Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow

Phase 3

Completed

• Conditions: Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

• Registration Number: NCT02281656
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Ulnar nerve compression at the elbow is a common problem and can significantly affect hand function in severe cases. The current, standard treatment is Ulnar nerve decompression with or without transposition (moving the ulnar nerve to a site where there is less compression). In severe compression, the clinical results after this surgery are typically poor. Distal transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve (anterior interosseous nerve to ulnar motor fascicles) have been suggested to "supercharge" or augment hand muscles while nerve axons regenerate from the level of the elbow after decompression/transposition. In fact, this treatment is becoming widely adopted without clear evidence that it changes outcomes. The investigators propose to prospectively compare the effectiveness of ulnar nerve decompression/transposition versus decompression/transposition and distal nerve transfer.

Detailed Description

The purpose of this study is to prospectively compare the outcomes of patients with severe (intrinsic hand muscle dysfunction) compressive ulnar neuropathy at the elbow treated with ulnar nerve decompression and subcutaneous transposition alone versus ulnar nerve decompression with subcutaneous transposition and AIN to ulnar nerve reverse end-to-side transfer. The study objectives of this project are the following: 1. To prospectively compare the clinical outcomes of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and AIN to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone. 2. To prospectively compare the electrophysiologic outcomes (nerve conduction studies and EMG) of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and AIN to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-11-02
• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2016-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients (greater than 18 years) with severe compressive ulnar nerve neuropathy (McGowan grade III) at the elbow who consent to either ulnar nerve decompression with transposition alone or ulnar nerve decompression with transposition plus nerve transfer.

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Exclusion Criteria

• Patients under the age of 18 and over 70.
• Patients with ulnar neuropathy at multiple anatomic locations along the course of the nerve.
• Patients with mild to moderate ulnar neuropathy (McGowan grade I and II).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain scores on the numeric pain rating scale	one year	The patient-rated ulnar nerve evaluation (PRUNE)

Secondary Outcome Measures

Name	Time	Method
functional performance assessment on the numeric scale	one year	The patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire
evaluation of reinnvervation of hand intrinsic muscles	one year	Electromyography (EMG)