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

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
Patient is at least 18 years of age and less than 80 years of age

Exclusion criteria

Patient is less than 18 years of age or greater than 79 years of age
Patient has a documented allergy to iodides
Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery
Patient is pregnant

Treatment and study plan

Indocyanine green

Drug

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

Primary outcomes

Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity

Time frame: up to 6 months post operative visit

Advanced Imaging Modality (AIM) arthroscopy videos for each dosing arm will be collected and five signal intensity readings will be collected from the rotator cuff within each video. The ability to visualize rotator cuff vascularity will be graded by surgeons blinded to the ICG dosing using a 5 point Likert scale where 1 indicates worst visibility and 5 indicates best visibility. Post-hoc ANOVA analysis of surgeons' responses to determine what dose of ICG is optimal for the surgery.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Apr 9, 2020
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed