Knee Surgery Clinical Trial
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.
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.
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