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
About this trial
This is an interventional diagnostic trial for Femoroacetabular Impingement
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).
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
NCT ID
NCT05921721
First Posted
June 6, 2023
Last Updated
June 19, 2023
Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
EOS imaging Inc.
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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Can EOS Hip Imaging Replace CT Hip Scans?
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