Changi General Hospital
Singapore, 529889
NCT Number: NCT06636695
The study hypothesizes that the combination of Cellular Matrix PRP-HA is superior to Hyaluronic Acid (HA) alone, specifically from the Orthovisc Kit, in relieving pain and function associated with knee osteoarthritis.
The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.
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Notify Me40 year–80 year
All sexes
Interventional
Phase 3
Singapore, 529889
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain at walkingof 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
Exclusion criteria
Group 1 (Cellular Matrix): Patients randomized to this group will be treated with two intra-articular injections of Cellular Matrix at D0 and M1.
Group 2 (HA): Patients randomized to this group will be treated with two intra-articular injections of HA alone provided by ORTHOVISC at D0 and M1
Time frame: Baseline, Month 1, Month 2, Month 6, Month 12
Visual Analogue Score (VAS) on a scale of 0 to 10. 10 being the worst possible pain.
Time frame: Baseline, Month 1, Month 2, Month 6, Month 12
EQ-5D-5L. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: 1- no problem; 5- extreme problem
Time frame: Baseline and Month 12
Whole-Organ Magnetic Resonance Imaging Score (WORMS). WORMS evaluates 14 specific features. Each feature is scored on a scale: 0 = Normal; 1-6 = Increasing severity of abnormalities.
Time frame: Baseline, Month 1, Month 2, Month 6, Month 12
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score is calculated by summing the scores from all three subscales: Pain, Stiffness, Physical Function. This can range from a minimum of 0 (indicating no symptoms) to a maximum of 96 (indicating severe symptoms).
Changi General Hospital
Other
Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis With MRI Analysis: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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