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Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial.
Ann Rheum Dis. 2010 Jan; 69(1):113-9.AR

Abstract

OBJECTIVES

The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed.

METHODS

Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study.

RESULTS

were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only. Results: A total of 253 patients (Kellgren-Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (-0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase.

CONCLUSIONS

This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo.

Authors+Show Affiliations

Department of Rheumatology, Henri Mondor Hospital, University Paris XII, Bd de Lattre de Tassigny, 94010 Créteil, France. Xavier.Chevalier@hmn.aphp.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19304567

Citation

Chevalier, X, et al. "Single, Intra-articular Treatment With 6 Ml Hylan G-F 20 in Patients With Symptomatic Primary Osteoarthritis of the Knee: a Randomised, Multicentre, Double-blind, Placebo Controlled Trial." Annals of the Rheumatic Diseases, vol. 69, no. 1, 2010, pp. 113-9.
Chevalier X, Jerosch J, Goupille P, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010;69(1):113-9.
Chevalier, X., Jerosch, J., Goupille, P., van Dijk, N., Luyten, F. P., Scott, D. L., Bailleul, F., & Pavelka, K. (2010). Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Annals of the Rheumatic Diseases, 69(1), 113-9. https://doi.org/10.1136/ard.2008.094623
Chevalier X, et al. Single, Intra-articular Treatment With 6 Ml Hylan G-F 20 in Patients With Symptomatic Primary Osteoarthritis of the Knee: a Randomised, Multicentre, Double-blind, Placebo Controlled Trial. Ann Rheum Dis. 2010;69(1):113-9. PubMed PMID: 19304567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. AU - Chevalier,X, AU - Jerosch,J, AU - Goupille,P, AU - van Dijk,N, AU - Luyten,F P, AU - Scott,D L, AU - Bailleul,F, AU - Pavelka,K, PY - 2009/3/24/entrez PY - 2009/3/24/pubmed PY - 2010/2/2/medline SP - 113 EP - 9 JF - Annals of the rheumatic diseases JO - Ann. Rheum. Dis. VL - 69 IS - 1 N2 - OBJECTIVES: The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed. METHODS: Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study. RESULTS: were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only. Results: A total of 253 patients (Kellgren-Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (-0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase. CONCLUSIONS: This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/19304567/Single_intra_articular_treatment_with_6_ml_hylan_G_F_20_in_patients_with_symptomatic_primary_osteoarthritis_of_the_knee:_a_randomised_multicentre_double_blind_placebo_controlled_trial_ L2 - https://ard.bmj.com/cgi/pmidlookup?view=long&pmid=19304567 DB - PRIME DP - Unbound Medicine ER -