2025 ISAKOS Biennial Congress ePoster
ACL RECONSTRUCTION WITH NEW GENERATION OF BIOMIMETIC, BIOACTIVE AND GRAFTED SYNTHETIC LIGAMENT: A
Giuliano Giorgio Cerulli, MD, Perugia, PG ITALY
Matteo Maria Tei, MD, PhD, Perugia ITALY
Tiribuzi Roberto, PhD, Perugia ITALY
Angie Zorba, MD, Perugia, Pg ITALY
IOTI - Villa Fiorita, Perugia, PG, ITALY
The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use: Movmedics, Grafted Synthetic ligament New generation of LARS
Summary
This study suggests that the new generation synthetic ligaments show promise as a viable option for ACL reconstruction. While no significant differences were observed in clinical outcomes compared to previous LARS ligament in the short term, the new ligament promises to be more integrated into the joint environment with less risk of developing synovitis
ePosters will be available shortly before Congress
Abstract
The new ligament has been grafted on the entire surface with a specific coating of Sodium Polystyrene Sulfonate (pNaSS) which imitates glycosaminoglycans. The glycosaminoglycans are involved in the interactions between the fibroblast, the extracellular matrix and the binding proteins using the integrins of the cell mebrane. Thereby, the fibroblasts adhesion is improved. The structural organization is more cohesive and controlled which will allow the secretion of collagen I and III. This new device is intended to increase targeted cellular growth and reduce functional rehabilitation period.
Methods
Forty patients aged 40 years and older, diagnosed with acute ACL injuries, were enrolled in this study. They were randomly assigned to one of two groups: Group A received ACL reconstruction using the new generation synthetic ligament, while Group B received an old ACL LARS ligament. The study
was conducted in a double-blinded manner, with both patients and assessors unaware of the type of graft used. The patients were checked with magnetic resonance imaging, traditional radiography, before and after surgery and with a biomechanical evaluation (arthrometric test ; isokinetic; stabilometric; gaitanalysis with surface electromyography) and clinical questionnires (VAS, IKDC, KOOS). Pre op; 90 days; 180 days; 360 days
Results
Preliminary findings indicate that patients in both groups experienced significant improvements in knee stability and function post-surgery, no major complications or adverse events were observed in either group.
Data from clinical investigation (pain, daily activities, sport activities and quality of life) were analyzed after 90, 180 and 365 days after surgery. Arthrometric analysis were performend in the pre-op group, 90 days after surgery,180 days after surgery, 365 days after surgery groups. Biomechanical test to investigate muscle deficit were performend on treated and controlateral side on : Pre-op, 90 days after surgery, 180 days after surgery, 365 days after surgery groups. Data were reported as mean ± SD. Statistical comparisons between groups were made using one way analysis of variance and Bonferroni’s multiple comparison test. P < .05 was considered significant, there were no statistically significant differences in clinical outcomes between the two groups at this early stage of analysis.
This study suggests that the new generation synthetic ligaments show promise as a viable option for ACL reconstruction. While no significant differences were observed in clinical outcomes compared to previous LARS ligament in the short term, the longer-term follow-up and a larger sample size are required to draw more conclusive results. Further research is warranted to assess the durability, cost-effectiveness, and long-term benefits of this novel synthetic ligament technology in ACL reconstruction procedures.