Anterior cruciate ligament (ACL) injury is a common traumatic event wherein currently established treatment consists of repair with autograft or allograft ligament. However, as patients frequently return to physical activities at a level similar to those prior to the injury, significant limitations of the current clinical approach have been noted, such as predisposed to developing osteoarthritis (OA), and a significant risk of re-rupture. The stiffness and strength of the grafts are often inferior to the properties of a native ACL, and these properties are reduced further before the graft is naturally repopulated with cells that remodel the ligament and generate a fully functional tissue.
Previously, Synthasome developed and manufactured a product, X-Repair, from a poly(L-lactic acid) mesh which has mechanical properties (stiffness and strength) similar to human rotator cuff tendon. The functionality of this device to reinforce tendon repair has been demonstrated in a preclinical large animal study, a human cadaveric study and a clinical study of rotator cuff repair.
The objective of this SP is to generate a synthetic and absorbable bone-ligament-bone construct to provide functional support to the graft while in vivo maturation is completed. The ligament component will be optimized to have mechanical properties matched to the human ACL. The ligament will also be slowly absorbable, resulting in maintenance of mechanical properties for months, but fully absorbed before 18 months. The bone components will be designed to provide attachment to the synthetic ligament and fixation to the tibia and femur, resulting in a stable and functional fixation of the device.
Images courtesy WFIRM, TEBL (UMD)