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Can EOS Hip Imaging Replace CT Hip Scans? (EOS)

Primary Purpose

Femoroacetabular Impingement, Hip Dysplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EOS
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Femoroacetabular Impingement

Eligibility Criteria

13 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals aged 13 years and older who are considered eligible to undergo periacetabular osteotomy (PAO). Symptomatic dysplasia (Severin grade II or III) or femoroacetabular impingement. Skeletal maturity, defined on pelvic radiographs by closure of the triradiate cartilage. Absence of subluxation (Severin grade I-III). Exclusion Criteria: Obvious joint incongruency. Loss of sphericity (Severin IV or above). Evidence of moderate or severe arthritis (Tonnis 2 or above).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    EOS imaging system

    Arm Description

    Participants will undergo CT and EOS imaging pre- and post- operatively. The EOS is being compared to the reference method CT scan.

    Outcomes

    Primary Outcome Measures

    Diagnostic accuracy of EOS
    Diagnostic accuracy of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older
    Inter- and intraobserver reliability of EOS
    Inter- and intraobserver reliability of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older

    Secondary Outcome Measures

    Predictive power of EOS
    Correlation of pre- and post-operative hip measurements from EOS and CT to predict disturbances in gait and quality of life at 6 and 18 months post-operative

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    June 19, 2023
    Sponsor
    Sheffield Children's NHS Foundation Trust
    Collaborators
    EOS imaging Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05921721
    Brief Title
    Can EOS Hip Imaging Replace CT Hip Scans?
    Acronym
    EOS
    Official Title
    Does the EOS Imaging System Improve Assessment of the Hip in Individuals Aged 13 Years and Over Compared to CT?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheffield Children's NHS Foundation Trust
    Collaborators
    EOS imaging Inc.

    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
    The orientation of the femoral neck in relation to the coronal or transcondylar axis of the distal femur is known as the femoral version. It is categorised as femoral anteversion when the femoral neck axis is anteriorly rotated in relation to transcondylar axis, while femoral head axis is anterior in relation to the femur coronal plane; or femoral retroversion when the femoral head-neck axis points are posterior to the femoral coronal plane. Some studies suggest that conventional radiography cannot adequately measure femoral version, and should be avoided in favour of more precise methods using computed tomography (CT) scanning. CT imaging is currently the reference method for measuring femoral version. However, its clinical use is limited by issues such as high levels of radiation exposure, which can adversely affect patients, especially children. Magnetic resonance imaging (MRI) is considered an alternative for measuring femoral version; however, it is expensive, time consuming and subject to motion artifacts. The associated costs and risks of MRI increase when anaesthesia is needed for the examination. The EOS imaging system could provide an alternative to the previously mentioned techniques. It uses lower doses of irradiation and the sterEOS software allows the production of 3D images. This study aims to compare the accuracy of the EOS imaging system with CT for the measurement of hip parameters in individuals aged 13 years and older. In addition, this study aims to correlate EOS and CT parameters with gait analysis and compare the ability of EOS and CT to predict gait abnormalities.
    Detailed Description
    The average range of anteversion at birth is from 30 to 40 degrees. These values reduce with growth, remaining in the10 to 15-degree range for most adults. Nevertheless, these values can be significantly different between populations or contralateral sides. Altered femoral version can affect the normal function and even stability of the hip and knee joints, so that it must be considered in the clinical assessment of cases involving femoral fractures, torsional alignment, slipped capital femoral epiphysis and Legg-Calve-Perthes disease. Femoral version can be evaluated by clinical investigation or radiographic assessment. Imaging examinations play an important role in the evaluation of femoral version prior to surgical interventions. However, some studies suggest that conventional radiography cannot adequately measure femoral version. CT imaging is currently the reference method for measuring femoral version. However, its clinical use is limited by issues such as high levels of radiation exposure, which can adversely affect patients, especially children. Magnetic resonance imaging (MRI) is considered an alternative for measuring femoral version; however, it is expensive, time consuming and subject to motion artifacts. The associated costs and risks increase when anaesthesia is needed for the examination. The EOS imaging system provides an alternative to the previously mentioned techniques. It uses lower doses of irradiation and the sterEOS software allows the production of 3D images. The EOS system can measure the torsional alignment of the lower limbs with 4 to 30 times less irradiation than a CT scan. Prior studies measuring femoral version using both EOS and CT have found a high correlation between the results of these techniques. Acetabular morphology and 3D orientation are important factors to be considered prior to orthopaedic surgery. Acetabular orientation is known to vary between genders as women have more anteverted acetabula than men, as well as a larger inclination angle. For hip preservation surgery, the most promising technique for the treatment of dysplasia in adolescents and young adults is peri-acetabular osteotomy (PAO). The benefits of PAO in the treatment of hip joint pathology are discussed in more detail and have been assessed either morphologically using MRI or functionally, by performing post-operative gait analysis. The EOS imaging system with 3D sterEOS software can produce 3D reconstructions of the acetabulum with 30-fold lower irradiation of patients compared to CT and 10-fold lower irradiation compared to chest radiographs. The innovation behind the EOS system earned its inventor a Nobel prize in physics (particle detection). This modality simultaneously captures biplanar radiographs (anteroposterior and lateral images) through the whole-body slot scanning with patients in standing position with ultralow irradiation. 3D reconstructions of the individual skeleton can be performed from these captured radiographs using sterEOS software. 2D and 3D EOS skeletal images are produced with similar volume and size to 1:1 scale, so that vertebral and spinal angles and lengths of lower limbs and other variable parameters can be measured accurately. The advantage is that sterEOS 3D reconstructions can be useful for evaluating rotational disorders of joints and lower limbs horizontally. The EOS system can acquire 3D information of individuals in standing, sitting and squatting positions. The EOS system has the advantage of allowing for 3D reconstructions of hip/pelvic parameters with lower irradiation than CT scans. This allows for the identification of underlying deformities while exposing patients to lower radiation dose. It would seem that the EOS system has potential to replace CT as the investigation of choice for assessing hip morphology.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoroacetabular Impingement, Hip Dysplasia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EOS imaging system
    Arm Type
    Experimental
    Arm Description
    Participants will undergo CT and EOS imaging pre- and post- operatively. The EOS is being compared to the reference method CT scan.
    Intervention Type
    Device
    Intervention Name(s)
    EOS
    Intervention Description
    This modality simultaneously captures biplanar radiographs (anteroposterior and lateral images) through the whole-body slot scanning with patients in standing position with ultralow irradiation
    Primary Outcome Measure Information:
    Title
    Diagnostic accuracy of EOS
    Description
    Diagnostic accuracy of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older
    Time Frame
    18 months
    Title
    Inter- and intraobserver reliability of EOS
    Description
    Inter- and intraobserver reliability of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Predictive power of EOS
    Description
    Correlation of pre- and post-operative hip measurements from EOS and CT to predict disturbances in gait and quality of life at 6 and 18 months post-operative
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals aged 13 years and older who are considered eligible to undergo periacetabular osteotomy (PAO). Symptomatic dysplasia (Severin grade II or III) or femoroacetabular impingement. Skeletal maturity, defined on pelvic radiographs by closure of the triradiate cartilage. Absence of subluxation (Severin grade I-III). Exclusion Criteria: Obvious joint incongruency. Loss of sphericity (Severin IV or above). Evidence of moderate or severe arthritis (Tonnis 2 or above).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul Dimtri
    Phone
    0114 2717000
    Email
    paul.dimitri@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amaka Offiah
    Organizational Affiliation
    University of Sheffield
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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