6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Recruiting · NCT05829733 · Interventional (participants receive a specific treatment) · Lead sponsor: Aptissen SA
View the official record on ClinicalTrials.gov →Interventions studied
SYNOLIS VA 80/160
What this trial is about
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
3 locations listed.
- Service de Rhumatologie, Hôpital Nord Franche-Comté - Belfort, France
- Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD - Dunkirk, France
- Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille - Lille, France