To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip. Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months. At the third month, if the score for overall pain is still \> 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Sodium hyaluronate 2.5 ml - 1 injection
placebo injection - 1 injection
Unnamed facility
Rueil-Malmaison, France
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
Time frame: 3 months
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Time frame: 3 months
WOMAC index (the 3 subscales)
Time frame: 3 months
Consumption of analgesics and NSAIDs
Time frame: 3 months
Evaluation of tolerability (AE reporting)
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.