FAI: Longitudinal Follow-up of Male Soccer Players Prone to Developing CAM Hip Deformity

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04418596
Collaborator
Johnson & Johnson (Industry)
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45
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Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)

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:
  1. Clinical screening of hip joint

  2. Radial MRI of bilateral hips

  3. Biplanar and conventional x-ray Imaging of hip and pelvic region

  4. Athlete-specific 3D motion analysis

  5. Questionnaires on injury history and physical activity levels.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Integrated Longitudinal Research on the Etiology of CAM Deformity in Adolescent Male Elite Soccer Players and Matched Control
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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.

Radiation: bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)
low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
Other Names:
  • Clinical Screening
  • Motion Analysis
  • 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

    Radiation: bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)
    low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
    Other Names:
  • Clinical Screening
  • Motion Analysis
  • Outcome Measures

    Primary Outcome Measures

    1. The formation of CAM deformity on the anterior head-neck junction of the femur [two years post baseline measurements]

      Detected using alpha angle on MRI/ Dunn's View x-ray

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    Male
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Leuven Hospitals Leuven Flanders Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven
    • Johnson & Johnson

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04418596
    Other Study ID Numbers:
    • S62916
    First Posted:
    Jun 5, 2020
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2021