Actively Recruiting
6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis
Led by Aptissen SA · Updated on 2025-12-12
70
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Synolis VA 80/160, 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 80/160 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years of age
- Diagnosed with hip osteoarthritis with symptoms for at least 2 months
- Oxford Hip Score of 21 or higher
- Kellgren-Lawrence X-ray stage II or III within 6 months before inclusion
- Inadequate response or intolerance to analgesics, NSAIDs, or low-grade opioids
- Signed informed consent
- No previous visco supplement or corticosteroid injection in the treated hip within the past 6 months
You will not qualify if you...
- Pregnant women
- Participation in another clinical trial
- Skin lesion near the injection site
- Recent or past infection of the affected joint
- Planned hip replacement surgery
- Medical condition impairing decision-making
- Hip-conserving surgery such as osteotomy or arthroscopy less than 12 months ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment event
Participants receive a single guided intra-articular injection of SYNOLIS VA 80/160 in the hip.
1 visit (in-person)
Duration - 6 months
Participants are monitored for efficacy and safety outcomes over 6 months following the injection.
Visits at Month 3 and Month 6
Trial Site Locations
Total: 3 locations
1
Service de Rhumatologie, Hôpital Nord Franche-Comté
Belfort, France
Actively Recruiting
2
Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
Dunkirk, France
Actively Recruiting
3
Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
Lille, France
Actively Recruiting
Research Team
E
Eduard Vidovic, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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