Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05829733

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Rhumatologie, Hôpital Nord Franche-Comté, Belfort, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYNOLIS VA 80/160

Device

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

Primary outcomes

  1. Evolution of the Oxford Hip Score (OXFORD 12)

    Time frame: 6 months (M6)

    Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.

Secondary outcomes

  1. Evolution of the Oxford Hip Score (OXFORD 12)

    Time frame: Month 3, Month 3 to Month 6

    Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.

  2. Self-assessment symptoms evolution

    Time frame: Month 3, Month 3 to Month 6

    7-point Likert scale (-3 to +3)

  3. MCID Oxford Hip Score (OXFORD 12)

    Time frame: Month 3, Month 3 to Month 6

    Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)

  4. Hip prosthesis placement after the injection

    Time frame: Month 6

    Number of Participants with Hip prosthesis placement

Other outcomes

  1. Safety and tolerability of SYNOLIS VA 80/160

    Time frame: Month 6

    Serious adverse event occurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Eduard Vidovic, MD

CONTACT

[email protected]

+41225522104

Sponsors and collaborators

Lead sponsor

Aptissen SA

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.