Known pregnancy
  • Inability to comprehend consent process
  • Age <18 or > 89
  • Significant blood loss risk without tourniquet inflation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Loma Linda University Healthcare Department of Orthopaedic Surgery

    Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Differential Subchondral Perfusion Mapping Using Indocyanin Green Laser Angiography

Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been utilized to assess the viability of soft tissue, most prominently in the general surgery and plastic surgery literature. This technique has been used for prediction of soft tissue viability by assessing the perfusion status. There is currently no Orthopaedic literature regarding the use of this device for assessment of subchondral perfusion of articular surfaces such as the distal femur or other chondral surfaces.

In this pilot study, the use of ICG to detect the perfusion status of a distal femur and proximal tibia during a surgical approach to the knee and correlating this to visible signs of arthritis. For example, due to the difference visible with ICG angiography correlate to gross changes in the cartilage health visible to the naked eye with radiographic imaging.

Read the detailed description

ICG has been FDA registered since 1959 and is a negatively charged, water-soluble, tricarbocyanine. It binds readily to plasma proteins after injection with almost exclusive bile excretion, and possesses an extremely low toxicity profile. In plasma, ICG has an absorption peak around 807 nm and an emission peak around 822 nm, both within the infrared range. ICG has a short half-life of 150-180 seconds, making multiple administrations possible intra-operatively. It is given intravenously during administration1-4. After it is given through an IV, it is rapidly distributed throughout the circulatory system. When a light of a specific wavelength interacts with the dye, the dye fluoresces in the near-infrared range, which can be acquired by a special camera.

In daily practice, both visualization and palpation are used to provide information about the health of articular cartilage, be it through arthroscopy or open treatment. However, real time assessment of cartilage viability and subchondral perfusion has not been available. Determination of the perfusion status of cartilage surfaces via intra-operative modalities may provide valuable information diagnostically, as well as guide therapeutic intervention. Some possible uses for this technology may be diagnosing and treating osteochondral defects, predicting future osteoarthritis, delineating or predicting areas of avascular necrosis, or use in oncologic surgery. It is currently thought that because this dye currently works extremely well in the soft tissue literature, this will directly translate to being able to accurately assess subchondral bone perfusion.

The incidence of symptomatic knee arthritis in the United States approaches 50% of the population by the time the patient turns 85 and has been shown to significantly impact a patient's quality of life. In 2003, the United States spent $128 billion on arthritis expenditures. Arthritis can be described as the degeneration, or absence of, healthy cartilage. The current way to intra-operatively assess cartilage viability is through inspection and palpation, although this is obviously not always indicative of the overall health of the cartilage. Although an MRI may be obtained pre-operatively showing similar information, this is costly and does not provide the same information that can be assessed intra-operatively. Furthermore, an MRI does not provide information on the perfusion status of the cartilage.

It is our belief that this imaging modality will provide valuable information diagnostically and be able to guide surgical decision making regarding treatments for patients. For example, prior to undergoing a unicompartmental knee replacement, if a patient is found to have degenerative changes of the other compartments, the surgeon may convert to a total knee arthroplasty. If a patient has an osteochondral defect, knowing the perfusion status may provide information on whether to reconstruct the defect with an allograft or drill the defect. A patient undergoing a cruciate retaining total knee arthroplasty may benefit from knowing if the posterior cruciate ligament is pathologic, leading to a posterior stabilized knee replacement. For a patient with avascular necrosis, valuable prognostic information on the viability of their cartilage may help determine if joint preserving surgery is possible. The use of intra-operative ICG may have an impact on intra-operative decision making as the perfusion observed may predict the overall health of structures we currently have no way of assessing in real-time.

Being tested
Indocyanin Green Dye (ICG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanin Green Dye (ICG)Diagnostic test

Study groups in NCT02918383
Study groupRoleWhat they receive
Indocyanin Green Dye (ICG)OtherOnce the patient is in the operating room, the operative intervention will take proceed as current standard protocol dictates for the described procedure. No changes in operative technique will be undertaken apart from injection of the dye and visualization with the camera. After the articular surface of the distal femur or proximal tibia has been exposed, 2.5 mg of indocyanin green will be injected intravenously by anesthetist through a pre-existing IV line outside the sterile field. The operating surgeon will grade 6 locations on a standard scale of chondromalacia or cartilage damage.
Receives: Diagnostic Test: Indocyanin Green Dye (ICG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differential Subchondral Perfusion Mapping using Indocyanin Green Laser Angiography

    Visible grade of chondromalacia from the 6 points mentioned above.

    • Video will be acquired using the Spy Elite or Pinpoint system of the distal femur or proximal tibial surface. Currently, the software with the SPY elite is able to quantify the degree of dye uptake, and this dye uptake number from the 6 points will also be recorded.
    • Video data will be given a key that corresponds to the subject, thus no videos will be labelled with patient data or information chondromalacia ondromalacia from the 6 points mentioned above.
    • Video will be acquired using the Spy Elite or Pinpoint system of the distal femur or proximal tibial surface. Currently, the software with the SPY elite is able to quantify the degree of dye uptake, and this dye uptake number from the 6 points will also be recorded.
    • Video data will be given a key that corresponds to the subject, thus no videos will be labelled with patient data or information

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: PI has decided to close the study.

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02918383
Sponsor's protocol ID
5160045
Acronym
ICG
Status last verified
Jan 2020
First submitted
27 Sep 2016
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Indocyanin Green Dye (ICG) in people with Distal Femoral and Proximal Tibial, run by Loma Linda University at 1 site in United States.

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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was stopped early (reason given: PI has decided to close the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differential Subchondral Perfusion Mapping using Indocyanin Green Laser Angiography (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jan 2020.

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