Real-World Evaluation of Repeated Intra-articular 1.0% Sodium Hyaluronate Injections for Knee Osteoarthritis: A 30-Week Post-market Clinical Performance Study
Tsu-Te Yeh, Ching-Ting Chen, Yung-Hsiang Lin, Chi-Fu Chiang, Yi-Wen MaoObjective
To evaluate the safety and clinical performance of a high-purity, non–cross-linked 1.0% sodium hyaluronate administered via intra-articular injection in patients with symptomatic knee osteoarthritis (OA).
Design
This 30-week, single-center, open-label post-market clinical performance evaluation enrolled adults with radiographically confirmed knee OA. Participants received five weekly intra-articular injections of 1.0% sodium hyaluronate. Resting pain (VAS), Kellgren–Lawrence (KL) grade, and patient satisfaction were assessed through Week 30, and adverse events were monitored throughout.
Results
Mean VAS pain scores decreased by 48.3% at Week 8 and 42.8% at Week 30 compared with baseline (both
Conclusions
Five weekly intra-articular injections of 1.0% sodium hyaluronate were well tolerated and were associated with reductions in resting pain and stable radiographic findings over 30 weeks, supporting its role as a well-tolerated viscosupplementation option in routine clinical care for knee OA.