WithdrawnNot Applicable

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

Stopped: No participants enrolled.

United States0Started 2021-04-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Subterminal key pinch strength

Timeframe: 18 months

Trial details

NCT IDNCT04647058

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-27