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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

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.

Study details
    Osteoarthritis
    Hip

NCT05829733

Aptissen SA

17 May 2024

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