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Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Primary Purpose

Cubital Tunnel Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immobilization followed by protected range of motion
Immediate range of motion
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona

Exclusion criteria:

  • Pregnancy
  • Patients who have had prior ulnar nerve surgery
  • Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome)
  • Workman's compensation patients
  • Subluxing ulnar nerve
  • Elbow contracture or stiffness
  • Negative electrodiagnostic studies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Immobilization

    Immediate range of motion

    Arm Description

    Immobilization followed by protected range of motion

    Immediate motion after anterior submuscular ulnar nerve transposition

    Outcomes

    Primary Outcome Measures

    Change in the distance between the ligaclips on lateral elbow radiographs

    Secondary Outcome Measures

    Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion

    Full Information

    First Posted
    January 29, 2013
    Last Updated
    November 26, 2014
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01781494
    Brief Title
    Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
    Official Title
    Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to test the hypothesis that immediate elbow motion is safe after anterior submuscular ulnar nerve transposition, and will not result in disruption of the repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate elbow motion after submuscular ulnar nerve transposition for performing activities of daily living and self-care are evident, however theoretical advantages include early "gliding" of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve function. A group of 44 consecutive patients that are determined to be candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing will be prospectively randomized to either immediate motion or long arm cast immobilization after surgery. All patients will be counseled about the two postoperative treatment options (immobilization followed by protected range of motion versus immediate range of motion), risks involved with each treatment protocol, postoperative follow-up and need for radiographs. If they choose not to participate, they will be treated by the same postoperative protocol currently used by the principal investigator: arm sling at rest for six weeks with intermittent active assisted range of motion exercises.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cubital Tunnel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immobilization
    Arm Type
    Active Comparator
    Arm Description
    Immobilization followed by protected range of motion
    Arm Title
    Immediate range of motion
    Arm Type
    Experimental
    Arm Description
    Immediate motion after anterior submuscular ulnar nerve transposition
    Intervention Type
    Procedure
    Intervention Name(s)
    Immobilization followed by protected range of motion
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate range of motion
    Primary Outcome Measure Information:
    Title
    Change in the distance between the ligaclips on lateral elbow radiographs
    Time Frame
    Baseline to 3 months post-operatively
    Secondary Outcome Measure Information:
    Title
    Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion
    Time Frame
    Baseline to 3 months post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona Exclusion criteria: Pregnancy Patients who have had prior ulnar nerve surgery Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome) Workman's compensation patients Subluxing ulnar nerve Elbow contracture or stiffness Negative electrodiagnostic studies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Renfree, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

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