Design Considerations for a Prosthetic Anterior Cruciate Ligament

Anterior cruciate ligament (ACL) tearing is a common knee injury often requiring reconstruction with an autograft or an allograft. A prosthetic ligament replacement with off-the-shelf availability could potentially provide significant advantages over the current options for both patients and surgeons. Limitations of previous prosthetics include lack of biocompatibility and susceptibility to fatigue, creep, and failure of bony incorporation. This paper describes design considerations and possible improvements for the next generation prosthetic ACL. Design controls, as mandated by the FDA, are a systematic set of practices within the design and development process used to ensure that a new medical device meets the needs of the intended users. The specified requirements, called the design inputs, for a prosthetic ACL are discussed pertaining to material and structural properties, resistance to creep and fatigue, ability to support secure initial fixation, biocompatibility, and long-term osseointegration. Design innovations to satisfy the design inputs are discussed with regards to material selection, textile pattern, bone tunnel features, and short term fixation. A risk analysis is presented along with descriptions of proposed testing. Design control methodology and tissue engineering may be used to develop a next generation prosthetic ligament, solving multiple problems, simultaneously, on a holistic level, providing major improvements over earlier devices and current treatment options. [DOI: 10.1115/1.4007945]