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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46634
Enrollment
10
Registered
2018-03-22
Start date
2019-08-03
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meniscus rupture meniscus tear

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Visibility of meniscal vascularization

Secondary

MeasureTime frame
For the secondary objectives, the extent of the vascularization as determined based on NIR fluorescence intra-operative angiography (defined as mm from outer edge of meniscus) will be compared with the extent of the vascularization as determined based on histology (defined as mm from outer edge of meniscus).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)