Safety and Efficacy of Hybrid Cooperative Complexes of Sodium Hyaluronate and Sodium Chondroitin for the Treatment of Patients with Symptomatic Knee Osteoarthritis

Abstract

Introduction: Knee osteoarthritis (KOA) represents a widespread degenerative disease that causes pain and motor disability. Conservative treatments mainly focus on relieving symptoms, improving joint function, and trying to delay surgery. Safety and efficacy of hybrid cooperative complexes (2.4% sodium hyaluronate and 1.6% sodium chondroitin; HA-SC) for symptomatic KOA were investigated in a single-arm, prospective, pilot study.

Methods: Patients with a visual analogue scale (VAS) pain score ≥ 4 and Kellgren-Lawrence Grade < 4 received a single intraarticular HA-SC injection. Patients with a VAS score change from baseline ≤ 1 received a second injection at day 30. Device-related adverse events (DR-AEs)/adverse events (AEs) were primary endpoints. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis Index LK 3.1 (WOMAC LK 3.1), VAS, patient global assessment of disease status (PtGA), and patient proportion needing a second injection.

Results: Of 83 patients with KOA (Kellgren-Lawrence Grade, 2-3), 34.9% had DR-AEs at day 7. No serious DR-AEs/AEs were reported. A significant (P < 0.0001) reduction over time in VAS pain score plus WOMAC pain, stiffness, physical function limitation, and total scores was reported. Median PtGA scores indicated a 'slight improvement' at most follow-up visits. Only 18.1% of patients required a second injection.

Conclusions: A single intraarticular HA-SC injection was safe, well-tolerated, and did not lead to major deterioration in terms of reducing knee pain, stiffness, and physical function limitation in patients with symptomatic KOA.

Keywords: Conservative therapy; Hyaluronic acid; Injections; Knee; Osteoarthritis; SINOGEL®; Viscosupplementation.

Fig. 1

Study design. ^aThe first injection was administered in ≤ 14 days of screening. AE adverse events, DR-AE device-related adverse events, K–L Kellgren and Lawrence, KOA knee osteoarthritis, N total number of patients, VAS visual analogue scale, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index

Fig. 2

WOMAC domain scores for pain (A), stiffness (B), and physical function (C), and WOMAC total score (D). Lines within the box plots represent median values, upper and lower whiskers represent maximum and minimum values, respectively, the top and end of each box represent upper quartile range (Q3) and lower quartile range (Q1), respectively, and crosses represent mean values. Statistical analysis results are shown in Table 3. F/u follow-up, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index

Fig. 3

VAS domain scores for pain (A) and patient's global assessment of disease status scores* (B). *As measured by the WOMAC scale. Lines within the box plots represent median values, upper and lower whiskers represent maximum and minimum values, respectively, the top and end of each box represent upper quartile range (Q3) and lower quartile range (Q1), respectively, and crosses represent mean values. Statistical analysis results are shown in Table 3. F/u follow-up, PtGA patient global assessment of disease activity, VAS Visual Analogue Scale, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index