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NOT YET RECRUITING
NCT07911696

Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis

Sponsor: Coordinación de Investigación en Salud, Mexico

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-11

Completion Date

2027-06

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DEVICE

Hylan G-F 20

Hylan G-F 20 (Synvisc) is a sterile, cross-linked hyaluronan preparation of avian origin supplied in prefilled 2 mL syringes at a concentration of 8 mg/mL. It is administered by intra-articular injection into the knee according to the approved product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol.

DEVICE

Cross-Linked Sodium Hyaluronate

Mesoheal is a sterile, non-animal-derived, cross-linked sodium hyaluronate preparation supplied in a prefilled 2.5 mL syringe containing 25 mg of sodium hyaluronate. It is administered by intra-articular injection into the knee according to the product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol.

Locations (1)

Hospital de Ortopedia, UMAE "Dr. Victorio de la Fuente Narváez", IMSS

Mexico City, Mexico City, Mexico