Femoro Acetabular ImpingementCAM-FAINCT04418596
Longitudinal Follow-up of Male Soccer Players Prone to Developing CAM Hip Deformity
An observational study of Femoro Acetabular Impingement and CAM, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs between the thighbone and the hip socket. In intensive, mostly still young, male athletes, this problem seems to be related to a bony deformity on the head of this thighbone, a so-called CAM. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Femoro Acetabular Impingement, CAM
- What is being tested?
- bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 17 years
- Men only
- No healthy volunteers
- Child
Study population: Adolescent healthy males that are starting the final age of skeletal maturity(12-18 years of age). The 2 groups of the study are separated principally on the frequency and intensity of their athletic training.
Who may be able to join
- For the the Elite Group: Playing soccer at high level and training for more that 10 hours a week
- For the Control group: Playing soccer or any other sport recreationally for a less than 5 hours a week
Who cannot join
- No prior history of major trauma or injury to the lower limbs and spine
- No prior history of neurological conditions that can effect movement and mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Longitudinal Research on the Etiology of CAM Deformity in Adolescent Male Elite Soccer Players and Matched Control
Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs between the thighbone and the hip socket. In intensive, mostly still young, male athletes, this problem seems to be related to a bony deformity on the head of this thighbone, a so-called CAM. FAI itself gives rise to pain symptoms, but in time can even lead to premature osteoarthritis. However, the cause of a CAM deformity itself, nor how FAI then arises, is insufficiently known. In view of FAI prevention and its better treatment, this project thus tries to better understand the underlying mechanisms. For this purpose, we will combine detailed biomechanical evaluations of specific movement patterns with advanced medical imaging and state of the art clinical evaluations to longitudinally follow up a group with a known high risk of developing a CAM deformity, being young male elite soccer players. Findings within this study will be additionally compared with similar analyses performed in patients with FAI. This research aims to thus form a basis to define novel (sports-specific) training schemes for the prevention of FAI, but also to define the actual treatment and rehabilitation plans in more patient-specific and a better-informed way.
Read the detailed description
This is a longitudinal follow-up study in which subjects are invited for data collection twice, the baseline time-point and the two years time-point.
Population:
12-16 years old male soccer players (40 elite level players , and 40 recreational level players)
In both data collection time-points the following measurements are preformed:
- Clinical screening of hip joint
- Radial MRI of bilateral hips
- Biplanar and conventional x-ray Imaging of hip and pelvic region
- Athlete-specific 3D motion analysis
- Questionnaires on injury history and physical activity levels.
- Conditions
- Femoro Acetabular Impingement, CAM
- Being tested
- bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)Radiation
Also called Clinical Screening, Motion Analysis
low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
| Study group | Role | What they receive |
|---|---|---|
| Elite Soccer Players | Adolescent male aged 12-16 years old elite athletes that are recruited from special sport school in Leuven-Belgium and play football at a high level. Receives: Radiation: bi-planer radiography (EOS), Conventional radiography (Hip+pelvis) | |
| Recreational Soccer players (control) | Adolescent male aged 12-16 years old recruited from ordinary school in Flanders Belgium that play soccer or any other sport recreationally with no high intensity training Receives: Radiation: bi-planer radiography (EOS), Conventional radiography (Hip+pelvis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The formation of CAM deformity on the anterior head-neck junction of the femur
Detected using alpha angle on MRI/ Dunn's View x-ray
Measured: two years post baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Sep 2019
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Stijn Ghijselings, M.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418596
- Sponsor's protocol ID
- S62916
- Acronym
- CAM-FAI
- Status last verified
- Apr 2025
- First submitted
- 3 Jun 2020
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Longitudinal Research on the Etiology of CAM Deformity in Adolescent Male Elite Soccer Players and Matched Control
- ClinicalTrials.gov ID
- NCT04418596
- Acronym / sponsor ID
- CAM-FAI / S62916
- Conditions
- Femoro Acetabular Impingement, CAM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs between the thighbone and the hip socket. In intensive, mostly still young, male athletes, this problem seems to be related to a bony deformity on the head of this thighbone, a so-called CAM. FAI itself gives rise to pain symptoms, but in time can even lead to premature osteoarthritis. However, the cause of a CAM deformity itself, nor how FAI then arises, is insufficiently known. In view of FAI prevention and its better treatment, this project thus tries to better understand the underlying mechanisms. For this purpose, we will combine detailed biomechanical evaluations of specific movement patterns with advanced medical imaging and state of the art clinical evaluations to longitudinally follow up a group with a known high risk of developing a CAM deformity, being young male elite soccer players. Findings within this study will be additionally compared with similar analyses performed in patients with FAI. This research aims to thus form a basis to define novel (sports-specific) training schemes for the prevention of FAI, but also to define the actual treatment and rehabilitation plans in more patient-specific and a better-informed way.
Detailed description
This is a longitudinal follow-up study in which subjects are invited for data collection twice, the baseline time-point and the two years time-point.
Population:
12-16 years old male soccer players (40 elite level players , and 40 recreational level players)
In both data collection time-points the following measurements are preformed:
- Clinical screening of hip joint
- Radial MRI of bilateral hips
- Biplanar and conventional x-ray Imaging of hip and pelvic region
- Athlete-specific 3D motion analysis
- Questionnaires on injury history and physical activity levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elite Soccer Players | – | Radiation: bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)Adolescent male aged 12-16 years old elite athletes that are recruited from special sport school in Leuven-Belgium and play football at a high level. |
| Recreational Soccer players (control) | – | Radiation: bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)Adolescent male aged 12-16 years old recruited from ordinary school in Flanders Belgium that play soccer or any other sport recreationally with no high intensity training |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescent healthy males that are starting the final age of skeletal maturity(12-18 years of age). The 2 groups of the study are separated principally on the frequency and intensity of their athletic training.
Key inclusion criteria (2 listed)
- For the the Elite Group: Playing soccer at high level and training for more that 10 hours a week
- For the Control group: Playing soccer or any other sport recreationally for a less than 5 hours a week
Key exclusion criteria (2 listed)
- No prior history of major trauma or injury to the lower limbs and spine
- No prior history of neurological conditions that can effect movement and mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)Also: Clinical Screening, Motion Analysislow dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically. | Radiation | Elite Soccer Players, Recreational Soccer players (control) |
Primary outcome
The formation of CAM deformity on the anterior head-neck junction of the femur
Time frame: two years post baseline measurements
Detected using alpha angle on MRI/ Dunn's View x-ray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn Ghijselings, M.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoro Acetabular Impingement and CAM, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The formation of CAM deformity on the anterior head-neck junction of the femur (time frame: two years post baseline measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.