PliaFX Flo Subtalar Fusion Study

Brief Summary

During a subtalar fusion, the bones making up the subtalar joint (talus and calcaneus) are permanently fused together. In the procedure, any damaged cartilage and bone at the subtalar joint is removed, then screws are inserted into the joint to fuse the bones together. Depending on the surgeon, a bone graft is sometimes applied between the bones prior to screw insertion to aid in bone bridging (growth of bone into the fusion site). Participants who consent to this study and are assigned to the PliaFX® Flo Allograft group, will receive PliaFX® Flo Allograft (human tissue donated from a donor) at the fusion site. The PliaFX® Flo system is demineralized bone fibers (hard minerals removed from bone using acid) in a sterile syringe that allows for delivery into small areas where bone graft is needed to assist bone fusion. The allograft bone fibers are produced from donated human cadaver (deceased human) bone. This study aims to determine whether the use of PliaFX® Flo Allograft in subtalar fusions will improve functioning and healing of the bone and cartilage for patients like you. Participants who are interested will discuss with their surgeon and be randomly assigned to one of the two study procedures below. The patient will not know what group they are in until after all data has been collected and all study visits are complete.