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Clinical Trial NCT07481461 (AMB-OK) for Knee Osteoarthritis (OA) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Altered Joint Mechanics and Biological Response in Osteoarthritic Knees. (AMB-OK) 30

Not yet recruiting
Clinical Trial NCT07481461 (AMB-OK) is an interventional study for Knee Osteoarthritis (OA) and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 30 participants. Led by Universitaire Ziekenhuizen KU Leuven, this study is expected to complete by 1 April 2030. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
Brief Summary
Osteoarthritis (OA) stands out as the most prevalent joint disease. It manifests as a progressive degradation of articular cartilage, new bone growth and often synovial tissue proliferation, resulting in pain and compromised joint functionality, ultimately leading to disability. Misalignment of the lower limb (varus or valgus knees) are recognised as a risk factor for osteoarthritis onset and progression. High tibial...Show More
Detailed Description
Osteoarthritis (OA) stands out as the most prevalent joint disease. It manifests as a progressive degradation of articular cartilage, new bone growth and often synovial tissue proliferation, resulting in pain and compromised joint functionality, ultimately leading to disability. In 83% of OA patients the knee is affected limiting people from engaging in physical activities, which paves the way for the onset of cardio...Show More
Official Title

Altered Joint Mechanics and Biological Response in Osteoarthritic Knees. A Study in Patients Undergoing Corrective Treatment for Knee Misalignment.

Conditions
Knee Osteoarthritis (OA)
Other Study IDs
  • AMB-OK
  • S70583
NCT ID Number
NCT07481461
Start Date (Actual)
2026-04
Last Update Posted
2026-03-18
Completion Date (Estimated)
2030-04
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHigh tibial osteotomy
High tibial osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. This study aimes to include 10 patients receiveing HTO surgery.
Photon counting CT scanning (PCCT scanning)
Photon Counting CT (PCCT) is a novel imaging technique that allows for in vivo high-resolution imaging of the bone microstructure. It has a large field of view and short scanning time compared to the current gold standard for bone microstructural quantification, High Resolution-peripheral CT (HR-pQCT). PCCT scans are performed at pre-treatment visit, 6 months, 12 months and 24 months post-treatment.
Magnetic resonance imaging (MRI scanning)
Cartilage is typically imaged with MRI for its high content of water. Different MRI sequences allow to quantify anatomical aspects such as cartilage volume and thickness, but also its contents (proteoglycans and collagen). MRI scans are performed at pre-treatment visit, 12 months and 24 months post-treatment.
Gait analysis
The load shift after limb realignment will also be measured. Gait analysis (combined with musculoskeletal modelling) will be used to measure joint contact forces and knee joint geometry will be derived from the PCCT and MRI scans. Forces and geometry will be given as input to a Finite Element (FE) model of the knee joint, computing stresses and strains distribution on bone and cartilage. The gait analysis will be per...Show More
ExperimentalBraces therapy
Braces realign the lower limb, this corrective treatments occures without the need for surgical intervention. This study aimes to include 20 patients in this treatment arm.
Photon counting CT scanning (PCCT scanning)
Photon Counting CT (PCCT) is a novel imaging technique that allows for in vivo high-resolution imaging of the bone microstructure. It has a large field of view and short scanning time compared to the current gold standard for bone microstructural quantification, High Resolution-peripheral CT (HR-pQCT). PCCT scans are performed at pre-treatment visit, 6 months, 12 months and 24 months post-treatment.
Magnetic resonance imaging (MRI scanning)
Cartilage is typically imaged with MRI for its high content of water. Different MRI sequences allow to quantify anatomical aspects such as cartilage volume and thickness, but also its contents (proteoglycans and collagen). MRI scans are performed at pre-treatment visit, 12 months and 24 months post-treatment.
Gait analysis
The load shift after limb realignment will also be measured. Gait analysis (combined with musculoskeletal modelling) will be used to measure joint contact forces and knee joint geometry will be derived from the PCCT and MRI scans. Forces and geometry will be given as input to a Finite Element (FE) model of the knee joint, computing stresses and strains distribution on bone and cartilage. The gait analysis will be per...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Bone microstructure quantification
Trabecular morphology will be described with the bone volume fraction (BV/TV), trabecular thickness (Tb.Th), trabecular separation (Tb.Sp) and trabecular number (Tb.N).
From enrollment to the end of study at 24 months
Mechanical properties in osteoarthritic knees
A PCCT-based finite element (FE) model will be built to estimate bone strength, stiffness and apparent modulus by simulating an axial compression.
From enrollment to the end of study at 24 months
Load shift quantification
An FE model, simulating forces acting in the knee joint during physiological walking will be built, deriving such forces from gait analysis.
From enrollment to the end of study at 24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proteoglycans quantification
As content of cartilage, proteoglycans will be quantified using a specific MRI sequence at pre-treatment and 12 and 24 months post-treatment. These measurements will be compared with the in silico models prediction through an agreement analysis.
From enrollment to the end of study at 24 months
Collagen quantification
As content of cartilage, collagen will be quantified using a specific MRI sequence at pre-treatment and 12 and 24 months post-treatment. These measurements will be compared with the in silico models prediction through an agreement analysis.
From enrollment to the end of study at 24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  • Chronic symptoms of (early) knee OA.
  • Misalignment of the lower limb and scheduled for HTO surgery (regardless of the HTO technique used (lateral or medial, closing or opening wedge)) or brace treatment.
  • Follow-up at UZ Leuven.

  • Acute OA symptoms onset (previous knee injury)
  • Pregnant women
  • MRI checklist incomplete or failed
  • BMI > 30
  • Impaired vision or neurological condition that affect coordination and balance
  • Age <18 (no minors will be included in the study)
Universitaire Ziekenhuizen KU Leuven logoUniversitaire Ziekenhuizen KU Leuven
Study Central Contact
Contact: Harry van Lenthe, Prof. Ir., +32 16 32 25 95, [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
Harry van Lenthe, Prof. Ir., Contact, +32 16 32 25 95, [email protected]
Anna Tarasiuk, Contact, +32 16 33 88 18, [email protected]
Harry van Lenthe, Prof. Ir., Principal Investigator
Hilde Vandenneucker, Prof. Dr., Sub-Investigator