Authors: Stefano Cacciapuoti, Marco Filipponi, Giuseppe Coviello, Marco Privitera.
Introduction: Viscosupplementation with high-molecular-weight hyaluronic acid does not offer efficacy and quality-of-life benefits compared to middle-molecular-weight hyaluronate formulations for intra-articular injection. Moreover, high-molecular-weight hyaluronic acid might have some biophysical liabilities. The paper reports the outcomes of a purely observational survey after a previous intra-articular treatment to simulate the real-world experience of patients and orthopaedics specialists with a middle-molecular-weight hyaluronate medical device in the general population of knee osteoarthritis patients.
Methods: Evaluations based on patient-assessed “Knee injury and Osteoarthritis Outcome Score” (KOOS) and investigator-assessed “Range Of Motion” (ROM). Primary efficacy endpoint: patient-assessed pain during selected daily activities at T1 and T2 vs baseline (T0); secondary efficacy endpoint: patient-assessed changes in four KOOS daily activities and investigator-assessed ROM limitations at T1 and T2 vs T0.
Results: The reduction of surveyed mean KOOS pain and function scores at T1 and T2 vs T0 was almost always highly significant for all surveyed pain categories—for instance, the mean “Straightening/Bending knee fully” pain score fell from 1.9 ± 0.85 to 0.8 ± 0.91 (–57.9%), the mean “Going upstairs/downstairs” pain score from 2.0 ± 0.69 to 0.9 ± 0.92 (–55.0%), the mean “Going upstairs/downstairs” function score from 2.0 ± 0.83 to 0.9 ± 1.01 (–55.9%), and the mean “Walking on flat surface” function score from 1.8 ± 0.97 to 0.9 ± 1.01 (–50.0%). The scores of all surveyed pain and function categories further improved significantly between the first and final follow-ups. ROM scores also showed a tendency to increase.
Discussion: The survey study confirms the persisting value of the intra-articular SAVETYAL middle-molecular weight hyaluronic acid, with a confirmed clinically meaningful and statistically significant relief of pain and difficulties in daily life. The likely cognitive bias intrinsic to the survey design does not weaken the robust objective (investigators) and subjective (treated patients) outcomes.
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