Clinical trial NCT05072717: Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot
Official title: Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Injuries
Keywords: meniscus
Indocyanine green
fluorescence
imaging
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: KARL STORZ Endoscopy-America, Inc.
First posted: 2021-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of meniscal blood supply using Indocyanine green (ICG)
timeFrame: Baseline, up to 20 minutes
Secondary outcomes:
measure: Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
timeFrame: Baseline, up to 20 minutes
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Michael B Sparks, MD
role: PRINCIPAL_INVESTIGATOR
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