Trial reportPloS one2019
A single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate vs 0.8% hylan G-F 20 in the treatment of symptomatic knee osteoarthritis: A 6-month, multicenter, randomized, controlled non-inferiority trial.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Intra-articular Hyaluronic Acid Injections May Be Beneficial in Patients with Less Advanced Knee Osteoarthritis: A Systematic Review of Randomised Controlled Trials.Sports medicine (Auckland, N.Z.) · 2025Pooled it
- Efficacy and safety of extracorporeal shock wave therapy combined with sodium hyaluronate in treatment of knee osteoarthritis: a systematic review and Meta-analysis.Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2024Pooled it
- Comparison of the efficacy and safety of acetaminophen versus NSAIDs for the treatment of chronic pain in older adults with osteoarthritis of the hip and knee: Findings from the randomized, double-blind, parallel-group, non-inferiority RETHINK study.Osteoarthritis and cartilage open · 2026Article
- Expert consensus on hyaluronic acid injections for knee osteoarthritis: a patient-centered approach.Aging clinical and experimental research · 2026Review
- Comparison of Different Molecular Weights of Intra-Articular Hyaluronic Acid Injections for Knee Osteoarthritis: A Level I Bayesian Network Meta-Analysis.Biomedicines · 2025Review
- Effect of sodium hyaluronate combined with rehabilitation training on knee joint injury caused by golf.World journal of clinical cases · 2024Article
- Advances in viscosupplementation and tribosupplementation for early-stage osteoarthritis therapy.Nature reviews. Rheumatology · 2024Review
- Effectiveness of gonarthrosis treatment via intra-articular injections of linear vs. cross-linked hyaluronic acids.Joint diseases and related surgery · 2024Article
- Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study.Journal of clinical medicine · 2023Article
- Article
- Acupotomy combined with intra-articular injection of sodium hyaluronate in the treatment of knee osteoarthritis.Medicine · 2022Article
- Review
- Article
- Intra-articular hyaluronic acid in knee osteoarthritis: clinical data for a product family (ARTHRUM), with comparative meta-analyses.Current therapeutic research, clinical and experimental · 2021Review
- One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial.Journal of pain research · 2021Article
- Acide hyaluronique intra-articulaire dans la gonarthrose: résultats cliniques d'une famille de produits (ARTHRUM), avec méta-analyses comparatives.Current therapeutic research, clinical and experimental · 2021Article
- Intra-articular Injections of Cross-linked Hyaluronic Acid in Japanese Patients with Symptomatic Osteoarthritis of the Hip.Progress in rehabilitation medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of the study was to demonstrate the non-inferiority of a single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate (SH) vs 0.8% hylan G-F 20 (control) in symptomatic knee osteoarthritis.
designThis was a double-blind, randomized, controlled trial conducted in patients with painful tibiofemoral osteoarthritis (American College of Rheumatology criteria) with insufficient response or intolerance to first-line analgesics and regular non-steroidal anti-inflammatory drugs. Subjects received a single intra-articular injection of either SH or hylan G-F 20. The primary outcome was the 6-month change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (WOMAC A), with a pre-specified lower margin for non-inferiority of 8 mm.
resultsOf the 292 patients randomized (SH: 144), 288 received an injection (SH: 142), 266 completed the study (SH: 134). In the Per Protocol dataset (SH: 113, control: 112), the WOMAC A change at 6 months was -34.3 mm (95% confidence interval (CI): -37.8, -30.8) and -36.2 mm (95% CI: -40.3, -32.1) for the SH and hylan G-F 20 patients, respectively (P = 0.5). The intergroup difference was -1.9 mm (95% CI: -7.3, 3.5). Results were similar in the Full Analysis Set (SH: 139, control: 141) with a difference between the groups of -2.9 mm (95% CI: -7.9, 2.2). A total of 31.3% of the injected patients reported a treatment-emergent adverse event, including injection site reactions (pain, inflammation or effusion) which occurred in 8.5% of the SH patients vs 13.0% of the hylan G-F 20 patients. No serious reactions were reported.
conclusionsThis clinical trial demonstrated the non-inferiority of a single intra-articular injection of SH vs hylan G-F 20 on the WOMAC A change from baseline at 6 months.
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