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.
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
- 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
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.
- Conditions
- Healthy Volunteers
- 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 group | Role | What they receive |
|---|---|---|
| Healthy Caucasian knees | Other | Healthy 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.
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
EOS scan
EOS imaging of the full leg
Measured: Day 1
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)
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.
- First posted13 Mar 2026
- Study start8 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lennart Scheys, Prof. Ir., Principal investigator, Universitaire Ziekenhuizen KU Leuven
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Healthy Caucasian Knees: Variability in Threedimensional Anatomy, Mediolateral Ligamentous Balance, Lower Limb Alignment and Trabecular Micro-structure.
- ClinicalTrials.gov ID
- NCT07470671
- Acronym / sponsor ID
- PC-CT KNEE / S68929
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Caucasian knees
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Caucasian knees | Other | Radiation: CT scan images of the knee, Radiation: EOS scan of full leg, Diagnostic Test: Ultrasound-based gap analysisHealthy Caucasian volunteers aged from 20 till 35 years old |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged 20-35 years old.
- 'Caucasian':
- Healthy knee and lower limb:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan images of the kneeCT scan images of the knee allow for detailed anatomical analysis of joint shape through the means of statistical shape modelling. | Radiation | Healthy Caucasian knees |
| EOS scan of full legSoftware-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. | Radiation | Healthy Caucasian knees |
| Ultrasound-based gap analysisFor 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. | Diagnostic test | Healthy Caucasian knees |
Primary outcome
CT scan
Time frame: Day 1
CT scan images of the knee allow for detailed anatomical analysis of joint shape through the means of statistical shape modelling (SSM).
EOS scan
Time frame: Day 1
EOS imaging of the full leg
Ultrasound
Time frame: Day 1
Ultrasound-based gap analysis is a non-invasive and previously validated method of determining medio-lateral laxity of the knee joint.
1 secondary outcome
International Physical Activity Questionnaire
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lennart Scheys, Prof. Ir. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
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.