Actively Recruiting
6-Month Study of Synolis VA 80160 Injection for Treating Hip Osteoarthritis Symptoms
Led by Aptissen SA · Updated on 2025-12-12
70
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Synolis VA 80160, a device containing hyaluronic acid and sorbitol, in adults with hip osteoarthritis. This study aims to assess the effectiveness and safety of this treatment over a 6-month period in patients experiencing symptoms related to this condition who have not responded well to standard pain relief treatments. The study is conducted independently across multiple centers. Participants will receive a single guided injection of Synolis VA 80160 directly into the affected hip joint. The study monitors changes in hip function and pain using the Oxford Hip Score at various points including 3 and 6 months after injection. Additional evaluations include patient self-assessments of symptom evolution and tracking whether participants require hip prosthesis placement within 6 months. During the study, participants will undergo assessments at baseline and follow-up visits where their hip function and symptoms are measured using standard questionnaires. The main outcome is the evolution of the Oxford Hip Score after 6 months. Researchers will also monitor safety and any need for hip replacement surgery. Participants will be involved for the full 6-month study duration, with data collected to understand both short-term and longer-term effects of the treatment.
CONDITIONS
Brief Title
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Research Team
E
Eduard Vidovic, MD
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