Assessment of the Health-Related Quality of Life Impact of EUFLEXXA (1% Sodium Hyaluronate) Using Short Form 36 (SF-36) Data Collected in a Randomized Clinical Trial Evaluating Treatment of Osteoarthritis Knee Pain
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2021;9(22):12 Pharmaceutica Analytica Acta (5(8):1-5)What this means for my practice?
A single injection of BioHA results in improvements of physical domains, as well as vitality and social functioning domains of the SF-36 at 26 weeks. A repeat injection led to a further improvement in bodily pain, however, no improvements were seen in any other domains with a repeat injection.
Study Summary
Data from the FLEXX Trial and FLEXX Trial extension study were used in order to evaluate the effect of bioengineered hyaluronic acid (BioHA) on quality of life. Short-Form 36 (SF-36) data from the FLEXX trial was compared to United States SF-36 normative values, as well as normative values for persons with osteoarthritis (OA). SF-36 was compared to baseline and the US normative values after 26 weeks, and after an additional injection followed by another 26 weeks. The study found significant improvements in quality of life compared to baseline in patients treated with BioHA which trended towards normative values for the US population after a single and a repeat injection.
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