Femoro-acetabular ImpingementVARIA-CFANCT05678894
Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.
A study testing Scanner and EOS imaging in people with Femoro-acetabular Impingement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoro-acetabular Impingement
- What is being tested?
- Scanner and EOS imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient at least 18 years of age but < 50 years of age
- Patient with a confirmed diagnosis of DWI for whom arthroscopic impingement surgery is proposed
- Patient who has given and signed free and informed consent
- A patient who is a member of a social security plan or a beneficiary of such a plan
- Healthy volunteer inclusion criteria:
- Person at least 18 years of age but < 50 years of age
Show all 9Show fewer
- Person with no existing DWI diagnosis
- Person who has given and signed free and informed consent
- Person affiliated with a social security plan or beneficiary of such a plan
Who cannot join
- Patient who has already undergone surgery on the same hip
- Patient with previous spine surgery
- Patient already included in the study for the opposite hip
- Pregnant or breastfeeding patient
- Patient who did not give consent
- Patient for whom it is impossible to give informed information
Show all 9Show fewer
- Mentally impaired or any other reason that may interfere with understanding
- Patient under court protection, guardianship or curatorship
- Patient in an exclusion period as determined by another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, 69009
Nicolas BONIN, MD, 04-37-49-66-77 ext. 33, Dr.bonin@lyon-ortho-clinic.com
Johanne BEUVELOT, PhD, jbeuvelot@capio.fr
About this study
The main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers.
Read the detailed description
The study will be presented to a population of symptomatic DWI patients who are offered hip arthroscopy. As these measurements have never been performed before in a control population, the study will also be proposed to a population of healthy volunteers, matched by age, sex, BMI and level of sports activity, in order to have comparative reference values.
The study consisted of cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions in both groups.
- Group 1: Symptomatic DWI patients
- Group 2: Healthy volunteers
For symptomatic patients, the preoperative workup will be the same as in routine practice and will include an X-ray as well as a CT scan. Low-dose EOS imaging of the pelvis in profile in 3 positions (standing sagittal tilt, sitting, maximum hip flexion) will complete this workup in the context of the study, to know the sacral slope associated with each of these positions. If the preoperative workup does not include a CT or arthroscan scan with measurement of femoral anteversion, it will be requested in the low-dose protocol.
The control group will perform a CT scan and EOS imaging in the same 3 positions as the patient group.
From the CT scan, a 3D reconstruction with the BoneMetrix software to calculate the superior acetabular anteversion plane will be performed, giving the anteversion for a supine patient. The software also allows to modify the orientation of the pelvis, according to the results of the sacral slope obtained from the EOS assessment for the calculation of the superior acetabular anteversion in the 3 requested positions. Finally, this 3D reconstruction will allow us to search for the impingement dynamically after pelvis-femur segmentation and to measure the position (degree of femoral flexion) in which it occurs.
As these measurements have never been performed before, a control population is needed to obtain reference values for acetabular behavior that does not lead to symptomatic CFA. This population will be matched by age, sex, BMI and sports activity to the study population.
The results obtained from the 2 populations will be compared. For the operated DWI patients in the cohort, the clinical scores will be evaluated at 6 months and 2 years postoperatively to search for a correlation between these scores and the superior acetabular version angles obtained.
This monocentric study will take place at the Clinique de la Sauvegarde. Patients will be seen in consultation by Dr Bonin or Dr Guicherd. They will be included during the pre-operative consultation during which they will be presented with the examinations to be performed, as well as the study. Their consent will be sought before any preliminary procedure. Imaging will be performed at the Clinique du Parc, as is already done for these patients, outside of any study.
- Conditions
- Femoro-acetabular Impingement
- Being tested
- Scanner and EOS imaging
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanner and EOS imagingOther
Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.
| Study group | Role | What they receive |
|---|---|---|
| femoro-acetabular impingement | Experimental | symptomatic patients with femoro-acetabular impingement Receives: Other: Scanner and EOS imaging |
| Healthy volunteers | Other | Healthy volunteers Receives: Other: Scanner and EOS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteversions comparison
Comparison of anteversions of the superior plane of the acetabulum obtained from 3D CT reconstruction of the pelvis positioned standing, seated, seated hip in maximum flexion, and supine after matching by low-dose EOS X-ray images, between patients with symptomatic DWI and healthy volunteers.
Measured: Day 0
Secondary outcomes (8)
Functional limitation
Functional limitation, the degree of activity via the HAGOS score
Measured: Month 6
Functional limitation
Functional limitation, the degree of activity via the HAGOS score
Measured: Month 24
Subject quality of life
Quality of life measured by the iHOT questionnaire
Measured: Month 6
Subject quality of life
Quality of life measured by the iHOT questionnaire
Measured: Month 24
Return to previous activities
Return to previous activities measured by mHHS score
Measured: Month 6
Return to previous activities
Return to previous activities measured by mHHS score
Measured: Month 24
Postoperative satisfaction
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Measured: Month 6
Postoperative satisfaction
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start28 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro-acetabular 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678894
- Sponsor's protocol ID
- 2022-A01313-40
- Acronym
- VARIA-CFA
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2022
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05678894
- Acronym / sponsor ID
- VARIA-CFA / 2022-A01313-40
- Conditions
- Femoro-acetabular Impingement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Jan 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 main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers.
Detailed description
The study will be presented to a population of symptomatic DWI patients who are offered hip arthroscopy. As these measurements have never been performed before in a control population, the study will also be proposed to a population of healthy volunteers, matched by age, sex, BMI and level of sports activity, in order to have comparative reference values.
The study consisted of cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions in both groups.
- Group 1: Symptomatic DWI patients
- Group 2: Healthy volunteers
For symptomatic patients, the preoperative workup will be the same as in routine practice and will include an X-ray as well as a CT scan. Low-dose EOS imaging of the pelvis in profile in 3 positions (standing sagittal tilt, sitting, maximum hip flexion) will complete this workup in the context of the study, to know the sacral slope associated with each of these positions. If the preoperative workup does not include a CT or arthroscan scan with measurement of femoral anteversion, it will be requested in the low-dose protocol.
The control group will perform a CT scan and EOS imaging in the same 3 positions as the patient group.
From the CT scan, a 3D reconstruction with the BoneMetrix software to calculate the superior acetabular anteversion plane will be performed, giving the anteversion for a supine patient. The software also allows to modify the orientation of the pelvis, according to the results of the sacral slope obtained from the EOS assessment for the calculation of the superior acetabular anteversion in the 3 requested positions. Finally, this 3D reconstruction will allow us to search for the impingement dynamically after pelvis-femur segmentation and to measure the position (degree of femoral flexion) in which it occurs.
As these measurements have never been performed before, a control population is needed to obtain reference values for acetabular behavior that does not lead to symptomatic CFA. This population will be matched by age, sex, BMI and sports activity to the study population.
The results obtained from the 2 populations will be compared. For the operated DWI patients in the cohort, the clinical scores will be evaluated at 6 months and 2 years postoperatively to search for a correlation between these scores and the superior acetabular version angles obtained.
This monocentric study will take place at the Clinique de la Sauvegarde. Patients will be seen in consultation by Dr Bonin or Dr Guicherd. They will be included during the pre-operative consultation during which they will be presented with the examinations to be performed, as well as the study. Their consent will be sought before any preliminary procedure. Imaging will be performed at the Clinique du Parc, as is already done for these patients, outside of any study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoro-acetabular impingement | Experimental | Other: Scanner and EOS imagingsymptomatic patients with femoro-acetabular impingement |
| Healthy volunteers | Other | Other: Scanner and EOS imagingHealthy volunteers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient at least 18 years of age but < 50 years of age
- Patient with a confirmed diagnosis of DWI for whom arthroscopic impingement surgery is proposed
- Patient who has given and signed free and informed consent
- A patient who is a member of a social security plan or a beneficiary of such a plan
- Person at least 18 years of age but < 50 years of age
Key exclusion criteria (9 listed)
- Patient who has already undergone surgery on the same hip
- Patient with previous spine surgery
- Patient already included in the study for the opposite hip
- Pregnant or breastfeeding patient
- Patient who did not give consent
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 |
|---|---|---|
| Scanner and EOS imagingCross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions. | Other | Healthy volunteers, femoro-acetabular impingement |
Primary outcome
Anteversions comparison
Time frame: Day 0
Comparison of anteversions of the superior plane of the acetabulum obtained from 3D CT reconstruction of the pelvis positioned standing, seated, seated hip in maximum flexion, and supine after matching by low-dose EOS X-ray images, between patients with symptomatic DWI and healthy volunteers.
8 secondary outcomes
Functional limitation
Time frame: Month 6
Functional limitation
Time frame: Month 24
Subject quality of life
Time frame: Month 6
Subject quality of life
Time frame: Month 24
Return to previous activities
Time frame: Month 6
Return to previous activities
Time frame: Month 24
Postoperative satisfaction
Time frame: Month 6
Postoperative satisfaction
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanner and EOS imaging in people with Femoro-acetabular Impingement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anteversions comparison (time frame: Day 0). 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 3 Dec 2025.