Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. This research will determine if one surgery is better than the other to alleviate symptoms.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy Ulnar
• Intervention / Treatment: Procedure: Simple decompression; Procedure: Subcutaneous anterior transposition

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunitha Malay; Phone Number: 734-763-1834; Email: smalay@umich.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory Healthcare
      • Principal Investigator: Eric Wagner, MD
      • Contact: Eric Wagner, MD; Phone Number: 404-778-3350; Email: eric.r.wagner@emory.edu
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Norton Healthcare
      • Contact: Ethan Blackburn, MD; Phone Number: 502-629-4263; Email: ethan.blackburn@nortonhealthcare.org
      • Principal Investigator: Ethan W Blackburn, MD
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Curtis National Hand Center
      • Contact: Aviram Giladi, MD, MS; Phone Number: 410-235-5405; Email: giladi@curtishand.com
      • Principal Investigator: Aviram Giladi, MD, MS
    • Baltimore, Maryland, United States, 21093
      • Terminated
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Michigan Medicine
      • Contact: Sunitha Malay; Phone Number: 734-763-1834; Email: smalay@umich.edu
      • Principal Investigator: Kevin Chung, MD, MS
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • OrthoCarolina Research Institute, Inc.
      • Contact: R. Glenn Gaston, MD; Phone Number: 704-323-3522; Email: Glenn.Gaston@orthocarolina.com
      • Principal Investigator: R. Glenn Gaston, MD
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Zhongyu Li; Phone Number: 336-716-9351; Email: zli@wakehealth.edu
      • Principal Investigator: Zhongyu Li, MD, PhD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Sonu A. Jain, MD; Phone Number: 614-366-4263; Email: sonu.jain@osumc.edu
      • Principal Investigator: Sonu A Jain, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • Recruiting
      • University of Oklahoma
      • Contact: Thomas Lehman, MD; Phone Number: 405-271-4426; Email: thomas-lehman@ouhsc.edu
      • Principal Investigator: Thomas Lehman, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: John R. Fowler, MD; Phone Number: 412-605-3245; Email: fowlerjr@upmc.edu
      • Principal Investigator: John R. Fowler, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow
• Confirmation of ulnar neuropathy using the American Association of Electrodiagnostic Medicine criteria for electrodiagnostic studies at the elbow. (Participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segment greater than 10 m/s slower than BE to wrist segment; A decrease in compound muscle action potential (CMAP) negative peak amplitude from BE to AE greater than 20%)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Able to read, understand and complete the questionnaires in English

Exclusion Criteria:

• Previous elbow fracture requiring surgical fixation
• Patients who have not attempted conservative management for UNE (e.g. night splinting)
• Subluxation of ulnar nerve on preoperative exam
• Recurrent UNE after previous surgery
• Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities
• Participants with severe comorbid conditions that prohibit surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simple decompression; In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.	Procedure: Simple decompression; Surgical technique; Other Names: In-situ Decompression
Active Comparator: Subcutaneous anterior transposition; Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation	Procedure: Subcutaneous anterior transposition; Surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score	The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales assessing overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. Scores range from 0-100, 100=no disability). In the pain scale, however, high scores indicate greater pain (0-100, 0=no pain).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score	The MHQ is a self-report measure that assesses the function of hand(s) and/or wrist(s). The MHQ contains six distinct scales. The score will be measured at various time points to identify the recovery trend.In a pain scale, high scores indicate greater pain (0-100, 0=no pain)	Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score	The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms. The score will be measured at various time points to identify the recovery trend.	Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score	The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms. The score will be measured at various time points to identify the recovery trend.	Up to 1 year
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer	Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend.	Up to 1 year
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge	Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend.	Up to 1 year
Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)	Thresholds on the tip of the finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacing's are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." The threshold difference will be measured at various time points to identify the recovery trend.	Up to 1 year
Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)	A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes. Interpretation scale for monofilaments: 2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only Sensory thresholds will be measured at various time points to identify the recovery trend.	Up to 1 year
Complication rates for both surgical procedures assessed using a checklist	Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits.	Up to 1 year
Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale	Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability.	Enrollment, approximately day 0

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Johns Hopkins University; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Oklahoma; Wake Forest University Health Sciences; OrthoCarolina Research Institute, Inc.; Ohio State University; Norton Healthcare; University of Pittsburgh Medical Center; Emory Healthcare; Curtis National Hand Center
• Investigators: Principal Investigator: Kevin Chung, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Elbow; Decompression; Ulnar Nerve; Anterior Subcutaneous Transposition
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Ulnar Neuropathies
• Other Study ID Numbers: HUM00133613; U01AR073485 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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