Cubital Tunnel Syndrome
Conditions
Brief summary
Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.
Detailed description
The purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. Commonly, this is determined by electrodiagnostic tests or physical examination. The researchers will use the SPY elite device along with an injection of a drug called SPY Agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if SPY is a useful tool for evaluating the success of nerve decompression surgery. The use of fluorescence angiography with the SPY elite device and SPY agent green is Food and Drug Administration (FDA) approved.
Interventions
DRUGIndocyanine green
The subject will receive 3mL of ICG followed by 10 mL of sterile saline intravenously as per the Spy Elite protocol. Within minutes of the injection, the SPY machine will be turned on and focused on the nerve. The SPY machine gives a digital read out of the % fluorescence when the dye reaches the nerve. This number correlates with blood flow or vascularity.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old or older; male and female patients * Ulnar Nerve Compression at the Elbow * Failed conservative treatment (i.e. hand therapy, pain medications, splinting) * Able to provide informed consent
Exclusion criteria
* Pregnancy/breastfeeding * Thyroid Disease * Vascular Disease * Known allergy to any study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in level of Fluorescence before and after nerve release. | 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits | Assessed by comparing the SPY angiography value before and after nerve release surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nerve function determined by grip strength | 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits | Assessed by comparing the value of grip strength at each follow-up visits to the value of grip strength before nerve release surgery |
| Change in Monofilament sensory testing | 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits | Assessed by comparing the Monofilament sensory testing score at each follow-up visit to the Monofilament sensory testing score before nerve release surgery |
| Change in DASH Score | 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits | DASH score at each follow-up visit does not differ from that before nerve release surgery. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on the test ranges is from 0 (no disability) to 100 (most severe disability). |
Countries
United States
Outcome results
None listed