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RecruitingNot ApplicableNCT05829733

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

6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis

Sponsor

Aptissen SA

Enrollment

70 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis, Hip

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria7

  • 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.

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Interventions

DEVICESYNOLIS VA 80/160

SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)

Locations(3)

Service de Rhumatologie, Hôpital Nord Franche-Comté

Belfort, France

Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD

Dunkirk, France

Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille

Lille, France

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