Preformed grafts of porcine small intestine submucosa (SIS) for bridging segmental bone defects

Previous studies suggest that fresh, morselized porcine small intestine submucosa (SIS) may have promise in the treatment of large bone defects. This study evaluated the bone regenerative potential of preformed tubular SIS grafts, designed to provide a scaffold for regeneration of diaphyseal bone. Critical length segmental defects in the femurs of male rats were either left unfilled (n = 11) or filled with morselized cancellous bone (n = 12), or spanned with intramedullary tubes (n = 12) or periosteal sleeves (n = 12) fabricated from SIS. All of the animals were euthanized 12 weeks postoperatively. Healing was assessed with biweekly radiographs, routine histology, and mechanical testing. Copious new bone formed in the defects of all of the animals treated with cancellous bone; 10 of the 12 animals in that group had healed their defects. In contrast, no new bone was formed in the defects left unfilled or treated with SIS; only fibrous tissue was found. In both of the SIS-treated groups, the SIS persisted at twelve weeks. The cellular response to the SIS involved a mild mononuclear infiltrate in the loose or delaminated superficial layers of the tubes and sleeves, with few cells in the deeper layers. The results of this study cast doubt on the ability of SIS to support or stimulate growth of bone across a critical length segmental bone defect. Additional work will be required to determine whether our results reflect the protocols used to prepare and fabricate the SIS grafts used in the study or the inherent inability of SIS to support new bone growth.