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Completed

NCT Number: NCT02281656

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

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.

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Key information

Conditions

Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer

Procedure

Other names: experimental

Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.

Procedure

Other names: standard care

Primary outcomes

  1. pain scores on the numeric pain rating scale

    Time frame: one year

    The patient-rated ulnar nerve evaluation (PRUNE)

Secondary outcomes

  1. evaluation of reinnvervation of hand intrinsic muscles

    Time frame: one year

    Electromyography (EMG)

  2. functional performance assessment on the numeric scale

    Time frame: one year

    The patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Dr Christopher Doherty
  • Dr Thomas Miller

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 3, 2014
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.