Clinique de la Sauvegarde
Lyon, 69009, France
Location status: Recruiting
Location contact
Johanne BEUVELOT, PhD
CONTACT
Nicolas BONIN, MD
CONTACT
04-37-49-66-77 ext. 33
Nicolas bonin, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05678894
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Lyon, 69009, France
Location status: Recruiting
Johanne BEUVELOT, PhD
CONTACT
Nicolas BONIN, MD
CONTACT
04-37-49-66-77 ext. 33
Nicolas bonin, MD
PRINCIPAL_INVESTIGATOR
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for symptomatic patients:
Healthy volunteer inclusion criteria:
Exclusion criteria
Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.
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.
Time frame: Month 6
Functional limitation, the degree of activity via the HAGOS score
Time frame: Month 24
Functional limitation, the degree of activity via the HAGOS score
Time frame: Month 6
Quality of life measured by the iHOT questionnaire
Time frame: Month 24
Quality of life measured by the iHOT questionnaire
Time frame: Month 6
Return to previous activities measured by mHHS score
Time frame: Month 24
Return to previous activities measured by mHHS score
Time frame: Month 6
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
Time frame: Month 24
Postoperative satisfaction measured by the numerical satisfaction scale (ENS)
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: VARIA-CFA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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