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

Last updated: May 8, 2025
Sponsor: Aptissen SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

SYNOLIS VA 80/160

Clinical Study ID

NCT05829733
PMCF A-SYN400 Hip
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years of age,

  • Patient with osteoarthritis of the hip. The diagnosis is based on the followingcriteria:

  • Treated hip pain: Oxford score ≥ 21/60,

  • Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no morethan 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/orNSAIDs 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 injectionin the hip to be treated (or more than 6 months old).

Exclusion

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 asosteotomy or arthroscopy less than 12 months old.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: SYNOLIS VA 80/160
Phase:
Study Start date:
May 27, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Service de Rhumatologie, Hôpital Nord Franche-Comté

    Belfort,
    France

    Active - Recruiting

  • Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD

    Dunkerque,
    France

    Active - Recruiting

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

    Lille,
    France

    Active - Recruiting

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