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

Primary Purpose

Femoro-acetabular Impingement

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scanner and EOS imaging
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Femoro-acetabular Impingement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinique de la Sauvegarde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

femoro-acetabular impingement

Healthy volunteers

Arm Description

symptomatic patients with femoro-acetabular impingement

Healthy volunteers

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional limitation
Functional limitation, the degree of activity via the HAGOS score
Functional limitation
Functional limitation, the degree of activity via the HAGOS score
Subject quality of life
Quality of life measured by the iHOT questionnaire
Subject quality of life
Quality of life measured by the iHOT questionnaire
Return to previous activities
Return to previous activities measured by mHHS score
Return to previous activities
Return to previous activities measured by mHHS score
Postoperative satisfaction
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Postoperative satisfaction
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)

Full Information

First Posted
December 22, 2022
Last Updated
December 22, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05678894
Brief Title
Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2027 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoro-acetabular Impingement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
femoro-acetabular impingement
Arm Type
Experimental
Arm Description
symptomatic patients with femoro-acetabular impingement
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers
Intervention Type
Other
Intervention Name(s)
Scanner and EOS imaging
Intervention Description
Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.
Primary Outcome Measure Information:
Title
Anteversions comparison
Description
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 Outcome Measure Information:
Title
Functional limitation
Description
Functional limitation, the degree of activity via the HAGOS score
Time Frame
Month 6
Title
Functional limitation
Description
Functional limitation, the degree of activity via the HAGOS score
Time Frame
Month 24
Title
Subject quality of life
Description
Quality of life measured by the iHOT questionnaire
Time Frame
Month 6
Title
Subject quality of life
Description
Quality of life measured by the iHOT questionnaire
Time Frame
Month 24
Title
Return to previous activities
Description
Return to previous activities measured by mHHS score
Time Frame
Month 6
Title
Return to previous activities
Description
Return to previous activities measured by mHHS score
Time Frame
Month 24
Title
Postoperative satisfaction
Description
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Time Frame
Month 6
Title
Postoperative satisfaction
Description
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Time Frame
Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas BONIN, MD
Phone
04-37-49-66-77
Ext
33
Email
Dr.bonin@lyon-ortho-clinic.com
First Name & Middle Initial & Last Name & Degree
Johanne BEUVELOT, PhD
Email
jbeuvelot@capio.fr
First Name & Middle Initial & Last Name & Degree
Nicolas bonin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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