Status:
UNKNOWN
NIR Arthroscopic Fluorescence Angiography of Menisci
Lead Sponsor:
Isala
Collaborating Sponsors:
Arthrex, Inc.
Diagnostic Green GmbH
Conditions:
Meniscus Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial is an explorative single center, single-arm study to assess whether vascularization of the meniscus can be visualized intraoperatively using arthroscopic near-infrared (NIR) fluorescence us...
Detailed Description
The meniscal healing process is based on two fundamental principles: a solid primary fixation, and a well-functioning biological process of cicatrization, where the presence of vascularization is thou...
Eligibility Criteria
Inclusion
- 18 years or older;
- Patients with on MRI confirmed Zone 1 meniscal tear
- Patients with a clinical indication for arthroscopic meniscal repair
- Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.
Exclusion
- Prior operative treatment of the ruptured meniscus
- Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. In specific, these conditions concern smoking, diabetes and being overweight.
- Pregnancy
- allergy to iodine, shellfish or ICG;
- 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;
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05420974
Start Date
September 1 2022
End Date
October 31 2023
Last Update
June 16 2022
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