EFFECTIVENESS AND SAFETY OF INTRA-ARTICULAR HYALURONIC ACID IN ATHLETES WITH ARTICULAR LESIONS: A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
Abstract
Objective: To evaluate the effectiveness and safety of a novel intra-articular formulation of hyaluronic acid (HA) to treat athletes with articular lesions. Methods: Multicenter, prospective, interventional, observational study analyzing the clinical evolution of athletes who received 2 or 3 intra-articular injections of HA. The study was scheduled in Visit 1 (week 0), Visit 2 (week 1), Visit 3 (week 2), Visit 4 (week 3), and Visit 5 (end of follow up, week 24). The change in Visual Analog Scale (VAS) of pain and in Knee Injury and Osteoarthritis Outcome Score (KOOS) and the rate of return to physical activity were evaluated upon treatment initiation for up to 24 weeks. The incidence of adverse events was recorded throughout the study. Results: Sixty patients were recruited: 28 (46.7%) in the 2-injection group and 32 (53.3%) in the 3-injection group. Mean VAS gradually decreased across the visits, with statistically significant reductions in both groups from Visit 2 to Visit 3 and to Visit 5 (P < 0.0001). Inter-group differences in the change in VAS from Visit 2 to Visit 5 were statistically comparable (P = 0.8271). At Visit 5, the KOOS of all subscales statistically improved in both treatment groups. At the end of follow-up (Visit 5), 75.9% of patients returned to sport in the overall population. Only one patient reported an adverse event. Conclusion: This novel formulation of HA is effective and safe for at least 24 weeks, resulting in a promising treatment option for athletes with articular lesions.
References
Hiligsmann M, Cooper C, Arden N, et al. (2013), Health economics in the field of osteoarthritis: An Expert’s consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin. Arthritis Rheum.; 43; 303–313. doi: 10.1016/j.semarthrit.2013.07.003.
Murray IR, Benke MT, Mandelbaum BR. (2016). Management of knee articular cartilage injuries in athletes: chondroprotection, chondrofacilitation, and resurfacing. Knee Surgery, Sport. Traumatol. Arthrosc. [Internet]; 24; 1617–1626. Available from: http://link.springer.com/10.1007/s00296-014-3093-0.
Vannini F, Spalding T, Andriolo L, et al. (2016). Sport and early osteoarthritis: the role of sport in aetiology, progression and treatment of knee osteoarthritis. Knee Surgery, Sport. Traumatol. Arthrosc.; 24; 1786–1796. doi: 10.1007/s00167-016-4090-5
Kujala UM, Marti P, Kaprio J, et al. (2003), Occurrence of Chronic Disease in Former Top-Level Athletes. Sport. Med. [Internet]; 33; 553–561. Available from: http://link.springer.com/10.2165/00007256-200333080-00001.
Flanigan DC, Harris JD, Trinh TQ, et al. (2010). Prevalence of chondral defects in Athletes’ Knees: A systematic review. Med. Sci. Sports Exerc.; 42: 1795– 1801. doi: 10.1249/MSS.0b013e3181d9eea0.
Kuijt M-TK, Inklaar H, Gouttebarge V, et al. (2012). Knee and ankle osteoarthritis in former elite soccer players: A systematic review of the recent literature. J. Sci. Med. Sport [Internet]; 15: 480–487. Available from: http://linkinghub.elsevier.com/ retrieve/pii/ S1440244012000631.
Karsdal MA, Michaelis M, Ladel C, et al. (2016). Disease-modifying treatments for osteoarthritis (DMOADs) of the knee and hip: lessons learned from failures and opportunities for the future. Osteoarthr. Cartil.; 24: 2013–2021. doi: 10.1016/j.joca.2016.07.017.
Glyn-Jones S, Palmer AJR, Agricola R, et al. (2015). Osteoarthritis. Lancet.; 386: 376–387. doi: 10.1016/S0140-6736(14)60802-3.
Goldring SR, Goldring MB. (2016). Changes in the osteochondral unit during osteoarthritis: Structure, function and cartilage bone crosstalk. Nat. Rev. Rheumatol. [Internet]; 12: 632–644. Available from: http://dx.doi.org/10.1038/nrrheum.2016.148.
Bijlsma JWJ, Berenbaum F, Lafeber FPJG. (2011). Osteoarthritis: An update with relevance for clinical practice. Lancet; 377: 2115–2126. doi:10.1016/S0140-6736(11)60243-2.
Loeser RF, Goldring SR, Scanzello CR, et al. (2012). Osteoarthritis: A disease of the joint as an organ. Arthritis Rheum.; 64: 1697–1707. oi: 10.1002/art.34453.
Goldring MB, Berenbaum F. (2015). Emerging targets in osteoarthritis therapy. Curr. Opin. Pharmacol [Internet]; 22:51–63. Available from: http://dx.doi.org/10.1016/j.coph. 2015.03.004.
McAlindon TE, Bannuru RR, Sullivan MC, et al. (2014). OARSI guidelines for the nonsurgical management of knee osteoarthritis. Osteoarthr. Cartil. [Internet].; 22: 363–388. Available from: http://dx.doi.org/10.1016/j.joca.2014.01.003.
Bjordal JM, Klovning A, Ljunggren AE, et al. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. Eur. J. Pain. 2007; 11:125–138. doi: 10.1016/j.ejpain.2006.02.013.
Zhang W, Ouyang H, Dass CR, et al. (2016). Current research on pharmacologic and regenerative therapies for osteoarthritis. Bone Res.; 4. doi: 10.1038/boneres.2015.40
Corvelli M, Che B, Saeui C, et al. (2015). Biodynamic performance of hyaluronic acid versus synovial fluid of the knee in osteoarthritis. Methods [Internet]; 84: 90–98. Available from: http://dx.doi.org/10.1016/j.ymeth.2015.03.019.
Demange MK, Sisto M, Rodeo S. (2014). Future trends for unicompartmental arthritis of the knee. Injectables & stem cells. Clin. Sports Med. [Internet].; 33: 161– 174. Available from: http://dx.doi.org/10.1016/j.csm.2013.06.006.
Jazrawi LM, Rosen J. (2011). Intra-articular hyaluronic acid: Potential treatment of younger patients with knee injury and/or post-traumatic arthritis. Phys. Sportsmed.; 39: 107–113. doi: 10.3810/psm.2011.05.1900.
Burianov OA, Omelchenko (2012). TM. DIART in the pathogenic treatment of osteoarthritis.; 3: 31–38. http://www.uf.ua/int/upload/Burianov_OA_Diart.pdf
Roos EM, Lohmander LS. (2003). The Knee injury and Osteoarthritis Outcome Score (KOOS): From joint injury to osteoarthritis. Health Qual. Life Outcomes.; 1: 1–8. doi: 10.1186/1477-7525-1-64
Hochberg MC. (2008). Mortality in osteoarthritis. Clin. Exp. Rheumatol.; 26.
Brandt KD, Heilman DK, Slemenda C, et al. (2000). A comparison of lower extremity muscle strength, obesity, and depression scores in elderly subjects with knee pain with and without radiographic evidence of knee osteoarthritis. J. Rheumatol.; 27: 1937–1946.
Gouttebarge V, Inklaar H, Frings-Dresen M. (2014). Risk and consequences of osteoarthritis after a professional football career: A systematic review of the recent literature. J. Sports Med. Phys. Fitness. p. 494–504.
Petrella RJ, Emans PJ, Alleyne J, et al. (2015). Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: A prospective, multicenter, randomized, double-blind feasibility trial Clinical rheumatology and osteoporosis. BMC Musculoskelet. Disord.; 16: 1–9. https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0513-6
Woods C, Hawkins R, Hulse M, et al. (2003). The Football Association Medical Research Programme: an audit of injuries in professional football: an analysis of ankle sprains. Br. J. Sports Med. [Internet]; 37: 233–238. Available from: http://bjsm.bmj.com/cgi/doi/10.1136/ bjsm.37.3.233.
Murray IR, LaPrade RF, Musahl V, et al. (2016). Biologic Treatments for Sports Injuries II Think TankCurrent Concepts, Future Research, and Barriers to Advancement, Part 2: Rotator Cuff. Orthop. J. Sport. Med. [Internet]; 4: 2325967116636586. Available from: http://journals.sagepub.com/doi/10.1177/0363546516634674.
Filardo G, Di Matteo B, Di Martino A, et al. (2015). Platelet-rich plasma intra-articular knee injections show no superiority versus viscosupplementation: A randomized controlled trial. Am. J. Sports Med.; 43: 1575–1582. doi: 10.1177/0363546515582027
Leighton R, Åkermark C, Therrien R, et al. (2014). NASHA hyaluronic acid vs 4 methylprednisolone for knee osteoarthritis: A prospective, multi-centre, randomized, non-inferiority trial. Osteoarthr. Cartil. [Internet]; 22: 17–25. Available from: http://dx.doi.org/10.1016/j.joca.2013.10.009.
Bellamy N, Campbell J, Robinson V, et al. (2005). Viscosupplementation for the 10 treatment of osteoarthritis of the knee. [Systematic Review] Cochrane Musculoskeletal Group. Cochrane Database Syst. Rev.; 2: 244. doi: 10.1002/14651858.CD005321.pub2.
Gobbi A, Karnatzikos G, Kumar A. (2014). Long-term results after microfracture treatment for fullthickness knee chondral lesions in athletes. Knee Surgery, Sport. Traumatol. Arthrosc.; 22: 1986–1996. doi: 10.1007/s00167-013-2676-8.
Bannuru RR, Natov NS, Dasi UR, et al. (2011). Therapeutic trajectory following intra18 articular hyaluronic acid injection in knee osteoarthritis - meta-analysis. Osteoarthr. Cartil. [Internet]; 19: 611–619. Available from: http://dx.doi.org/10.1016/j.joca.2010.09.014.
Zhang W, Robertson J, Jones AC, et al. (2008). The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann. Rheum. Dis. [Internet]; 67: 1716–1723. Available from: http://ard.bmj.com/cgi/doi/10.1136/ard.2008.092015.
Views:
376
Downloads:
175
Copyright (c) 2021 Jordi Puigdellívol Grifell, Juan Pérez Estévez, Enrique Herrera Otto, Jordi Marcos, Mindaugas Gudelis
This work is licensed under a Creative Commons Attribution 4.0 International License.
All articles are published in open-access and licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). Hence, authors retain copyright to the content of the articles.
CC BY 4.0 License allows content to be copied, adapted, displayed, distributed, re-published or otherwise re-used for any purpose including for adaptation and commercial use provided the content is attributed.