Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

Not Applicable

Withdrawn

• Conditions: Knee Injuries
• Interventions: Procedure: Perfusion with Indocyanine green

• Registration Number: NCT05072717
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

Single-center pilot prospective observational study to determine feasibility of assessing meniscal tissue vascularity using dynamic contrast-enhanced fluorescence arthroscopy

Detailed Description

The purpose of this pilot study is to determine whether it is possible to translate the dynamic contrast-enhanced fluorescence imaging methods we have been using to assess bone perfusion in orthopaedic trauma patients to the field of arthroscopic surgery. In other words, it is the development of dynamic contrast-enhanced fluorescence arthroscopy.

While fluorescence arthroscopes are available, there are several challenges associated with minimally invasive procedures compared with wide field imaging, and this pilot study will help determine whether these can be overcome. They are mainly to do with motion artifacts caused by the non-fixed position of the scope during wash-in/wash-out of the dye, and the use of an arthroscopic pump to pressurize the fluid in the surgical cavity.

The long-term goal of this work is to use dynamic contrast-enhanced fluorescence arthroscopy for the assessment of vascularity of meniscal tissue arthroscopically to determine potential healing capacity using dynamic contrast-enhanced fluorescence imaging.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Study Start: 2022-01-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients 18 years of age or older.
2. Meniscal tear based on MRI or preoperative assessment
3. Provision of informed consent.

Exclusion Criteria

1. Inability of patient to provide informed consent
2. Iodine allergy.
3. Evidence of septic arthritis of the proposed surgical joint.
4. Burns.
5. Incarceration.
6. Expected survival of less than 90 days.
7. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
8. Pregnant or Breastfeeding Women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with a meniscal tear requiring surgery	Perfusion with Indocyanine green	Patients will be administered Food and Drug Administration (FDA) approved Indocyanine green (ICG) through intravenous injection and imaged by a FDA approved surgical fluorescence imaging device. Both ICG fluorescence and the imaging system have been used for routine clinical practice for many years. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to meniscal perfusion can be captured by an arthroscopic imaging system.

Primary Outcome Measures

Name	Time	Method
Measurement of meniscal blood supply using Indocyanine green (ICG)	Baseline, up to 20 minutes	The primary study outcome is to measure meniscal blood flow in patients during surgery.

Secondary Outcome Measures

Name	Time	Method
Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.	Baseline, up to 20 minutes	assess the impact of arthroscopic pump pressure on the visualization of ICG-based dynamic contrast-enhanced fluorescence in the joint and to develop parameters around effect of the pump.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States