Neuroma, Neuroma Amputation, Neuroma of Lower Limb, Neuroma of Upper Limb
Conditions
Keywords
Neuroma, Indocyanine Green, Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, Nerve Repair, Fluorescence Angiography
Brief summary
The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography
Detailed description
Neuromas represent the frustrated regeneration of injured nerve axons encased in a bulbous scar. Symptomatic neuromas are particularly problematic in patients with amputations. Targeted Muscle Reinnervation is a novel surgical approach to neuroma treatment, resulting in improved residual limb pain in amputees. Nevertheless, a subset of Targeted Muscle Reinnervation patients achieve inadequate relief. Incomplete neuroma excision may be of particular concern in such cases, as failure to completely excise the neuroma risks leaving a scarred proximal nerve stump behind. Despite the critical importance of complete neuroma excision, there is no clear definition of a neuroma's zone of injury. Indeed, intraoperatively determining where to cut a nerve to ensure accurate and complete excision of a neuroma at the time of reconstruction or repair is an unsolved problem in peripheral nerve surgery. The proposed research aims to characterize the perfusion of neuromas using fluorescence angiography. Specifically, we will test the hypothesis that intravascular indocyanine green (ICG) renders visible the perturbations in nerve perfusion associated with neuromas, and that these altered perfusion patterns correlate with the nerve's zone of injury as identified by histopathology. Ultimately, indocyanine green (ICG) fluorescence angiography may facilitate intraoperative decision-making at the time of neuroma excision.
Interventions
DRUGIndocyanine green
Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma
Sponsors
American Society for Surgery of the Hand
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Clinical diagnosis of neuroma * Scheduled elective surgery for neuroma excision
Exclusion criteria
* Minors, or age \< 18 years old at the time of surgery * Unable to provide written, informed consent * Prisoners and decision-impaired individuals * Pregnant or lactating women * History of allergy to indocyanine green * History of allergy to iodides * History of allergic asthma * History of hepatic failure * History of renal failure * Patients in whom the planned surgical incision/approach does not include excision of the neuroma * Patients in whom adequate surgical exposure of the neuroma is unable to be obtained, as determined intraoperatively at the time of surgery by the Investigator or Co-Investigators * Any subject who, at the discretion of the Investigator or Co-Investigators, is not suitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuroma ICG Fluorescence Angiogram | Intraoperative | Nerve Tissue Perfusion as visualized by Fluorescence Angiogram |
Countries
United States
Outcome results
None listed