- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418596
Longitudinal Follow-up of Male Soccer Players Prone to Developing CAM Hip Deformity (CAM-FAI)
April 10, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Flanders
-
Leuven, Flanders, Belgium, 3000
- University of Leuven Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
Other Names:
|
|
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
|
low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
two years post baseline measurements
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stijn Ghijselings, M.D., Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
June 3, 2020
First Submitted That Met QC Criteria
June 3, 2020
First Posted (Actual)
June 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 11, 2025
Last Update Submitted That Met QC Criteria
April 10, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S62916
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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