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Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study.
Osteoarthritis Cartilage. 2011 Nov; 19(11):1294-300.OC

Abstract

OBJECTIVE

Knee osteoarthritis is a major cause of disability and pain. This phase III, double-blind (patient and observer blinded,) multicenter, randomized, non-inferiority study was conducted to demonstrate the non-inferiority of the highly purified intra-articular injection of hyaluronic acid (Sinovial(®)) in comparison to Hylan G-F20 (Synvisc(®)) in the treatment of knee osteoarthritis.

METHODS

A total of 381 patients were randomly assigned to receive either the test drug, 16 mg/2 ml (0.8%) highly purified ia hyaluronic acid of biofermentative origin (Sinovial(®)), or the comparative drug, 16 mg/2 ml of 0.8% hylan G-F20 (Synvisc(®)). The duration of the treatment was 2 weeks (three injections at 1-week interval), followed by an observation period of 6 months. The primary efficacy variable was the improvement in mean Western Ontario and McMaster Universities (WOMAC) pain subscore from baseline to the final visit (week 26), compared between the two treatment groups. The acceptable margin for non-inferiority was chosen to be 8 mm.

RESULTS

At week 26, WOMAC pain subscores decreased by a mean of 32.5 for both Sinovial(®) and Synvisc(®). These results met prespecified criteria for non-inferiority for both the Intent-to-Treat and Per-Protocol populations. There were no statistically significant differences between groups at 26 weeks, although Sinovial(®)-treated patients tended to have a slightly better outcome for select variables, as they did at earlier time-points, some of which reached statistical significance. Both hyaluronic acid preparations were well-tolerated, with no statistically significant differences in tolerability profile between groups.

CONCLUSION

Sinovial(®) and Synvisc(®) treatments were found to be equivalent, both in terms of efficacy and safety.

CLINICAL TRIAL NUMBER

NCT00556608 (ClinicalTrials.gov Identifier).

Authors+Show Affiliations

Institute of Rheumatology, Praha, Czech Republic. pavelka@revma.czNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21875678

Citation

Pavelka, K, and D Uebelhart. "Efficacy Evaluation of Highly Purified Intra-articular Hyaluronic Acid (Sinovial(®)) Vs Hylan G-F20 (Synvisc(®)) in the Treatment of Symptomatic Knee Osteoarthritis. a Double-blind, Controlled, Randomized, Parallel-group Non-inferiority Study." Osteoarthritis and Cartilage, vol. 19, no. 11, 2011, pp. 1294-300.
Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthr Cartil. 2011;19(11):1294-300.
Pavelka, K., & Uebelhart, D. (2011). Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis and Cartilage, 19(11), 1294-300. https://doi.org/10.1016/j.joca.2011.07.016
Pavelka K, Uebelhart D. Efficacy Evaluation of Highly Purified Intra-articular Hyaluronic Acid (Sinovial(®)) Vs Hylan G-F20 (Synvisc(®)) in the Treatment of Symptomatic Knee Osteoarthritis. a Double-blind, Controlled, Randomized, Parallel-group Non-inferiority Study. Osteoarthr Cartil. 2011;19(11):1294-300. PubMed PMID: 21875678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. AU - Pavelka,K, AU - Uebelhart,D, Y1 - 2011/08/16/ PY - 2011/02/22/received PY - 2011/06/23/revised PY - 2011/07/29/accepted PY - 2011/8/31/entrez PY - 2011/8/31/pubmed PY - 2012/1/19/medline SP - 1294 EP - 300 JF - Osteoarthritis and cartilage JO - Osteoarthr. Cartil. VL - 19 IS - 11 N2 - OBJECTIVE: Knee osteoarthritis is a major cause of disability and pain. This phase III, double-blind (patient and observer blinded,) multicenter, randomized, non-inferiority study was conducted to demonstrate the non-inferiority of the highly purified intra-articular injection of hyaluronic acid (Sinovial(®)) in comparison to Hylan G-F20 (Synvisc(®)) in the treatment of knee osteoarthritis. METHODS: A total of 381 patients were randomly assigned to receive either the test drug, 16 mg/2 ml (0.8%) highly purified ia hyaluronic acid of biofermentative origin (Sinovial(®)), or the comparative drug, 16 mg/2 ml of 0.8% hylan G-F20 (Synvisc(®)). The duration of the treatment was 2 weeks (three injections at 1-week interval), followed by an observation period of 6 months. The primary efficacy variable was the improvement in mean Western Ontario and McMaster Universities (WOMAC) pain subscore from baseline to the final visit (week 26), compared between the two treatment groups. The acceptable margin for non-inferiority was chosen to be 8 mm. RESULTS: At week 26, WOMAC pain subscores decreased by a mean of 32.5 for both Sinovial(®) and Synvisc(®). These results met prespecified criteria for non-inferiority for both the Intent-to-Treat and Per-Protocol populations. There were no statistically significant differences between groups at 26 weeks, although Sinovial(®)-treated patients tended to have a slightly better outcome for select variables, as they did at earlier time-points, some of which reached statistical significance. Both hyaluronic acid preparations were well-tolerated, with no statistically significant differences in tolerability profile between groups. CONCLUSION: Sinovial(®) and Synvisc(®) treatments were found to be equivalent, both in terms of efficacy and safety. CLINICAL TRIAL NUMBER: NCT00556608 (ClinicalTrials.gov Identifier). SN - 1522-9653 UR - https://www.unboundmedicine.com/medline/citation/21875678/Efficacy_evaluation_of_highly_purified_intra_articular_hyaluronic_acid__Sinovial_®___vs_hylan_G_F20__Synvisc_®___in_the_treatment_of_symptomatic_knee_osteoarthritis__A_double_blind_controlled_randomized_parallel_group_non_inferiority_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1063-4584(11)00230-5 DB - PRIME DP - Unbound Medicine ER -