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Cognitive radios (CRs) mainly aim to reuse the spectrum holes in order to efficiently utilize the available scarce radio spectrum. However, current CRs techniques have a throughput limitation problem which ultimately limits telecommunication applications horizons nowadays. Moreover, achieving high throughput will overcome the bottleneck of CRs application limitations to the reporting and browsing applications only. To tackle this emerging throughput limitation issue in the CRs, this paper proposes the online greedy throughput maximization (OGTM) algorithm which overcomes the throughput limitations. OGTM allows the sensing cycle frame to have a variable length according to the assumed decision validity interval. Then, OGTM varies the decision validity interval of secondary users (SUs) based on the primary users (PUs) historical behavior. As a proof of concept, we developed a simulator in order to evaluate the performance of the proposed OGTM technique. The simulation results show that SUs benefit from the limited PU historical behavior learning, which resultantly increases the throughput up to 95% and at the same time decreases the miss detection probability by 50%.

Purpose: Growing rods are the gold-standard for treatment of early onset scoliosis (EOS). However, these implanted rods experience frequent fractures, requiring additional surgery. A recent study by the U.S. Food and Drug Administration (FDA) identified four common rod fracture locations. Leveraging this data, Agarwal et al. were able to correlate these fractures to high-stress regions using a novel finite element analysis (FEA) framework for one patient. The current study aims to further validate this framework through FEA modeling extended to multiple patients., Methods: Three patient-specific FEA models were developed to match the pre-operative patient data taken from both registry and biplanar radiographs. The surgical procedure was then simulated to match the post-operative deformity. Body weight and flexion bending (1 Nm) loads were then applied and the output stress data on the rods were analyzed., Results: Radiographic data showed fracture locations at the mid-construct, adjacent to the distal and tandem connector across the patients. Stress analysis from the FEA showed these failure locations matched local high-stress regions for all fractures observed. These results qualitatively validate the efficacy of the FEA framework by showing a decent correlation between localized high-stress regions and the actual fracture sites in the patients., Conclusions: This patient-specific, in-silico framework has huge potential to be used as a surgical tool to predict sites prone to fracture in growing rod implants. This prospective information would therefore be vital for surgical planning, besides helping optimize implant design for reducing rod failures., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

MicroCT-based finite element models were used to compute power law relations for uniaxial compressive yield stress versus bone volume fraction for 78 cores of human trabecular bone from five anatomic sites. The leading coefficient of the power law for calcaneus differed from those for most of the other sites ( p  < 0.05). However, after normalizing by site-specific mean values, neither the leading coefficient ( p  > 0.5) nor exponent ( p  > 0.5) differed among sites, suggesting that a given percentage deviation from mean bone volume fraction has the same mechanical consequence for all sites investigated. These findings help explain the success of calcaneal x-ray and ultrasound measurements for predicting hip fracture risk.

Thoracolumbosacral pedicle screw systems (TPSSs) are spinal implants commonly utilized to stabilize the spine as an adjunct to fusion for a variety of spinal pathologies. These systems consist of components including pedicle screws, rods, hooks, and various connectors that allow the surgeon to create constructs that can be affixed to a wide range of spinal anatomy. During the development and regulatory clearance process, TPSSs are subjected to mechanical testing such as static and dynamic compression bending per ASTM F1717, axial and torsional grip testing per ASTM F1798, and foam block pullout testing per ASTM F543. In this study, design and mechanical testing data were collected from 200 premarket notification (510(k)) submissions for TPSSs submitted to FDA between 2007 and 2018. Data were aggregated for the most commonly performed mechanical tests, and analyses were conducted to assess differences in performance based on factors such as component type, dimensions, and materials of construction. Rod material had a significant impact on construct stiffness in static compression bending testing with cobalt chromium rods being significantly stiffer than titanium rods of the same diameter. Pedicle screw type had an impact on compression bending yield strength with monoaxial screws having significantly higher yield strength as compared to polyaxial or uniplanar screws. Axial and torsional gripping capacities between components and the rods were significantly lower for cross-connectors than the other component types. The aggregated data presented here can be utilized for comparative purposes to aid in the development of future TPSSs., (Published by Elsevier Ltd.)

Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement. These additional steps may cause further complications along with increased surgical time and cost. Currently, there are no standardized test methods that evaluate clinically relevant impaction loading conditions on IBFDs. This study aims to develop an in vitro test method that would evaluate implant resistance to failure during intra-operative impaction. To achieve this, (1) surgical implantations of IBFDs were simulated in nine lumbar cadaver specimens by three different orthopedic spine surgeons (n = 3/surgeon). Impact force and mallet speed data were acquired for each surgeon. (2) Based on the acquired surgeon data, a benchtop mechanical test setup was developed to differentiate between two TLIF IBFD designs and two inserter designs (for a total of four IBFD-inserter combinations) under impaction loading. During implant insertion, impact force measurements indicated that lumbar IBFDs are subjected to high energy forces that may exceed their mechanical strength. Our test method successfully replicated clinically-relevant loading conditions and was effective at differentiating failure parameters between different implant and inserter instrument designs. The mechanical test method developed shows promise in its ability to assess impaction resistance of IBFD/inserter designs and evaluate potential risks of device failure during intraoperative loading., (Published by Elsevier Ltd.)

Background: While growing rods are an important contribution to early-onset scoliosis treatment, rod fractures are a common complication that require reoperations. A recent retrieval analysis study performed on failed traditional growing rods revealed that there are commonalities among patient characteristics based on the location of rod fracture. However, it remains unknown if these locations correspond to high stress regions in the implanted construct., Methods: A patient-specific finite element scoliotic model was developed to match the pre-operative (pre-op) scoliotic curve of a patient as described in previously published articles, and by using the patient registry information along with biplanar radiographs. A dual stainless-steel traditional growing rod construct was implanted into this scoliotic model and the surgical procedure was simulated to match the post-operative (post-op) scoliotic curve parameters. Muscle stabilization and gravity was simulated through follower load application. Rod distraction magnitudes were chosen based on pre-op to post-op cobb angle correction, and flexion bending load was simulated to identify the high stress regions on the rods., Results: The patient-specific finite element model identified two high stress regions on the posterior surface of the rods, one at mid construct and the other adjacent to the distal anchors. This correlated well with the data obtained from the retrieval analysis performed by researchers at U.S. Food and Drug Administration (FDA) which showed the posterior surface of the rod as the fracture initiation site, and the three locations of failure as mid-construct, adjacent to distal anchors, and adjacent to tandem connector., Conclusions: The result of this study confirms that the high stress regions on the growing rods, as identified by the FEA, match the fracture prone sites identified in the retrieval analysis performed at the FDA. This proof-of-concept patient-specific approach can be used to predict sites prone to fracture in growing rods., Competing Interests: Dr. Aakash Agarwal reports Director of Research position at Spinal Balance, and editorial board position from Clinical Spine Surgery, Spine, outside the submitted work (thus doesn't influence the work reported in this paper)., (© 2020 The Authors. Published by Elsevier Ltd on behalf of North American Spine Society.)

Background: The quality of the vertebral body structures such as endplate, cortex, and trabecular bone is important for understanding the performance of implants, particularly at the bone-implant interface. Although vertebral body structures have been analyzed separately in the literature, there is no comprehensive study to assess these anatomical measurements along with their interrelationships in the lumbar spine. Therefore, the purpose of this study was to assess variations in trabecular microstructure, vertebral endplate thickness and concavity, and vertebral body cortex thickness within the lumbar spine., Methods: A total of 80 lumbar vertebrae (L1-L5) were dissected from 16 human cadaver specimens and imaged with microcomputed tomography to determine trabecular microstructure, vertebral cortex thickness, endplate thickness, and maximum endplate concavity depth. A paired t test and regression analysis were used to determine significant differences ( P < .05) between different vertebral levels and correlations between the analyzed anatomical parameters., Results: L1 vertebra had significantly better ( P  < .02) trabecular bone microstructure (eg, trabecular bone volume fraction) than all other lumbar vertebrae. However, L1 vertebra also had significantly thinner ( P  ≤ .02) anterior, left, and right cortices compared to all other vertebral levels. Within L3-L5 intervertebral disc spaces, cranial endplates had significantly greater ( P  ≤ .03) thickness and maximum concavity depth compared to their respective caudal endplates. No strong correlations were observed between trabecular bone microstructure, maximum endplate concavity depth, vertebral cortex, and endplate thickness parameters., Conclusions: Detailed reference data of these anatomical parameters for each lumbar vertebral body can aid in improved understanding of bone quality, particularly when assessing different implant designs and fixation approaches. Moreover, such anatomical knowledge may help clinicians with optimal implant design selection and surgical placement of these devices into their respective locations., Competing Interests: Disclosures and COI: The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this article.

Several approaches (anterior, posterior, lateral, and transforaminal) are used in lumbar fusion surgery. However, it is unclear whether one of these approaches has the greatest subsidence risk as published clinical rates of cage subsidence vary widely (7-70%). Specifically, there is limited data on how a patient's endplate morphometry and trabecular bone quality influences cage subsidence risk. Therefore, this study compared subsidence (stiffness, maximum force, and work) between anterior (ALIF), lateral (LLIF), posterior (PLIF), and transforaminal (TLIF) lumbar interbody fusion cage designs to understand the impact of endplate and trabecular bone quality on subsidence. Forty-eight lumbar vertebrae were imaged with micro-ct to assess trabecular microarchitecture. micro-ct images of each vertebra were then imported into image processing software to measure endplate thickness (ET) and maximum endplate concavity depth (ECD). Generic ALIF, LLIF, PLIF, and TLIF cages made of polyether ether ketone were implanted on the superior endplates of all vertebrae and subsidence testing was performed. The results indicated that TLIF cages had significantly lower (p < 0.01) subsidence stiffness and maximum subsidence force compared to ALIF and LLIF cages. For all cage groups, trabecular bone volume fraction was better correlated with maximum subsidence force compared to ET and concavity depth. These findings highlight the importance of cage design (e.g., surface area), placement on the endplate, and trabecular bone quality on subsidence. These results may help surgeons during cage selection for lumbar fusion procedures to mitigate adverse events such as cage subsidence., (Copyright © 2019 by ASME.)

Background Context: Commercially available lumbar integrated fixation cages (IFCs) have variable designs. For example, screw-based designs have up to four screws inserted at different locations across the vertebral end plate as well as at different angles in the sagittal and transverse planes. This is important as end plate and trabecular bone quality may vary across the vertebra and may affect the screw's fixation ability, particularly if bone purchase at the bone-screw interface is poor., Purpose: This study aimed to evaluate whether variations in local bone quality surrounding IFC screws inserted at different locations in the vertebrae would affect their mechanical performance., Study Design: This study is an in vitro human cadaveric biomechanical analysis., Materials and Methods: Fourteen lumbar (L3 and L4) vertebrae from 10 cadavers (age: 76±10 years, bone mineral density: 0.89±0.17 g/cm 2 ) were used for this study. Pilot holes (3.5-mm diameter×15-mm length) representing three different IFC screw orientations (lateral to medial [LM], midsagittal [MS], and medial to lateral [ML]) were created in vertebrae using an IFC guide and bone awl. The screw locations and trajectories chosen are representative of commercially available IFC designs. These pilot holes were then imaged with high-resolution microcomputed tomography to obtain a three-dimensional structure of the bone surrounding the pilot hole. Local bone morphology was then quantified by evaluating a 3-mm-thick circumferential volume surrounding the pilot hole. Integrated fixation screws were implanted into pilot holes while recording maximum screw insertional torques. Screws were toggled in the cranial direction from 10 to 50 N for first 10,000 cycles, and the maximum load was increased by 25 N for every 5,000 cycles for a total of 25,000 cycles., Results: Total bone volume (BV) and trabecular bone volume fraction surrounding ML screws were significantly greater (p<.03) compared with those around MS screws and LM screws. The maximum insertional torque for ML screws were greater (p=.06) than LM and significantly greater (p<.02) than MS screws. The number of cycles to failure for the ML screw was significantly greater (p<.04) than that for the LM and the MS screws. Total BV (R 2 ≤46.2%, p<.03) and the maximum insertional torque (R 2 ≤59.6%, p<.03) provided better correlations to screw loosening compared with all the other bone quality parameters., Conclusions: Our findings indicate that bone quality in the vertebral body varied spatially depending on the orientation and the insertion location of the IFC screw. These alterations in local bone quality significantly affected the screw's ability to fixate to bone. These variations in bone quality may be assessed intraoperatively using screw insertional torque measurements. By understanding available bone purchase at the bone-implant interface, the appropriate implant design can be selected to maximize the fixation strength., (Published by Elsevier Inc.)

Study Design: Randomized Biomechanical Cadaveric Study-Level II., Objective: We aimed to elucidate that placing lateral lumbar interbody cages that span the stronger ring apophysis will require increasing loads for failure, decreasing rates of subsidence, regardless of bone density or endplate integrity., Summary of Background Data: There are several reports regarding the rates and grades of cage subsidence when utilizing the lateral lumbar interbody fusion technique. However, there is limited data on how spanning the lateral cage across the ring apophysis can prevent it., Methods: Eight fresh-frozen human spines (L1-L5) were utilized. Each vertebra was placed with their endplates horizontal in an MTS actuator. A total of 40 specimens were randomized into Groups:Load displacement data was collected at 5 Hz until failure., Results: Longer cages spanning the ring apophysis provided more strength in compression with less subsidence relative to shorter cages, regardless of endplate integrity.Longer cages, spanning the ring apophysis, resting on intact endplates (G2) had a significant (P < 0.05) increase in strength and less subsidence when compared with the smaller cage group resting on intact endplates (G1) (P = 0.003).Longer cages spanning the ring apophysis of intact endplates (G2) showed a significant (P < 0.05) increase in strength and resistance to subsidence when compared with similar length cages resting on decorticated endplates (G4) (P = 0.028)., Conclusion: Spanning the ring apophysis increased the load to failure by 40% with intact endplates and by 30% with decorticated endplates in this osteoporotic cadaveric model. Larger cages that span the endplate ring apophysis could improve the compressive strength and decrease subsidence at the operative level despite endplate violation or osteoporosis., Level of Evidence: 2.

Background: Screw loosening is a well-known adverse event in traditional spinal fusion instrumentation. This phenomenon may hinder segmental stability of the spine leading to bony non-union. In recent years numerous lumbar integrated fixation cages (IFC) have been introduced that offer a low profile alternative to a standard cage with an anterior plate (AP+C). The fixation approach for IFCs is different than a traditional anterior approach; therefore, it is unclear whether IFCs may loosen from the surrounding bone over time. The purpose of this study was to quantify screw loosening of IFC devices compared to AP+C implants under fatigue loading using micro-CT and image processing techniques., Methods: L2-3 and L4-5 functional spinal units (FSUs) were obtained from nine human lumbar spines. These FSUs were then reconstructed with either AP+C or IFC implants designed to attach to vertebral bodies using four screws (two top and two bottom for AP+C; two medial and two lateral for IFC). The reconstructed specimens were fatigued in flexion-extension load of ±3 Nm at 1Hz for first 5,000 cycles and it was increased to ±5 Nm until 20,000 cycles. After removing screws to prevent image artifact, micro-CT scans were performed on all FSUs post-fatigue. These images were post-processed to calculate three-dimensional volumes around screw holes created due to damage at the screw-implant interface., Results: IFC screws had significantly greater (p=0.008) screw hole volumes compared to AP+C screws after fatigue testing. This increased screw hole volume for IFC devices was mainly due to loosening in medial screws. Medial screws had significantly greater (p<0.003) screw hole volumes compared to lateral IFC screws and all AP+C screws. There was no difference (p>0.888) between the screw hole volumes of lateral IFC, top AP+C, and bottom AP+C screws., Conclusions: This study elucidated screw-loosening mechanisms in integrated fixation cages under simulated physiological loading. In particular, spatial differences in fixation was observed for IFC screws across the vertebra where medial screws loosened at a greater frequency compared to lateral screws post-fatigue. This novel technique may also be used to quantitatively investigate screw fixation post-fatigue testing in a variety of spinal devices.

OBJECTIVE Lumbar cages with integrated fixation screws offer a low-profile alternative to a standard cage with anterior supplemental fixation. However, the mechanical stability of integrated fixation cages (IFCs) compared with a cage with anterior plate fixation under fatigue loading has not been investigated. The purpose of this study was to compare the biomechanical stability of a screw-based IFC with a standard cage coupled with that of an anterior plate under fatigue loading. METHODS Eighteen functional spinal units were implanted with either a 4-screw IFC or an anterior plate and cage (AP+C) without integrated fixation. Flexibility testing was conducted in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) on intact spines, immediately after device implantation, and post-fatigue up to 20,000 cycles of FE loading. Stability parameters such as range of motion (ROM) and lax zone (LZ) for each loading mode were compared between the 2 constructs at multiple stages of testing. In addition, construct loosening was quantified by subtracting post-instrumentation ROM from post-fatigue ROM. RESULTS IFC and AP+C configurations exhibited similar stability (ROM and LZ) at every stage of testing in FE (p ≥ 0.33) and LB (p ≥ 0.23) motions. In AR, however, IFCs had decreased ROM compared with AP+C constructs at pre-fatigue (p = 0.07) and at all post-fatigue time points (p ≤ 0.05). LZ followed a trend similar to that of ROM in AR. ROM increased toward intact motion during fatigue cycling for AP+C and IFC implants. IFC specimens remained significantly (p < 0.01) more rigid than specimens in the intact condition during fatigue for each loading mode, whereas AP+C construct motion did not differ significantly (p ≥ 0.37) in FE and LB and was significantly greater (p < 0.01) in AR motion compared with intact specimens after fatigue. Weak to moderate correlations (R 2 ≤ 56%) were observed between T-scores and construct loosening, with lower T-scores leading to decreased stability after fatigue testing. CONCLUSIONS These data indicate that a 4-screw IFC design provides fixation similar to that provided by an AP+C construct in FE and LB during fatigue testing and better stability in AR motion.

Synthetic polyurethane foams are frequently used in biomechanical testing of spinal medical devices. However, it is unclear what types of foam are most representative of human vertebral trabecular bone behavior, particularly for testing the bone-implant interface. Therefore, a study was conducted to compare polyurethane foam microstructure and screw pullout properties to human vertebrae. Cadaveric thoracolumbar vertebrae underwent microcomputed tomography to assess trabecular bone microstructure. Spine plate screws were implanted into the vertebral body and pullout testing was performed. The same procedure was followed for eight different densities (grades 5-30) of commercially available closed cell (CCF) and open cell foams (OCF). The results indicated that foam microstructural parameters such as volume fraction, strut thickness, strut spacing, and material density rarely matched that of trabecular bone. However, certain foams provided mechanical properties that were comparable to the cadavers tested. Pullout force and work to pullout for screws implanted into CCF grade 5 were similar to osteoporotic female cadavers. In addition, screw pullout forces and work to pullout in CCF grade 8, grade 10, and OCF grade 30 were similar to osteopenic male cadavers. All other OCF and CCF foams possessed pullout properties that were either significantly lower or higher than the cadavers tested. This study elucidated the types and densities of polyurethane foams that can represent screw pullout strength in human vertebral bone. Synthetic bone surrogates used for biomechanical testing should be selected based on bone quantity and quality of patients who may undergo device implantation.

Background Context: Numerous integrated fixation cages (IFCs) have recently been introduced to the market with "zero-profile" designs that incorporate screw fixation through the vertebral endplate. It is unclear whether differences in bone quality and quantity in this insertion location may affect fixation compared with screws used in traditional anterior plate (AP) fixation. Moreover, endplate preparation for IFC implantation may affect fixation strength., Purpose: This study aimed to compare pullout strength of screws used in IFCs with screws used for AP implantations., Study Design: A biomechanical cadaveric study., Methods: T12 and L1 vertebrae from 13 human cadaver spines were prepared for pullout testing. End plates in T12 vertebrae were scraped according to surgical practice for fusion procedures. Conversely, endplates in L1 vertebrae were kept intact (unscraped). Integrated fixation cage screws were implanted at a 45° angle into the endplate and AP screws were implanted horizontally into the same vertebral body. Pullout testing was performed on all screws, and peak pullout force (PPF) and work were compared between groups to determine fixation strength. In addition, micro-CT imaging was used to assess bone quantity and quality parameters such as trabecular bone volume fraction, endplate and anterior cortex thickness at screw insertion location, endplate mineralization, and anterior cortex mineralization., Results: Peak pullout force for IFC screws (176±68 N) with scraped endplates was similar (p=.26) to AP screws (192±84 N). However, PPF for IFC screws (231±75 N) with unscraped endplates was significantly greater (p<.01) than AP screws (176±50 N). Peak pullout force for IFC screws with scraped endplates was significantly lower (p=.03) than IFC screws with unscraped endplates. Scraped endplates group (0.17±0.05 mm) were thinner (p=.05) than unscraped endplates (0.21±0.06 mm) by approximately 40 µ on average., Conclusions: These data indicate that IFC and AP screws exhibited similar fixation behavior when the endplate is prepared according to common surgical practices. However, endplate scraping reduces endplate thickness by 20% on average, resulting in a decrease in fixation strength when compared with the unscraped endplates and provides bounds for IFC screw fixation strength., (Published by Elsevier Inc.)

Background: The efficacy of dynamic anterior cervical plates is somewhat controversial. Screws in static-plate designs have a smaller diameter and can cut through bone under load. While not ideal, this unintended loosening can help mitigate stress shielding. Stand-alone interbody devices with integral fixation have large endplate contact areas that may inhibit or prevent loosening of the fixation. This study investigates the load sharing ability of a novel dynamic plate design in preventing the stress shielding of the graft material compared to the non-dynamic devices., Methods: An experimentally validated intact C5-C6 finite element model was modified to simulate discectomy and accommodate implant-graft assembly. Four implant iterations were modeled; InterPlate titanium device with dynamic surface features (springs), InterPlate titanium non-dynamic device, InterPlate titanium design having a fully enclosed graft chamber, and the InterPlate design in unfilled PEEK having a fully enclosed graft chamber. All the models were fixed at the inferior-most surface of C6 and the axial displacement required to completely embed the dynamic surface features was applied to the model., Results: InterPlate device with dynamic surface features induced higher graft stresses compared to the other design iterations resulting in uniform load sharing. The distribution of these graft stresses were more uniform for the InterPlate dynamic design., Conclusions: These results indicate that the dynamic design decreases the stress shielding by increasing and more uniformly distributing the graft stress. Fully enclosed graft chambers increase stress shielding. Lower implant material modulus of elasticity does not reduce stress shielding significantly.

In the thoracolumbar region, between 7% and 30% of spinal fusion failures are at risk for pseudarthrosis. From a biomechanical perspective, the nonconformity of the intervertebral graft to the endplate surface could contribute to pseudarthrosis, given suboptimal stress distributions. The objective of this study was to quantify the effect of endplate-graft conformation on endplate stress distribution, maximum Von Mises stress development, and stability. The study design used an experimentally validated finite element (FE) model of the L4-L5 functional spinal unit to simulate two types of interbody grafts (cortical bone and polycaprolactone (PCL)-hydroxyapatite (HA) graft), with and without endplate-conformed surfaces. Two case studies were completed. In Case Study I, the endplate-conformed grafts and nonconformed grafts were compared under without posterior instrumentation condition, while in Case Study II, the endplate-conformed and nonconformed grafts were compared with posterior instrumentation. In both case studies, the results suggested that the increased endplate-graft conformity reduced the maximum stress on the endplate, created uniform stress distribution on endplate surfaces, and reduced the range of motion of L4-L5 segments by increasing the contact surface area between the graft and the endplate. The stress distributions in the endplate suggest that the load sharing is greater with the endplate-conformed PCL-HA graft, which might reduce the graft subsidence possibility.

Total disc replacement (TDR) is expected to provide a more physiologic alternative to fusion. However, long-term clinical data proving the efficacy of the implants is lacking. Limited clinical data suggest somewhat of a disagreement between the in vitro biomechanical studies and in vivo assessments. This conceptual paper presents the potential biomechanical challenges affecting the TDR that should be addressed with a hope to improve the clinical outcomes and our understanding of the devices. Appropriate literature and our own research findings comparing the biomechanics of different disc designs are presented to highlight the need for additional investigations. The biomechanical effects of various surgical procedures are analyzed, reiterating the importance of parameters like preserving uncinate processes, disc placement and its orientation within the cervical spine. Moreover, the need for a 360° dynamic system for disc recipients who may experience whiplash injuries is explored. Probabilistic studies as performed already in the lumbar spine may explore high risk combinations of different parameters and explain the differences between "standard" biomechanical investigations and clinical studies. Development of a patient specific optimized finite element model that takes muscle forces into consideration may help resolve the discrepancies between biomechanics of TDR and the clinical studies. Factors affecting long-term performance such as bone remodeling, subsidence, and wear are elaborated. In vivo assessment of segmental spine motion has been, and continues to be, a challenge. In general, clinical studies while reporting the data have placed lesser emphasis on kinematics following intervertebral disc replacements. Evaluation of in vivo kinematics following TDR to analyze the quality and quantity of motion using stereoradiogrammetric technique may be needed.