NCT04418596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

June 3, 2020

Last Update Submit

April 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 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

Radiation: bi-planer radiography (EOS), Conventional radiography (Hip+pelvis)

Interventions

low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.

Also known as: Clinical Screening, Motion Analysis
Elite Soccer PlayersRecreational Soccer players (control)

Eligibility Criteria

Age12 Years - 17 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsGenetic component of being a male is required .
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leuven Hospitals

Leuven, Flanders, 3000, Belgium

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stijn Ghijselings, M.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

September 1, 2019

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations