NCT04340752

Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

Detailed description

The primary study objective is to determine optimal dosing of an intravenous fluorescence solution (IC-Green) for arthroscopic evaluation of rotator cuff vascularity. The primary endpoint is surgeon's ability to assess vascularity within the rotator cuff based on a 5-point likert scale. The likert values from each of the three doses will undergo an ANOVA test to compare means of the three doses.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DRUG	Indocyanine Green	ICG is an injectable fluorescent pigment that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision. The ICG will not affect the course of the operative or postoperative period, and will be injected intravenously prior to the actual repair

Timeline

• Start date: 2021-01-27
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-04-09
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study