Abstract
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 ± 1.9 cm (T0) to 1.9 ± 1.5 cm (T16) in polynucleotide group and from 4.9 ± 2.0 cm (T0) to 2.1 ± 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.
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Acknowledgments
The study took place at the IRCCS Foundation, Orthopaedic and Traumatology Department, S. Matteo Hospital Institute, University of Pavia, Italy. This work was supported by Mastelli s.r.l., Sanremo Italy. Special thanks to Dr. Giulia Cattarini and Dr. Andrea Armando for their assistance with the study and manuscript. Authors would also like to thank Prof. Martino Recchia for the statistical analysis.
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Vanelli, R., Costa, P., Rossi, S.M.P. et al. Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a randomized, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc 18, 901–907 (2010). https://doi.org/10.1007/s00167-009-1039-y
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DOI: https://doi.org/10.1007/s00167-009-1039-y