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

The menisci act as a shock absorbers within the knee and are therefore of
paramount importance for the preservation of cartilage. Further, they play an
important role in the stability of the knee. A meniscal tear is one of the most
frequent pathologies treated by orthopaedic surgeons. Whenever possible, a
meniscal tear will be repaired with sutures to ensure its critical role within
the knee joint. However, such meniscal repair is only feasible when the tear is
localized within the vascularized region of the meniscus. Despite careful
patient selection, improved surgical techniques and postoperative
rehabilitation, failure rates of meniscal repair of up to 30-40% have been
documented. One of the potential reasons for failure of meniscal repair is the
current inability to visualize whether the meniscal repair sutures are placed
within viable, vascularized meniscal tissue. Intra-operative near infrared
fluorescence angiography of the meniscus using ICG could guide the orthopaedic
surgeon in the decision which meniscal tear could be repaired. This pilot study
will explore the possibility of near-infrared fluorescence angiography of the
meniscus in patients undergoing a total knee prosthesis. Further research will
be necessary to explore the possibility of performing NIR angiography
arthroscopically.

To explore the possibility of NIR fluorescence intra-operative angiography of
the meniscus using ICG in patients undergoing total knee arthroplasty

This trial is a phase II singlecenter, single-arm study to assess the
possibility of NIR fluorescence intra-operative angiography of the meniscus
using ICG in patients undergoing total knee arthroplasty. All patients will
undergo standard-of-care. This includes a pre-operative AP and lateral X-ray of
the knee. In addition to the standard-of-care, during the total knee
arthroplasty patients receive a single intravenous (IV) dose of 10 mg ICG. NIR
fluorescence imaging will be performed prior to the routine resection of the
medial and lateral meniscus. Fluorescence spots and fluorescence at the end of
zone 2 will be tagged with a suture. After resection of the menisci, both
menisci will be stored in formaldehyde and send to the pathology department.
The end of vascularity in zone 2 and 2 random fluorescence spots that are
marked with a suture will be checked for vascularization in histological
sections. Standard of care will proceed.

During surgery of the total knee prosthesis, 10 mg of ICG will be administred
intravenously and ICG-NIRF imaging of the vascularization of the meniscus will
be performed. This will take 15 minutes. Further, standard of care (surgery)
will proceed afterwards.