PMID- 37296122 OWN - NLM STAT- MEDLINE DCOM- 20230612 LR - 20231121 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 13 IP - 1 DP - 2023 Jun 9 TI - A randomized controlled trial for comparing efficacy and safety between intraarticular polynucleotide and hyaluronic acid for knee osteoarthritis treatment. PG - 9419 LID - 10.1038/s41598-023-35982-z [doi] LID - 9419 AB - Although the use of intra-articular polynucleotide (IA PN) injection as a viscosupplement for knee osteoarthritis (OA) treatment has been proposed, its efficacy and safety compared to high molecular weight hyaluronic acid (HMWHA) injection has not yet been established. The present double-blind, multicenter, randomized controlled trial aimed to investigate the efficacy and safety of IA PN injection compared to IA HMWHA injection. A total of 60 patients (15 men, 45 women, 64.5 +/- 7.5 years) with knee OA (Kellgren-Lawrence grade 1-4) were randomly allocated to each group. All patients were given three IA injections of PN (n = 30) or HMWHA (n = 30) at intervals of 1 week. The primary endpoint was the change rate in weight-bearing pain (WBP) 16 weeks from the baseline. The secondary endpoint included multiple measurements: the change rate in WBP rate at 8 weeks; the change rate in pain level at rest and during walking at 8 and 16 weeks; the Korean-Western Ontario and McMaster University Osteoarthritis index; the Euro-Quality of Life-5 Dimension; Clinical Global Impression, Patient Global Impression at 8 and16 weeks, and total consumption of rescue medicine. The mean change rate in the WBP at 16 weeks from the baseline was - 54.0 +/- 38.1% in the IA PN group and - 42.8 (+/- 35.8%) in the IA HMWHA group, and there was no significant difference between the two groups (p = 0.296). All secondary endpoints related with pain and functional outcome also showed no significant difference between the two groups. Pain at the injection site and swelling were reported as adverse events, and the incidence was similar between the two groups. IA PN showed comparable efficacy and safety to IA HMWHA at 3 times injection with an interval of 1 week. IA PN can be useful alternative to IA HMWHA for the treatment of knee OA. CI - (c) 2023. The Author(s). FAU - Kim, Tae Woo AU - Kim TW AD - Department of Orthopedic Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. FAU - Chang, Moon Jong AU - Chang MJ AD - Department of Orthopedic Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. AD - Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea. FAU - Shin, Chung Yeop AU - Shin CY AD - Department of Orthopedic Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. FAU - Chang, Chong Bum AU - Chang CB AD - Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea. AD - Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea. FAU - Kang, Seung-Baik AU - Kang SB AD - Department of Orthopedic Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. ossbkang@gmail.com. AD - Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea. ossbkang@gmail.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230609 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - Male MH - Humans MH - Female MH - *Hyaluronic Acid/adverse effects MH - *Osteoarthritis, Knee MH - Quality of Life MH - Treatment Outcome MH - Pain/complications MH - Injections, Intra-Articular MH - Double-Blind Method PMC - PMC10256705 COIS- The authors declare no competing interests. EDAT- 2023/06/10 15:14 MHDA- 2023/06/12 06:42 PMCR- 2023/06/09 CRDT- 2023/06/09 23:15 PHST- 2023/01/30 00:00 [received] PHST- 2023/05/26 00:00 [accepted] PHST- 2023/06/12 06:42 [medline] PHST- 2023/06/10 15:14 [pubmed] PHST- 2023/06/09 23:15 [entrez] PHST- 2023/06/09 00:00 [pmc-release] AID - 10.1038/s41598-023-35982-z [pii] AID - 35982 [pii] AID - 10.1038/s41598-023-35982-z [doi] PST - epublish SO - Sci Rep. 2023 Jun 9;13(1):9419. doi: 10.1038/s41598-023-35982-z.