Randomized Trial of Supercharged End-to-Side Anterior Interosseous Nerve Transfer for Severe Cubital Tunnel Syndrome

Summary

Functional motor recovery distal to a peripheral nerve lesion is predicated upon time to reinnervation of the motor end plate and the number of regenerate axons that reach the target. Supercharged end-to-side (SETS) transfer of the anterior interosseous nerve to the motor fascicle of the ulnar nerve at the level of the distal forearm has been proposed as an adjunct procedure in severe cubital tunnel syndrome to augment motor recovery of the ulnar-innervated intrinsic muscles. Multiple Level IV Therapeutic studies and a systematic review of Level IV Therapeutic studies have reported favorable clinical and electrodiagnostic outcomes following SETS for cubital tunnel syndrome, with low rates of complications. However, in the absence of controls, it remains unclear what proportion of the observed intrinsic motor recovery is attributable to the SETS procedure. The objective of this randomized trial is to compare the results of ulnar nerve decompression with or without SETS for severe cubital tunnel syndrome.

Conditions

• Cubital Tunnel Syndrome
• Ulnar Nerve Compression
• Ulnar Nerve Palsy
• Ulnar Nerve Entrapment
• Ulnar Nerve Entrapment at Elbow
• Ulnar Nerve Entrapment Syndrome
• Ulnar Neuropathies
• Ulnar Claw

Interventions

PROCEDURE

Cubital tunnel release

The control group will undergo cubital tunnel release in situ. In cases of preoperative or intraoperative ulnar nerve instability, anterior transposition of the ulnar nerve will be performed.

PROCEDURE

Supercharged end-to-side (SETS) nerve transfer

The SETS group will undergo the same procedure as described above, with the addition of the SETS procedure consisting of a end-to-side transfer of the anterior interosseous nerve to the ulnar nerve motor branch. Decompression of Guyon's canal during the SETS procedure is at the discretion of the treating surgeon.

Sponsors & Collaborators

• Philip Blazar

  collaborator UNKNOWN

• Matthew J. Carty

  collaborator UNKNOWN

• Arriyan S. Dowlatshahi

  collaborator UNKNOWN

• George S. M. Dyer

  collaborator UNKNOWN

• Brandon E. Earp

  collaborator UNKNOWN

• Carl M. Harper

  collaborator UNKNOWN

• Lydia A. Helliwell

  collaborator UNKNOWN

• Tamara D. Rozental

  collaborator UNKNOWN

• Christian E. Sampson

  collaborator UNKNOWN

• Simon G. Talbot

  collaborator UNKNOWN

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Dafang Zhang, MD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-05

Primary Completion

2022-01-27

Completion

2022-01-27

Countries

• United States

Study Locations