Long-Term Effects of Mobithron Advance on Knee Osteoarthritis Aims to Investigate the Effects of Mobithron Advance on OA Progression

The study will be conducted as a prospective single-arm trial with a one-year follow-up at the Orthopaedic Clinic, Hospital Universiti Sains Malaysia (HUSM), Malaysia. Participants will include adults over 50 years old diagnosed with primary knee osteoarthritis (OA) of Kellgren-Lawrence grade 1 to 3, based on clinical and radiological criteria. A total of 84 patients will be recruited, accounting for a 10% dropout rate, and will receive daily oral Mobithron Advance for 12 months. Pain will be assessed monthly using the Visual Analogue Scale (VAS) and physical function will be evaluated with the WOMAC index at follow-up visits. Cartilage preservation will be measured through MRI scans at baseline, six months, and twelve months, using a cartilage-specific 3D WATSc sequence to monitor central femoral condyle thickness. Safety and tolerability will be assessed by monitoring renal function, including creatinine and eGFR, alongside recording any adverse events. Data will include demographics, clinical outcomes, and radiological findings, and will be analysed using descriptive statistics, paired t-tests or Wilcoxon signed-rank tests, and linear mixed-effects models to evaluate changes over time.

Inclusion criteria

• Males and female patients above 50 years old at the time of recruitment.
• OA Diagnosis: Patients with one or both knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR).
• OA Grade: Kellgren Lawrence grade 1-3

Exclusion criteria

• Secondary arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
• History of joint surgery.
• Patients who received steroid injection treatment within the last 3 months or hyaluronic acid injection treatment within the last 6 months.
• Contraindications to Mobithron Advance (e.g., known allergies, severe liver or kidney disease).
• Patients planning for knee surgery within the research period.
• Patients on pharmacological treatment for osteoarthritis, other than rescue analgesic agent, e.g: glucosamine, chondroitin, oral steroid