Efficacy and safety of Synolis VA for hip osteoarthritis
6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis
This study is testing if a new treatment called Synolis VA can help people with hip osteoarthritis feel less pain and move better over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aptissen SA Industry-sponsored |
| Locations | 3 sites (Belfort and 2 other locations) |
| Trial ID | NCT05829733 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of hip osteoarthritis who have not responded to standard analgesics or NSAIDs.
Not a fit: Patients who are pregnant, have had recent infections in the affected joint, or are scheduled for hip surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients suffering from hip osteoarthritis.
How similar studies have performed: Previous studies on hyaluronic acid treatments for osteoarthritis have shown varying degrees of success, indicating potential but also the need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Belfort and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.