Early Intra-Articular Hyaluronic Acid injection following Anterior Cruciate ligament reconstruction provides short term pain relief and improves early postoperative function with no clinical benefits at 6 and 12 Months: A Randomized Controlled Trial.

Abstract

Purpose: This randomized-controlled trial assessed the safety and effectiveness of intra-articular hyaluronic acid (IAHA) when administered at various time points following arthroscopic anterior cruciate ligament reconstruction (ACLR) surgery.

Methods: Ninety ACL tear patients undergoing arthroscopic ACLR were divided into three groups: Early HA group received HA on day 2 and saline at 2 months; Late HA group received saline on day 2 and HA at 2 months; Placebo group received saline at both times. Clinical (range of motion-ROM, knee circumference, Lysholm score, IKDC, VAS, EQ5D5L, Tegner scores) and blood parameters (blood ESR, and CRP) were assessed at baseline, monthly up to 6 months, and at 12 months. The synovial TNF-alpha level was measured at baseline, day 2, and 3 months.

Results: Early HA group showed significantly better ROM than Placebo (P=0.041) and Late HA groups (P=0.029) at one and two months' post-surgery. Pain was significantly lower in Early HA group at one month compared to Placebo (P=0.033). Early HA group achieved a faster median recovery to a Lysholm score of 83 (P=0.01) and had superior Lysholm scores at two months. EQ5D5L and IKDC scores were also significantly better at one and two months in Early HA group. There were no differences in blood ESR and CRP levels between the groups at any follow up. However, both HA groups had a significant decrease in TNF-alpha from baseline (P<0.05). No adverse events were reported. The Minimal Clinically Important Difference (MCID) for the VAS at one month was achieved by 93.3%, 60.7% and 65.5% participants respectively (p-value<0.01). However, no significant differences were observed between the groups in the percentages of patients achieving MCID for VAS at one year or for IKDC and Lysholm scores at one month, two months, and one year.

Conclusion: Early IAHA injection following ACLR effectively reduces pain and improves ROM during the early postoperative period, leading to enhanced functional outcomes and quality of life. However, these benefits were not sustained beyond 2 months and no clinical benefits were noted at 6- and 12-month follow-ups. The treatment was found to be safe and well-tolerated for postoperative use. Notably, there was no significant difference in the number of patients achieving MCID for functional scores, except for pain at one month.