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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
View on ClinicalTrials.gov →
NCT05829733
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
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Actively Recruiting
PhaseN/A
SponsorAptissen SA
Started2024-05-27
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05829733