Intra-articular Duration of Durolane™ after Single Injection into the Rabbit Knee

Abstract

Objective: The aim of the present study was to investigate the intra-articular duration of Durolane™ in a rabbit model to allow comparison between Durolane™ residence time and data reported for other hyaluronic acid products as well as native hyaluronic acid. Design: 14C-labeled Durolane™ was manufactured by labeling the cross-linker used for stabilization. A single injection of approximately 0.3 mL 14C-labeled Durolane™ was administered intra-articularly in both knee joints of male New Zealand White rabbits. At days 1, 2, 3, 7, 28, 60, 96, and 120 after injection, the knee joints of 4 animals were collected, and the radioactivity of the remaining gel was measured. The obtained data were fitted by exponential models to calculate the half-life of the gel. Two additional rabbits were used for histology of the joint 127 days after the injection. Results: The elimination of 14C-labeled Durolane™ followed first-order kinetics with an apparent half-life of approximately 32 days. Histology showed no morphological changes in the knee joints. Conclusions: This study shows that Durolane™ has a half-life of 32 days in the rabbit knee joint, which is much longer compared to literature data on hyaluronic acid and other modified hyaluronic acid products.