ICG Fluorescence in Knee Arthroscopy Study

ConditionTo Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age14-89

SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be within ages of 14-89. Patient ages 14-17 will be included to capture an important sporting demographic who sustain ACL injuries which would stand to benefit from this intervention if successful.

Have signed an approved informed consent form for the study.

Be willing to comply with the protocol

Disqualifiers

Patient is less than 14 years of age or greater than 89 years of age

Patients who have had iodide-based radiology studies within the last seven (7) days prior to surgery

Previous surgical repair of targeted surgical area

Known allergy or history of adverse reaction to SPY Agent Green, ICG,

Trial design

Design model

Sequential

Treatments tested in this trial

Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)
Combination product
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)
Combination product
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)
Combination product
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)
Combination product
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.

Treatment groups

40 Participants

are divided into 4 treatment groups

Group A: 2 mL of SPY Agent Green (5.0 mg dose)Experimental treatment 1 intervention

Group B: 3 mL of SPY Agent Green (7.5 mg dose)Experimental treatment 1 intervention

Group C: 4.0 mL of SPY Agent Green (10.0 mg dose)Experimental treatment 1 intervention

Group D: 5.0 mL of SPY Agent Green (12.5 mg dose)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Fluorescence signal

To determine if a fluorescence signal is present in knee structures during arthroscopic surgery after an intravenous administration of SPY Agent Green is given.

Time frame

From enrollment to first follow up appointment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Stryker Orthopaedics

Collaborator

Source ClinicalTrials.gov

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