Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
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- Who runs it
- Coordinación de Investigación en Salud, Mexico
- Trial code
- NCT07911696
- Record updated
- 3 November 2026
- Original description
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy.Read full original descriptionShow less
Comparative Evaluation of the Clinical Effectiveness, Safety, and Cost-Effectiveness of Two Hyaluronic Acid Products for Viscosupplementation in Patients With Knee Osteoarthritis: Real-World Evidence
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy.
One treatment option is viscosupplementation, which involves injecting a gel-like substance called hyaluronic acid into the knee joint. Different products are available, but it is not clear whether they provide similar benefits, have similar side effects, or differ in cost.
The goal of this study is to compare two hyaluronic acid products, Mesoheal and Synvisc, in adults with knee osteoarthritis. The researchers want to find out:
* How well each product reduces knee pain. * How much each product improves knee movement and daily activities. * What side effects may occur. * How the costs of the two treatments compare with their benefits.
The study will include approximately 160 adults who need viscosupplementation as part of their usual medical care. Each person's doctor will choose the treatment based on their medical needs and routine clinical practice. The researchers will not assign treatments.
Participants will be followed for six months. During this time, researchers will assess changes in pain, knee function, and any side effects that may occur.
The results may help doctors and healthcare providers better understand the benefits, safety, and costs of these treatments in routine clinical care.
Inclusion: Male or female patients older than 18 years; Clinical and radiographic evidence of primary knee osteoarthritis according to the American College of Rheumatology criteria, with Kellgren-Lawrence grade II or higher; Pain while walking, with a Visual Analog Scale (VAS) score greater than 4; Knee pain, stiffness, and functional impairment, with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score greater than 7; Ambulatory patients; Candidates for viscosupplementation according to the Mexican Social Security Institute (IMSS) Clinical Practice Guidelines; Inadequate response to conventional pharmacological and non-pharmacological treatments; Ability to quantify nonsteroidal anti-inflammatory drug (NSAID) consumption during follow-up visits by completing a patient diary; Ability to provide informed consent independently.
Exclusion: Intra-articular viscosupplementation within the previous 9 months; Knee surgery within the previous 6 months; Concomitant inflammatory joint diseases, including rheumatoid arthritis or psoriatic arthritis; Systemic or intra-articular corticosteroid use within the previous 3 months; Risk of severe bleeding, including patients receiving anticoagulant therapy without medical supervision; Known allergy to hyaluronate or its derivatives; Kellgren-Lawrence grade IV patellofemoral or tibiofemoral joint degeneration, or equivalent; Significant valgus or varus knee deformities; Knee instability, ligamentous laxity, or joint locking; Pregnant or breastfeeding women.