Real-World Evaluation of Repeated Intra-articular 1.0% Sodium Hyaluronate Injections for Knee Osteoarthritis: A 30-Week Post-market Clinical Performance Study.
- 1Department of Orthopaedic Surgery, Tri-Service General Hospital, School of Medicine, National Defense Medical University, Taipei, Taiwan.
- 2Maxigen Biotech Inc., Taoyuan, Taiwan.
- 3Research & Design Center, TCI Co., Ltd., Taipei, Taiwan.
Abstract
ObjectiveTo 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).DesignThis 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.ResultsMean VAS pain scores decreased by 48.3% at Week 8 and 42.8% at Week 30 compared with baseline (both p < 0.001). KL grades were generally stable over time, with no clear radiographic worsening observed during follow-up. Approximately 90% of patients reported satisfaction with treatment, and no treatment-related serious adverse events occurred.ConclusionsFive 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.
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BibTeX
@article{yeh2026realworld,
title = {{Real-World Evaluation of Repeated Intra-articular 1.0% Sodium Hyaluronate Injections for Knee Osteoarthritis: A 30-Week Post-market Clinical Performance Study.}},
author = {Tsu-Te Yeh and Ching-Ting Chen and Yung-Hsiang Lin and Chi-Fu Chiang and Yi-Wen Mao},
journal = {Cartilage},
year = {2026},
month = oct,
doi = {10.1177/19476035261493633},
url = {https://europepmc.org/article/MED/42900674},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Real-World Evaluation of Repeated Intra-articular 1.0% Sodium Hyaluronate Injections for Knee Osteoarthritis: A 30-Week Post-market Clinical Performance Study.
AU - Tsu-Te Yeh
AU - Ching-Ting Chen
AU - Yung-Hsiang Lin
AU - Chi-Fu Chiang
AU - Yi-Wen Mao
PY - 2026
DA - 2026/10/20
JO - Cartilage
DO - 10.1177/19476035261493633
UR - https://europepmc.org/article/MED/42900674
AB - ObjectiveTo 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).DesignThis 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.ResultsMean VAS pain scores decreased by 48.3% at Week 8 and 42.8% at Week 30 compared with baseline (both p < 0.001). KL grades were generally stable over time, with no clear radiographic worsening observed during follow-up. Approximately 90% of patients reported satisfaction with treatment, and no treatment-related serious adverse events occurred.ConclusionsFive 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.
SN - 1947-6035
SN - 1947-6043
ER -