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Clinical Trials in France / NCT05829733
Recruiting Not applicable

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

NCT05829733 · tracked via the Priya Life Science France tracker
Sponsor
Aptissen SA
Phase
Not applicable
Started
2024-05-27
Last updated
2025-12-12

Condition(s) studied

Osteoarthritis, Hip

Investigational drug(s) / intervention(s)

SYNOLIS VA 80/160

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)

Trial sites (3)

FacilityCityRegionStatus
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 Lille France Recruiting

Other trials for the same condition

Official registry record

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.

View NCT05829733 on ClinicalTrials.gov ↗ ← All trials in France