Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls

NCT06272292 | Recruiting

• 1 other identifier: S66441
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• The presence of CAM morphology in combination with symptoms

  1. = yes morphology, yes symptoms; 2. = yes morphology, no symptoms; 3. = no morphology, no symptoms

  Baseline

Secondary Outcomes (3)

• The Copenhagen Hip and Groin Outcome Score (HAGOS)

  Baseline

• Radiographic spinopelvic parameters

  Baseline

• 3D motion analysis parameters

  Baseline

Study Arms (3)

Symptomatic CAM-FAI patients

EXPERIMENTAL

33 patients that exhibit symptomatic CAM-FAI on medical imaging (Alpha angle \>60) and have reduced hip internal rotation (IR\<15). All participants in this group will be males aged between 21 and 35 years old.

Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis

Asymptomatic CAM-FAI patients

EXPERIMENTAL

33 healthy control that exhibit asymptomatic CAM on x-ray scans (Alpha angle \>60). All participants in this group will be males aged between 21 and 35 years old.

Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis

Healthy controls

EXPERIMENTAL

33 healthy control that exhibit no symptoms or abnormal morphologies of the proximal femur (Alpha angle \>60 , IR\>15). All participants in this group will be males aged between 21 and 35 years old.

Diagnostic Test: EOS; Diagnostic Test: 3D motion lab analysis

Interventions

EOS DIAGNOSTIC_TEST

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).

Asymptomatic CAM-FAI patients; Healthy controls; Symptomatic CAM-FAI patients

3D motion lab analysis DIAGNOSTIC_TEST

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 lunges, running uphill and downhill) Each movements will be repeated 6 times. Three times with the dominant foot/opposite leg on the force plate to collect kinetic data. All data will be captured using two 10-15 camera 3D motion capture systems and one capturing an instrumented treadmill (M-gait)

Asymptomatic CAM-FAI patients; Healthy controls; Symptomatic CAM-FAI patients

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stijn Ghijselings, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stijn Ghijselings, MD

CONTACT

+32 16 33 88 18; stijn.ghijselings@uzleuven.be

Orthopedic Research

CONTACT

+32 16 33 88 18; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 3 study groups, based on clinical examination and medical imaging: * symptomatic CAM-FAI patients * asymptomatic CAM controls * healthy controls
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional, case-control prospective clinical study

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: February 22, 2024
• Study Start: July 28, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)