CClinicalTrials.gg
RecruitingNCT05678894VARIA-CFAUpdated Dec 3, 2025

Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.

An interventional study of Scanner and EOS imaging in Femoro-acetabular Impingement, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Femoro-acetabular Impingement
03

In context

Femoracetabular Impingement

108 studies on the registry are indexed under Femoracetabular Impingement; 35 are open to participants now.

This study's planned enrollment of 140 is above the median of 75 across 63 interventional studies indexed under Femoracetabular Impingement.

Browse Femoracetabular Impingement studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    femoro-acetabular impingement

    symptomatic patients with femoro-acetabular impingement

    Other: Scanner and EOS imaging

  • Other
    Healthy volunteers

    Healthy volunteers

    Other: Scanner and EOS imaging

Interventions

  • OtherScanner and EOS imaging

    Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0

Secondary outcomes

  1. Functional limitation

    Functional limitation, the degree of activity via the HAGOS score

    Time frame: Month 6

  2. Functional limitation

    Functional limitation, the degree of activity via the HAGOS score

    Time frame: Month 24

  3. Subject quality of life

    Quality of life measured by the iHOT questionnaire

    Time frame: Month 6

  4. Subject quality of life

    Quality of life measured by the iHOT questionnaire

    Time frame: Month 24

  5. Return to previous activities

    Return to previous activities measured by mHHS score

    Time frame: Month 6

  6. Return to previous activities

    Return to previous activities measured by mHHS score

    Time frame: Month 24

  7. Postoperative satisfaction

    Postoperative satisfaction measured by the numerical satisfaction scale (ENS)

    Time frame: Month 6

  8. Postoperative satisfaction

    Postoperative satisfaction measured by the numerical satisfaction scale (ENS)

    Time frame: Month 24

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05678894
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Jan 10, 2023
Start date
Sep 28, 2023
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Dec 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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