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

December 5, 2025 updated by: Aptissen SA

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Belfort, France
        • Recruiting
        • Service de Rhumatologie, Hôpital Nord Franche-Comté
        • Contact:
          • Thierry Conrozier, Dr
      • Dunkirk, France
        • Recruiting
        • Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
        • Contact:
          • Nicolas Jan, Dr
      • Lille, France
        • Recruiting
        • Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
        • Contact:
          • Henri Migaud, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYNOLIS VA 80/160
Single guided intra-articular injection of SYNOLIS VA 80/160
Device: SYNOLIS VA 80/160
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months (M6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3, Month 3 to Month 6
Self-assessment symptoms evolution
Time Frame: Month 3, Month 3 to Month 6
7-point Likert scale (-3 to +3)
Month 3, Month 3 to Month 6
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)
Month 3, Month 3 to Month 6
Hip prosthesis placement after the injection
Time Frame: Month 6
Number of Participants with Hip prosthesis placement
Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of SYNOLIS VA 80/160
Time Frame: Month 6
Serious adverse event occurrence
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptissen SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMCF A-SYN400 Hip

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe