Study design: Biomechanical study in cadaveric specimens. Background:The commercially available lumbar disc prostheses do not reproduce the intact disc's Instantaneous centre of Rotation (ICR), thus inducing an overload on adjacent anatomical structures, promoting secondary degeneration.Aim: To examine biomechanical testing of cadaveric lumbar spine specimens in order to evaluate and define the ICR of intact lumbar discs.Material and Methods: Twelve cold preserved fresh human cadaveric lumbosacral spine specimens were subjected to computerized tomography (CT), magnetic resonance imaging (MRI) and biomechanical testing. Kinematic studies were performed to analyse range of movements in order to determine ICR.Results: Flexoextension and lateral bending tests showed a positive linear correlation between the angle rotated and the displacement of the ICR in different axes.Discussion: ICR has not been taken into account in any of the available literature regarding lumbar disc prosthesis. Considering our results, neither the actual ball-and-socket nor the withdrawn elastomeric nucleus models fit the biomechanics of the lumbar spine, which could at least in part explain the failure rates of the implants in terms of postoperative failed back syndrome (low back pain). It is reasonable to consider then that an implant should also adapt the equations of the movement of the intact ICR of the joint to the post-surgical ICR.Conclusions: This is the first cadaveric study on the ICR of the human lumbar spine. We have shown that it is feasible to calculate and consider this parameter in order to design future prosthesis with improved clinical and biomechanical characteristics. * Corresponding author.spine [78] . When the intervertebral disc degenerates, it loses its capacity to transmit this load and thus may become a source of low back pain [66] .Lumbar disc arthroplasty was introduced in 1960 [27] , although results were not promising until the 1980 ′ s [7 , 36 , 60 , 115] . The aim of this surgical procedure is to preserve motion as well as to avoid spinal fusion related complications and side-effects. The first successfully implanted device was the SB Charitè [7 , 15] . The initial suboptimal results, which occurred due to mechanical failure [7 , 19 , 52 , 101 , 102] , were mitigated by repeatedly improving on the design [60] . Ever since, many other disc

Study design : Biomechanical study of a nucleus replacement with a finite element model. Objective : To validate a Bionate 80A ring-shaped nucleus replacement. Methods : The ANSYS lumbar spine model made from lumbar spine X-rays and magnetic resonance images obtained from cadaveric spine specimens were used. All materials were assumed homogeneous, isotropic, and linearly elastic. We studied three options: intact spine, nucleotomy, and nucleus implant. Two loading conditions were evaluated at L 3 -L 4 , L 4 -L 5 , and L 5 -S 1 discs: a 1000 N axial compression load and this load after the addition of 8 Nm flexion moment in the sagittal plane plus 8 Nm axial rotation torque. Results : Maximum nucleus implant axial compression stresses in the range of 16–34 MPa and tensile stress in the range of 5–16 MPa, below Bionate 80A resistance were obtained. Therefore, there is little risk of permanent implant deformation or severe damage under normal loading conditions. Nucleotomy increased segment mobility, zygapophyseal joint and end plate pressures, and annulus stresses and strains. All these parameters were restored satisfactorily by nucleus replacement but never reached the intact status. In addition, annulus stresses and strains were lower with the nucleus implant than in the intact spine under axial compression and higher under complex loading conditions. Conclusions : Under normal loading conditions, there is a negligible risk of nucleus replacement, permanent deformation or severe damage. Nucleotomy increased segmental mobility, zygapophyseal joint pressures, and annulus stresses and strains. Nucleus replacement restored segmental mobility and zygapophyseal joint pressures close to the intact spine. End plate pressures were similar for the intact and nucleus implant conditions under both loading modes. Manufacturing customized nucleus implants is considered feasible, as satisfactory biomechanical performance is confirmed.

Response to foreign materials includes local tissue reaction, osteolysis, implant loosening, and migration to lymph nodes and organs. Bionate 80A human explants show minor wear and slight local tissue reaction, but we do not know the response at the spinal cord, nerve roots, lymph nodes, or distant organs. This study aims to figure out reactions against Bionate 80A when implanted at the spinal epidural space of 24 20-week-old New Zealand white rabbits. In one group of 12 rabbits, we implanted Bionate 80A on the spinal epidural space, and another group of 12 rabbits was used as the control group. We studied tissues, organs, and tissue damage markers on blood biochemistry, urine tests, and necropsy. The animals’ clinical parameters and weight showed no statistically significant differences. At 3 months, the basophils increased slightly in the implant group, platelets decreased in all, and at 6 months, implanted animals showed slight eosinophilia, but none of these changes was statistically significant. External, organ, and spinal tissue examination showed neither toxic reaction, inflammatory changes, or noticeable differences between groups or survival periods. Under microscopic examination, the Bionate 80A particles induced a chronic granulomatous response always outside the dura mater , with giant multinucleated cells holding phagocytized particles and no particle migration to lymph nodes or organs. Thus, it was concluded that Bionate particles, when implanted in the rabbit lumbar epidural space, do not generate a significant reaction limited to the surrounding soft tissues with giant multinucleated cells. In addition, the particles did not cross the dura mater or migrate to lymph nodes or organs.

Design: cadaveric spine nucleus replacement study. Objective: determining Bionate 80A nucleus replacement biomechanics in cadaveric spines. Methods: in cold preserved spines, with ligaments and discs intact, and no muscles, L3-L4, L4-L5, and L5-S1 nucleus implantation was done. Differences between customized and overdimensioned implants were compared. Flexion, extension, lateral bending, and torsion were measured in the intact spine, nucleotomy, and nucleus implantation specimens. Increasing load or bending moment was applied four times at 2, 4, 6, and 8 Nm, twice in increasing mode and twice in decreasing mode. Spine motion was recorded using stereophotogrammetry. Expulsion tests: cyclic compression of 50–550 N for 50,000 cycles, increasing the load until there was extreme flexion, implant extrusion, or anatomical structure collapse. Subsidence tests were done by increasing the compression to 6000 N load. Results: nucleotomy increased the disc mobility, which remained unchanged for the adjacent upper level but increased for the lower adjacent one, particularly in lateral bending and torsion. Nucleus implantation, compared to nucleotomy, reduced disc mobility except in flexion-extension and torsion, but intact mobility was no longer recovered, with no effect on upper or lower adjacent segments. The overdimensioned implant, compared to the customized implant, provided equal or sometimes higher mobility. Lamina, facet joint, and annulus removal during nucleotomy caused more damaged than that restored by nucleus implantation. No implant extrusion was observed under compression loads of 925–1068 N as anatomical structures collapsed before. No subsidence or vertebral body fractures were observed under compression loads of 6697.8–6812.3 N. Conclusions: nucleotomized disc and L1-S1 mobility increased moderately after cadaveric spine nucleus implantation compared to the intact status, partly due to operative anatomical damage. Our implant had shallow expulsion and subsidence risks.

Background context. Dental implants are designed to replace a missing tooth. Implant stability is vital to achieving osseointegration and successful implantation. Although there are many implants available on the market, there is room for improvement. Purpose. We describe a new dental implant with improved primary stability features. Study design. Lab bench test studies. Methods. We evaluated the new implant using static and flexion–compression fatigue tests with compression loads, 35 Ncm tightening torque, displacement control, 0.01 mm/s actuator movement speed, and 9–10 Hz load application frequency, obtaining a cyclic load diagram. We applied variable cyclic loadings of predetermined amplitude and recorded the number of cycles until failure. The test ended with implant failure (breakage or permanent deformation) or reaching five million cycles for each load. Results. Mean stiffness was 1151.13 ± 133.62 SD N/mm, mean elastic limit force 463.94 ± 75.03 SD N, and displacement 0.52 ± 0.04 SD mm, at failure force 663.21 ± 54.23 SD N and displacement 1.56 ± 0.18 SD mm, fatigue load limit 132.6 ± 10.4 N, and maximum bending moment 729.3 ± 69.43 mm/N. Conclusions. The implant fatigue limit is satisfactory for incisor and canine teeth and between the values for premolars and molars for healthy patients. The system exceeds five million cycles when subjected to a 132.60 N load, ensuring long-lasting life against loads below the fatigue limit.