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

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Hip
• Interventions: Device: SYNOLIS VA 80/160

• Registration Number: NCT05829733
• Lead Sponsor: Aptissen SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Study Start: 2024-05-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYNOLIS VA 80/160	SYNOLIS VA 80/160	Single guided intra-articular injection of SYNOLIS VA 80/160

Primary Outcome Measures

Name	Time	Method
Evolution of the Oxford Hip Score (OXFORD 12)	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 Outcome Measures

Name	Time	Method
Hip prosthesis placement after the injection	Month 6	Number of Participants with Hip prosthesis placement
Evolution of the Oxford Hip Score (OXFORD 12)	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.
Self-assessment symptoms evolution	Month 3, Month 3 to Month 6	7-point Likert scale (-3 to +3)
MCID Oxford Hip Score (OXFORD 12)	Month 3, Month 3 to Month 6	Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)

Trial Locations

Locations (3)

Service de Rhumatologie, Hôpital Nord Franche-Comté; 🇫🇷 Belfort, France

Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD; 🇫🇷 Dunkerque, France

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