This pilot prospective cohort study is designed to provide feasibility data for a large global study that will critically evaluate the impact of sport activity and FAI development during the critical phase of hip maturation.Primary Feasibility…
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- Bone disorders (excl congenital and fractures)
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Outcome measures
Primary outcome
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 years) across all 4 possible scoring categories.
Adult and child versions of the HAES questionnaire will be administered to
ensure accuracy of reporting from subjects
Radiographic signs of FAI are common in asymptomatic individuals and will
therefore be interpreted along with a detailed history and physical
examination. Symptomatic FAI in children and adolescents is typically
characterized by anterior hip pain aggravated by flexion activities, decreased
hip internal rotation, and a positive impingement sign. For the purposes of
this study, physical examination will include range of motion measurements
documented in the supine position by the blinded local investigator or a
research assistant (using a goniometer), as well as response of provocative hip
tests, specifically the anterior and posterior hip impingement tests on both
hips28. The study hip considered for evaluation will be that on the subject*s
dominant leg (i.e. right or left).
We will use a non-contrast 3D-volumetric interpolated breath-hold examination
(VIBE) sequence MRI. This three dimensional protocol has been used to document
FAI related morphology and minimizes both radiation exposure and eliminates the
use intra-articular contrast injections for the asymptomatic study subject. The
radiographic criteria to determine the presence of a cam morphology or other
FAI morphology include:
1. An alpha angle greater than 50 degrees
2. A femoral head and neck offset ratio less than 4.5mm, where prior research
has shown offset ratios in asymptomatic patients and those with cam impingement
at 0.21 ± 0.03 and 0.13 ± 0.05 respectively
3. We will also document secondary signs of FAI including hernation pits at the
femoral head and neck junction, chondral and labral lesions, and/or protrusio
acetabuli (when the femoral head is overlapping the ilioischial line medially)
An independent, blinded Central Adjudication Committee (CAC) will review all
MRIs and physical exam notes to characterize cam morphology according to these
definitions. They will also evaluate any adverse events. This committee will
be comprised of 2 orthopaedic surgeons with specialized expertise in diagnosing
and treating FAI (Drs. Musahl and Gandhi) and 2 musculoskeletal radiologists
(Drs. Choudur and Mascarenhas). Any disagreements among the CAC members will be
resolved during regular conference calls and/or in-person meetings. The CAC
members will be blinded. All recruiting sites are asked to send coded, blinded
MRI images to the Methods Centre for review.
Secondary outcome
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.
Background summary
Femoroacetabular impingement (FAI) is a recently described condition that
causes hip pain and can lead to the development of osteoarthritis of the hip
later in life. Some cross-sectional studies have estimated that the prevalence
of hip impingement ranges from 14-17% among asymptomatic young adults to almost
95% among competitive athletes. FAI occurs as a result of a size and shape
mismatch between the femoral head (ball) and the acetabulum (socket). FAI is
typically classified into 2 subtypes; cam-type (a misshaped femoral head / cam
morphology) or Pincer type (an over covered or deep socket). Most adult
patients (18+ years) have a combination of both types of impingement. With FAI,
the abnormal femoral head and acetabular rim of the hip joint collide or
*impinge* during movements such as hip flexion and rotation. Typically,
patients with this condition experience hip pain and loss of hip function. The
development of hip pain in this manner serves as an indicator for early
cartilage and labral damage, potentially resulting in hip osteoarthritis.
The number and diagnoses of FAI has recently risen across all age groups, but
it has been especially notable within paediatric and adolescent populations. In
the adult, FAI is most commonly attributed to an *idiopathic anatomic variant*.
In the paediatric population, implicated causes of FAI have included genetics,
subclinical paediatric hip disease, and stresses to the hip joint from
high-intensity, repetitive activity typically attributed to certain sports.
According to Packer et al., there is no definitive evidence that FAI is
transmitted genetically, and in otherwise healthy children, there is growing
evidence that FAI, particularly with cam morphology, has a higher prevalence in
athletes who performed at a high level during adolescence.
Sports and the Development of FAI in the Paediatric Population
Over the past 20 years, sport injuries among children have dramatically
increased, where more than 38 million young athletes participate in organized
sports annually in US and of those, 3.5 million that receive medical treatment
for their injuries are 14 years and younger. High impact and high intensity
activity common in many sports have the potential to cause hip damage,
especially during physeal closure in young children. Research is needed to
determine *how much is too much* sport activity in order to advocate for the
young who cannot easily protect themselves from excesses. This concern has been
highlighted in publications addressing the potential deleterious impact of
early sport specialization in young athletes.
High impact activities in combination with intensity of various kinds have been
shown to affect the developing femur. Among children, open physes and growing
cartilage make them more susceptible to injury and shear forces that can result
in premature physeal arrest, apophyseal avulsion fractures, and chondral
injuries. A higher prevalence of cam morphology (>50%), both symptomatic and
asymptomatic, has been shown in adolescent athletes that play ice hockey,
basketball, and soccer when compared to controls that did not play sports.
These sports involve repetitive deep flexion, flexion-adduction or
extension-abduction movements, which bring the cam lesion on the femoral head
or the pincer lesion on the acetabulum into conflict. Therefore, participating
in high impact sports during growth likely plays an important role in the
development of a cam deformity. This is concerning given the increasing trend
toward year-round participation in youth sports with early specialization.
Preliminary Studies
Most studies in the current literature that evaluate the relationship between
sports and the development of FAI are relatively small, retrospective
case-controls. There are 2 recent systematic reviews on this topic that overlap
in primary study data. There were up to 4 studies included across both reviews
that were published since 2011 and evaluated varying sports and levels of
training intensity through a meta-analysis. Both reviews describe an increased
risk of development of a cam morphology in athletes that play ice hockey,
basketball, soccer, and other jumping sports. In addition, adolescent males
that train for these sports at least 3 times per week were at a greater risk
than their non-athletic counterparts of developing femoral head-neck
deformities associated with FAI.
The studies in these reviews were predominantly cross-sectional in design, with
small sample sizes (wide confidence intervals), and did not describe changes in
hip morphology during the critical phase in hip development and maturation. New
evidence demonstrates conflicting results regarding how and when primary
cam-type FAI develops in relation to skeletal maturity. Accordingly, the
current literature notes the need for longitudinal or prospective MRI studies
to understand the etiology of primary FAI development to identify preventive
strategies, delineate radiographic values, define specific indications for
operative management, and examine long-term outcomes to determine optimal
management.
Significance
As FAI is diagnosed most frequently in athletes, and it is estimated that 30 to
45 million adolescents age 6-18 years old are involved in sports, it is
becoming imperative to identify factors that may predict its development, study
treatments, and improve outcomes. The presentation of a cam morphology can
include hip pain, loss of function, and the need for surgical treatment along
with its potential complications (complication rates of hip arthroscopy in
children and adolescents range from 1.8-12.9%). Considering that research has
demonstrated the connection between FAI and osteoarthritis in adulthood,
potentially leading to the need for total hip replacement, it has now become
critical to mitigate the risk of developing cam morphology at a young age. A
prospective evaluation of the impact of sport activity, and the increasing
tendency for sport specialization, in the very young athlete is important to
protect the millions of adolescents involved in sports that may be at risk of
developing FAI
Study objective
This pilot prospective cohort study is designed to provide feasibility data for
a large global study that will critically evaluate the impact of sport activity
and FAI development during the critical phase of hip maturation.
Primary Feasibility Objective
To assess feasibility of a global prospective cohort study that will evaluate
the association between the level and type of sport activity and the
development of hip deformity in the paediatric population. In order to assess
the feasibility of large-scale prospective cohort, we will conduct a 50-subject
pilot study across multiple sites. Measures of feasibility will include rates
of participant enrolment and protocol compliance (e.g. participant follow-up
and completion of outcome measures).
Secondary Study Objective 1
To determine if the level and type of sport activity is associated with the
development of hip deformities in the paediatric population at 2 years.
Intensive sport training and specialization has been implicated in the
development of abnormal hip morphology in adolescents. Certain sports (e.g.
soccer, basketball, ice hockey, football) have also been identified as placing
excessive stress on the hip and surrounding soft tissues, which bring the cam
morphology on the femoral head and the pincer morphology on the acetabulum into
conflict. We hypothesize that: 1) Participants engaging in high sport activity
levels will have a higher prevalence of cam morphology diagnosed through three
dimensional magnetic resonance imaging (3D MRI) of the dominant hip compared to
non-athletes in the same age group (controls) at 2 years; and 2) Participants
with specialized activity in certain sports (e.g. soccer, basketball, ice
hockey, football) will have a higher prevalence of cam morphology diagnosed
through MRI compared to non-athletes at 2 years.
Secondary Study Objective 2
To determine if the presence of hip deformity is associated with varying hip
function and health-related quality of life (HRQL) in the paediatric population
at 2 years. Hip morphology will be diagnosed through MRI of the dominant hip to
avoid radiation exposure to the developing hip. For any impingement morphology
(cam or pincer) identified, not all subjects may be symptomatic. We hypothesize
that: 1) Participants diagnosed with cam morphology will have decreased
function and HRQL at 2 years compared to those without; and 2) Participants
with symptomatic cam morphology will have the lowest function and HRQL scores
at 2 years compared to asymptomatic individuals.
Study design
This is a pilot prospective cohort study of 50 athlete and non-athlete
participants (25 per group) between the ages of 12 and 14. Participants will be
recruited from experienced hip surgeons and sports medicine researchers at
multiple international clinical sites. Participants will be evaluated
clinically and radiographically at baseline and again at the 2-year follow-up.
The primary outcome for the overall pilot study is feasibility (Primary
Feasibility Objective). We will also measure sport and general activity levels,
function, HRQL, and will independently adjudicate hip morphology changes using
MRI over 2 years (Secondary Study Objectives).
Study burden and risks
There are no known risks involved in our study, aside from the inconvenience of
completing questionnaires. The magnetic resonance imaging does not involve any
radiation and therefore the study procedure is safe for children. Participants
will be made aware of potential risks in the informed consent form and during
the consent process
293 Wellington St N, Suite 110
Hamilton ON, L8L 8E7
CA
293 Wellington St N, Suite 110
Hamilton ON, L8L 8E7
CA
Listed location countries
Age
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
Known hip pathology
Previous hip surgery
Contra-indication to undergo MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63530.078.18 |