A Systematic Review of the Novel Compound Arthrosamid Polyacrylamide (PAAG) Hydrogel for Treatment of Knee Osteoarthritis
Main Article Content
Abstract
Background: Polyacrylamide (PAAG) hydrogel is a novel compound that has recently become available in the UK market under the name Arthrosamid to treat osteoarthritis (OA). It adheres to and bulks up the synovial membrane and acts as a scaffold to treat the synovium.
The purpose of this systematic review was to explore all available patient reported outcome measures (PROMs) and adverse events of this novel compound for a management option for knee OA.
Study Design & Methods: We undertook a comprehensive literature review of PubMed, OVID, and MEDLINE databases up until April 2022 for reports of outcomes of PAAG and OA. Using keywords: (“Polyacrylamide” OR “PAAG” OR “Arthrosamid”) AND (“Osteoarthritis” OR “OA”). Study participants were those that had PAAG hydrogel intraarticular injection for knee OA. All results were screened, and relevant papers reviewed in full. This review was performed in accordance with the Preferred Reporting Items of Systematic reviews and Meta-analysis (PRISMA) 2020 statement.
Results: A total combined number of 463 patients’ outcomes were reported and assessed. Statistically significant data was identified in two studies at both 52 weeks and 13 months. Indicating the efficacy of PAAG hydrogel at one year post injection. Further continuation of one of these studies provided statistically significant results at 2 years. In a Randomised Control Trial (RCT) numerically superior data was identified compared to hyaluronic acid. Injection of PAAG hydrogel intraarticularly into the knee has been shown to be safe with no long-lasting adverse events reported.
Conclusion: From the literature this PAAG hydrogel seems to be an efficacious and safe treatment option for knee OA and provides positive results for at least 2 years.
Article Details
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
2. Swain S, Sarmanova A, Mallen C, et al. Trends in incidence and prevalence of osteoarthritis in the United Kingdom: findings from the Clinical Practice Research Datalink (CPRD). Osteoarthritis Cartilage. 2020;28(6):792-801. doi:10.1016/j.joca.2020.03.004
3. O'Neill TW, Parkes MJ, Maricar N, et al. Synovial tissue volume: a treatment target in knee osteoarthritis (OA). Ann Rheum Dis. 2016;75(1):84-90. doi:10.1136/annrheumdis-2014-206927
4. Wernecke C, Braun HJ, Dragoo JL. The Effect of Intra-articular Corticosteroids on Articular Cartilage: A Systematic Review. Orthop J Sports Med. 2015; 3(5):2325967115581163. Published 2015 Apr 27. doi:10.1177/2325967115581163
5. D.D. McCollister, C.L. Hake, S.E. Sadek, V.K. Rowe, Toxicologic investigations of polyacrylamides, Toxicology and Applied Pharmacology, Volume 7, Issue 5, 1965, Pages 639-651,
6. . Tnibar, A-B. Persson, H. Nielsen, E. Svalastoga, U. Westrup, F. McEvoy, J. Knudsen, P.D. Thomsen, L.C. Berg, S. Jacobsen, L.H. Christensen, Evaluation of a polyacrylamide hydrogel in the treatment of induced osteoarthritis in a goat model: a randomized controlled pilot study, Osteoarthritis and Cartilage, Volume 22, Supplement, 2014, Page S477, ISSN 1063-4584, https://doi.org/10.1016/j.joca.2014.02.906.
7. von Buelow, Silvester M.D.; von Heimburg, Dennis M.D., Ph.D.; Pallua, Norbert M.D., Ph.D. Efficacy and Safety of Polyacrylamide Hydrogel for Facial Soft-Tissue Augmentation, Plastic and Reconstructive Surgery: September 15, 2005 - Volume 116 - Issue 4 - p 1137-1146 doi: 10.1097/01.prs.0000179349.14392.a4
8. Brahm J, Lessel R, Ditlev S, Schmidt R. Flux of selected body fluid constituents and benzylpenicillin in polyacrylamide hydrogel (PAAG). J Tissue Eng Regen Med. 2012 Nov;6(10):793-802. doi: 10.1002/term.485. Epub 2011 Nov 3. PMID: 22052857.
9. von Buelow, Silvester M.D.; von Heimburg, Dennis M.D., Ph.D.; Pallua, Norbert M.D., Ph.D. Efficacy and Safety of Polyacrylamide Hydrogel for Facial Soft-Tissue Augmentation, Plastic and Reconstructive Surgery: September 15, 2005 - Volume 116 - Issue 4 - p 1137-1146
doi: 10.1097/01.prs.0000179349.14392.a4
10. Lose, G., Sørensen, H.C., Axelsen, S.M. et al. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence. Int Urogynecol J 21, 1471–1477 (2010). https://doi.org/10.1007/s00192-010-1214-1
11. Fraser JR, Laurent TC, Pertoft H, Baxter E. Plasma clearance, tissue distribution and metabolism of hyaluronic acid injected intravenously in the rabbit. Biochem J. 1981;200(2):415-424. doi:10.1042/bj2000415
12. Tnibar, A, Persson, AB & Jensen, HE 2017, 'Mechanisms of Action of an Intraarticular 2.5% Polyacrylamide Hydrogel (Arthramid Vet) in a Goat Model of osteoarthritis: Preliminary Observations', SM Journal of Biomedical Engineering , vol. 3, no. 3, 1022.
13. Christensen, Lise & Daugaard, Søren. (2016). Histological Appearance of the Synovial Membrane after Treatment of Knee Osteoarthritis with Polyacrylamide Gel Injections: A Case Report. Journal of Arthritis. 5. 10.4172/2167-7921.1000217.
14. Tnibar, A, Persson, AB & Jensen, HE 2017, 'Mechanisms of Action of an Intraarticular 2.5% Polyacrylamide Hydrogel (Arthramid Vet) in a Goat Model of osteoarthritis: Preliminary Observations', SM Journal of Biomedical Engineering , vol. 3, no. 3, 1022.
15. Liu-Bryan, R., Terkeltaub, R. Emerging regulators of the inflammatory process in osteoarthritis. Nat Rev Rheumatol 11, 35–44 (2015). https://doi.org/10.1038/nrrheum.2014.162
16. Narins RS, Schmidt R. Polyacrylamide hydrogel differences: getting rid of the confusion. J Drugs Dermatol. 2011 Dec;10(12):1370-5. PMID: 22134560.
17. Maulana R, Cole A, Lee P.Y.F, Reduction in Patellofemoral Bone. Marrow Lesions Following Single Arthrosamid Intra-articular Injection of Polyacrylamide Hydrogel (ipaag) in the Treatment of Advanced Osteoarthritis. J Arthritis. 2022, 11 (3), 01-02.
18. Kobayashi S, Pappas E, Fransen M, Refshauge K, Simic M. The prevalence of patellofemoral osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2016 Oct;24(10):1697-1707. doi: 10.1016/j.joca.2016.05.011. Epub 2016 May 14. PMID: 27188684.
19. Maricar, N., Parkes, M. J., Callaghan, M. J., Felson, D. T., & O'Neill, T. W. (2013). Where and how to inject the knee--a systematic review. Seminars in arthritis and rheumatism, 43(2), 195–203. https://doi.org/10.1016/j.semarthrit.2013.04.010
20. Bliddal H, Overgaard A, Hartkopp A, Beier J, Conaghan PG, et al. (2021) Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther 6: 1188. DOI: 10.29011/2575-8241.001188
21. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar;372:n71.
22. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016 Dec;5(1):210.
23. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ WV (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022) [Internet]. Cochrane; 2022. Available from: www.training.cochrane.org/handbook
24. Neal R Haddaway, Matthew J Page, Chris C Pritchard, Luke A McGuinness. (2022). PRISMA2020: An R package and Shiny app for producing PRISMA 2020-compliant flow diagrams, with interactivity for optimised digital transparency and Open Synthesis. Zenodo. https://doi.org/10.1002/cl2.1230
25. Henriksen M, Overgaard A, Hartkopp A, Bliddal H. Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. 2018 Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID: 30148430.
26. Bliddal H, Overgaard A, Hartkopp A, Beier J, Conaghan PG, et al. (2021) Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther 6: 1188. DOI: 10.29011/2575-8241.001188
27. Overgaard A, Bliddal H, Henriksen M (2019) Safety of Intra-Articular Polyacrylamide Hydrogel for the Treatment of Knee Osteoarthritis Symptoms: A Retrospective Case Series. Clin Ortho Adv Res J: COARJ-100001