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

Primary Purpose

Neuropathy Ulnar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simple decompression
Subcutaneous anterior transposition
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy Ulnar focused on measuring Decompression, Anterior Subcutaneous Transposition, Elbow, Ulnar Nerve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory HealthcareRecruiting
  • Norton HealthcareRecruiting
  • Johns Hopkins University
  • Curtis National Hand CenterRecruiting
  • Michigan MedicineRecruiting
  • OrthoCarolina Research Institute, Inc.Recruiting
  • Wake Forest University Health SciencesRecruiting
  • Ohio State UniversityRecruiting
  • University of OklahomaRecruiting
  • University of Pittsburgh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Simple decompression

Subcutaneous anterior transposition

Arm Description

In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.

Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 31, 2020
Last Updated
July 10, 2023
Sponsor
University of Michigan
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
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1. Study Identification

Unique Protocol Identification Number
NCT04254185
Brief Title
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Official Title
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy Ulnar
Keywords
Decompression, Anterior Subcutaneous Transposition, Elbow, Ulnar Nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simple decompression
Arm Type
Active Comparator
Arm Description
In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
Arm Title
Subcutaneous anterior transposition
Arm Type
Active Comparator
Arm Description
Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation
Intervention Type
Procedure
Intervention Name(s)
Simple decompression
Other Intervention Name(s)
In-situ Decompression
Intervention Description
Surgical technique
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous anterior transposition
Intervention Description
Surgical technique
Primary Outcome Measure Information:
Title
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
Description
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)
Time Frame
Up to 1 year
Title
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
Description
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.
Time Frame
Up to 1 year
Title
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
Description
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.
Time Frame
Up to 1 year
Title
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
Description
Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend.
Time Frame
Up to 1 year
Title
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
Description
Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend.
Time Frame
Up to 1 year
Title
Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)
Description
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.
Time Frame
Up to 1 year
Title
Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)
Description
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.
Time Frame
Up to 1 year
Title
Complication rates for both surgical procedures assessed using a checklist
Description
Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits.
Time Frame
Up to 1 year
Title
Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
Description
Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability.
Time Frame
Enrollment, approximately day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunitha Malay
Phone
734-763-1834
Email
smalay@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Chung, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Phone
404-778-3350
Email
eric.r.wagner@emory.edu
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Blackburn, MD
Phone
502-629-4263
Email
ethan.blackburn@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Ethan W Blackburn, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Terminated
Facility Name
Curtis National Hand Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aviram Giladi, MD, MS
Phone
410-235-5405
Email
giladi@curtishand.com
First Name & Middle Initial & Last Name & Degree
Aviram Giladi, MD, MS
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunitha Malay
Phone
734-763-1834
Email
smalay@umich.edu
First Name & Middle Initial & Last Name & Degree
Kevin Chung, MD, MS
Facility Name
OrthoCarolina Research Institute, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Glenn Gaston, MD
Phone
704-323-3522
Email
Glenn.Gaston@orthocarolina.com
First Name & Middle Initial & Last Name & Degree
R. Glenn Gaston, MD
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongyu Li
Phone
336-716-9351
Email
zli@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Zhongyu Li, MD, PhD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonu A. Jain, MD
Phone
614-366-4263
Email
sonu.jain@osumc.edu
First Name & Middle Initial & Last Name & Degree
Sonu A Jain, MD
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Lehman, MD
Phone
405-271-4426
Email
thomas-lehman@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Thomas Lehman, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John R. Fowler, MD
Phone
412-605-3245
Email
fowlerjr@upmc.edu
First Name & Middle Initial & Last Name & Degree
John R. Fowler, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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