Femoroacetabular Impingement Clinical Trial
— CAM-FAI adultOfficial title:
An Integrated Biomechanical Investigation of Subjects With Symptomatic FAI and Two Groups of Asymptomatic Controls: a Comparison in Dynamic Tasks
NCT number | NCT06272292 |
Other study ID # | S66441 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2022 |
Est. completion date | December 31, 2024 |
Femoroacetabular impingement (FAI) is an orthopaedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms. This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology.
Status | Recruiting |
Enrollment | 99 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 35 Years |
Eligibility | Exclusion Criteria: - Participants in all three study groups will be excluded if x-ray scans shows a pincer FAI morphology or radiological sign of osteoarthritis. Inclusion Criteria: - All participants will be males aged between 21 and 35 years old. - For symptomatic CAM-FAI patients 1. The presence of CAM-FAI morphology at the head-neck junction of the femur 2. Alpha angle >60 3. Reduced hip internal rotation (IR<15) - For asymptomatic CAM controls: 1. Exhibit asymptomatic CAM on x-ray scansAlpha angle >60 - For Healthy control group: 1. Exhibit no symptoms or abnormal morphologies of the proximal femur (Alpha angle >60 , IR>15). |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals of Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The presence of CAM morphology in combination with symptoms | = yes morphology, yes symptoms;
= yes morphology, no symptoms; = no morphology, no symptoms |
Baseline | |
Secondary | The Copenhagen Hip and Groin Outcome Score (HAGOS) | Consists of six separate subscales assessing Pain, Symptoms, Physical function in daily living, Physical function in Sport and Recreation, Participation in Physical Activities and hip and/or groin-related Quality of Life (QOL). | Baseline | |
Secondary | Radiographic spinopelvic parameters | Radiographic spinopelvic parameters will be collected via a radiographic analysis of the hip and spine using a low-dose, full-body biplanar X-ray acquisition (in standing, sitting and squatting position) as well as a classic x-ray image in 45° Dunn view of both hips. | Baseline | |
Secondary | 3D motion analysis parameters | 3D motion analysis parameters will be collected via a hipspecific 3D motion analysis where different movements will be performed on the force plate. | Baseline |
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