Knee Injuries
Conditions
Keywords
meniscus, Indocyanine green, fluorescence, imaging
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.
Interventions
PROCEDUREPerfusion with Indocyanine green
Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.
Sponsors
KARL STORZ Endoscopy-America, Inc.
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed