Osteoarthritis, HipNCT05829733
6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
A study testing SYNOLIS VA 80/160 in people with Osteoarthritis, Hip, run by Aptissen SA at 3 sites in France.
Trial summary
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- SYNOLIS VA 80/160
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 27 May 2024to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Service de Rhumatologie, Hôpital Nord Franche-Comté
Belfort
Thierry Conrozier, Dr
- Recruiting
Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
Dunkirk
Nicolas Jan, Dr
- Recruiting
Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
Lille
Henri Migaud, Pr
About this study
Official title: 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
- Conditions
- Osteoarthritis, Hip
- Being tested
- SYNOLIS VA 80/160
- Keywords
- Osteoarthritis, Hip osteoarthritis, Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNOLIS VA 80/160Device
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
| Study group | Role | What they receive |
|---|---|---|
| SYNOLIS VA 80/160 | Experimental | Single guided intra-articular injection of SYNOLIS VA 80/160 Receives: Device: SYNOLIS VA 80/160 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the Oxford Hip Score (OXFORD 12)
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.
Measured: 6 months (M6)
Secondary outcomes (4)
Evolution of the Oxford Hip Score (OXFORD 12)
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.
Measured: Month 3, Month 3 to Month 6
Self-assessment symptoms evolution
7-point Likert scale (-3 to +3)
Measured: Month 3, Month 3 to Month 6
MCID Oxford Hip Score (OXFORD 12)
Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)
Measured: Month 3, Month 3 to Month 6
Hip prosthesis placement after the injection
Number of Participants with Hip prosthesis placement
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start27 May 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptissen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829733
- Sponsor's protocol ID
- PMCF A-SYN400 Hip
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No