6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Recruiting now · Not applicable
Conditions studied: Osteoarthritis, Hip
In brief
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Key facts
- Study ID
- NCT05829733
- Run by
- Aptissen SA
- People needed
- 70
- Starts
- 2024-05-27
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Service de Rhumatologie, Hôpital Nord Franche-Comté — Belfort, France (enrolling)
- Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD — Dunkirk, France (enrolling)
- Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille — Lille, France (enrolling)
Full record on ClinicalTrials.gov
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