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

Femoro Acetabular Impingement Clinical Trial

— CAM-FAI  

Official title:

Integrated Longitudinal Research on the Etiology of CAM Deformity in Adolescent Male Elite Soccer Players and Matched Control

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04418596
• Other study ID #: S62916
• Status: Active, not recruiting
• Start date: September 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Gender: Male
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• CAM
• Femoracetabular Impingement
• Femoro Acetabular Impingement

Intervention

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

Locations

Country	Name	City	State
Belgium	University of Leuven Hospitals	Leuven	Flanders

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Johnson & Johnson

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two years post baseline measurements