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

Femoro-acetabular Impingement Clinical Trial

— VARIA-CFA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05678894
• Other study ID #: 2022-A01313-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: December 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria for symptomatic patients:

• 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:

• 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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro-acetabular Impingement

Intervention

Other:
• Scanner and EOS imaging
Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	Functional limitation	Functional limitation, the degree of activity via the HAGOS score	Month 6
Secondary	Functional limitation	Functional limitation, the degree of activity via the HAGOS score	Month 24
Secondary	Subject quality of life	Quality of life measured by the iHOT questionnaire	Month 6
Secondary	Subject quality of life	Quality of life measured by the iHOT questionnaire	Month 24
Secondary	Return to previous activities	Return to previous activities measured by mHHS score	Month 6
Secondary	Return to previous activities	Return to previous activities measured by mHHS score	Month 24
Secondary	Postoperative satisfaction	Postoperative satisfaction measured by the numerical satisfaction scale (ENS)	Month 6
Secondary	Postoperative satisfaction	Postoperative satisfaction measured by the numerical satisfaction scale (ENS)	Month 24