Intraoperative near-infrared (NIR) fluorescence imaging of the vascularization of the meniscus in patients treated with a total knee prosthesis * a pilot study

Phase 2

Completed

• Conditions: meniscus rupture; meniscus tear; 10043237; 10005944

• Registration Number: NL-OMON46634
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Visibility of meniscal vascularization </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> For the secondary objectives, the extent of the vascularization as determined<br /><br>based on NIR fluorescence intra-operative angiography (defined as mm from outer<br /><br>edge of meniscus) will be compared with the extent of the vascularization as<br /><br>determined based on histology (defined as mm from outer edge of meniscus). </p><br>