Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04822571 |
| Other study ID # |
S64417 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2021 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Femoroacetabular impingement is an orthopedic condition that is primarily characterized by
the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum
resulting in an abnormal contact between the two during hip motion, especially in positions
of increased hip flexion and rotation, ultimately leading to hip pain.
The main study was initiated with the goal of exploring the etiology of FAI in a
multidimensional and novel way that addresses the major gaps in literature. Within the main
study a 3D motion capture protocol has been designed in line with the latest literature
recommendations, which called for more hip ROM specific movements and athlete oriented 3D
motion capture protocols that incorporate the spinopelvic complex. While the protocol surely
contains movements that have been previously validated and published such as squats and
lunges, a unique addition of high velocity soccer kicks and hop- lunges have been included.
Such additions elevate the relevancy of the 3D motion analysis protocol, however they also
pose questions on how reliable and accurate these additions are. This is especially important
a 3D motion analysis has a very subjective component, which is the placement of the skin
markers by the clinician. Errors or alteration to markers placement between different
sessions or different subjects have been shown to significantly affect the quality of data.
Furthermore, not all physical movement can be properly documented using motion analysis. The
velocity at which the movement is preformed combined with how complex it is can affect the
quality of data collected by the motion analysis system. Also another important component is
the uniqueness of the population recruited for the main study. Most studies with highly
dynamic motion protocols have been validated and published on adult populations. Thus the
investigators cannot use their findings liberally to compare with the adolescent protocol, as
differences in patterns of motion between adults and adolescence have been documented.
Indeed, a need to test the reliability of the investigators' protocol among their own study
groups is highly imperative.
Description:
Femoroacetabular impingement is an orthopedic condition that is primarily characterized by
the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum
resulting in an abnormal contact between the two during hip motion, especially in positions
of increased hip flexion and rotation, ultimately leading to hip pain. FAI can be
radiologically classified into 3 types of morphology: Pincer, CAM and mixed type. Pincer
morphology is mainly characterized on radiological films by an over-coverage of the
acetabulum, has a high center edge angle and is seen in females more frequently. CAM
morphology is characterized by an increase in bone formation at the femoral head-neck
junction and is mainly identified by a large alpha angle on medical imaging scans. Unlike
pincer, CAM morphology occurs mainly in males. Mixed morphology is a third type of FAI and
consists of a combination of both CAM and pincer impingement characteristics. FAI has been
increasingly garnering attention in the last two decades due to two main reasons.
The first reason is its recognition as a leading cause of hip pain in the young
economically-active adult. Epidemiological reports show the average age of FAI patients is 28
years old. Furthermore, a significant number of FAI patients are athletes who have
professional careers that heavily depend on their physical wellbeing. The second reason FAI
has been in the spotlight of orthopedic research recently, is the growing evidence linking it
to early cartilage and labral damage, and subsequently to the development of hip
osteoarthritis (OA). Ganz and colleagues were the first to make this link and assumed that
the presence of the inter-articular morphological abnormality leads to abutment of the
femoral head-neck junction against the acetabular rim. This repeated mechanical abutment is
assumed to then lead to acetabular labral damage and progressive breakdown of the
chondrolabral junction, thereby leading to chondral defects and the eventual onset of OA. Hip
OA by itself is an acknowledged source of pain/disability and is associated with an
ever-increasing socioeconomic cost.
A recent systematic review on the prevalence of symptomatic hip morphology reported the
prevalence of CAM type deformity to be 37%; the prevalence of pincer deformity was 67% in the
general population. Interestingly, there was an almost 3:1 ratio of CAM deformity in an
athletic population compared with non-athletes. This was not the case for pincer deformity.
Furthermore, such morphological findings are increasingly being reported in the adolescent
athletic population specifically. A number of recent studies found a markedly higher
prevalence of cam deformities in asymptomatic adolescents participating in, specifically,
soccer, ice-hockey and basketball as compared with their non-athlete controls. Such reports
have led researchers to speculate whether participating in high intensity physical activity
at the critical period of bone maturation prior to femoral physis closure (10 - 15 years of
age) could cause CAM deformity post femoral physis closure (15 -18 years of age old). It is
hypothesized that a CAM in this population could form either due to new bone formation at the
anterosuperior head-neck junction, or be induced by changes in the shape of the growth plate
due to high shear forces acting on the growing hip during these athletic activities. However,
as of date there is no concrete evidence to support this hypothesis. Consequently, the
reasons behind the formations of CAM deformity in adolescent athletes remain unclear and call
for further research. Such research is imperative to increase our understanding of the effect
high training load can have on the wellbeing and long term health of young athletes.
It is with this background in mind that the main study was initiated with the goal of
exploring the etiology of FAI in a multidimensional and novel way that addresses the major
gaps in literature. Within the main study a 3D motion capture protocol has been designed in
line with the latest literature recommendations, which called for more hip ROM specific
movements and athlete oriented 3D motion capture protocols that incorporate the spinopelvic
complex. While the protocol surely contains movements that have been previously validated and
published such as squats and lunges, a unique addition of high velocity soccer kicks and hop-
lunges have been included.
Such additions elevate the relevancy of the 3D motion analysis protocol, however they also
pose questions on how reliable and accurate these additions are. This is especially important
a 3D motion analysis has a very subjective component, which is the placement of the skin
markers by the clinician. Errors or alteration to markers placement between different
sessions or different subjects have been shown to significantly affect the quality of data.
Furthermore, not all physical movement can be properly documented using motion analysis. The
velocity at which the movement is preformed combined with how complex it is can affect the
quality of data collected by the motion analysis system. Also another important component is
the uniqueness of the population recruited for the main study. Most studies with highly
dynamic motion protocols have been validated and published on adult populations. Thus the
investigators cannot use their findings liberally to compare with the adolescent protocol, as
differences in patterns of motion between adults and adolescence have been documented.
Indeed, a need to test the reliability of the investigators' protocol among their own study
groups is highly imperative.
