Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.

NCT07481461 | Not Yet Recruiting

• 1 other identifier: S70583
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Proteoglycans quantification

  From enrollment to the end of study at 24 months

• Collagen quantification

  From enrollment to the end of study at 24 months

Study Arms (2)

High tibial osteotomy

EXPERIMENTAL

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.

Diagnostic Test: Photon counting CT scanning (PCCT scanning); Diagnostic Test: Magnetic resonance imaging (MRI scanning); Diagnostic Test: Gait analysis

Braces therapy

EXPERIMENTAL

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.

Diagnostic Test: Photon counting CT scanning (PCCT scanning); Diagnostic Test: Magnetic resonance imaging (MRI scanning); Diagnostic Test: Gait analysis

Interventions

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.

Braces therapy; High tibial osteotomy

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.

Braces therapy; High tibial osteotomy

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.

Braces therapy; High tibial osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Resonance Imaging; Gait Analysis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Gait; Physical Examination; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Harry van Lenthe, Prof. Ir.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry van Lenthe, Prof. Ir.

CONTACT

+32 16 32 25 95; harry.vanlenthe@kuleuven.be

Anna Tarasiuk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a prospective interventional study without IMP. There will be no randomisation as the patients will undergo to the treatment (High tibial osteotomy (HTO) or braces) prescribed to them independently from the study. Patients will be recruited after the treatment has already been recommended by their ortopaedic surgeon, independently from the study purposes, and accepted by the patient. For this study we aim at enrolling 30 patients: 10 receiving HTO surgery and 20 braces therapy.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BE (1)