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Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
Sponsor: Semikal Technology
Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis. Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients. It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.
Official title: Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-01-15
Completion Date
2026-01-31
Last Updated
2025-08-21
Healthy Volunteers
No
Conditions
Interventions
Cross-linked intra-articular hyaluronic acid
Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.
Placebo
Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.
Locations (1)
Antalya Training and Research Hospital
Antalya, Turkey (Türkiye)