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"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoroscopy guided steroid injection
Blind Steroid Injection
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

- Adults with knee OA clinically deemed to qualify for steroid injection

Exclusion Criteria:

- Children Non-English Speakers Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Blind Steroid Injection

    Fluoroscopy guided steroid injection

    Arm Description

    Blind Steroid Injection for patients with OA deemed qualified for it clinically

    Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.

    Outcomes

    Primary Outcome Measures

    Numerical Rating Scale (pain)
    Decrease in pain from baseline at one month

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2014
    Last Updated
    December 11, 2017
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02104726
    Brief Title
    "Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
    Official Title
    Prospective Randomized-Controlled Two-Arm Study of "Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2014 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    5. Study Description

    Brief Summary
    To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    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
    Blind Steroid Injection
    Arm Type
    Active Comparator
    Arm Description
    Blind Steroid Injection for patients with OA deemed qualified for it clinically
    Arm Title
    Fluoroscopy guided steroid injection
    Arm Type
    Active Comparator
    Arm Description
    Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.
    Intervention Type
    Other
    Intervention Name(s)
    Fluoroscopy guided steroid injection
    Intervention Description
    We want to compare if there is a difference between the two arms, with the assumption that with fluoroscopy will deliver the steroid more accurately and see better outcomes.
    Intervention Type
    Other
    Intervention Name(s)
    Blind Steroid Injection
    Intervention Description
    Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain
    Primary Outcome Measure Information:
    Title
    Numerical Rating Scale (pain)
    Description
    Decrease in pain from baseline at one month
    Time Frame
    1 month

    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: - Adults with knee OA clinically deemed to qualify for steroid injection Exclusion Criteria: - Children Non-English Speakers Pregnant

    12. IPD Sharing Statement

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    "Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

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