6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis

Study Overview
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Brief Summary
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Multicenter, independent study of Synolis VA 80/160 over a period of 6 months

Official Title
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6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: SYNOLIS VA 80/160


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years of age, Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria: Treated hip pain: Oxford score ≥ 21/60, Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit), Symptoms related to osteoarthritis of the hip for at least 2 months, Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60), Informed consent form signed by the patient, The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old). Exclusion Criteria: Pregnancy, Participation in another clinical trial, Skin lesion near the injection site, Recent or old infection of the affected joint, Patient with a programmed arthroplasty, Patient with a pathology that makes decision-making impossible, The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNOLIS VA 80/160<br>Single guided intra-articular injection of SYNOLIS VA 80/160 | Device: SYNOLIS VA 80/160<br>* SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Oxford Hip Score (OXFORD 12) | Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms. | 6 months (M6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Oxford Hip Score (OXFORD 12) | Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms. | Month 3, Month 3 to Month 6 | 
| Self-assessment symptoms evolution | 7-point Likert scale (-3 to +3) | Month 3, Month 3 to Month 6 | 
| MCID Oxford Hip Score (OXFORD 12) | Minimum clinically important difference on the Oxford Hip Score (OXFORD 12) | Month 3, Month 3 to Month 6 | 
| Hip prosthesis placement after the injection | Number of Participants with Hip prosthesis placement | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Hip osteoarthritis, Hyaluronic acid