Improvement in condition-specific and generic quality of life outcomes in patients with knee osteoarthritis following Synvisc-One: Results from the LOBRAS study

Hyaluronic Acid, Knee Osteoarthritis, Quality of Life, Synvisc-One

Abstract

Objective: To evaluate the effectiveness of viscosupplementation with Synvisc-One in knee Osteoarthritis (OA), during routine clinical care, in a 52 week observational study.

Main outcome measures: Western Ontario and McMaster (WOMAC) OA Index, and the Short Form 36 questionnaire (SF-36 v2).

Results: 131 patients with knee OA were enrolled, of whom 119 provided both pre- and post-intervention WOMAC data. Statistically significant improvements (with a maximum of p ≤ .025) from baseline to Week 12, Month 6 and Week 52 were detected, by intention-to-treat (ITT) and per-protocol (PP) analyses, in WOMAC Pain, Stiffness, Function, PGA, and Total Score, SF-36 PCS, and WOMAC-derived HUI3. Adverse events (AEs) monitoring detected treatment-related AEs in 5.3% of patients.

Conclusions: The effectiveness of Synvisc-One in routine clinical care is supported by the detection of statistically significant, clinically important improvements in WOMAC Pain, Stiffness, Function, Total, and PGA outcomes, and statistically significant improvements in SF-36 PCS and WOMAC-derived HUI3 outcomes at multiple time points. Limitations of this study include lack of a control group or blinding. No predictive indicators of the response to treatment were identified. In general Synvisc-One was well tolerated with very few patients experiencing any Synvisc-One related adverse events. Collectively, these observations attest to the effectiveness of Synvisc-One and complement previous observations in routine clinical care.

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