This randomized, double-blind clinical trial was conducted over 16 weeks to assess the efficacy and safety profile of intra-articular
polynucleotides gel
injections in the treatment of
knee osteoarthritis associated with persistent knee
pain. 60 patients were enrolled and randomized to receive intra-articular
polynucleotides (
n = 30) or
hyaluronan (
n = 30); patients received five weekly intra-articular knee
injections and the follow-up period was 3 months after the end of treatment. Primary endpoint was to determine
polynucleotides (PN) efficacy in reducing knee
pain at the end of the study, over baseline value and over standard
hyaluronan viscosupplementation (HA).
Pain levels were measured using a 0-10 cm Visual Analogue Scale (VAS). Secondary endpoints included
Knee Osteoarthritis Outcome Score (KOOS),
NSAIDs consumption, crackling during movement and articular
mobility limitation. The mean global VAS
pain decreased from 5.7 + or - 1.9 cm (T0) to 1.9 + or - 1.5 cm (T16) in
polynucleotide group and from 4.9 + or - 2.0 cm (T0) to 2.1 + or - 1.4 cm (T16) in
hyaluronan group. The reduction in
pain was statistically significant for both groups. KOOS increases from baseline values were statistically significant in both groups. No significant adverse events were reported. These findings suggest that intra-articular
polynucleotides can be a valid alternative to traditional
hyaluronan supplementation for the treatment of
knee osteoarthritis.