NCT05829733 6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
| NCT ID | NCT05829733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aptissen SA |
| Condition | Osteoarthritis, Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-05-27 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05829733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis, Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05829733 currently recruiting?
Yes, NCT05829733 is actively recruiting participants. Contact the research team at clinic@aptissen.com for enrollment information.
Where is the NCT05829733 trial being conducted?
This trial is being conducted at Belfort, France, Dunkirk, France, Lille, France.
Who is sponsoring the NCT05829733 clinical trial?
NCT05829733 is sponsored by Aptissen SA. The trial plans to enroll 70 participants.