Application of a stand-alone interbody fusion cage based on porous TiO2/glass composites -: Part 2:: Biomechanical evaluation after implantation in the sheep cervical spine

Animals are becoming more and more common as 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 examinations human cervical spine specimens were tested after fusion with either a cubical stand-alone interbody fusion cage manufactured from a new porous TiO2/glass composite (Ecopore) or polymethylmethacrylate (PMMA) after discectomy. Following our first experience with the use of the new material and its influence on the primary stability after in vitro application we carried out fusions of 20 sheep cervical spines levels with either PMMA or an Ecopore-cage, and performed radiological examinations during the following 2-4 months. In this second part of the study we intended the biomechanical evaluation of the spine segments with reference to the previously determined morphological findings, like subsidence of the implants, significant increase of the kyphosis angle and degree of the bony fusion along with the interpretation of the results. 20 sheep cervical spines segments with either PMMA or Ecoporefusion in the levels C2/3 and C4/5 were tested, in comparison to 10 native corresponding sheep cervical spine segments. Non-destructive biomechanical testing was performed, including flexion/extension, lateral bending and axial rotation using a spine testing apparatus. Three-dimensional range of motion (ROM) was evaluated using an ultrasound measurement system. In the native spine segments C2/3 and C4/5 the ROM increased in cranio-caudal direction particulary in flexion/extension, less pronounced in lateral flexion and axial rotation (p < 0,05). The overall ROM of both tested segments was greatest in lateral flexion, reduced to 52% in flexion/extension and to 16% in axial rotation. After 2 months C2/3- and C4/5-segments with PMMA-fusion and C2/3-segments with Ecopore-interposition showed decrease of ROM in lateral flexion in comparison to the native segments, indicating increasing stiffening. However, after 4 months all operated segments, independent from level or implanted material, were stiffer than the comparable native segments. The decrease of the ROM correlated with the radiological-morphological degree of fusion. Our evaluation of the new porous TiO2/glass composite as interbody fusion cage has shown satisfactory radiological results as well as distinct biomechanical stability and fusion of the segments after 4 months in comparison to PMMA. After histological analysis of the bone-biomaterial-interface, further examinations of this biomaterial previous to an application as alternative to other customary cages in humans are necessary.