Abstract
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of intra-articular injection of the "triple injection" in the treatment of early and middle-stage knee osteoarthritis (KOA). MATERIALS AND METHODS: A total of 120 patients with unilateral KOA, recruited from October 2021 to December 2023, were randomly divided into two groups with 60 cases in each group. The control group received intra-articular injection of 2 mL sodium hyaluronate once a week for 5 consecutive weeks. The experimental group received intra-articular "triple injection" (0.3 mL betamethasone + 0.7 mL lidocaine + 2 mL sodium hyaluronate) in the first week, followed by intra-articular injection of 2 mL sodium hyaluronate once a week for 4 consecutive weeks. The clinical efficacy was evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Hospital for Special Surgery (HSS) knee score, and flexion range of motion (ROM) before treatment, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after treatment. RESULTS: Comparisons of WOMAC scores, VAS scores, HSS scores, and ROM before treatment revealed no statistically significant differences between the two groups (all P > 0.05). In contrast, statistically significant differences in WOMAC scores, VAS scores, HSS scores, and ROM between the two groups were observed at different time points after treatment (all P < 0.05). Additionally, the comparison of overall efficacy in K-L grade III patients between the two groups showed a statistically significant difference (P < 0.05), and no complications were observed in any of the patients. CONCLUSION: Intra-articular injection of sodium hyaluronate and the "triple injection" are both effective therapeutic modalities for the early and mid-stage of KOA. Compared with sodium hyaluronate, the "triple injection" can more effectively relieve pain and improve knee joint function. CLINICAL TRIAL REGISTRATION: Identifier ChiCTR2100048131 with a registration date of 04/07/2021.