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

NCT05829733 | Recruiting

• 1 other identifier: PMCF A-SYN400 Hip
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Osteoarthritis, Hip

Keywords

Osteoarthritis; Hip osteoarthritis; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months (M6)

Secondary Outcomes (4)

• Evolution of the Oxford Hip Score (OXFORD 12)

  Month 3, Month 3 to Month 6

• Self-assessment symptoms evolution

  Month 3, Month 3 to Month 6

• MCID Oxford Hip Score (OXFORD 12)

  Month 3, Month 3 to Month 6

• Hip prosthesis placement after the injection

  Month 6

Other Outcomes (1)

• Safety and tolerability of SYNOLIS VA 80/160

  Month 6

Study Arms (1)

SYNOLIS VA 80/160

EXPERIMENTAL

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

Device: SYNOLIS VA 80/160

Interventions

SYNOLIS VA 80/160 DEVICE

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

SYNOLIS VA 80/160

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aptissen SA: lead

Study Sites (3)

Service de Rhumatologie, Hôpital Nord Franche-Comté

Belfort, France

RECRUITING

Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD

Dunkirk, France

RECRUITING

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

Lille, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Eduard Vidovic, MD

CONTACT

+41225522104; clinic@aptissen.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 26, 2023
• Study Start: May 27, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

FR (3)