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Clinical Trial NCT07470671 (PC-CT KNEE) for Healthy Volunteers is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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An Analysis of Healthy Caucasian Knees (PC-CT KNEE) 200 Non-Invasive
Clinical Trial NCT07470671 (PC-CT KNEE) is an interventional study for Healthy Volunteers that is recruiting. It started on August 8, 2025 with plans to enroll 200 participants. Led by Universitaire Ziekenhuizen KU Leuven, it is expected to complete by January 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 13, 2026.
Brief 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 resolution capabilities from photon-counting CT, lower limb weightbearing orthogonal imaging (EOS) of full l...Show More
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 achi...Show More
Official Title
An Analysis of Healthy Caucasian Knees: Variability in Threedimensional Anatomy, Mediolateral Ligamentous Balance, Lower Limb Alignment and Trabecular Micro-structure.
Conditions
Healthy VolunteersOther Study IDs
- PC-CT KNEE
- S68929
NCT ID Number
Start Date (Actual)
2025-08-08
Last Update Posted
2026-03-13
Completion Date (Estimated)
2027-01
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Healthy Caucasian knees
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherHealthy Caucasian knees Healthy Caucasian volunteers aged from 20 till 35 years old | CT scan images of the knee 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 leg 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 analysis 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
CT scan | CT scan images of the knee allow for detailed anatomical analysis of joint shape through the means of statistical shape modelling (SSM). | Day 1 |
EOS scan | EOS imaging of the full leg | Day 1 |
Ultrasound | Ultrasound-based gap analysis is a non-invasive and previously validated method of determining medio-lateral laxity of the knee joint. | Day 1 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Day 1 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
20 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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:
- 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.
- 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.
Study Central Contact
Contact: Lennart Scheys, Prof. Ir., +32 16 33 88 18, [email protected]
Contact: Anna Tarasiuk, +32 16 33 88 18, [email protected]
1 Study Locations in 1 Countries
Vlaams-Brabant
Universitaire Ziekenhuizen KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium
Lennart Scheys, Prof. Ir., Contact, +32 16 33 88 18, [email protected]
Anna Tarasiuk, Contact, +32 16 33 88 18, [email protected]
Lennart Scheys, Prof. Ir., Principal Investigator
Recruiting