The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
1 intraarticular administration of Adant® 5ml
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
Hospital Reina Sofia
Córdoba, Andalusia, Spain
The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee.
Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria. Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable. The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated.
Time frame: 1 year
To evaluate the safety of the different dosage regimens
Safety endpoints: Recording of adverse events and physical examination
Time frame: 1 year
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