[Application of a stand-alone interbody fusion cage based on a novel porous TiO2/glass composite. I. Implantation in the sheep cervical spine and radiological evaluation].

Animals are becoming more and more common as in vitro and in vivo models for the human spine. Especially the sheep cervical spine is stated to be of good comparability and usefulness in the evaluation of in vivo radiological, biomechanical and histological behaviour of new bone replacement materials, implants and cages for cervical spine interbody fusion. In preceding biomechanical in vitro examination human cervical spine specimens were tested after fusion with either a cubical stand-alone interbody fusion cage manufactured from a new porous TiO/glass composite (Ecopore) or polymethyl-methacrylate (PMMA) after discectomy. First experience with the use of the new material and its influence on the primary stability after in vitro application were gained. After fusion of 10 sheep cervical spines in the levels C2/3 and C4/5 in each case with PMMA and with an Ecopore-cage, radiologic as well as computertomographic examinations were performed postoperatively and every 4 weeks during the following 2 and 4 months, respectively. Apart from establishing our animal model, we analysed the radiological changes and the degree of bony fusion of the operated segments during the course. In addition we performed measurements of the corresponding disc space heights (DSH) and intervertebral angles (IVA) for comparison among each other, during the course and with the initial values. Immediately after placement of both implants in the disc spaces the mean DSH and IVA increased (34.8% and 53.9%, respectively). During the following months DSH decreased to a greater extent in the Ecopore-segments than in the PMMA-segments, even to a value below the initial value (p>0.05). Similarly, the IVA decreased in both groups in the postoperative time lapse, but more distinct in the Ecopore-segments (p<0.05). These changes in terms of a subsidence of the implants, were confirmed morphologically in the radiological examination in the course. The radiologically evaluated fusion, i.e. bony bridging of the operated segments, was more pronounced after implantation of an Ecopore-cage (83%), than after PMMA interposition (50%), but did not gain statistical significance. In this first in vivo examination of our new porous ceramic bone replacement material we showed its application in the spondylodesis model of the sheep cervical spine. Distinct radiological changes regarding evident subsidence and detectable fusion of the segments, operated on with the new biomaterial, were seen. We demonstrated the radiological changes of the fused segments during several months and analysed them morphologically, before the biomechanical evaluation will be presented in a subsequent publication.