|

6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis

RECRUITINGN/ASponsored by Aptissen SA
Actively Recruiting
PhaseN/A
SponsorAptissen SA
Started2024-05-27
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

Multicenter, independent study of Synolis VA 80/160 over a period of 6 months

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

ArthritisOsteoarthritis, Hip

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.