Cam morphologie Femoroacetabular Impingement (FAI)
Conditions
Interventions
None listed
Sponsors
McMaster University Hospital
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Age 12-14 years at baseline Sex: 5 boys and 5 girls Activity level: 5 highly active children and 5 sendentary controls
Exclusion criteria
Exclusion criteria: Known hip pathology Previous hip surgery Contra-indication to undergo MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility Outcomes: Several aspects of feasibility will be assessed including rates of participant enrollment and protocol compliance. Rates of participant enrollment will be assessed by comparing projected and actual participant enrolment at each pilot clinical site. We will carefully document any issues with compliance with the protocol which will include missing case report form data and incomplete participant follow-up at 2 years. Additionally, we will closely monitor the completion of outcome measures including the Habitual Activity Estimation Scale (HAES)25, Hip Outcome Score (HOS)26, and Paediatric Quality of Life Inventory (PedsQL)27 and documentation of adverse events at the initial and final follow-up assessments. Primary Study Outcome (Secondary Objective): The primary study outcome is the incidence of radiographic cam morphology between the highly active (including sports) exposure subjects and the inactive/less active control subjects at 2 years, as determined by the dedicated MRI of the hip. We will define activity levels using the HAES questionnaire. The HAES quantifies the duration, in hours, of 4 levels of activity ranging from very inactive (lying down, napping), somewhat inactive (sitting, reading, watching television, playing video games), somewhat active (walking, light chores), to very active (running, bicycling, activities leading to sweating or breathing hard) over a complete waking day. The HAES is designed for administration in the paediatric population and has been shown to be both a valid and reliable form of quantifying levels of physical activity. The exposure group (highly active, athletes) will include those that score *very active* on the HAES and report prior sporting activity. The control group will include those that score from *very inactive* to *somewhat active* and who report minimal to no prior sporting activity. A sensitivity analysis will evaluate cam morphology incidence (from baseline to 2 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Study Outcomes (Secondary Objective 2): Secondary outcomes include hip function and HRQL between subjects with a diagnosed hip deformity and no deformity at 2 years, as determined by the HOS and PedsQL questionnaires. The HOS is a self-administered hip score that was designed to capture hip function. The HOS has been shown to have the greatest clinimetric evidence for use in patients with FAI or labral tears. The HOS was developed for young adults and has been shown to be appropriate for use in adolescents with hip impingement. It has been validated in the Dutch language. The PedsQL is a validated and responsive measure of HRQL in children and adolescents, and can be used with healthy children and those with acute and chronic health conditions. The PedsQL was specifically designed to measure the core health dimensions outlined by the World Health Organization (physical, emotional, and social functioning), which will ensure adaptability in the global study. Adult and child versions of the HOS and PedsQL will be utilized to ensure accuracy of reporting. | — |
Countries
Netherlands
Outcome results
None listed