NCT04254185

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Feb 2020Oct 2027

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

7.7 years

First QC Date

January 31, 2020

Last Update Submit

August 28, 2025

Conditions

Neuropathy Ulnar

Keywords

DecompressionAnterior Subcutaneous TranspositionElbowUlnar Nerve

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score

    Up to 1 year

  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score

    Up to 1 year

  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score

    Up to 1 year

  • Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer

    Up to 1 year

  • Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge

    Up to 1 year

  • +4 more secondary outcomes

Study Arms (2)

Simple decompression

ACTIVE COMPARATOR

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

Procedure: Simple decompression

Subcutaneous anterior transposition

ACTIVE COMPARATOR

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

Interventions

Simple decompressionPROCEDURE

Surgical technique

Also known as: In-situ Decompression
Simple decompression
Subcutaneous anterior transpositionPROCEDURE

Surgical technique

Subcutaneous anterior transposition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Emory Healthcare

Atlanta, Georgia, 30329, United States

RECRUITING

Norton Healthcare

Louisville, Kentucky, 40241, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21093, United States

TERMINATED

Curtis National Hand Center

Baltimore, Maryland, 21218, United States

RECRUITING

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73126, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (1)

  • Chung KC, Malay S, Burns PB, Kim HM, Ki J; SUN Study Group. Predictors of disease severity for ulnar neuropathy at the elbow, analysis from a randomized clinical trial. Plast Reconstr Surg. 2025 Sep 23. doi: 10.1097/PRS.0000000000012472. Online ahead of print.

    PMID: 40991254DERIVED

MeSH Terms

Conditions

Ulnar Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Kevin Chung, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunitha Malay

CONTACT

734-763-1834smalay@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Charles B de Nancrede Professor of Surgery, Professor of Surgery, Professor of Orthopaedic Surgery and Assistant Dean for Instructional Faculty, Medical School

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 18, 2020

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)