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Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

Primary Purpose

Surgical Release of Ai Pulley Trigger Finger

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Surgical release A1 pulley for Trigger finger of the hand
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Release of Ai Pulley Trigger Finger

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.

Exclusion Criteria:

  • Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
  • Patients with multiple trigger fingers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Open surgical release A1 Pulley

    Ultrasound guided close release A1 pulley

    Arm Description

    Outcomes

    Primary Outcome Measures

    Resolution of triggering expressed as the "success rate" per digit.

    Secondary Outcome Measures

    The time for taking postoperative pain killers
    Range of motion recovery
    QuickDASH test scores (Greek version)
    Time to return to normal activities (including work)
    Cosmetic results

    Full Information

    First Posted
    July 6, 2016
    Last Updated
    February 25, 2020
    Sponsor
    National and Kapodistrian University of Athens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02830672
    Brief Title
    Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
    Official Title
    Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National and Kapodistrian University of Athens

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Release of Ai Pulley Trigger Finger

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Open surgical release A1 Pulley
    Arm Type
    Active Comparator
    Arm Title
    Ultrasound guided close release A1 pulley
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical release A1 pulley for Trigger finger of the hand
    Primary Outcome Measure Information:
    Title
    Resolution of triggering expressed as the "success rate" per digit.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    The time for taking postoperative pain killers
    Time Frame
    12 weeks
    Title
    Range of motion recovery
    Time Frame
    12 weeks
    Title
    QuickDASH test scores (Greek version)
    Time Frame
    12 weeks
    Title
    Time to return to normal activities (including work)
    Time Frame
    12 weeks
    Title
    Cosmetic results
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months. Exclusion Criteria: Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease. Patients with multiple trigger fingers

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

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