6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
ConditionOsteoarthritis, Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAptissen SA
About this trial
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years of age,
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,
Disqualifiers
Pregnancy,
Participation in another clinical trial,
Skin lesion near the injection site,
Recent or old infection of the affected joint,
Trial design
Design model
Single group
Treatments tested in this trial
SYNOLIS VA 80/160
DeviceSYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg)
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: SYNOLIS VA 80/160Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 months (M6)Secondary 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.
Time frame
Month 3, Month 3 to Month 62
Self-assessment symptoms evolution
7-point Likert scale (-3 to +3)
Time frame
Month 3, Month 3 to Month 63
MCID Oxford Hip Score (OXFORD 12)
Minimum clinically important difference on the Oxford Hip Score (OXFORD 12)
Time frame
Month 3, Month 3 to Month 64
Hip prosthesis placement after the injection
Number of Participants with Hip prosthesis placement
Time frame
Month 6Other outcomes
1
Safety and tolerability of SYNOLIS VA 80/160
Serious adverse event occurrence
Time frame
Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov