Randomized Trial of Supercharged End-to-Side Anterior Interosseous Nerve Transfer for Severe Cubital Tunnel Syndrome
Cubital Tunnel Syndrome, Ulnar Nerve Compression, Ulnar Nerve Palsy
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring cubital tunnel syndrome, ulnar nerve compression, cubital tunnel release, cubital tunnel decompression, supercharged end-to-side, SETS, anterior interosseous nerve transfer
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years of age or older
- Severe cubital tunnel syndrome is defined in this study as McGowan classification stage IIB or III disease (sensory deficits, motor deficits, and the presence of intrinsic atrophy)
- Indicated for surgical treatment of severe cubital tunnel syndrome at one of the two participating institutions
- Preoperative nerve conduction study and electromyography documenting ulnar neuropathy at the elbow with present fibrillations and positive sharp waves in the FDI or ADM within one year of surgery
Exclusion Criteria:
- Ulnar nerve transections
- Traumatic brachial plexus injuries
- Brachial plexus neuritis (e.g. Parsonage-Turner)
- Cervical radiculopathy
- Primary motor neuropathy (e.g. Charcot-Marie-Tooth)
- Prior cubital tunnel surgery
- Oncologic etiologies of ulnar nerve compression
- Patients who are not capable of decision-making or are unable to understand the study procedures
- Non-English speaking patients are excluded since our secondary outcome variables may not have been translated and validated in other language(s).
Sites / Locations
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Cubital tunnel release
Supercharged end-to-side (SETS) nerve transfer
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.
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.