drugset / Trial / NCT04340752
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2021-01-27
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indocyanine Green | Diagnostic / imaging agent | 7.5 mg | Intravenous |
| Subject | Indocyanine Green | Diagnostic / imaging agent | 12.5 mg | Intravenous |
| Subject | Indocyanine Green | Diagnostic / imaging agent | 25 mg | Intravenous |