SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression

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.

Study Overview

• Status: Withdrawn
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Drug: Indocyanine green

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adam Jacoby, MD; Phone Number: 203-980-5245; Email: adam.jacoby@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Group; Participants will have planned surgical procedure to repair the median or ulnar nerve compression. During the procedure, the doctor will administer a small injection of indocyanine green (ICG) and laser angiography using the SPY Elite device will be used to evaluate blood flow and extent of nerve decompression at the surgical site. Participation will also involve filling out two questionnaires on pain and function level and an examination of hand strength and range of motion.

Drug: Indocyanine 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.; Other Names: SPY AGENT GREEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of Fluorescence before and after nerve release.	Assessed by comparing the SPY angiography value before and after nerve release surgery	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nerve function determined by grip strength	Assessed by comparing the value of grip strength at each follow-up visits to the value of grip strength before nerve release surgery	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Change in Monofilament sensory testing	Assessed by comparing the Monofilament sensory testing score at each follow-up visit to the Monofilament sensory testing score before nerve release surgery	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Change in DASH Score	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).	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Study Director: Jacques Hacquebord, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Cubital Tunnel Syndrome
• Other Study ID Numbers: 21-01449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be used for this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No