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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829733
• Other study ID #: PMCF A-SYN400 Hip
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Aptissen SA
• Contact: Eduard Vidovic, MD
• Phone: +41225522104
• Email: clinic[@]aptissen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Aptissen SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of SYNOLIS VA 80/160	Serious adverse event occurrence	Month 6
Primary	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	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.	Month 3, Month 3 to Month 6
Secondary	Self-assessment symptoms evolution	7-point Likert scale (-3 to +3)	Month 3, Month 3 to Month 6
Secondary	MCID Oxford Hip Score (OXFORD 12)	Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)	Month 3, Month 3 to Month 6
Secondary	Hip prosthesis placement after the injection	Number of Participants with Hip prosthesis placement	Month 6