An Analysis of Healthy Caucasian Knees

NCT07470671 | Recruiting

• 1 other identifier: S68929
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Keywords

Healthy Caucasian knees

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• International Physical Activity Questionnaire

  Day 1

Study Arms (1)

Healthy Caucasian knees

OTHER

Healthy Caucasian volunteers aged from 20 till 35 years old

Radiation: CT scan images of the knee; Radiation: EOS scan of full leg; Diagnostic Test: Ultrasound-based gap analysis

Interventions

CT scan images of the knee RADIATION

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

Healthy Caucasian knees

EOS scan of full leg RADIATION

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.

Healthy Caucasian knees

Ultrasound-based gap analysis DIAGNOSTIC_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.

Healthy Caucasian knees

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Lennart Scheys, Prof. Ir.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lennart Scheys, Prof. Ir.

CONTACT

+32 16 33 88 18; lennart.scheys@uzleuven.be

Anna Tarasiuk

CONTACT

+32 16 33 88 18; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: March 13, 2026
• Study Start: August 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)