Large mandibular segmental defects resulting from tumor resection, trauma, and congenital anomalies remain one of the most difficult clinical challenges in CMF reconstruction. Autologous tissue grafts and synthetic materials are the current clinical gold standard but suffer from significant drawbacks that make these solutions far from ideal. In particular, prosthetic devices implanted to fill mandibular bone defects and attached to the adjacent host tissues with titanium plates or screws are prone to failure due to metal fatigue and fracture or bone resorption at the host tissue-metal interface. To compete in the CMF reconstruction market, a degradable biomaterial platform able to act as a carrier for osteobiologics must be established. Tissue Regeneration Systems, Inc (TRS) has developed a platform technology to design and fabricate bioactive resorbable coated devices for CMF reconstruction. TRS also completed a SBIR phase I to demonstate the fidelity and reproducibility of its platform. With this proposal, we will move modular osteoconductive scaffold platforms in two aims: 1) determine the best osteoconductive coating conditions in vitro for cell and protein attachment, and 2) test our CMF scaffolds in a clinical setting to reconstruct large mandibular defects in a large animal model, the Yorkshire pig. Successful completion of this proposal will represent a significant advance in TE reconstruction of mandibular defects, using an innovative modular osteoconductive scaffold. Furthermore, testing in a large pre-clinical animal model will give TRS the data necessary to support a 510K submission for FDA device approval.
Mandibular reconstruction following tumor resection, trauma, and congenital defects remains one of the most difficult challenges in craniomaxillofacial (CMF) surgery. Successful reconstruction must simultaneously fill complex defects, sustain chewing forces, and achieve a complete repair of compromised bone tissue. To address these issues, we propose to engineer modular osteoconductive scaffolds for use with intra Operating Room (intraOR) biologics to reconstruct large segmental mandibular defects in a pre-clinical porcine animal model. These bioresorbable scaffolds will address current limitations in mandibular reconstruction associated with the use of metal plates including dehiscence, fatigue fracture, hardware loosening and difficulties in achieving complete aesthetic and functional reconstruction.