Femoroacetabular ImpingementEOSNCT05921721
Can EOS Hip Imaging Replace CT Hip Scans?
A study testing EOS in people with Femoroacetabular Impingement and Hip Dysplasia, run by Sheffield Children's NHS Foundation Trust.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement, Hip Dysplasia
- What is being tested?
- EOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Obvious joint incongruency.
- Loss of sphericity (Severin IV or above).
- Evidence of moderate or severe arthritis (Tonnis 2 or above).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the EOS Imaging System Improve Assessment of the Hip in Individuals Aged 13 Years and Over Compared to CT?
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.
Read the 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.
- Conditions
- Femoroacetabular Impingement, Hip Dysplasia
- Being tested
- EOS
- Medical subject headings
- Femoracetabular Impingement, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSDevice
This modality simultaneously captures biplanar radiographs (anteroposterior and lateral images) through the whole-body slot scanning with patients in standing position with ultralow irradiation
| Study group | Role | What they receive |
|---|---|---|
| EOS imaging system | Experimental | Participants will undergo CT and EOS imaging pre- and post- operatively. The EOS is being compared to the reference method CT scan. Receives: Device: EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
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
Measured: 18 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- EOS imaging Inc.
- Responsible party
- Sponsor
- Investigators
- Amaka Offiah, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921721
- Sponsor's protocol ID
- SCH-2653
- Acronym
- EOS
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the EOS Imaging System Improve Assessment of the Hip in Individuals Aged 13 Years and Over Compared to CT?
- ClinicalTrials.gov ID
- NCT05921721
- Acronym / sponsor ID
- EOS / SCH-2653
- Conditions
- Femoroacetabular Impingement, Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- EOS imaging Inc.
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOS imaging system | Experimental | Device: EOSParticipants will undergo CT and EOS imaging pre- and post- operatively. The EOS is being compared to the reference method CT scan. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Obvious joint incongruency.
- Loss of sphericity (Severin IV or above).
- Evidence of moderate or severe arthritis (Tonnis 2 or above).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOSThis modality simultaneously captures biplanar radiographs (anteroposterior and lateral images) through the whole-body slot scanning with patients in standing position with ultralow irradiation | Device | EOS imaging system |
Primary outcome
Diagnostic accuracy of EOS
Time frame: 18 months
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
Time frame: 18 months
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
1 secondary outcome
Predictive power of EOS
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amaka Offiah principal investigator
University of Sheffield
Questions about this trial
What is this clinical trial studying?
A study testing EOS in people with Femoroacetabular Impingement and Hip Dysplasia, run by Sheffield Children's NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Dimtri (0114 2717000, paul.dimitri@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of EOS (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.