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ICG Fluorescence in Knee Arthroscopy Study
Sponsor: Henry Ford Health System
Summary
The purpose of this study is to first evaluate whether ICG fluorescence angiography can be used to evaluate blood flow of the anterior cruciate ligament (ACL), tendons, and knee structures during an arthroscopic surgery. The secondary purpose is to evaluate differences in the blood flow in patients with varying grades of ACL tears. To determine optimal intravenous dose of SPY Agent Green and time to visualize fluorescence in tendons and structures intraoperatively during arthroscopic surgery (if primary objective is deemed yes). We hypothesize that ICG will be effective in evaluating blood flow in patients undergoing knee arthroscopy.
Official title: Intraoperative Evaluation of Blood Flow for Knee Arthroscopy Using Indocyanine Green Fluorescence Angiography
Key Details
Gender
All
Age Range
14 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-06-01
Completion Date
2027-03-01
Last Updated
2026-08-28
Healthy Volunteers
No
Interventions
Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose)
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose)
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 5 mL of SPY Agent Green (12.5 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
Locations (1)
Henry Ford Center for Athletic Medicine
Detroit, Michigan, United States