Clinical Decision-Making in FAIS
CDM-FAIS
Optimizing Treatment Pathway and Clinical Desicion-making in Young Adults With Femoroacetabular Impingement Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 17, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
Study Completion
Last participant's last visit for all outcomes
July 1, 2029
May 6, 2026
April 1, 2026
3 years
April 10, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
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.
From enrollment to the end of the study, following a 12-month follow-up period
Secondary Outcomes (3)
Changes in International Physical Activity Questionnaire (IPAQ)
From enrollment to the end of the study, following a 12-month follow-up period
Change in Pain Catastrophizing Scale (PCS)
From enrollment to the end of the study, following a 12-month follow-up period
Change in Tampa Scale for Kinesiophobia (TSK)
From enrollment to the end of the study, following a 12-month follow-up period
Study Arms (2)
Responder to conservative treatment
OTHERAfter 4 months of conservative treatment patients come to a follow-up consultation for clinical re-assessment with the respective treating orthopaedic surgeon to review symptoms progress and treatment plan. Based on clinical reassessment and PROMS results participants will be divided into Responder or Non-responder to conservative treatment based on iHOT-33 change and PASS. Responders: continuation of nonoperative care (8-10 sessions).
Non-responder to conservative treatment
OTHERAfter 4 months of conservative treatment patients come to a follow-up consultation for clinical re-assessment with the respective treating orthopaedic surgeon to review symptoms progress and treatment plan. Based on clinical reassessment and PROMS results participants will be divided into Responder or Non-responder to conservative treatment based on iHOT-33 change and PASS. Non-responders: offered surgery (arthroscopic or mini-open), with full discussion of risks and benefits according to routine practice.
Interventions
Functional 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.
Participants 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.
A 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.
In 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.
Eligibility Criteria
You may qualify if:
- 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.
- Willingness and ability to participate rehabilitation and complete the recommended physiotherapy sessions and attend scheduled follow-up visits.
- Ability to perform basic squat / hip-hinge tasks safely in the motion lab, as judged by the treating clinician.
You may not qualify if:
- 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).
- Other musculoskeletal conditions that significantly interfere with assessments (e.g. symptomatic lumbar disc disease, severe knee pathology, recent adductor muscle pathology).
- Contraindications to MRI (e.g. non-MRI compatible pacemaker or implant, severe claustrophobia not manageable with standard care).
- Contraindications to X-ray or MRI related to pregnancy: known pregnancy at any time, or positive pregnancy test prior to imaging; breastfeeding women will not undergo additional research imaging.
- Inability to perform basic squat/hip-hinge tasks safely (e.g. due to balance, pain or cardiopulmonary limitations).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stijn Ghijselings, Dr.
Universitaire Ziekenhuizen KU Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2026
First Posted
April 17, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-04