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Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Primary Purpose

Carpal Tunnel Syndrome, Entrapment Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
keyhole approach
Sponsored by
Ivan Segura Duran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring microsurgical treatment, pain, dexterity, Phalen sign, functional status

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.

Exclusion Criteria:

  • Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    keyhole approach

    Arm Description

    open minimally invasive approach

    Outcomes

    Primary Outcome Measures

    Levine Severity Scale
    pain grades with 5 grades of intensity

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Ivan Segura Duran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03062722
    Brief Title
    Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
    Official Title
    Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    December 1, 2015 (Actual)
    Study Completion Date
    July 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ivan Segura Duran

    4. Oversight

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

    5. Study Description

    Brief Summary
    Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.
    Detailed Description
    Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome, Entrapment Neuropathy
    Keywords
    microsurgical treatment, pain, dexterity, Phalen sign, functional status

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    keyhole approach
    Arm Type
    Experimental
    Arm Description
    open minimally invasive approach
    Intervention Type
    Procedure
    Intervention Name(s)
    keyhole approach
    Intervention Description
    The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.
    Primary Outcome Measure Information:
    Title
    Levine Severity Scale
    Description
    pain grades with 5 grades of intensity
    Time Frame
    2 years follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy. Exclusion Criteria: Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo Ramos Zuñiga, M.D. PhD
    Organizational Affiliation
    Universidad se Guadalajara
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28484650
    Citation
    Ramos-Zuniga R, Garcia-Mercado CJ, Segura-Duran I, Zepeda-Gutierrez LA. Efficacy of Keyhole Approach to Carpal Tunnel Syndrome under Ambulatory Strategy. Neurol Res Int. 2017;2017:3549291. doi: 10.1155/2017/3549291. Epub 2017 Apr 6.
    Results Reference
    derived

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    Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

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