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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

Primary Purpose

Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer
Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Reverse End-to-side

    Surgery:standard care

    Arm Description

    Surgery: a "reverse" end-to-side AIN to ulnar nerve transfer whereby the motor branch of the ulnar is left intact and the end of the AIN nerve is coapted to the side of the ulnar motor fascicle(5,6). The advantage of this technique is it preserves the continuity of the ulnar motor branch for axons if they do eventually reinnervate the intrinsic muscles while augmenting or "babysitting" these muscles during the time period until this occurs.

    Surgery: the anterior interosseous (AIN) to motor branch of the ulnar nerve transfer has been established as an effective means to reinnervate ulnar innervated intrinsic hand muscles (without loss of function from using the AIN) when nerve injury is too proximal for recovering axons to reach the hand by 18 months. . The procedure (surgery) is presently the standard of care

    Outcomes

    Primary Outcome Measures

    pain scores on the numeric pain rating scale
    The patient-rated ulnar nerve evaluation (PRUNE)

    Secondary Outcome Measures

    evaluation of reinnvervation of hand intrinsic muscles
    Electromyography (EMG)
    functional performance assessment on the numeric scale
    The patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire

    Full Information

    First Posted
    September 22, 2014
    Last Updated
    November 2, 2018
    Sponsor
    Lawson Health Research Institute
    Collaborators
    Dr Christopher Doherty, Dr Thomas Miller
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02281656
    Brief Title
    Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow
    Official Title
    Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute
    Collaborators
    Dr Christopher Doherty, Dr Thomas Miller

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reverse End-to-side
    Arm Type
    Experimental
    Arm Description
    Surgery: a "reverse" end-to-side AIN to ulnar nerve transfer whereby the motor branch of the ulnar is left intact and the end of the AIN nerve is coapted to the side of the ulnar motor fascicle(5,6). The advantage of this technique is it preserves the continuity of the ulnar motor branch for axons if they do eventually reinnervate the intrinsic muscles while augmenting or "babysitting" these muscles during the time period until this occurs.
    Arm Title
    Surgery:standard care
    Arm Type
    Active Comparator
    Arm Description
    Surgery: the anterior interosseous (AIN) to motor branch of the ulnar nerve transfer has been established as an effective means to reinnervate ulnar innervated intrinsic hand muscles (without loss of function from using the AIN) when nerve injury is too proximal for recovering axons to reach the hand by 18 months. . The procedure (surgery) is presently the standard of care
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer
    Other Intervention Name(s)
    experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.
    Other Intervention Name(s)
    standard care
    Primary Outcome Measure Information:
    Title
    pain scores on the numeric pain rating scale
    Description
    The patient-rated ulnar nerve evaluation (PRUNE)
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    evaluation of reinnvervation of hand intrinsic muscles
    Description
    Electromyography (EMG)
    Time Frame
    one year
    Title
    functional performance assessment on the numeric scale
    Description
    The patient-rated ulnar nerve evaluation (PRUNE); Michigan hand outcome questionnaire
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
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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

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