Osteoarthritis, Hip
Conditions
Keywords
Osteoarthritis, Hip osteoarthritis, Hyaluronic acid
Brief summary
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Interventions
DEVICESYNOLIS VA 80/160
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Sponsors
Aptissen SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Hip prosthesis placement after the injection | Month 6 | Number of Participants with Hip prosthesis placement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of SYNOLIS VA 80/160 | Month 6 | Serious adverse event occurrence |
Countries
France
Contacts
Primary ContactEduard Vidovic, MD
Outcome results
None listed