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Recruiting NCT06272292

Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls

No phase Interventional Femoroacetabular Impingement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EOS, 3D motion lab analysis.
Who it may be relevant to
Registry conditions: Femoroacetabular Impingement. Basic parameters: 21 years — 35 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Integrated Biomechanical Investigation of Subjects With Symptomatic FAI and Two Groups of Asymptomatic Controls: a Comparison in Dynamic Tasks

Overview

Femoroacetabular impingement (FAI) is an orthopaedic 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. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms. This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology.

Detailed description

Femoroacetabular impingement (FAI) is an orthopaedic 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. While a clear-cut radiological classification makes the identification of FAI seem quite straightforward, it fails to differentiate between symptomatic and asymptomatic patients.

Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Not only this movement restriction is a significantly debilitating factor in such a young active population, a recent study reported FAI patients to see on average 4.0 health care providers, undergo on average 3.4 diagnostic imaging tests, and receive on average 3.1 treatments prior to final diagnosis. This raises the cost of an individual FAI diagnosis to be €1,563.26 higher than the calculated minimum required cost. Such calculations clearly reveal the long-lasting, multifactorial burden of FAI on society.

Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. To our knowledge only three studies have looked into muscle strength by using mainly hand-held dynamometers to record the isometric strength of hip musculature. Their findings suggest hip muscle weakness in symptomatic FAI subjects, but whether this weakness is a pain protective consequence, or an actual cause of FAI is still unknown.

In conclusion, the diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms.

This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology.

Interventions

  • Diagnostic test EOS
    Every subject in this study will undergo a radiographic analysis of the hip and spine using a low-dose, full-body biplanar X-ray acquisition (in standing, sitting and squatting position, EOS imaging).
  • Diagnostic test 3D motion lab analysis
    A hip-specific 3D motion analysis will be performed. The 3D motion protocol will be divided into 2 main sections. First section: Consist of movements categorized within the activities of daily living (walking at self-selected speed, uphill walking, standardized deep squat and non-standardized deep squat) Second section: Consists of movements that are categorized within athletic training and have been specifically chosen to induce large hip ranges of motion (Sumo squats, dead lifts, forward lun

Primary outcome measures

  • The presence of CAM morphology in combination with symptoms [Time frame: Baseline]
Secondary outcome measures (3)
  • The Copenhagen Hip and Groin Outcome Score (HAGOS) [Time frame: Baseline]
  • Radiographic spinopelvic parameters [Time frame: Baseline]
  • 3D motion analysis parameters [Time frame: Baseline]

Eligibility criteria

Exclusion criteria

\- Participants in all three study groups will be excluded if x-ray scans shows a pincer FAI morphology or radiological sign of osteoarthritis.

Inclusion criteria

  • All participants will be males aged between 21 and 35 years old.
  • For symptomatic CAM-FAI patients
  • The presence of CAM-FAI morphology at the head-neck junction of the femur
  • Alpha angle >60
  • Reduced hip internal rotation (IR<15)
  • For asymptomatic CAM controls:

1\. Exhibit asymptomatic CAM on x-ray scansAlpha angle >60

  • For Healthy control group:
  • Exhibit no symptoms or abnormal morphologies of the proximal femur (Alpha angle >60 , IR>15).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • University Hospitals of Leuven — Leuven

Identifiers

NCT: NCT06272292 · S66441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗