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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2027-10-31

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.

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Detailed Description

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Conditions

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Neuropathy Ulnar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blinded

Study Groups

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Simple decompression

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

Group Type ACTIVE_COMPARATOR

Simple decompression

Intervention Type PROCEDURE

Surgical technique

Subcutaneous anterior transposition

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

Group Type ACTIVE_COMPARATOR

Subcutaneous anterior transposition

Intervention Type PROCEDURE

Surgical technique

Interventions

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Simple decompression

Surgical technique

Intervention Type PROCEDURE

Subcutaneous anterior transposition

Surgical technique

Intervention Type PROCEDURE

Other Intervention Names

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In-situ Decompression

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR