Early Intra-articular Hyaluronic Acid Injection After 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: To assess the safety and effectiveness of intra-articular hyaluronic acid (HA) when administered at various time points after arthroscopic anterior cruciate ligament reconstruction (ACLR) surgery.

Methods: Ninety patients with anterior cruciate ligament tears undergoing arthroscopic ACLR were divided into 1 of 3 groups: The early HA group received HA on day 2 and saline solution at 2 months, the late HA group received saline solution on day 2 and HA at 2 months, and the placebo group received saline solution at both times. Clinical variables (range of motion [ROM], knee circumference, Lysholm score, International Knee Documentation Committee [IKDC] score, visual analog scale [VAS] score, EQ-5D-5L [EuroQol 5-dimension 5-level questionnaire] score, and Tegner score) and blood parameters (erythrocyte sedimentation rate and C-reactive protein level) were assessed at baseline, monthly up to 6 months, and at 12 months. The synovial tumor necrosis factor α level was measured at baseline, on day 2, and at 3 months.

Results: The early HA group showed significantly better ROM than the placebo group (P = .041) and late HA group (P = .029) at 1 and 2 months after surgery. Pain was significantly lower in the early HA group at 1 month compared with the placebo group (P = .033). The early HA group achieved a faster median recovery time to a Lysholm score greater than 83 (P = .01) and had superior Lysholm scores at 2 months. In addition, EQ-5D-5L and IKDC scores were significantly better at 1 and 2 months in the early HA group. There were no differences in erythrocyte sedimentation rate and C-reactive protein level between the groups at any follow-up. However, both HA groups showed a significant decrease in tumor necrosis factor α level from baseline (P < .05). No adverse events were reported. The minimal clinically important difference (MCID) for the VAS score at 1 month was achieved by 93.3%, 60.7%, and 65.5% of participants in the early HA group, late HA group, and placebo group, respectively (P < .01). However, no significant differences were observed between the groups in the percentage of patients achieving the MCID for the VAS score at 1 year or the MCIDs for the IKDC and Lysholm scores at 1 month, 2 months, and 1 year.

Conclusions: Early intra-articular HA injection after ACLR effectively reduced pain and improved 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-up. 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 the MCIDs for functional scores, except for pain at 1 month.

Level of evidence: Level I, double-blind randomized controlled study.