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Evaluation of Ultrasound for Detecting Hip Impingement

Primary Purpose

Femoroacetabular Impingement

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic resonance imaging
Ultrasound
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Femoroacetabular Impingement focused on measuring femoroacetabular impingement, morphometry, dynamic, magnetic resonance imaging, ultrasound, screening, diagnosis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Surgical group:

  • Hip pain longer than 6 months referred to the groin/lateral aspect of the hip
  • Positive Impingement Sign

Plain radiographs:

  • Absence of arthritis (Tonnis Grade 0 or 1)
  • Absence of dysplasia (center edge >25 degrees) on anterior-posterior radiograph
  • α-angle greater than 60 degrees on MRI.

Exclusion Criteria:

  • Patients who don't meet inclusion criteria
  • Control group: subjects with hip pain or with alpha angle > 50 degrees on MRI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Surgical group

    Control

    Arm Description

    Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.

    Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.

    Outcomes

    Primary Outcome Measures

    Ultrasound grade
    Ultrasound grade evaluated on a four point scale following ultrasound imaging session

    Secondary Outcome Measures

    Ultrasound parameters
    Morphometry of hip measured in ultrasound images: alpha angle, clearance angle
    MRI parameters
    Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.

    Full Information

    First Posted
    October 6, 2014
    Last Updated
    April 13, 2018
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02260726
    Brief Title
    Evaluation of Ultrasound for Detecting Hip Impingement
    Official Title
    Diagnosing Deformities of the Hip Associated With Arthritis: MRI vs Ultrasound
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding available
    Study Start Date
    October 2014 (Anticipated)
    Primary Completion Date
    October 2015 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    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
    Patients are being asked to participate in this study because a previous research MRI of their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip. We have already collected cartilage imaging data and data on how the hip joint moves on people with painful/symptomatic FAI and people with normal hip function. We would now like to compare the motion of the hip joint to those with painful FAI using ultrasound.
    Detailed Description
    Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to deformities in the hip joint. However some individuals have these deformities but do not exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not clear which deformities will cause degeneration, requiring surgical intervention. We propose to evaluate the deformity and impingement between the femur and acetabulum using dynamic ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip joint and is thus suitable for such diagnostic purposes. In this pilot study we will evaluate the feasibility of ultrasound in diagnosing hip impingement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoroacetabular Impingement
    Keywords
    femoroacetabular impingement, morphometry, dynamic, magnetic resonance imaging, ultrasound, screening, diagnosis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Surgical group
    Arm Type
    Experimental
    Arm Description
    Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic resonance imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound
    Primary Outcome Measure Information:
    Title
    Ultrasound grade
    Description
    Ultrasound grade evaluated on a four point scale following ultrasound imaging session
    Time Frame
    Upon enrollment
    Secondary Outcome Measure Information:
    Title
    Ultrasound parameters
    Description
    Morphometry of hip measured in ultrasound images: alpha angle, clearance angle
    Time Frame
    Upon enrollment
    Title
    MRI parameters
    Description
    Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.
    Time Frame
    Upon enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Surgical group: Hip pain longer than 6 months referred to the groin/lateral aspect of the hip Positive Impingement Sign Plain radiographs: Absence of arthritis (Tonnis Grade 0 or 1) Absence of dysplasia (center edge >25 degrees) on anterior-posterior radiograph α-angle greater than 60 degrees on MRI. Exclusion Criteria: Patients who don't meet inclusion criteria Control group: subjects with hip pain or with alpha angle > 50 degrees on MRI
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul E Beaule, MD, FRCSC
    Organizational Affiliation
    University of Ottawa / The Ottawa Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Evaluation of Ultrasound for Detecting Hip Impingement

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