NCT04647058

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

November 16, 2020

Last Update Submit

January 27, 2022

Conditions

Cubital Tunnel SyndromeUlnar Nerve CompressionUlnar Nerve PalsyUlnar Nerve EntrapmentUlnar Nerve Entrapment at ElbowUlnar Nerve Entrapment SyndromeUlnar NeuropathiesUlnar Claw

Keywords

cubital tunnel syndromeulnar nerve compressioncubital tunnel releasecubital tunnel decompressionsupercharged end-to-sideSETSanterior interosseous nerve transfer

Outcome Measures

Primary Outcomes (1)

  • Subterminal key pinch strength

    The primary outcome variable of this study is subterminal key pinch strength assessed by dynanometer measured in kg. Subterminal key pinch strength is a direct assessment of ulnar-innervated muscle strength.

    18 months

Secondary Outcomes (3)

  • Patient-Rated Ulnar Nerve Evaluation (PRUNE) score

    18 months

  • Disabilities of the Arm, Shoulder and Hand (DASH) score

    18 months

  • MRC forearm pronation strength

    18 months

Study Arms (2)

Cubital tunnel release

ACTIVE COMPARATOR

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.

Procedure: Cubital tunnel release

Supercharged end-to-side (SETS) nerve transfer

EXPERIMENTAL

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.

Procedure: Supercharged end-to-side (SETS) nerve transfer

Interventions

Cubital tunnel releasePROCEDURE

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.

Cubital tunnel release
Supercharged end-to-side (SETS) nerve transferPROCEDURE

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.

Supercharged end-to-side (SETS) nerve transfer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (9)

  • Barbour J, Yee A, Kahn LC, Mackinnon SE. Supercharged end-to-side anterior interosseous to ulnar motor nerve transfer for intrinsic musculature reinnervation. J Hand Surg Am. 2012 Oct;37(10):2150-9. doi: 10.1016/j.jhsa.2012.07.022.

    PMID: 23021177BACKGROUND

  • Jarvie G, Hupin-Debeurme M, Glaris Z, Daneshvar P. Supercharge End-to-Side Anterior Interosseous Nerve to Ulnar Motor Nerve Transfer for Severe Ulnar Neuropathy: Two Cases Suggesting Recovery Secondary to Nerve Transfer. J Orthop Case Rep. 2018 Sep-Oct;8(5):25-28. doi: 10.13107/jocr.2250-0685.1194.

    PMID: 30740369BACKGROUND

  • Davidge KM, Yee A, Moore AM, Mackinnon SE. The Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer for Restoring Intrinsic Function: Clinical Experience. Plast Reconstr Surg. 2015 Sep;136(3):344e-352e. doi: 10.1097/PRS.0000000000001514.

    PMID: 26313839BACKGROUND

  • Dengler J, Dolen U, Patterson JMM, Davidge KM, Kahn LC, Yee A, Mackinnon SE. Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer Restores Intrinsic Function in Cubital Tunnel Syndrome. Plast Reconstr Surg. 2020 Oct;146(4):808-818. doi: 10.1097/PRS.0000000000007167.

    PMID: 32590517BACKGROUND

  • Dunn JC, Gonzalez GA, Fernandez I, Orr JD, Polfer EM, Nesti LJ. Supercharge End-to-Side Nerve Transfer: Systematic Review. Hand (N Y). 2021 Mar;16(2):151-156. doi: 10.1177/1558944719836213. Epub 2019 Mar 29.

    PMID: 30924361BACKGROUND

  • Koriem E, El-Mahy MM, Atiyya AN, Diab RA. Comparison Between Supercharged Ulnar Nerve Repair by Anterior Interosseous Nerve Transfer and Isolated Ulnar Nerve Repair in Proximal Ulnar Nerve Injuries. J Hand Surg Am. 2020 Feb;45(2):104-110. doi: 10.1016/j.jhsa.2019.11.005. Epub 2019 Dec 20.

    PMID: 31866151BACKGROUND

  • MacDermid JC, Grewal R. Development and validation of the patient-rated ulnar nerve evaluation. BMC Musculoskelet Disord. 2013 Apr 26;14:146. doi: 10.1186/1471-2474-14-146.

    PMID: 23617407BACKGROUND

  • Bertelli JA. Subterminal key pinch dynamometry: a new method to quantify strength deficit in ulnar nerve paralysis. J Hand Surg Eur Vol. 2020 Oct;45(8):813-817. doi: 10.1177/1753193420919283. Epub 2020 Apr 29.

    PMID: 32349609BACKGROUND

  • Head LK, Zhang ZZ, Hicks K, Wolff G, Boyd KU. Evaluation of Intrinsic Hand Musculature Reinnervation following Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer. Plast Reconstr Surg. 2020 Jul;146(1):128-132. doi: 10.1097/PRS.0000000000006903.

    PMID: 32590654BACKGROUND

MeSH Terms

Conditions

Cubital Tunnel SyndromeUlnar Nerve Compression SyndromesUlnar Neuropathies

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Dafang Zhang, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Orthopaedic Surgery

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 30, 2020

Study Start

April 5, 2021

Primary Completion

January 27, 2022

Study Completion

January 27, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)