A Novel Patient-Specific Regenerative Meniscal Replacement System

Abstract

Knee meniscal injuries account for the greatest number of surgical procedures performed by orthopaedic surgeons worldwide. Each year in excess of 400,000 operations are performed in Europe and over one million in the United States and yet no suitable replacement for the meniscus is available. Fibrocartilage tissue engineering holds great potential in the regeneration of meniscal tissue however current developments have been limited. Difficulties in imitating the anisotropic nature of the meniscus, patient specific geometry, attaining sterility assurance requirements remain as developmental challenges for meniscal scaffold devices. A novel approach was developed to rapidly form terminally sterilized pre-packaged scaffold templates into anatomically matched regenerative meniscal implants. Formed meniscal implants exhibited the structural and functional architecture of the native meniscus. Meniscal implants fabricated using this method displayed mechanical properties approaching to that of the native meniscus and imparted rotational stability. Fixation techniques influenced the biomechanical response of implants and 45S5 bioactive glass modification was found to enhance radio-opacity of the scaffold. Biocompatibility of the implant was confirmed using a fibroblast cell culture model.