NL-OMON46634
Completed
Phase 2
Intraoperative near-infrared (NIR) fluorescence imaging of the vascularization of the meniscus in patients treated with a total knee prosthesis * a pilot study - NIRF of vascularity of the meniscus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 18 years or older; \* Patients undergoing a total knee arthroplasty \* No history of allergy to iodine, shellfish or ICG; \* Not pregnant; \* Absence of any psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial; \* Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.
Exclusion Criteria
- •\- History of allergy to iodine, shellfish or ICG; \- Hemodialyse \- Patients with hyperthyroidism; \- Pregnant or lactating woman; \- Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. \- Patients with severe liver failure
Outcomes
Primary Outcomes
Not specified
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