Subchondral Perfusion Mapping Using Indocyanin Green Laser

NCT ID: NCT02918383

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-12-31

Brief 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. 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.

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.

Conditions

Distal Femoral; Proximal Tibial; Knee Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanin Green Dye (ICG)

Once 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.

Group Type: OTHER

Indocyanin Green Dye (ICG)

Intervention Type: DIAGNOSTIC_TEST

Interventions

Indocyanin Green Dye (ICG)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective orthopedic intervention in which the distal femoral or proximal tibial articular surface is visualized through arthroscopic or open technique

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Lee Zuckerman, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee Zuckerman, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Healthcare Department of Orthopaedic Surgery

Loma Linda, California, United States

Countries

United States

Other Identifiers

5160045

Identifier Type: -

Identifier Source: org_study_id