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

University of Michigan

Status: Enrolling

Conditions: Neuropathy Ulnar

Treatments: Procedure: Subcutaneous anterior transposition; Procedure: Simple decompression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04254185

U01AR073485 (U.S. NIH Grant/Contract)

HUM00133613

Details and patient eligibility

About

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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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378 participants in 2 patient groups

Simple decompression

Active Comparator group

Description:

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

Treatment:

Procedure: Simple decompression

Subcutaneous anterior transposition

Active Comparator group

Description:

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

Treatment:

Procedure: Subcutaneous anterior transposition