AIN Transfer for Cubital Tunnel Syndrome

NCT05242302 | Completed Phase 1

• 1 other identifier: Pro00066610
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Ulnar nerve compressive injury due to cubital tunnel syndrome is very common. Because of the long distance to the target muscles in the hand, functional outcome in severe cases even with decompression surgery is often poor. Therefore, alternative treatment options are much needed. Recently, anterior interosseous nerve reverse end to side (RETS) transfer to the ulnar nerve above the wrist has gained popularity. However, whether a substantial portion of motor axons in the donor nerve are indeed capable of breaching the connective tissues in the ulnar nerve to reach the target muscles in the hand remains untested. To answer this crucial question, in this study the investigators plan to recruit 60 cubital tunnel syndrome patients with marked motor axonal loss who will undergo the RETS procedure. Motor unit number estimation will be done on the ulnar and anterior interosseous nerves at baseline and repeated at 3 and 6 months post operatively. Hand motor function and disability scores will also be tested at the same time points. Given the importance of this critical question and the potential utilities of distal nerve transfers, this should be a worthwhile effort.

Conditions

Nerve Injury; Surgery

Keywords

nerve transfer; cubital tunnel syndrome; nerve generation

Outcome Measures

Primary Outcomes (1)

• Motor nerve conduction study

  Amplitudes of the maximum compound muscle action potentials evoked by median nerve stimulation

  patients will be followed for 6 months after surgery

Secondary Outcomes (1)

• Key pinch strength

  patients will be followed for 6 months after surgery

Study Arms (3)

reverse end to side nerve transfer

EXPERIMENTAL

Procedure: nerve transfer

end to end nerve transfer

ACTIVE COMPARATOR

Procedure: nerve transfer

nerve decompression

ACTIVE COMPARATOR

Procedure: nerve transfer

Interventions

nerve transfer PROCEDURE

the anterior interosseous nerve will be used as a donor to reinnervation the injured ulnar nerve.

end to end nerve transfer; nerve decompression; reverse end to side nerve transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \> 18)
• Symptoms and signs indicative of cubital tunnel syndrome
• Markedly depleted motor unit number estimate in the ulnar intrinsic hand muscles \> 2 SD below the mean

You may not qualify if:

• Other co-existing neurological or musculoskeletal conditions affecting hand function
• Cognitive impairments rendering patient unable to follow instructions to perform functional tasks
• Unwilling to consent to the study

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 16, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: April 6, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)