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Subchondral Perfusion Mapping Using Indocyanin Green Laser (ICG)

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ClinicalTrials.gov Identifier: NCT02918383
Recruitment Status : Terminated (PI has decided to close the study.)
First Posted : September 28, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Zuckerman, MD, Loma Linda University

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Differential Subchondral Perfusion Mapping using Indocyanin Green Laser Angiography [ Time Frame: 15 months ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
Differential Subchondral Perfusion Mapping using Indocyanin Green Laser Angiography [ Time Frame: 15 months ]
  • Visible grade of ch• 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
Change History Complete list of historical versions of study NCT02918383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subchondral Perfusion Mapping Using Indocyanin Green Laser
Official Title  ICMJE Differential Subchondral Perfusion Mapping Using Indocyanin Green Laser Angiography
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Distal Femoral
  • Proximal Tibial
  • Knee Surgery
Intervention  ICMJE Diagnostic Test: Indocyanin Green Dye (ICG)
Study Arms  ICMJE 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.
Intervention: Diagnostic Test: Indocyanin Green Dye (ICG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
30
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918383
Other Study ID Numbers  ICMJE 5160045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee Zuckerman, MD, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Travis Losey, M.D. Loma Linda University Faculty
PRS Account Loma Linda University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP