Evaluation of cryopreserved bone and synthetic biomaterials in promoting spinal fusion

The purpose of the study was to evaluate the use of cryopreserved allograft bone and tricalcium phosphate in promoting spinal fusion. Nine 20-30 lb swine underwent posterior spinal fusion at T5-T6, T13-T14, and L2-L3. Autogenous bone, cryopreserved allograft bone, or equal parts of allograft bone and tricalcium phosphate were added to the decorticated posterior elements. A total of 27 sites were prepared for fusion. The spines were retrieved at 6 months and evaluated for integrity and stability of the fusion sites by clinical examination, three-point bending tests, multiplanar radiographs, and undecalcified tetracycline-labeled and decalcified histologic sections. The nine sites that received autogenous bone were solidly fused. There were one clinical and two radiographic nonunions in the nine sites that received cryopreserved allograft bone. Sites that received a mixture of allograft bone and tricalcium phosphate demonstrated slight motion at two locations and radiographic evidence of fusion at all levels. The extent and degree of fusion was not site-specific. Three-point bending analysis did not demonstrate a significant trend as to site or materials specificity. No adverse histologic response was noted. Histologic sections and tetracycline labels confirmed abundant new bone formation at all sites at 6 months. Although autogenous bone remains the gold standard for use in spinal arthrodesis, this study demonstrates the value of cryopreserved allograft bone alone and in combination with tricalcium phosphate in promoting spinal fusion.