Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
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ClinicalTrials.gov Identifier: NCT04254185 |
Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : July 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Neuropathy Ulnar | Procedure: Simple decompression Procedure: Subcutaneous anterior transposition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 378 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Investigator) |
Masking Description: | double-blinded |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow |
Actual Study Start Date : | February 18, 2020 |
Estimated Primary Completion Date : | February 2025 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
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Active Comparator: Simple decompression
In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
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Procedure: Simple decompression
Surgical technique
Other Name: 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
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Procedure: Subcutaneous anterior transposition
Surgical technique |
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254185
Contact: Sunitha Malay | 734-763-1834 | smalay@umich.edu |
United States, Georgia | |
Emory Healthcare | Recruiting |
Atlanta, Georgia, United States, 30329 | |
Contact: Eric Wagner, MD 404-778-3350 eric.r.wagner@emory.edu | |
Principal Investigator: Eric Wagner, MD | |
United States, Kentucky | |
Norton Healthcare | Recruiting |
Louisville, Kentucky, United States, 40241 | |
Contact: Ethan Blackburn, MD 502-629-4263 ethan.blackburn@nortonhealthcare.org | |
Principal Investigator: Ethan W Blackburn, MD | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21093 | |
Contact: Dawn LaPorte, MD 410-955-3134 dlaport1@jhmi.edu | |
Principal Investigator: Dawn LaPorte, MD | |
Curtis National Hand Center | Recruiting |
Baltimore, Maryland, United States, 21218 | |
Contact: Aviram Giladi, MD, MS 410-235-5405 giladi@curtishand.com | |
Principal Investigator: Aviram Giladi, MD, MS | |
United States, Michigan | |
Michigan Medicine | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Sunitha Malay 734-763-1834 smalay@umich.edu | |
Principal Investigator: Kevin Chung, MD, MS | |
United States, North Carolina | |
OrthoCarolina Research Institute, Inc. | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Contact: R. Glenn Gaston, MD 704-323-3522 Glenn.Gaston@orthocarolina.com | |
Principal Investigator: R. Glenn Gaston, MD | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Zhongyu Li 336-716-9351 zli@wakehealth.edu | |
Principal Investigator: Zhongyu Li, MD, PhD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Sonu A. Jain, MD 614-366-4263 sonu.jain@osumc.edu | |
Principal Investigator: Sonu A Jain, MD | |
United States, Oklahoma | |
University of Oklahoma | Recruiting |
Oklahoma City, Oklahoma, United States, 73126 | |
Contact: Thomas Lehman, MD 405-271-4426 thomas-lehman@ouhsc.edu | |
Principal Investigator: Thomas Lehman, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: John R. Fowler, MD 412-605-3245 fowlerjr@upmc.edu | |
Principal Investigator: John R. Fowler, MD |
Principal Investigator: | Kevin Chung, MD, MS | University of Michigan |
Responsible Party: | 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 |
ClinicalTrials.gov Identifier: | NCT04254185 |
Other Study ID Numbers: |
HUM00133613 U01AR073485 ( U.S. NIH Grant/Contract ) |
First Posted: | February 5, 2020 Key Record Dates |
Last Update Posted: | July 16, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Decompression Anterior Subcutaneous Transposition Elbow Ulnar Nerve |
Ulnar Neuropathies Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |