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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02281656
Enrollment
40
Registered
2014-11-03
Start date
2015-01-31
Completion date
2016-10-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESurgery:ulnar nerve transposition with AIN to ulnar nerve transfer
PROCEDURESurgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.

Sponsors

Dr Christopher Doherty
CollaboratorUNKNOWN
Dr Thomas Miller
CollaboratorUNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
pain scores on the numeric pain rating scaleone yearThe patient-rated ulnar nerve evaluation (PRUNE)

Secondary

MeasureTime frameDescription
evaluation of reinnvervation of hand intrinsic musclesone yearElectromyography (EMG)
functional performance assessment on the numeric scaleone yearThe patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026