Status:
ACTIVE_NOT_RECRUITING
Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
Lead Sponsor:
Semikal Technology
Collaborating Sponsors:
Antalya Training and Research Hospital
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 obj...
Detailed Description
The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren \& Lawrence Stage II and III knee...
Eligibility Criteria
Inclusion
- Adults aged 18 and over, both male and female
- Diagnosed with clinical knee osteoarthritis according to the American College of
- Rheumatology (ACR) criteria, with Kellgren \& Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs
- Able to provide written informed consent
Exclusion
- \-
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06141018
Start Date
January 15 2025
End Date
January 31 2026
Last Update
August 21 2025
Active Locations (1)
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1
Antalya Training and Research Hospital
Antalya, Turkey (Türkiye)