Objective
The study aims to evaluate and compare the clinical and functional outcomes in patients with or without intra-articular hyaluronic acid (IAHA) treatment given for Kellgren and Lawrence grade I, II, III osteoarthritis (OA) of the knee. The primary focus was to assess the efficacy of IAHA in alleviating pain and improving functional outcomes.
Method
A prospective randomised controlled study from November 2020-June 2023 was conducted in patients with OA knee and randomly assigned to one of the two groups. Group A (control group) was managed conservatively with oral anti-inflammatory drugs and physiotherapy while Group B (treatment group) with IAHA injection (6ml Hylan G-F 20) along with oral anti-inflammatory drugs and physiotherapy. Visual Analog Scale (VAS) was used to compare subjective pain alleviation. Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, International Knee Documentation Committee (IKDC)score, Knee Injury and Osteoarthritis Outcome Score (KOOS) were used to assess subjective pain and functional outcomes. Assessments were conducted at baseline (pre-procedure), 6 weeks, 3 months, 6 months, and 1year post-procedure.
Result
The study involved 240 patients (120 in each group), with an average age of 53 ± 10 year, and a predominance of females (73%). In Group A, mean VAS at baseline, 6 weeks, 3 months, 6 months, and 1 year was 7.2 ± 1.0, 6.8 ± 1.0, 6.3 ± 1.2, 6.1 ± 1.2, and 6.1 ± 1.2 respectively. While in Group B, VAS was 6.3 ± 0.1, 5.0 ± 1.0, 4.0 ± 1.2, 2.8 ± 1.1, and 2.9 ± 1.2 demonstrating significantly greater improvement than Group A (p<0.001). However, within Group B, significant improvement was observed upto 6 months (p<0.001), and was maintained at 1 year (p>0.05). Similarly, WOMAC scores at baseline, 6 weeks, 3 months, 6 months, and 1 year in Group B (38.8 ± 6.7, 27.4 ± 6.6, 21.6 ± 5.8, 18.6 ± 4.4 and 18.9 ± 4.9) compared to Group A (34.4 ± 12.8, 30.4 ± 10.7, 28.9 ± 10.2, 28.5 ± 9.1 and 29.4 ± 10.7) showed notable improvement (p<0.001).
Functional outcomes, as assessed by the IKDC score, showed significant improvement in both the groups (p<0.001). The IKDC score in Group B at baseline, 6 weeks, 3 months, 6 months, and 1 year was 42.0 ± 8.5, 49.0 ± 6.0, 56.0 ± 8.0, 64.0 ± 10.0, and 64.0 ± 10.0 respectively, significantly outperforming Group A: 44.0 ± 4.2, 46.0 ± 4.5, 48.0 ± 5.7, 49.0 ± 6.1, and 46.7 ± 6.2 (p<0.001). Similar results were found for KOOS scores as well.
Conclusion
Group B showed greater and more sustained improvement in VAS, WOMAC, IKDC and KOOS scores compared to Group A. These findings suggest that intra-articular hyaluronic acid, in short term, effectively alleviates pain and improves function in Kellgren and Lawrence grade I, II, III knee osteoarthritis and can be used as a promising non-surgical alternative.