Journal of Clinical Trials
Open Access

Abstract

Effects of Hyaluronic Acid-Sorbitol Formulation in Patients Undergoing Knee Arthroscopy: A Randomized Controlled Single-Blind Clinical Trial

Simone Giusti*, B. Di Paola, Edoardo De Fenu, C. Caria, Ezio Adriani

Background: Although there is no best irrigation solution for knee arthroscopy, many studies show that the most commonly irrigation fluids are toxic for the articular chondrocytes, suppressing their metabolism and function. The purpose of this study is to evaluate the clinical outcome of patients injected with 6 ml of hyaluronic acid (2%) and sorbitol (4%) formulation (Synolis VA) after knee arthroscopy and compare pain and functionality outcomes with patients who did not receive Synolis VA in the post-operative period.

Materials and Methods: 60 patients were randomly divided using a computer-produced causal number generator algorithm into 2 groups. At the end of the procedure 30 patients received an intra-articular 6ml injection of Synolis VA the remaining 30 patients did not receive any treatment. Inclusion criteria: age 18 to 60 years, meniscectomy or debridement and lavage for cartilage lesions (non-bleeding knee arthroscopy), body mass index (<30). Patients with joint-line misalignment, ligamentous lesions, synovial membrane pathology or inflammatory joint disease were excluded from the study. Patients were reviewed at several follow-up points and monitored using outcomes such as the IKDC subjective knee evaluation score, pain variation (using VAS and WOMAC pain sub-score) and variation of stiffness (using WOMAC stiffness sub-score). Patients were also asked to fill in a self-assessment questionnaire on a weekly basis. The statistical analysis was performed with IBM SPSS Statistics for Windows, Version 28.0.

Results: Patients injected with Synolis VA showed better clinical outcomes in the first 4 weeks’ post-intervention compared to patients that were not injected with the product; these patients had higher IKDC Subjective Knee Evaluation scores, as well as lower subjective pain scores and reduced stiffness.

Conclusion: Based on our results, post-operative injection with Synolis VA in patients undergoing non-bleeding knee arthroscopy for degenerative and traumatic pathology, effectively reduces pain and improves mobility in the short term post-operative phase.

Published Date: 2025-03-28; Received Date: 2025-02-21