Femoroacetabular ImpingementCAM-FAI adultNCT06272292
Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls
A study testing EOS and 3D motion lab analysis in people with Femoroacetabular Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- EOS and 3D motion lab analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jul 2022to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants will be males aged between 21 and 35 years old.
- For symptomatic CAM-FAI patients
- The presence of CAM-FAI morphology at the head-neck junction of the femur
- Alpha angle >60
- Reduced hip internal rotation (IR<15)
- For asymptomatic CAM controls:
Show all 9Show fewer
- 1. Exhibit asymptomatic CAM on x-ray scansAlpha angle >60
- For Healthy control group:
- Exhibit no symptoms or abnormal morphologies of the proximal femur (Alpha angle >60 , IR>15).
Who cannot join
- Participants in all three study groups will be excluded if x-ray scans shows a pincer FAI morphology or radiological sign of osteoarthritis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals of Leuven
Leuven, Vlaams-Brabant, 3000
Stijn Ghijselings, MD, +32 16 33 88 18, stijn.ghijselings@uzleuven.be
Orthopedic Research, +32 16 33 88 18, orthopedie.research@uzleuven.be
About this study
Official title: An Integrated Biomechanical Investigation of Subjects With Symptomatic FAI and Two Groups of Asymptomatic Controls: a Comparison in Dynamic Tasks
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.
Read the detailed description
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. FAI can be radiologically classified into 3 types of morphology: Pincer, CAM and mixed type. While a clear-cut radiological classification makes the identification of FAI seem quite straightforward, it fails to differentiate between symptomatic and asymptomatic patients.
Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Not only this movement restriction is a significantly debilitating factor in such a young active population, a recent study reported FAI patients to see on average 4.0 health care providers, undergo on average 3.4 diagnostic imaging tests, and receive on average 3.1 treatments prior to final diagnosis. This raises the cost of an individual FAI diagnosis to be €1,563.26 higher than the calculated minimum required cost. Such calculations clearly reveal the long-lasting, multifactorial burden of FAI on society.
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. To our knowledge only three studies have looked into muscle strength by using mainly hand-held dynamometers to record the isometric strength of hip musculature. Their findings suggest hip muscle weakness in symptomatic FAI subjects, but whether this weakness is a pain protective consequence, or an actual cause of FAI is still unknown.
In conclusion, 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- EOS, 3D motion lab analysis
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSDiagnostic test
Every subject in this study will undergo a radiographic analysis of the hip and spine using a low-dose, full-body biplanar X-ray acquisition (in standing, sitting and squatting position, EOS imaging).
3D motion lab analysisDiagnostic test
A hip-specific 3D motion analysis will be performed. The 3D motion protocol will be divided into 2 main sections.
First section: Consist of movements categorized within the activities of daily living (walking at self-selected speed, uphill walking, standardized deep squat and non-standardized deep squat)
Second section: Consists of movements that are categorized within athletic training and have been specifically chosen to induce large hip ranges of motion (Sumo squats, dead lifts, forward lunges, running uphill and downhill)
Each movements will be repeated 6 times. Three times with the dominant foot/opposite leg on the force plate to collect kinetic data. All data will be captured using two 10-15 camera 3D motion capture systems and one capturing an instrumented treadmill (M-gait)
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic CAM-FAI patients | Experimental | 33 patients that exhibit symptomatic CAM-FAI on medical imaging (Alpha angle >60) and have reduced hip internal rotation (IR<15). All participants in this group will be males aged between 21 and 35 years old. Receives: Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis |
| Asymptomatic CAM-FAI patients | Experimental | 33 healthy control that exhibit asymptomatic CAM on x-ray scans (Alpha angle >60). All participants in this group will be males aged between 21 and 35 years old. Receives: Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis |
| Healthy controls | Experimental | 33 healthy control that exhibit no symptoms or abnormal morphologies of the proximal femur (Alpha angle >60 , IR>15). All participants in this group will be males aged between 21 and 35 years old. Receives: Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of CAM morphology in combination with symptoms
- = yes morphology, yes symptoms;
- = yes morphology, no symptoms;
- = no morphology, no symptoms
Measured: Baseline
Secondary outcomes (3)
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).
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start28 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional, case-control prospective clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stijn Ghijselings, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272292
- Sponsor's protocol ID
- S66441
- Acronym
- CAM-FAI adult
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No