Objective:

To compare the efficacy of Hyruan ONE, hylan G-F 20, and saline in reducing pain and improving function in patients with symptomatic knee osteoarthritis.

Approach:

• Study Design: A single-center, double-blind, randomized, placebo-controlled trial involving 276 patients with symptomatic knee osteoarthritis.
• Intervention: Patients received a single intra-articular injection of either Hyruan ONE, hylan G-F 20, or saline.
• Outcome Measures: Primary outcomes included pain at rest and during motion measured on a 100-mm visual analog scale, with secondary outcomes including various functional and quality of life assessments.
• Statistical Analysis: Linear mixed-effects models were used to analyze repeated measurements, accounting for treatment group, time, and demographic covariates.

Key Findings:

• No statistically significant differences in pain or functional outcomes between Hyruan ONE, hylan G-F 20, and saline.
• Pain scores decreased from baseline in all groups, but without significant between-group differences.
• Most patient-reported outcomes improved from baseline, but Timed Up and Go performance did not show significant improvement.
• Rescue corticosteroid use was similar across groups, with no significant differences.

Interpretation:

The improvement in the saline group aligns with previous evidence of responses to intra-articular saline injections.

Limitations:

• 24-week follow-up period with completion rates of approximately 73% to 80%.
• Approximately 90% of participants had Kellgren-Lawrence grade II or III disease, excluding those with significant mechanical-axis deviation.
• Adverse events were not systematically assessed.

Conclusion:

Intra-articular injections of ultra-high MW and HMW cross-linked HAs did not demonstrate superior efficacy in pain reduction or functional improvement compared with saline in patients with symptomatic knee OA.

Sources:

• JBJS Open Access