Subchondral Perfusion Mapping Using Indocyanin Green Laser

NCT02918383 | Terminated DMC

• 1 other identifier: 5160045
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Femoral; Proximal Tibial; Knee Surgery

Outcome Measures

Primary Outcomes (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

  15 months

Study Arms (1)

Indocyanin Green Dye (ICG)

OTHER

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.

Diagnostic Test: Indocyanin Green Dye (ICG)

Interventions

Indocyanin Green Dye (ICG) DIAGNOSTIC_TEST

Indocyanin Green Dye (ICG)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Healthcare Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

Study Officials

• Lee Zuckerman, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)