Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.

ConditionKnee Osteoarthritis (OA)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Acute OA symptoms onset (previous knee injury)

Pregnant women

MRI checklist incomplete or failed

BMI > 30

Trial design

Design model

Parallel

Treatments tested in this trial

Photon counting CT scanning (PCCT scanning)
Diagnostic test
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)
Diagnostic test
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
Diagnostic test
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: High tibial osteotomyExperimental treatment 3 interventions

Group B: Braces therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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).

Time frame