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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuropathy Ulnar

Intervention / Treatment
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* Procedure: Simple decompression
* Procedure: Subcutaneous anterior transposition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a double-blind, multicenter, phase 3, randomized controlled superiority trial examining the treatment effectiveness of in-situ decompression and subcutaneous anterior transposition for UNE.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simple decompression<br>In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve. | Procedure: Simple decompression<br>* Surgical technique<br>* Other names: In-situ Decompression;|
| Active Comparator: Subcutaneous anterior transposition<br>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<br>* Surgical technique<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulnar Nerve, Decompression, Anterior Subcutaneous Transposition, Elbow