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
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
21875678
DOI
10.1016/j.joca.2011.07.016
PII: S1063-4584(11)00230-5
Knihovny.cz E-resources
- MeSH
- Osteoarthritis, Knee drug therapy MeSH
- Biocompatible Materials administration & dosage therapeutic use MeSH
- Pain drug therapy MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Injections, Intra-Articular MeSH
- Hyaluronic Acid administration & dosage analogs & derivatives therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Pain Measurement MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Viscosupplements administration & dosage therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Biocompatible Materials MeSH
- hylan MeSH Browser
- Hyaluronic Acid MeSH
- Viscosupplements MeSH
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).
References provided by Crossref.org
Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice
ClinicalTrials.gov
NCT00556608
