SYNOLIS VA 80/160: SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Study summary
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Evolution of the Oxford Hip Score (OXFORD 12) — 6 months (M6) 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.
Trial sites (3)
Facility
City
Region
Status
Service de Rhumatologie, Hôpital Nord Franche-Comté
Belfort
France
Recruiting
Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
Dunkirk
France
Recruiting
Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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