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Trial record 1 of 1 for:    NCT04254185
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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
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Curtis National Hand Center
Emory Healthcare
Norton Healthcare
Ohio State University
OrthoCarolina Research Institute, Inc.
University of Pittsburgh Medical Center
Wake Forest University Health Sciences
Johns Hopkins University
University of Oklahoma
Information provided by (Responsible Party):
Dr. Kevin C. Chung, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathy Ulnar Procedure: Simple decompression Procedure: Subcutaneous anterior transposition Not Applicable

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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
Active Comparator: Simple decompression
In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
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
Procedure: Subcutaneous anterior transposition
Surgical technique




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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.


  3. 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.


  4. 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.

  5. 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.

  6. 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.

  7. 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.


  8. 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.

  9. 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.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Sunitha Malay 734-763-1834 smalay@umich.edu

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Kevin C. Chung, University of Michigan:
Decompression
Anterior Subcutaneous Transposition
Elbow
Ulnar Nerve
Additional relevant MeSH terms:
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Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases