AzTrials
AzTrials

Healthy VolunteersPC-CT KNEENCT07470671

An Analysis of Healthy Caucasian Knees

A study testing CT scan images of the knee, EOS scan of full leg and Ultrasound-based gap analysis in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In current literature, databases of healthy knee anatomy and function are confined to small sample sizes or singular imaging modalities. In this study, the investigator propose constructing a unique and large-scale database of healthy Caucasian knee anatomy and function by utilizing a combination of ultra-high… Read more about this study

Who is it for?
Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
CT scan images of the knee, EOS scan of full leg and Ultrasound-based gap analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBelgium
Study dates
8 Aug 2025to Jan 2027
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 20 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 20-35 years old.
  • 'Caucasian':
  • Self-identification as Caucasian or of European descent.
  • Self-identification as having 'fair' skin tone.
  • Both parents and all grandparents are of Caucasian or European descent.
  • Healthy knee and lower limb:
Show all 9Show fewer
  • No bony orthopaedic or trauma history in the lower limb (pelvis - foot).
  • No ligamentary or soft tissue trauma history in the knee.
  • No ligamentary or soft tissue trauma in the lower limb requiring cast immobilization.

Who cannot join

  • Individuals identifying with a race or ethnicity other than Caucasian or European descent.
  • Participants with known mixed racial or ethnic backgrounds that include non-Caucasian ancestry.
  • Participant uncertainty of pregnancy status.
  • Open wounds over the knee joint.

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, 1 recruiting
  • Universitaire Ziekenhuizen KU Leuven

    Leuven, Vlaams-Brabant, 3000

    Lennart Scheys, Prof. Ir., +32 16 33 88 18, lennart.scheys@uzleuven.be

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

    Recruiting

Other trials in Belgium

About this study

Official title: An Analysis of Healthy Caucasian Knees: Variability in Threedimensional Anatomy, Mediolateral Ligamentous Balance, Lower Limb Alignment and Trabecular Micro-structure.

In current literature, databases of healthy knee anatomy and function are confined to small sample sizes or singular imaging modalities. In this study, the investigator propose constructing a unique and large-scale database of healthy Caucasian knee anatomy and function by utilizing a combination of ultra-high resolution capabilities from photon-counting CT, lower limb weightbearing orthogonal imaging (EOS) of full leg, and non-invasive ultrasound-based functional testing of the knee. This study is a collaborative effort between the orthopaedics, radiology and biomechanical engineering departments in which the same prospectively acquired database will be used for multiple independent research questions.

Read the detailed description

Total knee arthroplasty (TKA) is the mainstay of treatment of end-stage osteoarthritis. Despite recent robotic advancements in TKA surgical technique, satisfaction rates remain low compared to the golden standard of hip arthroplasty surgery. Personalization in TKA, i.e. accurate recreation of individual anatomy and biomechanical properties of the knee joint, is increasingly recognized as an important variable in achieving satisfaction after TKA. Therefore, this study aims to gain foundational knowledge necessary for further research in anatomical and biomechanical personalization in TKA.

Anatomical personalization in TKA aims at recreating the pre-arthritic anatomy of each patient. The combination of native knee joint-line anatomy as well as native overall lower limb alignment anatomy can be referred to as the concept of 'constitutional anatomy'.

Historically, anatomical personalization in TKA focused primarily on variable tibiofemoral anatomy in the coronal plane. This led to the groundbreaking work, introducing the concept of coronal plane alignment of the knee (CPAK) phenotyping. This classification categorized knees into nine coronal morphologies based on limb alignment and knee joint line obliquity.

Another facet of personalization lies in biomechanical components, particularly the variable native mediolateral ligamentous balance of the knee (referred to as 'constitutional balance'). Presently, personalized ligamentous balancing in TKA remains largely unexplored, with surgeons aiming for a standardized balancing target regardless of patient-specific variations. This systematic approach towards knee balancing is a result of difficulty in predicting constitutional balance in arthritic knees, as progressive osteoarthritis alters the native ligamentous balance due to osteophyte formation, ligamentous wear and contractures. Given that joint biomechanics result (in part) from threedimensional joint line anatomy, it is plausible that variable constitutional balance might directly relate to variable constitutional anatomy. This assumption will be further evaluated in this study and, if confirmed, would imply the clinical possibility of determining constitutional balance by determining constitutional anatomical phenotype.

This study aims to identify phenotypes of constitutional anatomy and balance and correlate both by analysis of a prospectively acquired database of Caucasian volunteers with 'healthy knees' (see inclusion criteria for definition of a 'healthy knee').

For the anatomical analysis, a combination of photon-counting CT (PC-CT) and EOS full leg imaging will be used. The combination of these novel imaging modalities allows for a highly detailed evaluation of knee joint line anatomy combined with analysis of weight-bearing lower limb alignment in all three anatomic planes, whilst ensuring minimal exposure levels to ionizing radiation.

For the analysis of constitutional balance, this study will use an ultrasound-based technique. Ultrasound-based gap analysis is a non-invasive and previously validated method of determining medio-lateral laxity of the knee joint.

Being tested
CT scan images of the knee, EOS scan of full leg, Ultrasound-based gap analysis
Keywords
Healthy Caucasian knees

What participants receive

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

  • CT scan images of the kneeRadiation

    CT scan images of the knee allow for detailed anatomical analysis of joint shape through the means of statistical shape modelling.

  • EOS scan of full legRadiation

    Software-based reconstruction of orthogonal images provided by EOS imaging allows for a comprehensive three-dimensional analysis of lower limb alignment without the need for a full leg CT scan, minimizing exposure to ionizing radiation in the pelvic region.

  • Ultrasound-based gap analysisDiagnostic test

    For the analysis of constitutional balance, this study will use an ultrasound-based technique. This is a non-invasive and previously validated method of determining medio-lateral laxity of the knee joint.

Study groups in NCT07470671
Study groupRoleWhat they receive
Healthy Caucasian kneesOtherHealthy Caucasian volunteers aged from 20 till 35 years old
Receives: Radiation: CT scan images of the knee; Radiation: EOS scan of full leg; Diagnostic Test: Ultrasound-based gap analysis

What is being measured

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

  1. CT scan

    CT scan images of the knee allow for detailed anatomical analysis of joint shape through the means of statistical shape modelling (SSM).

    Measured: Day 1

  2. EOS scan

    EOS imaging of the full leg

    Measured: Day 1

  3. Ultrasound

    Ultrasound-based gap analysis is a non-invasive and previously validated method of determining medio-lateral laxity of the knee joint.

    Measured: Day 1

Secondary outcomes (1)
  1. International Physical Activity Questionnaire

    The questionnaire is used to estimate physical activity level. The questionnaire consists of 31 questions divided into 5 sub-areas. A higher score corresponds to a more physically strenuous activity.

    Measured: Day 1

Timeline

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

  1. First posted13 Mar 2026
  2. Study start8 Aug 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (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
Not applicable
Intervention model
Single group
Model description
The participants in this study are Healthy Volunteers who would not have received the interventions (EOS scan, Ultrasound and CT scan) for which this study is registered as a prospective interventional study without IMD or IMP.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470671
Sponsor's protocol ID
S68929
Acronym
PC-CT KNEE
Status last verified
Mar 2026
First submitted
17 Apr 2025
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CT scan images of the knee, EOS scan of full leg and Ultrasound-based gap analysis in people with Healthy Volunteers, 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 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 Lennart Scheys, Prof. Ir. (+32 16 33 88 18, lennart.scheys@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CT scan (time frame: Day 1). The study lists 3 primary outcomes in all. 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 13 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in