Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.
NCT07481461 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-18
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 osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. Similarly to HTO, braces realign the lower limb, without the need for surgical intervention. These corrective treatments are recommended for the youngest group of patients as it allows them to stay active, as opposed to Total Knee Replacement (TKR). Until today, the effects of braces and HTO on the subchondral bone microstructure and cartilage are not well understood. Investigating these aspects to better understand treatment failures is becoming more and more crucial because global prevalence of knee OA is expected to increase with the ageing of populations.
Conditions
- Knee Osteoarthritis (OA)
Interventions
- DIAGNOSTIC_TEST
-
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.
- DIAGNOSTIC_TEST
-
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.
- DIAGNOSTIC_TEST
-
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 performed pre-treatment and 12 months post-treatment.
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Harry van Lenthe, Prof. Ir. · Universitaire Ziekenhuizen KU Leuven
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2030-04-30
- Completion
- 2030-04-30
Countries
- Belgium
Study Locations
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