AzTrials
AzTrials

Femoracetabular ImpingementCDM-FAISNCT07536295

Clinical Decision-Making in FAIS

A study testing Functional lateral x-ray scans, Multi-echo Fast Field Echo (mFFE) MRI and Markerless 3D motion capture in people with Femoracetabular Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Femoracetabular Impingement
What is being tested?
Functional lateral x-ray scans, Multi-echo Fast Field Echo (mFFE) MRI and Markerless 3D motion capture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
Jul 2026to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site
  • Universitaire Ziekenhuizen KU Leuven

    Leuven, Vlaams-Brabant, 3000

    Stijn Ghijselings, Dr., +32 16 33 88 72, stijn.ghijselings@uzleuven.be

    Anna Tarasiuk, +32 16 33 88 18, orthopedie.research@uzleuven.be

Other trials in Belgium

About this study

Official title: Optimizing Treatment Pathway and Clinical Desicion-making in Young Adults With Femoroacetabular Impingement Syndrome

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.

Read the detailed description

The escalating socioeconomic burden of hip osteoarthritis has driven a strategic shift toward earlier, joint-preserving interventions. Over the past two decades, femoroacetabular impingement syndrome (FAIS) has been increasingly recognized as a key contributor to cartilage injury and the development of early osteoarthritis. This recognition has not only led to the wider adoption of surgical interventions but also fueled significant advances in arthroscopic management. Yet, despite these developments, a central clinical challenge remains: determining which patients will benefit from prolonged conservative care and which require timely surgical care to optimize outcomes. Indeed, several randomized controlled trials have compared arthroscopy with conservative treatment, consistently showing that both approaches improve pain and function. Arthroscopy has demonstrated reliable short- to mid-term gains in patient-reported outcomes, while rehabilitation and conservative management also enable a substantial proportion of patients to achieve meaningful improvement. Although, these findings highlight the value of both strategies, the optimal sequence and timing of non-surgical and surgical care remains unknown.

Emerging literature makes it clear that the timing of surgical intervention is a critical factor in hip preservation. A recent multi-level systematic review showed that shorter symptom duration before arthroscopy is consistently associated with superior outcomes, including greater functional gains, higher rates of achieving clinically meaningful thresholds, and a lower risk of persistent pain. Similarly, a 10-year longitudinal study demonstrated that durable improvements are most likely when surgery is performed earlier in the disease course, whereas delays reduce the likelihood of achieving Minimal Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds.

Together, these findings establish timing as a critical determinant of long-term outcomes and underscore the pressing need for dynamic, clinic-ready tools that can guide the transition from rehabilitation to surgery in young adults with FAIS.

However, current diagnosis and treatment planning for FAIS relies heavily on static imaging and passive clinical examination, which cannot capture the dynamic, movement-related nature of the condition. Advanced biomechanical studies have shown that patients with FAIS differ from controls not only in femoral and spinopelvic morphology[8] but also in movement strategies during hip-hinging tasks such as deep squats. While these insights have enhanced our understanding of FAIS, their clinical translation remains very limited due to ethical and practical limitations. Firstly, while CT-based 3D imaging can provide detailed morphological assessment, its relatively high radiation dose makes it unsuitable for repeated monitoring in young adults. Similarly, 3D motion analysis has demonstrated important alterations in kinematics, yet the cost, time demands, and need for technical expertise restrict its use to research laboratories. As a result, there are still no feasible, clinic-ready protocols that adequately capture the dynamic nature of FAIS for everyday decision-making. Consequently, treatment planning in young adults, including the above combination of non-surgical and surgical care, often depends on subjective judgment and limited examination factors, which increases the risk of suboptimal care.

The central challenge, therefore, is not whether FAIS should be managed conservatively or surgically, but how to effectively determine which patients are best suited for each pathway and at what point in their care. As hip preservation moves toward preventive strategies and increasingly refined arthroscopic techniques, developing practical, individualized and objective tools to support timely decision-making is essential. This project aims to directly address that need.

Being tested
Functional lateral x-ray scans, Multi-echo Fast Field Echo (mFFE) MRI, Markerless 3D motion capture, Marker-based 3D motion capture (optional)
Keywords
FAIS
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional lateral x-ray scansDiagnostic test

    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.

  • Multi-echo Fast Field Echo (mFFE) MRIDiagnostic test

    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.

  • Markerless 3D motion captureDiagnostic test

    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.

  • Marker-based 3D motion capture (optional)Diagnostic test

    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.

Study groups in NCT07536295
Study groupRoleWhat they receive
Responder to conservative treatmentOtherAfter 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).
Receives: Diagnostic Test: Functional lateral x-ray scans; Diagnostic Test: Multi-echo Fast Field Echo (mFFE) MRI; Diagnostic Test: Markerless 3D motion capture; Diagnostic Test: Marker-based 3D motion capture (optional)
Non-responder to conservative treatmentOtherAfter 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.
Receives: Diagnostic Test: Functional lateral x-ray scans; Diagnostic Test: Multi-echo Fast Field Echo (mFFE) MRI; Diagnostic Test: Markerless 3D motion capture; Diagnostic Test: Marker-based 3D motion capture (optional)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of the study, following a 12-month follow-up period

Secondary outcomes (3)
  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).

    Measured: From enrollment to the end of the study, following a 12-month follow-up period

  2. 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.

    Measured: From enrollment to the end of the study, following a 12-month follow-up period

  3. 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.

    Measured: From enrollment to the end of the study, following a 12-month follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536295
Sponsor's protocol ID
S71997
Acronym
CDM-FAIS
Status last verified
Apr 2026
First submitted
10 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional lateral x-ray scans, Multi-echo Fast Field Echo (mFFE) MRI and Markerless 3D motion capture in people with Femoracetabular Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stijn Ghijselings, Dr. (+32 16 33 88 72, stijn.ghijselings@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Hip Outcome Tool-33 (iHOT-33) (time frame: From enrollment to the end of the study, following a 12-month follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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