RCT Knee OA
Principal Investigator: Dr. Alexandre Sepriano
Study duration: between April/2014 and November/2017
This study aims to test the hypothesis that Intra-Articular Hyaluronic Acid (AHIA) is superior to placebo in delaying structural progression as well as in the long-term symptomatic effect in patients with primary knee osteoarthritis (OA). Patients with a diagnosis of primary knee osteoarthrosis were included, followed up in a rheumatology appointment at the Santa Maria and Egas Moniz hospitals.
It is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint is defined as the average change in the articular interline of the most affected compartment of the tibiofemoral joint, on the knee X-ray, at the end of the follow-up. However, several other secondary endpoints are contemplated, namely:
- the proportion of patients who achieved symptomatic relief according to the 2004 OMERACT / OARSI response criteria at 6 months of follow-up in both groups;
- the proportion of patients who achieved symptomatic relief according to the 2004 OMERACT / OARSI response criteria at each follow-up visit;
- the proportion of patients undergoing knee arthroplasty at the end of the follow-up;
- the average consumption of paracetamol and NSAIDs (mg/day) in each visit;
- the average value of the SF-36 questionnaire in each medical appointment;
- the total number of adverse events that occur in both groups at each follow-up visit.
The assessment of disease activity includes the KOOS, SF36, and EQ5D questionnaires, patients and physicians visual analogue scales, as well as the assessment of pain in both the target knee and the opposite knee.
Each patient will attend 10 follow-up visits within 2 years, with questionnaires of pain, function and quality of life, as well as ultrasound of the knee and biological samples collection to quantify markers of bone and cartilage remodeling.