Pre-clinical in vitro tests are needed to evaluate the biomechanical performance of new spinal implants. For such experiments large animal models are frequently used. Whether these models allow any conclusions concerning the implant's performance in humans is difficult to answer. The aim of the present study was to investigate whether calf, pig or sheep spine specimens may be used to replace human specimens in in vitro flexibility and cyclic loading tests with two different implant types. First, a dynamic and a rigid fixator were tested using six human, six calf, six pig and six sheep thoracolumbar spine specimens. Standard flexibility tests were carried out in a spine tester in flexion/ extension, lateral bending and axial rotation in the intact state, after nucleotomy and after implantation. Then, the Coflex interspinous implant was tested for flexibility and intradiscal pressure using another six human and six calf lumbar spine segments. Loading was carried out as described above in the intact condition, after creation of a defect and after implantation. The fixators were most easily implantable into the calf. Qualitatively, they had similar effects on ROM in all species, however, the degree of stability achieved differed. Especially in axial rotation, the ROM of sheep, pig and calf was partially less than half the human ROM. Similarly, implantation of the Coflex interspinous implant caused the ROM to either increase in both species or to decrease in both of them, however, quantitatively, differences were observed. This was also the case for the intradiscal pressure. In conclusion, animal species, especially the calf, may be used to get a first idea of how a new pedicle screw system or an interspinous implant behaves in in vitro flexibility tests. However, the effects on ROM and intradiscal pressure have to be expected to differ in magnitude between animal and human. Therefore, the last step in pre-clinical implant testing should always be an experiment with human specimens.

BackgroundOne of the greatest challenges in the development of a nucleus prosthesis is to minimize the risk of implant expulsion. At the same time, the physiological flexibility, compressive behavior, and height of the disc should be restored. In this biomechanical in vitro study we investigated the ability of a new nucleus prosthesis made of knitted titanium filaments to meet these challenges.MethodsFlexibility, axial deformation, and height of six bovine lumbar spine segments were measured in the intact condition, after implantation of the new prosthesis, and during and after complex cyclic loading (100,000 cycles). For this purpose, six new prostheses preformed according to the shape of the bovine nucleus pulposus were manufactured. Flexibility was tested in the three main planes under pure moment loads of 7.5 Nm. Axial deformation was measured under application of an axial force of 1000 N. Radiographs taken before and after cyclic testing were used to assess implant migration and expulsion.ResultsIn lateral bending, the intact range of motion (RoM) could almost be restored after implantation. However, in axial rotation, the RoM increased slightly with the implant. This was also the case in extension, with an increase from -2.9° to -6.4°, whereas in flexion, RoM decreased from 4.3° to 3.2°. In all loading planes, cyclic loading caused the RoM to increase asymptotically by 0.1° to 1.8°. The axial deformation of the specimens was nearly equivalent in all tested states, as was their height. Cyclic loading did not cause implant expulsion.ConclusionsIn this feasibility study, the new knitted nucleus prosthesis showed promising results in segmental flexibility, axial deformability, height, and implant expulsion. However, further study is needed for other factors, such as wear and fatigue behavior.

BackgroundOne of the greatest challenges in the development of a nucleus prosthesis is to minimize the risk of implant expulsion. At the same time, the physiological flexibility, compressive behavior, and height of the disc should be restored. In this biomechanical in vitro study we investigated the ability of a new nucleus prosthesis made of knitted titanium filaments to meet these challenges. MethodsFlexibility, axial deformation, and height of six bovine lumbar spine segments were measured in the intact condition, after implantation of the new prosthesis, and during and after complex cyclic loading (100,000 cycles). For this purpose, six new prostheses preformed according to the shape of the bovine nucleus pulposus were manufactured. Flexibility was tested in the three main planes under pure moment loads of 7.5 Nm. Axial deformation was measured under application of an axial force of 1000 N. Radiographs taken before and after cyclic testing were used to assess implant migration and expulsion. ResultsIn lateral bending, the intact range of motion (RoM) could almost be restored after implantation. However, in axial rotation, the RoM increased slightly with the implant. This was also the case in extension, with an increase from -2.9° to -6.4°, whereas in flexion, RoM decreased from 4.3° to 3.2°. In all loading planes, cyclic loading caused the RoM to increase asymptotically by 0.1° to 1.8°. The axial deformation of the specimens was nearly equivalent in all tested states, as was their height. Cyclic loading did not cause implant expulsion. ConclusionsIn this feasibility study, the new knitted nucleus prosthesis showed promising results in segmental flexibility, axial deformability, height, and implant expulsion. However, further study is needed for other factors, such as wear and fatigue behavior.