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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2025

Interventions

  • Procedure: Simple decompression
    • Surgical technique
  • Procedure: Subcutaneous anterior transposition
    • Surgical technique

Arms, Groups and Cohorts

  • Active Comparator: Simple decompression
    • In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score
    • Time Frame: 1 year
    • 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).

Secondary Measures

  • Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
    • Time Frame: Up to 1 year
    • 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)
  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
    • Time Frame: Up to 1 year
    • 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.
  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
    • Time Frame: Up to 1 year
    • 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.
  • Difference in Grip Strength (unaffected hand – affected hand) measured by a Jamar dynamometer
    • Time Frame: Up to 1 year
    • Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend.
  • Difference in Pinch Strength (unaffected hand – affected hand) as measured by a pinch gauge
    • Time Frame: Up to 1 year
    • Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend.
  • Difference in distance assessed by the 2 Point Discrimination (unaffected hand – affected hand)
    • Time Frame: Up to 1 year
    • 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.
  • Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand – affected hand)
    • Time Frame: Up to 1 year
    • 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.
  • Complication rates for both surgical procedures assessed using a checklist
    • Time Frame: Up to 1 year
    • Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits.
  • Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
    • Time Frame: Enrollment, approximately day 0
    • Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Kevin C. Chung, Charles B de Nancrede Professor of Surgery, Professor of Surgery, Professor of Orthopaedic Surgery and Assistant Dean for Instructional Faculty, Medical School – University of Michigan
  • Overall Official(s)
    • Kevin Chung, MD, MS, Principal Investigator, University of Michigan

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