6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
NCT ID: NCT05829733
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-05-27
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SYNOLIS VA 80/160
Single guided intra-articular injection of SYNOLIS VA 80/160
SYNOLIS VA 80/160
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Interventions
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SYNOLIS VA 80/160
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Aptissen SA
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Thierry Conrozier, Dr
Role: primary
Nicolas Jan, Dr
Role: primary
Henri Migaud, Pr
Role: primary
Other Identifiers
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PMCF A-SYN400 Hip
Identifier Type: -
Identifier Source: org_study_id
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