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

Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281656
• Other study ID #: 7126
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)
• Ulnar Neuropathies

Intervention

Procedure:
• Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer

• Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Dr Christopher Doherty, Dr Thomas Miller

References & Publications (1)

1. McGowan AJ. The Results of Transposition of the Ulnar Nerve for Traumatic Ulnar Neuritis. The Journal of Bone and Joint Surgery, 32B (3): 293-301, 1950. 2. Macadam SA, Gandhi R, Bezuhly M et al. Simple Decompression Versus Anterior Subcutaneous and Submuscular Transposition of the Ulnar Nerve for Cubital Tunnel Syndrome: A Meta-Analysis. Journal of Hand Surgery (Am), 33A: 1314-1324, 2008. 3. Chung KC. Treatment of Ulnar Nerve Compression at the Elbow. Journal of Hand Surgery (Am), 33A: 1625-1627, 2008. 4. Haase SC and Chung KC. Anterior Interosseous Nerve Transfer to the Motor Branch of the Ulnar Nerve for High Ulnar Nerve Injuries. Annals of Plastic Surgery, 49: 285-290, 2002. 5. Barbour J, Yee A, Kahn LC and Mackinnon SE. Supercharged End-to-Side Anterior Interosseous to Ulnar Motor Nerve Transfer for Intrinsic Musculature Reinnervation. Journal of Hand Surgery (Am), 37A: 2150-2159, 2012. 6. Kale SS, Glaus SW, Yee A et al. Reverse End-to-Side Nerve Transfer: From Animal Model to Clinical Use. Journal of Hand Surgery (Am), 36A: 1631-1639, 2011. 7. Isaacs J. Supercharged End-to-Side Nerve Transfer: Too Soon for "Prime Time"? Journal of Hand Surgery (Am), 38A: 617-618, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores on the numeric pain rating scale	The patient-rated ulnar nerve evaluation (PRUNE)	one year
Secondary	evaluation of reinnvervation of hand intrinsic muscles	Electromyography (EMG)	one year
Secondary	functional performance assessment on the numeric scale	The patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire	one year