Efficacy and safety of Synolis VA for hip osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study evaluates the efficacy and safety of Synolis VA 80/160 in patients with hip osteoarthritis over a 6-month period. Participants will receive the treatment and be monitored for improvements in hip pain and function, as well as any potential side effects. The study aims to determine whether this hyaluronic acid-based intervention can provide relief for patients who have not responded adequately to other treatments.

Why it matters

Who can join: the full rules

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's running

• 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

Study contacts

• Study coordinator: Eduard Vidovic, MD
• Email: clinic@aptissen.com
• Phone: +41225522104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.