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Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial.
Cartilage 2018; 9(3):276-283C

Abstract

OBJECTIVE

To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.

DESIGN

This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.

RESULTS

A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks (P = 0.0099) and 26 weeks (P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.

CONCLUSIONS

Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

Authors+Show Affiliations

1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.2 Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic, Budapest, Hungary.3 NZOZ Medi SPATZ, Gilwice, Poland.4 ARTIMED Niepubliczny Zakład Opieki Zdrowotnej, Kielce, Poland.5 Jutrix Medical LLC, Kecskémet, Hungary.6 Medical Plus s.r.o., Uherske Hradiste, Czech Republic.7 Consultative Outpatients' Medical Office for Rheumatologic Diseases, Sofia, Bulgaria.1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.1 Department of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.8 Dynastat Biostatistical Consulting, Austin, TX, USA.9 Semmelweis Egyetem Orthopaedic Clinic, Budapest, Hungary.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28535076

Citation

Hangody, Laszlo, et al. "Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: a Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial." Cartilage, vol. 9, no. 3, 2018, pp. 276-283.
Hangody L, Szody R, Lukasik P, et al. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018;9(3):276-283.
Hangody, L., Szody, R., Lukasik, P., Zgadzaj, W., Lénárt, E., Dokoupilova, E., ... Szendroi, M. (2018). Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage, 9(3), pp. 276-283. doi:10.1177/1947603517703732.
Hangody L, et al. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: a Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018;9(3):276-283. PubMed PMID: 28535076.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. AU - Hangody,Laszlo, AU - Szody,Robert, AU - Lukasik,Piotr, AU - Zgadzaj,Wojciech, AU - Lénárt,Endre, AU - Dokoupilova,Eva, AU - Bichovsk,Daniela, AU - Berta,Agnes, AU - Vasarhelyi,Gabor, AU - Ficzere,Andrea, AU - Hangody,György, AU - Stevens,Gary, AU - Szendroi,Miklos, Y1 - 2017/05/23/ PY - 2017/5/24/pubmed PY - 2019/5/14/medline PY - 2017/5/24/entrez KW - clinical trial KW - diagnosis KW - general KW - intraarticular delivery KW - joint involved KW - knee KW - osteoarthritis KW - therapeutic delivery SP - 276 EP - 283 JF - Cartilage JO - Cartilage VL - 9 IS - 3 N2 - OBJECTIVE: To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis. DESIGN: This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks. RESULTS: A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks (P = 0.0099) and 26 weeks (P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported. CONCLUSIONS: Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond. SN - 1947-6043 UR - https://www.unboundmedicine.com/medline/citation/28535076/Intraarticular_Injection_of_a_Cross_Linked_Sodium_Hyaluronate_Combined_with_Triamcinolone_Hexacetonide__Cingal__to_Provide_Symptomatic_Relief_of_Osteoarthritis_of_the_Knee:_A_Randomized_Double_Blind_Placebo_Controlled_Multicenter_Clinical_Trial_ L2 - http://journals.sagepub.com/doi/full/10.1177/1947603517703732?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -