Clinical Decision-Making in FAIS
ConditionFemoracetabular Impingement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Femoroacetabular impingement syndrome is increasingly recognized as a contributor to cartilage injury and early hip osteoarthritis. Both structured conservative care and arthroscopic surgery can improve pain and function, but a major unresolved clinical problem is deciding who should continue conservative care and who should escalate to surgery, and when. Evidence indicates that shorter symptom duration before surgery is associated with better long-term improvement, meaning delays may reduce the chance of achieving meaningful recovery. Current decision-making still depends largely on static imaging and passive clinical examination, which do not capture the dynamic, movement-related nature of the condition, while advanced three-dimensional imaging and laboratory motion analysis are not practical for routine clinical monitoring. This study aims to address this gap by developing and validating feasible, clinic-ready dynamic assessment methods and integrating weight-bearing pelvic and spinal alignment with three-dimensional hip modeling to support more objective, individualized, and timely treatment decisions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Male or Female, Age 18-35 years inclusive.
First consultation at participating site with clinical diagnosis of FAIS by a hip orthopaedic surgeon, including positive impingement tests and reduced hip ROM in the transverse plane compatible with FAIS.
Radiographic cam and/or pincer morphology on standard imaging (e.g. α-angle >60°, lateral center-edge angle >40°, crossover sign) as per local protocol.
Disqualifiers
Previous surgery on the bilareral hip.
History of major hip trauma or pediatric hip disease (e.g. Slipped capital femoral epiphysis, Perthes disease).
Developmental dysplasia (lateral center-edge ≤20°) or other severe structural deformity incompatible with the standard FAIS pathway.
Radiographic signs of hip degeneration (Tönnis grade >2).
Trial design
Design model
Parallel
Treatments tested in this trial
Functional lateral x-ray scans
Diagnostic testFunctional lateral x-ray scans will be obtained in three postures: standing, relaxed sitting, and deep flexed sitting. This previously validated protocol, provides posture-specific measures of spinopelvic alignment under physiological load and allows to integrate weight-bearing spinopelvic alignment into 3D hip coverage analysis. By extending imaging beyond a femur-centric perspective, this method better reflects the dynamic, multi-regional nature of FAIS.
Multi-echo Fast Field Echo (mFFE) MRI
Diagnostic testA multi-echo Fast Field Echo (mFFE) MRI will be acquired to generate highcontrast, bone-like images without ionizing radiation. The imaging sequence can be readily implemented on standard 1.5T and 3T MRI scanners available at the collaborating sites. An in-house pipeline will enable automated 3D segmentation of the lumbar spine, pelvis, acetabulum, proximal femur and condyles.
Markerless 3D motion capture
Diagnostic testParticipants will complete markerless 3D motion capture during three hip-hinge tasks: deep squat, sumo squat, and Romanian deadlift (20% body weight). Lumbar, pelvic and hip movements will be measured in all three planes. Data will be recorded using two research-dedicated iPads running the movement tracking software.
Marker-based 3D motion capture (optional)
Diagnostic testIn a subgroup of participants, during three hip-hinge tasks: deep squat, sumo squat, and Romanian deadlift (20% body weight). Lumbar, pelvic, and hip movements will be measured in all three planes using our validated marker-based 3D motion capture system.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Responder to conservative treatmentOther 4 interventions
Group B: Non-responder to conservative treatmentOther 4 interventions
Trial outcomes
Primary outcomes
1
Change in International Hip Outcome Tool-33 (iHOT-33)
The iHOT-33 questionnaire is a patient-reported questionnaire designed to measure the health-related quality of life in young, active patients with symptomatic hip disease. The questionnaire consists of 33 items divided into four main domains: 1. Symptoms and Functional Limitations; 2. Sports and Recreational Activities; 3. Job-Related Concerns; 4. Social, Emotional, and Lifestyle Concerns. The final score of this questionnaire ranges from 0 to 100, where 100 represents a perfect quality of life with no hip-related limitations, while 0 represents the highest level of disability.
Time frame
From enrollment to the end of the study, following a 12-month follow-up periodSecondary outcomes
1
Changes in International Physical Activity Questionnaire (IPAQ)
The IPAQ (International Physical Activity Questionnaire) is a standardized tool used to estimate an individual's total physical activity and energy expenditure. The questionnaire asks you to recall your physical activity over the last 7 days. Based on the total score, individuals are categorized into three levels: 1.Low: Not meeting the criteria for the other categories (inactive). 2. Moderate: Roughly equivalent to 30 minutes of at least moderate-intensity activity on most days.3. High: Equivalent to about one hour of activity per day (or very high-intensity training).
Time frame
From enrollment to the end of the study, following a 12-month follow-up period2
Change in Pain Catastrophizing Scale (PCS)
The PCS (Pain Catastrophizing Scale) is a tool designed to measure how a person thinks and feels about their pain. It consists of 13 statements describing different thoughts and feelings. Patients rate how much they experience these thoughts on a 5-point scale, from 0 (Not at all) to 4 (All the time). Patients with high PCS scores often experience higher pain intensity.
Time frame
From enrollment to the end of the study, following a 12-month follow-up period3
Change in Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) is a questionnaire used to measure a patient's fear of movement (kinesiophobia). The questionnaire consists of 17 items rated on a 4-point scale (from "Strongly Disagree" to "Strongly Agree"). Scores range from 17 to 68. A score of 37 or higher is generally considered "high," indicating that the person has significant fear that is likely interfering with their recovery.
Time frame
From enrollment to the end of the study, following a 12-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov
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