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BACKGROUND: ‘SMART’ implants refer to modified orthopedic implants that combine the biomechanical safety and efficacy of traditional devices with the intelligence of data-logging sensors. This review aims to systematically assess the available literature on SMART spinal implants and present these findings in a clinically relevant manner. METHODS: A search of PubMed, Scopus, and Google Scholar databases was conducted by two separate reviewers. Information including sensor type, intended application, and sample size, was extracted from included studies. Risk of bias assessment was conducted using the Office of Health Assessment and Translation (OHAT) risk of bias tool. RESULTS: Eighteen studies were included for analysis. Eight studies involved SMART rods and ten studies used SMART vertebral body replacements (VBR). No more than 20 patients are reported to have received a SMART spinal implant. Including non-primary evidence, seven unique designs for SMART spinal implants were found. The majority of these used strain gauges with recent designs including thermometers and accelerometers. DISCUSSION: At present, SMART spinal implants have primarily focused on utilising strain gauges to report loading on the implant itself. This is a logical first step as it allows quantification of real-world requirements of an implant, detection of catastrophic failure, while also allowing researchers and clinicians to estimate changes in load sharing between newly forming bone and the implant itself, providing real-time information on the progression of healing and fusion. Future work includes documenting the correlation between data provided by these SMART implants and clinical findings, including complications such as pedicle screw loosening and interbody cage subsidence.

Bone models serve many purposes, including improving anatomical understanding, preoperative surgical planning, and intraoperative referencing. Several techniques for the maceration of soft tissues have been described, mainly for forensic analysis. For clinical research and medical use, these methods have been superseded by three-dimensional (3D) printed models, which require substantial equipment and expertise, and are costly. Here, cadaveric sheep vertebral bone was cleaned by vacuum sealing the specimen with commercial dishwashing detergent, immersing in a hot water bath, and subsequently manually removing the soft tissue. This eliminated the disadvantages of the previously existing maceration methods, such as the existence of foul odors, usage of hazardous chemicals, substantial equipment, and high costs. The described technique produced clean, dry samples while maintaining anatomical detail and structure to accurately model the osseous structures that can be useful for preoperative planning and intraoperative referencing. The method is simple, low-cost, and effective for bone model preparation for education and surgical planning in veterinary and human medicine.

Background Cage subsidence is a known complication of spinal fusion. Various aspects of cage design have been investigated for their influence on cage subsidence, whereas the potential contribution of graft material to load sharing is often overlooked. We aimed to determine whether graft in the aperture affects endplate pressure distribution. Methods The pressure distributions of a polyetheretherketone interbody cage with 3 different aperture graft conditions were evaluated: empty, demineralized bone matrix, and supercritical CO2-treated allograft bone crunch (SCCO2). Results Graft materials contributed as much as half the load transmission for SCCO2, whereas demineralized bone matrix contributed one third. Endplate areas in contact with the cage demonstrated decreased areas within the highest-pressure spectrum with SCCO2 graft materials compared with empty cages. Conclusions Graft choice plays a role in reducing peak endplate pressures. This finding is relevant to implant subsidence, as well as graft loading and remodeling.

BACKGROUND CONTEXT The interface and interactions between an interbody cage, graft material, and host bone can all participate in the fusion. Shortcomings of Poly(aryl-ether-ether-ketone) interbody cages have been addressed with novel titanium surfaces. Titanium surfaces paired with macroscale topography features on the endplates and within the aperture may provide additional benefits. PURPOSE To evaluate the influence of cage design parameters on interbody fusion in a large animal preclinical model. STUDY DESIGN/SETTING A comparative preclinical large animal model was performed to evaluate how macroscale topography features of an interbody cage can facilitate early integration between the host bone, graft material, and interbody cage and these effects on biomechanical stability and fusion. METHODS Forty single level interbody fusions (L4–L5) using iliac crest autograft and bilateral pedicle screw fixation were performed in adult sheep to evaluate the effect of undercut macrostructure topography features of an interbody cage on the endplates and within the aperture. Fusions were evaluated at 6 and 12 weeks (n=10 per group) using radiography, microcomputed tomography, biomechanical integrity, and histology endpoints. RESULTS The presence of the undercut macrostructures present on the endplates and within the aperture statistically improved biomechanical integrity at 6 and 12 weeks compared with controls. Microcomputed tomography and histology demonstrated bony interdigitation within the endplate and aperture features contributing to the improvement in properties. CONCLUSIONS The present study demonstrates that Poly(aryl-ether-ether-ketone) implants with titanium surfaces can be augmented by undercut macrostructures present on the endplates and within the aperture to provide opportunities for a series of anchoring points that, with new bone formation and remodelling, result in earlier and improved biomechanical integrity of the treated level. CLINICAL SIGNIFICANCE This preclinical study showed that bone interdigitation with the undercut macrostructures present on the endplates and within the aperture resulted in improved fusion and biomechanical stability in a clinically relevant spinal fusion model. Future clinical study is warranted to evaluate such implants’ performance in humans.

Background: The aim of this study was to investigate total hip arthroplasty (THA) Morse taper pull-off strengths after impaction prior to cyclical loading compared to cyclical loading alone. The practical relevance of the experiment is to provide a perspective on what may be clinically satisfactory taper assembly given the spectrum of head tapping patterns used by surgeons, as well as compare traditional impaction performed in standard THA with alternate methods of taper engagement such as ‘ in situ assembly’ used in micro-invasive techniques. Methods: 36 taper constructs utilising a combination of cobalt-chrome alloy and ceramic-titanium alloy junctions were investigated in vitro in wet and dry conditions with cyclical loading of the constructs. Taper disengagement strengths with and without impaction were compared. Secondary investigation of the surface roughness of the heads and tapers was also assessed. Results: An impaction to a wet taper resulted in a greater pull off force compared to a dry taper with a CoCr head and taper combination. Impacting the head and dryness of the taper did not affect pull off forces of a ceramic femoral head on titanium taper. Pulling a head off a taper significantly alters the head surface roughness. Conclusion: Impaction of a taper does not provide any benefit over cyclical loading of a taper assembly alone for pull-off strength.

Water is a crucial component of bone, affecting the interplay of collagen and minerals and contributing to bone's high strength and ductility. Dehydration has been shown to significantly effect osseous mechanical properties; however, studies comparing the effects of various dehydrating environments on fracture toughness of bone are scarce. Accordingly, the crack resistance curve (R-curve) behavior of human and sheep cortical bone was characterized in a bio-bath, in ambient pressure air, and in scanning electron microscopes (SEMs) under three different environmental conditions (water vapor pressure, air pressure, and high-vacuum). The aim of this work was to better understand the impact of test environment on both intrinsic and extrinsic toughening and hence crack initiation toughness, K

Background The rabbit lumbar spine is a commonly utilized model for studying intervertebral disc degeneration and for the pre‐clinical evaluation of regenerative therapies. Histopathology is the foundation for which alterations to disc morphology and cellularity with degeneration, or following repair or treatment are assessed. Despite this, no standardized histology grading scale has yet been established for the spine field for any of the frequently utilized animal models. Aims The purpose of this study was to establish a new standardized scoring system to assess disc degeneration and regeneration in the rabbit model. Materials and Methods The scoring system was formulated following a review of the literature and a survey of spine researchers. Validation of the scoring system was carried out using images provided by 4 independent laboratories, which were graded by 12 independent graders of varying experience levels. Reliability testing was performed via the computation of intra‐class correlation coefficients (ICC) for each category and the total score. The scoring system was then further refined based on the results of the ICC analysis and discussions amongst the authors. Results The final general scoring system involves scoring 7 features (nucleus pulposus shape, area, cellularity and matrix condensation, annulus fibrosus/nucleus pulposus border appearance, annulus fibrosus morphology, and endplate sclerosis/thickening) on a 0 (healthy) to 2 (severe degeneration) scale. ICCs demonstrated overall moderate to good agreement across graders. An addendum to the main scoring system is also included for use in studies evaluating regenerative therapeutics, which involves scoring cell cloning and morphology within the nucleus pulposus and inner annulus fibrosus. Discussion Overall, this new scoring system provides an avenue to improve standardization, allow a more accurate comparison between labs and more robust evaluation of pathophysiology and regenerative treatments across the field. Conclusion This study developed a histopathology scoring system for degeneration and regeneration in the rabbit model based on reported practice in the literature, a survey of spine researchers, and validation testing., The rabbit lumbar spine is a commonly utilized model for studying intervertebral disc degeneration and for the pre‐clinical evaluation of regenerative therapies, and histopathology is the foundation for which alterations to disc morphology and cellularity with degeneration, or following repair or treatment are assessed. Despite this, no standardized histology grading scale has yet been established for the spine field for any of the frequently utilized animal models. Therefore, the purpose of this study was to establish a new standardized scoring system to assess disc degeneration and regeneration in the rabbit model.

Background Consideration of sagittal alignment is an integral part of spinal fusion surgery correlating with superior outcomes. Segmental lordosis is an important contributor to sagittal alignment. This study assessed surgical factors influencing segmental lordosis in a 360° fusion model, including cage dimensions, anterior longitudinal ligament resection, facetectomy, and posterior compression. Methods Six L3-4 synthetic spinal motion segments were used in a repeated measures design. Each sample was sequentially instrumented with lateral cages of increasing height and angle. Lordosis was assessed from lateral radiographs of intact and each instrumented condition. The effect of anterior longitudinal ligament resection, posterior compression with pedicle screws, and bilateral facetectomy was additionally examined. Results A linear relationship between segmental lordosis and cage height was found. This effect was greater with the anterior longitudinal ligament divided. In cages of the same anterior height, increased intrinsic cage lordosis did not result in increased segmental lordosis; cages with no intrinsic lordosis resulted in the highest segmental lordosis. In examining this finding, it was shown that posterior cage height had a larger influence on segmental lordosis. Posterior compression with pedicle screws and bilateral facetectomy increased the segmental lordosis by a further 3.4° and 2.6°, respectively. Conclusions Cage height was a key factor, with posterior compression further increasing lordosis. The finding that 0° cages results in the most segmental lordosis was an unexpected finding and highlights the importance of appropriate sizing on resulting lordosis. These findings are relevant to cage selection but require further study prior to applying to clinical practice and may influence future cage design.

Primary stability and secondary fixation of orthopedic implants to bony tissues are important for healing and long-term functionality. Load sharing and stress transfer are key requirements of an effective implant/tissue interface. This paper presents a novel, macro-scale osseointegration surface morphology which addresses the implant/tissue interface from both the biologic as well as biomechanical perspective. The surface morphology is a controlled, engineered, open topography manifested as discrete pillars projecting from the implant enabling continuous bone ingrowth. The pillared surface is distinct from other porous surfaces and can be differentiated by the localization of the implant material into discrete pillars enabling a continuous mass of bone to freely and easily interdigitate into the pillared structure. Traditional porous structures distribute the implant material throughout the surface forcing the bone to grow in a discontinuous manner. Creating an open and continuous space or "open porosity" in and around the pillar structure allows the bone to easily interdigitate with the implant surface without encumberment from a continuous porous structure. An in-vivo study, using an established ovine model, was undertaken examining the effects of pillar morphology on bone ingrowth and mechanical performance. Cortical and cancellous sites were evaluated utilizing histology, histomophometry, and mechanical pushout, at 4 and 12 weeks. Robust bone ingrowth occurred for all morphologies as was noted in review of the study results. An increase in volume and maturity of bone was noted between the intermediated and final time points. Histomophometry demonstrated over 40% and 80% new bone occupied the available "ingrowth" area at 12 weeks for cancellous and cortical sites (respectively). Histologic review showed little fibrous tissue ingrowth at the interface with no adverse cellular reactions. Testing of cortical samples demonstrated a significant increase in pushout load between the 4 and 12 week timepoints and a 4-8 fold increase in pushout load as compared to the grit blast control. These results demonstrated the effectiveness of the novel interface for orthopedic applications in an in-vivo ovine model.

Objective Lower back pain associated with degenerative disc disease (DDD) is a leading cause of disability worldwide. Anterior lumbar interbody fusion (ALIF) has been shown to be effective for treating refractory DDD, but it remains unclear which patients may benefit most from the procedure. This study aims to develop a predictive model for clinical success in L5/S1 ALIF for DDD. Methods A retrospective cohort study of 68 patients with refractory DDD who underwent L5/S1 ALIF was performed. Clinical success was defined as an improvement in Oswestry Disability Index (ODI) of 20 points postoperatively. Exploratory analyses were performed on 16 preoperative clinical and radiographic parameters, followed by a multivariate logistic regression. Evaluation of the predictive model was performed. Results After exploratory analyses, 4 parameters were suitable for inclusion in the multivariate model. Workers' compensation status (odds ratio [OR], 0.02; 95% confidence interval [CI], 0.001–0.262; P = 0.004) and preoperative ODI (OR, 1.13; 95% CI, 1.05–1.23; P = 0.002) were statistically significant parameters. Furthermore, posterior disc height and disc depth contributed significantly to the model variance (OR, 0.69, 95% CI, 0.44–1.09 and OR, 0.97, 95% CI, 0.81–1.15, respectively). The model had a sensitivity of 81.5%, specificity of 83.3%, C-statistic of 0.921, and a calibration plot similar to the 45° reference line. Conclusions This analysis confirms workers' compensation and low preoperative ODI as risk factors for successful L5/S1 ALIF performed for DDD. It also identifies novel prognostic factors, namely posterior disc height and disc depth. This model can aid in patient counseling and selection in the management of L5/S1 DDD.

BackgroundWhat is the right surface for an implant to achieve biological fixation? Surface technologies can play important roles in encouraging interactions between the implant surface and the host bone to achieve osseointegration. Preclinical animal models provide important insight into in vivo performance related to bone ongrowth and implant fixation.MethodsA large animal model was used to compare the in vivo response of HA and plasma-sprayed titanium coatings in a well-reported adult ovine model to evaluate bone ongrowth in terms of mechanical properties in cortical sites, and histology and histomorphometry in cortical and cancellous sites at 4 and 12 weeks.ResultsTitanium plasma-sprayed surfaces outperformed the HA-coated samples in push-out testing in cortical sites while both surfaces supported new bone ongrowth and remodeling in cortical and cancellous sites.ConclusionsWhile both HA and Ti plasma provided an osteoconductive surface for bone ongrowth, the Ti plasma provided a more robust bone-implant interface that ideally would be required for load transfer and implant stability in the longer term.

Background Context Degenerative disc disease (DDD) is a common, widespread socioeconomic problem. Appropriate large animal models of DDD are required for improved understanding and to serve as preclinical test beds for therapeutic strategies. Purpose To evaluate the effects of short and medium duration immobilization on the sheep lumbar intervertebral disc (IVD) and facet joints (FJs), and to establish a large animal model for DDD research. Study Design An in vivo sheep model evaluating the effect of short- and medium-term immobilization on disc degeneration. Methods Eighteen sheep were equally randomized into three groups: short-term (6-week) immobilization (n=6), medium-term (26-week) immobilization (n=6), and control (no surgery) (n=6). Immobilization of L3–L4 was achieved with pedicle screw and rod implantation, the IVD was kept intact, and the annulus and end plates were not disrupted. The IVD and FJs were assessed with planar radiography, computerized tomography (CT), magnetic resonance imaging (MRI), pure moment biomechanical testing, and histologic analysis. Results Disc height was reduced for 6- and 26-week immobilization groups. The MRI and histologic analysis demonstrated significant disc degeneration for both immobilized groups compared with control, but no statistical difference was detected between short- and medium-term duration. Progressive degenerative changes in FJs were observed with micro-CT and histologic end points. Immobilization significantly reduced lateral bending and flexion-extension range of motion. Conclusions The mechanical environment set up by immobilization alone is capable of inducing lumbar disc degeneration at both 6 and 26 weeks in sheep. Longer duration immobilization did not advance disc degeneration process beyond of that found with short duration. The present model produces a degenerative disc with intact annulus and without acute injury, more closely representing the scenario common in human disc degeneration. This provides a suitable large animal in vivo model for the evaluation of the new therapies for disc degeneration. Further studies would do well to examine the effect of remobilization after immobilization in this model.

Increasing bone ongrowth and ingrowth of polyether ether ketone (PEEK) interbody fusion devices has the potential to improve clinical outcomes.This study evaluated the in vivo response of promoting new bone growth and bone apposition with NanoMetalene (NM) compared with PEEK alone in a cancellous implantation site with an empty aperture.This is a randomized control animal study.Implants and funding for this study were provided by SeaSpine (60,000 USD). Cylindrical dowels with two apertures were prepared as PEEK with a sub-micron layer of the titanium (NM). The titanium coating was applied over the entire implant (Group 1) or just the apertures (Group 2). Polyether ether ketone implants with no coating served as controls (Group 3). Implants were placed in the cancellous bone of the distal femur or proximal tibia with no graft material placed in the apertures in eight adult sheep. Bone ongrowth to the surface of the implant and ingrowth into the apertures was assessed at 4 and 8 weeks after surgery with micro-computed tomography (CT) and undecalcified histology.The apertures in the implants were notably empty in the PEEK group at 4 and 8 weeks. In contrast, new bone formation into the apertures was found in samples coated with NM even though no graft material was placed into the defect. The bone growing into the aperture tracked along the titanium layer. Apertures with the titanium coating demonstrated significantly more bone by micro-CT qualitative grading compared with PEEK with average bone coverage scores of Group 1 (NM) 1.62±0.89, Group 2 (NM apertures only) 1.62±0.77, and Group 3 (PEEK) 0.43±0.51, respectively, at 4 weeks (p.01) and Group 1 (NM) 1.79±1.19, Group 2 (NM apertures only) 1.98±1.18, and Group 3 (PEEK) 0.69±0.87, respectively, at 8 weeks (p.05). The amount of bone in the apertures (ingrowth) quantified using the volumetric data from the micro-CT supported an overall increase in bone volume inside the apertures with the titanium coating compared with PEEK. Histology showed newly formed woven bone tracked along the surface of the titanium in the apertures. The PEEK interface presented the typical nonreactive fibrous tissue inside the apertures at 4 weeks and some focal contact with bone on the outside at 4 weeks and 8 weeks.Micro-CT and histology demonstrated bone ongrowth to the surfaces coated with NM where the newly formed bone tracked along the thin titanium-coated surfaces. Polyether ether ketone surfaces presented the nonreactive fibrous tissue at the interface as previously reported in preclinical scenarios.

BACKGROUND: Intervertebral disc degeneration is a major cause of chronic low back pain, and excessive loading contributes to intervertebral disc degeneration. However, the lack of an effective bipedal in vivo animal model limits research about this condition. QUESTIONS/PURPOSES: To evaluate the utility of a new type of bipedal standing mouse model for intervertebral disc degeneration, we asked: (1) Are there spinal degeneration changes in bipedal mice as determined by lumbar disc height, histologic features, and immunohistochemistry measures compared with control mice? (2) Are the bipedal mice comparable to aged mice for simulating the spinal degeneration caused by increased stress? METHODS: Thirty-two 8-week-old male C57BL/6 mice were divided into experimental and control groups. Based on their hydrophobia, mice in the experimental group were placed in a limited water-containing space (5 mm deep) and were thereby induced to actively take a bipedal standing posture. This was conducted twice a day for a total of 6 hours a day, 7 days a week. Control mice were similarly placed in a limited but water-free space. Video surveillance was used to calculate the percentage of time spent in the bipedal stance for the two groups of mice. Compared with the control group, the percentage of time standing on both feet in the experimental group was higher (48% ± 5%, 95% confidence interval [CI], 42%–54% versus 95% ± 1%, 95% CI, 92%–97%; p < 0.001). Eight mice from both groups were then randomly euthanized at either 6 or 10 weeks and lumbar spine specimens (L3-L6) were collected. The lumbar disc height index (DHI%) of the two groups was compared using micro-CT measurements, and the extent of disc degeneration was assessed based on histologic staining (cartilage endplate height, disc degeneration score) and by immunohistochemistry (Col2a1,CollagenX, matrix metalloprotease-13 [MMP-13], osteocalcin [OCN]). In addition, the histopathologic features of spinal degeneration were compared with 12- and 18-month-old mice. A p value < 0.05 indicated a significant difference. RESULTS: Lumbar disc degeneration was aggravated after 10 weeks with the DHI% decreasing (5.0% ± 0.4%; 95% CI, 4.6%–5.5% versus 4.6 ± 0.3%; 95% CI, 4.3%–4.9%; p = 0.011). Histologically, the cartilage endplate height of the experimental group was decreased compared with the control group (30 ± 6 μm; 95% CI, 24–37 μm versus 70 ± 7 μm; 95% CI, 63–79 μm; p < 0.001), and the disc degeneration score was increased (5 ± 1; 95% CI, 4–6 versus 1 ± 1; 95% CI, 0–2; p < 0.001). Expression of Col2a1, vimentin, and aggrecan in the experimental group was decreased compared with the control group, whereas the expressions of collagen X (60% ± 2%; 95% CI, 55%–66% versus 19% ± 3%; 95% CI, 17%–24%; p < 0.001), MMP-13 (54% ± 8%; 95% CI, 49%–61% versus 1% ± 1%; 95% CI, 1%–2%; p < 0.001), and OCN (41% ± 3%; 95% CI, 34%–49% versus 5% ± 1%; 95% CI, 2%–7%, p < 0.001) were increased. The spine degeneration caused by this model was primarily manifested in the degeneration of the annulus fibrosus and facet joints compared with aged mice, whereas the degree of degeneration in the nucleus pulposus tissue and cartilage endplates was mild. CONCLUSIONS: We believe we have established a noninvasive and effective in vivo bipedal mouse model for studying disc degeneration and biologic signal transduction comparable to that seen in intervertebral disc degeneration. CLINICAL RELEVANCE: This in vivo mouse model of intervertebral disc degeneration can simulate the pathogenesis of spinal degeneration caused by increased stress and this can be used to study questions such as disc herniation in young adults.

Optimization of porous titanium alloy scaffolds designed for orthopedic implants requires balancing mechanical properties and osseointegrative performance. The tradeoff between scaffold porosity and the stiffness/strength must be optimized towards the goal to improve long term load sharing while simultaneously promoting osseointegration . Osseointegration into porous titanium implants covering a wide range of porosity (0%–90%) and manufactured by laser powder bed fusion (LPBF) was evaluated with an established ovine cortical and cancellous defect model. Direct apposition and remodeling of woven bone was observed at the implant surface , as well as bone formation within the interstices of the pores. A linear relationship was observed between the porosity and benchtop mechanical properties of the scaffolds, while a non-linear relationship was observed between porosity and the ex vivo cortical bone-implant interfacial shear strength . Our study supports the hypothesis of porosity dependent performance tradeoffs, and establishes generalized relationships between porosity and performance for design of topological optimized implants for osseointegration. These results are widely applicable for orthopedic implant design for arthroplasty components, arthrodesis devices such as spinal interbody fusion implants, and patient matched implants for treatment of large bone defects.

Long-term survival of orthopedic implants requires a strong and compliant interface between the implant and surrounding bone. This paper further explores the in-vivo response to a novel, macro-scale osseointegration surface morphology. In this study, we examine the effects of material composition on osseointegration in relation to the controlled surface geometry. The pillared surface is constructed of discontinuous surface geometry which creates an open space for unencumbered bone migration. In creating an open, macro-scale morphology we have demonstrated a bone migration and integration that is less dependent on the underlying implant material and is substantially driven thru surface geometry. In this in-vivo study an established ovine model was used to examine the effects of implant material composition on bone ingrowth and mechanical performance. Cortical and cancellous sites in the tibia and distal femur were examined at 6 and 12 weeks with μCT, histology, histomorphometry, and mechanical performance. Implant materials tested included PEEK (Evonik, VISTAKEEP®), PEEK HA (Invibio, PEEK-OPTIMA HA Enhanced), Titanium coated PEEK, Titanium (Ti–6Al–4V, Grade 5), and Ultra-High Molecular Weight Polyethylene (UHMWPE). Extensive bone ingrowth was noted in all implant materials at 12 weeks with maturation of the bone within the pillar structure from 6 weeks to 12 weeks. Histology demonstrated little fibrous deposition at the implant interface with no adverse cellular reactions. Histomorphometric review of cortical sites revealed greater than 60% bone ingrowth at 6 weeks increasing to nearly 80% by the 12 week timepoint. Cancellous sites yielded a mean of 30% ingrowth at 6 weeks increasing to 35% by 12 weeks. Pushout testing of cortical site samples demonstrated increase in pushout force between the 6 and 12 week timepoints. Increases were significant in all but the UHMWPE samples. Stiffness likewise increased in all samples between the two times. These results demonstrated the effectiveness of the pillar morphology with full integrating from the surrounding bony tissue regardless of the material.

Objective To perform a repeatable idealized in vitro model to evaluate the effects of key design features and integrated screw fixation on unloaded surface engagement, subsidence, and torsional stability. Methods We evaluated four different stand-alone anterior lumbar interbody fusion (ALIF) cages with two, three, and four screw designs. Polyurethane (saw-bone) foam blocks were used to simulate the vertebral bone. Fuji Film was used to measure the contact footprint, average pressure, and load generated by fixating the cages with screws. Subsidence was tested by axially loading the constructs at 10 N/s to 400 N and torsional load was applied +/−1 Nm for 10 cycles to assess stability. Outcome measures included total subsidence and maximal torsional angle range. Results Cages 1, 2, and 4 were symmetrical and produced similar results in terms of contact footprint, average pressure, and load. The addition of integrated screws into the cage-bone block construct demonstrated a clear trend towards decreased subsidence. Cage 2 with surface titanium angled ridges and a keel produced the greatest subsidence with and without screws, significantly more than all other cages ( P < 0.05). Angular rotation was not significantly affected by the addition of screws ( P < 0.066). A statistically significant correlation existed between subsidence and reduced angular rotation across all cage constructs ( P = 0.018). Conclusion Each stand-alone cage featured unique surface characteristics, which resulted in differing cage–foam interface engagement, influencing the subsidence and torsional angle. Increased subsidence significantly reduced the torsional angle across all cage constructs.

IntroductionAnterior cruciate ligament reconstruction (ACLR) is associated with poor return to sport and high graft re-rupture rates. This study explored the use of a wearable inertial sensor (ViMove) that incorporates an accelerometer and gyroscope, and MatScan pressure sensing mat (TekScan, South Boston, Massachusetts, USA) to provide objective return-to-sport measures.MethodsThree cohorts’ ACLR patients, non-athletic controls and elite athletes (Australian seven’s rugby Olympic Gold medallist). Patients performed biometric and functional tests (thigh circumference and triple hop) and the ViMove knee module (consisting of single and double leg squats, hops and box drops) for lower limb alignment assessment, concurrently with force plate.ResultsElite athletes had less varus/valgus (VV) movement during ViMove exercises compared with the ACLR cohort, who in turn had less VV malalignment than controls. When analysing side-to-side differences, single leg squats and box drop were asymmetrical in the ACL group, with greater malalignment in the reconstructed leg (pConclusionThe inertial sensor detected differences in motion for patients following ACLR, which are known to be associated with graft rupture and were not detected with functional return to sport testing. Coupling the device with data from a pressure plate provides a powerful assessment tool detecting alignment differences known to be associate with graft failure only previously detected in formal gait analysis.

BACKGROUND CONTEXT The potential for osseointegration to provide biological fixation for implants may be related to anatomical site and loading conditions. PURPOSE To evaluate the influence of anatomical site on osseointegration of 3D-printed implants. STUDY DESIGN A comparative preclinical study was performed evaluating bone ingrowth in cortical and cancellous sites in long bones as well as lumbar interbody fusion with posterior pedicle screw stabilization using the same 3D-printed titanium alloy design. METHODS 3D-printed dowels were implanted in cortical bone and cancellous bone in adult sheep and evaluated at 4 and 12 weeks for bone ingrowth using radiography, mechanical testing, and histology/histomorphometry. In addition, a single-level lumbar interbody fusion using cages based on the same 3D-printed design was performed. The aperture was filled with autograft or ovine allograft processed with supercritical carbon dioxide. Interbody fusions were assessed at 12 weeks via radiography, mechanical testing, and histology/histomorphometry. RESULTS Bone ingrowth in long bone cortical and cancellous sites did not translate directly to interbody fusion cages. While bone ingrowth was robust and improved with time in cortical sites with a line-to-line implantation condition, the same response was not found in cancellous sites even when the implants were placed in a press fit manner. Osseointegration into the porous walls with 3D porous interbody cages was similar to the cancellous implantation sites rather than the cortical sites. The porous domains of the 3D-printed device, in general, were filled with fibrovascular tissue while some bone integration into the porous cages was found at 12 weeks when fusion within the aperture was present. CONCLUSION Anatomical site, surgical preparation, biomechanical loading, and graft material play an important role in in vivo response. Bone ingrowth in long bone cortical and cancellous sites does not translate directly to interbody fusions.

Background: Midcarpal arthrodesis is a treatment of choice in patients with midcarpal arthritis. Traditionally a four corner fusion has been favoured, however recent research has shown improved results when the triquetrum and scaphoid are excised. There is no clear evidence as to which remaining bones should be fused or which implants should be used. The purpose of this study is to compare the biomechanics of midcarpal arthrodesis after scaphoid and triquetrum excision, using memory staples or cannulated screws, in recognised construct patterns. Methods: 36 identical sets of carpal bones were 3D printed from acetyl butyl styrene. Midcarpal arthrodeses were performed in three configurations with shape memory alloy staples or headless compression screws. This gave 6 treatment groups; lunocapitate single staple or screw, lunocapitate with 2 staples or screws, three corner fusion with 2 staples or screws. Peak torque to distraction was measured and analysed. Results: The peak torque to distraction was significantly greater in almost all constructs utilizing screws compared to staples, with two lunocapitate screws having the highest peak torque at both 1 and 3 mm distraction with 244 Nmm and 749 Nmm respectively (p < 0.05). Conclusions: Constructs utilizing screws have a peak torque to distraction significantly higher when compared to staples. Our recommendation when performing a midcarpal arthrodesis after scaphoid and trapezium excision is to fuse the midcarpal joint with 2 headless compression screws.

As spinal fusions require large volumes of bone graft, different bone graft substitutes are being investigated as alternatives. A subclass of calcium phosphate materials with submicron surface topography has been shown to be a highly effective bone graft substitute. In this work, a commercially available biphasic calcium phosphate (BCP) with submicron surface topography (MagnetOs; Kuros Biosciences BV) was evaluated in an Ovine model of instrumented posterolateral fusion. The material was implanted stand-alone, either as granules (BCPgranules) or as granules embedded within a fast-resorbing polymeric carrier (BCPputty) and compared to autograft bone (AG). Twenty-five adult, female Merino sheep underwent posterolateral fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion (ROM) testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. The three treatment groups showed a significant decrease in lateral bending at the fusion levels at 12 weeks (P < 0.05) and 26 weeks (P < 0.001) compared to the 6 week time-point. Flexion-extension and axial rotation were also reduced over time, but statistical significance was only reached in flexion-extension for AG and BCPputty between the 6 and 26 week time-points (P < 0.05). No significant differences in ROM were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for AG, BCPgranules and BCPputty, respectively. The fusion rates were further increased 26 weeks postimplantation. Similar trends of bone growth were observed by histomorphometry. The fusion mass consisted of at least 55% bone for all treatment groups 26 weeks after implantation. These results suggest that this BCP with submicron surface topography, in granules or putty form, is a promising alternative to autograft for spinal fusion.

With the potential of bias from subjective evaluation scores in spine surgery, there is a need for practical and accurate quantitative methods of analysing patient recovery. In recent years, technologies such as accelerometers and global positioning systems have been introduced as potential objective measures for pain and symptoms following spine surgery. Overall, this perspective article aims to discuss and critique currently utilised methods of monitoring spine surgical outcomes. After analysing current modalities it will briefly analyse new potential methods before examining the place for accelerometers in the field of spine surgery. A literature review was performed on the use of accelerometers for objective evaluation of symptoms and disability after spine surgery, and perspectives are summarised in this article. Physical activity measurement with the use of accelerometers following spine surgery patients is practical and quantitative. The currently available accelerometers have the potential to transform the way functional outcomes from spine surgery are assessed. One key advantage is the collection of standardised objective measurements across studies. Future studies should aim to validate accelerometer data in relation to traditional measures of functional recovery, patient outcomes, and physical activity.

Objective Anterior cervical discectomy and fusion is the most commonly employed surgical technique for treating cervical spondylosis. Although autologous bone grafts are considered the gold standard in achieving fusion, associated short- and long-term morbidities have led to a search for alternative materials. These have included carbon-fiber, titanium alloy (Ti) and ceramic and polyetheretherketone (PEEK) based implants. Recent attempts to optimize cage implants through using composite designs have combined Ti and PEEK. However, there are few published reports on the clinical and radiological outcomes of commercially available composite cages. Our study aimed to provide and evaluate initial outcomes of a composite Ti/PEEK cage. Methods In this prospective single senior surgeon cohort study, 31 consecutive patients underwent a modified Smith–Robinson technique under general anesthesia and relevant data were collected. The study patients were aged between 18 and 75 years and underwent surgery from November 2013 to May 2014. Indications for surgery included traumatic and degenerative cervical disease that was unsuitable for or unresponsive to conservative management. All cages were between 5 and 8 mm and packed with super critical fluid sterilized allograft and bone marrow aspirate before insertion. Patients were followed-up for a minimum of 12 months. Fusion was assessed using fine cut CT and anteroposterior and lateral radiographs. Clinical outcomes were measured using a Visual Analogue Scale, Neck Oswestry Disability Index and Patient's Satisfaction Index. Results Six of the original cohort were unavailable for adequate follow-up. The remaining 25 patients (17 men, 8 women; 33 operative levels) were observed for a mean of 14.6 months (range, 12–16 months). All operation levels were between C4 and C7. Single-level operations were performed in 19 patients and additional plating in 14 patients. A fusion rate of 96% was achieved. Patients in both plated and non-plated groups experienced statistically significant improvements; good to excellent outcomes being seen in 92% of patients. There was one complication, namely recurrent laryngeal nerve palsy, which had partially resolved at 6 months follow-up. Conclusion The present study shows that enhancement of PEEK cages with Ti endplates is a safe and effective treatment with the potential for early osseointegration and early radiological evidence of fusion.

The primary objective of this paper was to provide a systematic review of the available clinical studies of Ti/PEEK combined cages in spinal interbody fusion surgeries, focusing on their radiological and clinical outcomes. A secondary aim was to provide a review and evaluation of the in vitro and preclinical studies reported on Ti/PEEK-coated implants. A systematic search of the literature was performed in March 2015 via three databases: Medline, Embase and Cochrane library. The following key search terms were combined with synonyms to identify relevant articles: “spinal fusion,” “PEEK,” “titanium” and “cage.” The novelty of this intervention translates into a paucity of clinical trials, albeit the results of the seven clinical studies that met the criteria for inclusion are promising. All studies reported rate of fusion as a primary outcome. Two studies reported slightly improved fusion in the experimental Ti/PEEK combination cohort, one study identical fusion (91.7 %) and three studies excellent fusion (96, 100 and 94 %) in the Ti/PEEK cohort, although no differences reached statistical significance. Clinical studies at this early stage demonstrate that Ti/PEEK implants are safe and efficacious, exhibiting similar fusion rates and clinical outcomes compared to the current standard PEEK. There is clinical evidence substantiating the improved radiographic fusion of Ti/PEEK, albeit the differences were not significant. This field is promising, gaining substantial popularity, and further clinical trials are needed in the future to establish Ti/PEEK cages as a mainstay of clinical practice.

Background. The optimal fixation method for the first tarsometatarsal arthrodesis remains controversial. This study aimed to develop a reproducible first tarsometatarsal testing model to evaluate the biomechanical performance of different reconstruction techniques. Methods. Crossed screws or a claw plate were compared with a single or double shape memory alloy staple configuration in 20 Sawbones models. Constructs were mechanically tested in 4-point bending to 1, 2, and 3 mm of plantar displacement. The joint contact force and area were measured at time zero, and following 1 and 2 mm of bending. Peak load, stiffness, and plantar gapping were determined. Results. Both staple configurations induced a significantly greater contact force and area across the arthrodesis than the crossed screw and claw plate constructs at all measurements. The staple constructs completely recovered their plantar gapping following each test. The claw plate generated the least contact force and area at the joint interface and had significantly greater plantar gapping than all other constructs. The crossed screw constructs were significantly stiffer and had significantly less plantar gapping than the other constructs, but this gapping was not recoverable. Conclusions. Crossed screw fixation provides a rigid arthrodesis with limited compression and contact footprint across the joint. Shape memory alloy staples afford dynamic fixation with sustained compression across the arthrodesis. A rigid polyurethane foam model provides an anatomically relevant comparison for evaluating the interface between different fixation techniques. Clinical Relevance. The dynamic nature of shape memory alloy staples offers the potential to permit early weight bearing and could be a useful adjunctive device to impart compression across an arthrodesis of the first tarsometatarsal joint. Levels of Evidence: Therapeutic, Level V: Bench testing

BACKGROUND CONTEXT Implant design, material, surfaces, graft and surgical techniques play important roles in the success of interbody fusions and the ability to radiographically assess. PEEK's positive attributes of mechanical properties and radiolucency are maintained using a molecularly bonded submicron deposition of titanium to improve bone on-growth. Novel macroscale topography features on the endplate surfaces and inside the aperture were hypothesized to allow early bone integration and mechanical stability. PURPOSE To evaluate the effect of macroscale topography on a PEEK/Titanium composite cage in a large animal model of interbody fusion. STUDY DESIGN/SETTING Preclinical large animal model. PATIENT SAMPLE Not applicable. OUTCOME MEASURES Not applicable METHODS Lateral L45 interbody fusions were performed in 4-5-year-old ewes using a PEEK/titanium composite cage (Control group) compared to the same cage with macro 3D features on the endplate and inside the aperture (Test group). Iliac crest autograft was placed in the aperture and bilateral pedicle screws and rods for posterior stabilisation. Fusion assessment at 6 and 12 weeks (n=10 per group) included manual palpation, X-rays, mCT, tensile testing and pmMA histology. RESULTS The Test group's manual palpation was 9/10 and 10/10 at 6 and 12 weeks while the control was 4/10 and 7/10 at 6 and 12 weeks. Radiographs and mCT confirmed new bone formation in the aperture of the Control group cages with time while some areas of aperture radiolucency were present. Radiographs and mCT of the Test group cages revealed new bone formation and integration within the topography features on the endplates and inside the aperture which progressed with time. Histology confirmed the radiographic findings in the control group and integration with the host endplates and remodeled bone within the apertures in the Test group. Tensile testing demonstrated nearly a 3-fold statistically significant increase in mechanical properties at both time points for the Test group vs the control group. CONCLUSIONS The macroscale features in the Test group provided multiple opportunities for bone integration between the host endplates and graft within the aperture. Early bony integration translated to a statistically significant increase in mechanical strength compared to the control cage which did not include the same geometric features. Promising data in this clinically relevant animal model warrants further study in humans. FDA DEVICE/DRUG STATUS Shoreline RT (Approved for this indication).

3D-printing technologies such as electron beam melting (EBM) have allowed for patient-specific orthopaedic implants, however differences generated from the fabrication process may alter the corrosion properties of Ti6Al4V implants. This study evaluated the corrosion characteristics of EBM-fabricated Ti6Al4V, alongside any linked microstructural and surface changes. EBM-fabricated Ti6Al4V and wrought Ti6Al4V specimens (n = 10 per group) underwent microstructural and surface characterisation before and after corrosion testing. Cyclic potentiodynamic polarisation of specimens was conducted in accordance with ASTM Standard F2129-17. The degree of corrosion damage was subsequently assessed via qualitative and quantitative measures. EBM-fabricated Ti6Al4V demonstrated a higher proportion of β phases and greater surface roughness, compared to wrought Ti6Al4V. Significant differences were observed for all corrosion parameters between the two groups. The lower breakdown potentials (Eb) for EBM-fabricated Ti6Al4V (2.035 V), compared to wrought Ti6Al4V (3.667 V), indicate a lower resistance to pitting corrosion. A greater resultant spread, and severity of corrosion damage was noted on wrought Ti6Al4V. An inferior in vitro corrosion resistance was observed for EBM-fabricated Ti6Al4V. Without post-processing, the rougher surface and differences in microstructure are likely to contribute to this. This suggests potential clinical implications upon in vivo implantation, although corrosion measures remain above recommended minimums.

Background: A pedicle screw insertion technique known as “hubbing” involves the removal of cortical bone around the screw insertion with the aim of improving fixation and decreasing screw loosening. However, the efficacy of this procedure relative to bone density and early loading have not been fully explored. The purpose of this study is to establish the contribution of the cortical layer (hubbing), cancellous density, early loading (toggling) in an idealised model. This is an in vitro laboratory study. Methods: Synthetic bone blocks with cancellous bulk and a simulated cortical shell were implanted with 6.5 mm pedicle screws. Three key variables were evaluated in this study; density of the simulated bone (10–20 lb/ft 3 ), toggling (±0.5 mm for 10,000 cycles), and the presence or absence of the surrounding cortex (hubbing). Pullout testing after toggling was performed to determine maximum load, stiffness and energy. Results were analyzed to assess interaction and main effects. Results: Removal of the cortex decreased the pullout loads by approximately 1,100 N after toggling. Toggling in the presence of the cortical shell had no effect. However, once the cortical shell is removed damage to the weaker cancellous bone accumulates and further compromises the fixation. Conclusions: The addition of a cortical layer in the Sawbone model is significant and provides a more realistic model of load sharing. The cortex plays a considerable role in the protection of underlying cancellous bone as well as contributing to initial pullout strength. The results of this study demonstrate a negative synergistic effect when both toggling and hubbing are applied to the weaker bone.

This section presents a comprehensive review of the current state of nucleus replacement technology. The healthy intervertebral disc function on a microbiological and biomechanical level is reviewed. Established methods for evaluating spinal motion are covered. The progression of diseased disc states (degenerative disc disease and herniation) are presented. Traditional treatments of fusion, total disc replacement and discectomy are touched on with relation to nucleus replacement. The concept of nucleus replacement is covered and current designs and research are discussed according to four categories of implants: solid preformed implants, preformed hydrogel implants, externally inflated implants, and injectable implants. This review includes the results of published animal and clinical trials. Considerations relating to the evaluation of a nucleus replacement in laboratory testing environments with biological tissues are covered and a discussion of suitable animal models is presented.

Background context The ideal tissue-engineered solution for any bone graft substitute is to assist in the rapid formation of bone and facilitate fusion. Purpose The present study aims to evaluate this E-BMP-2 (Escherichia coli–derived human bone morphogenetic protein-2) in ovine posterolateral lumbar fusion (PLF) to examine the influence of dose and overall performance in a model with similar graft size and diffusive challenges to the human. Study design/setting In vivo large animal model study. Methods An adult ovine PLF was performed in 30 animals with groups of E-BMP-2 with a beta-tricalcium phosphate (β-TCP) carrier at three different dosages, β-TCP alone, and autograft from the iliac crest. The fusions were assessed by radiography (X-ray and microcomputed tomography), mechanical testing, and hard-tissue histology with bone labels at 6, 8, and 10 weeks along with routine paraffin histology at 12 weeks. Results Results showed increasing new bone and fusion rate with E-BMP-2 dose, whereas β-TCP alone was largely resorbed and did not achieve fusion in this model at 12 weeks. Autograft showed similar grading for the amount of bone between the transverse processes but a lower fusion rate than β-TCP/E-BMP-2 groups. Bone labels revealed new bone formation at all time points for the E-BMP2 groups, whereas the autograft group showed active bone formation at 10 weeks. Beta-tricalcium phosphate displayed reliable incorporation into the decorticated host bone, whereas limited new bone was found between the transverse processes. At the center of the fusion mass, increased E-BMP-2 dose led to increased incorporation of β-TCP by new bone. Conclusions These results suggest that E-BMP-2 was capable of producing posterolateral fusion in the ovine model that is equal to or superior to autologous graft in terms of fusion rate and mechanical strength. E-BMP-2 dose had considerable influence on β-TCP granule resorption.

To investigate the corrosion resistance properties of 5 commercially available nitinol stents used to treat peripheral artery disease and compare their surface quality, elemental composition, and geometrical design.Samples of 5 different designs of nitinol peripheral stents [LifeStent (n=4), Philon (n=6), Epic (n=6), S.M.A.R.T. Control (n=7), and Complete SE (n=7)] were examined using stereomicroscopy, environmental scanning electron microscopy, and x-ray photoelectron spectroscopy. Corrosion resistance testing was performed in accordance with ASTM International Standard F2129-08.Thirteen (43%) of 30 stents corroded during this experiment. Stent fracture was observed in 12 (92%) of these corroded stents. Mean breakdown potentials ranged from 517 to 835 mV (vs. Ag/AgCl) for the Philon, Complete SE, S.M.A.R.T. Control, Epic, and LifeStent models from lowest to highest. A statistically significant difference in breakdown potential was observed between the LifeStent vs. Philon stents (835 vs. 517 mV, p=0.01) and Epic vs. Philon stents (833 vs. 517 mV, p=0.03). Stents with lower breakdown potential and relative breakdown potentials were associated with a higher fracture frequency (Spearman correlation coefficient -0.44, p=0.015 and -0.869, p0.01, respectively).In this in vitro study, corrosion led independently to stent fracture. There is a significant association between lower mean breakdown/relative breakdown potentials and stent fracture.

Four commercially available Polymethylmethacrylate (PMMA)-based bone cements of differing viscosities were tested after open bowl and vacuum mixing techniques. Their properties were evaluated using scanning electron microscopy, density measurements, and mechanical testing. High viscosity cements had greater density, implying reduced porosity, when mixed under vacuum conditions. The decrease was related to the timing of the waiting phase of mixing. However, the decrease in porosity was not associated with an increase in the compressive strength. High viscosity cements, particularly those with a late completion of the waiting phase, may be more suitable to vacuum mixing techniques.

The increased concentration of platelets within platelet-rich plasma (PRP) provides a vehicle to deliver supra-physiologic concentrations of growth factors to an injury site, possibly accelerating or otherwise improving connective tissue regeneration. This potential benefit has led to the application of PRP in several applications; however, inconsistent results have limited widespread adoption in bone healing. This review provides a core understanding of the bone healing mechanisms, and corresponds this to the factors present in PRP. In addition, the current state of the art of PRP preparation, the key aspects that may influence its effectiveness, and treatment outcomes as they relate specifically to bone defect healing are presented. Although PRP does have a sound scientific basis, its use for bone healing appears only beneficial when used in combination with osteoconductive scaffolds; however, neither allograft nor autograft appear to be appropriate carriers. Aggressive processing techniques and very high concentrations of PRP may not improve healing outcomes. Moreover, many other variables exist in PRP preparation and use that influence its efficacy; the effect of these variables should be understood when considering PRP use. This review includes the essentials of what has been established, what is currently missing in the literature, and recommendations for future directions.

Different metallic materials have different polarization characteristics as dictated by the open circuit potential, breakdown potential, and passivation potential of the material. The detection of these electrochemical parameters identifies the corrosion factors of a material. A reliable and well-functioning corrosion system is required to achieve this. Corrosion of the samples was achieved via a potentiodynamic polarization technique employing a three-electrode configuration, consisting of reference, counter, and working electrodes. Prior to commencement a baseline potential is obtained. Following the stabilization of the corrosion potential (Ecorr), the applied potential is ramped at a slow rate in the positive direction relative to the reference electrode. The working electrode was a stainless steel screw. The reference electrode was a standard Ag/AgCl. The counter electrode used was a platinum mesh. Having a reliable and well-functioning in vitro corrosion system to test biomaterials provides an in-expensive technique that allows for the systematic characterization of the material by determining the breakdown potential, to further understand the material's response to corrosion. The goal of the protocol is to set up and run an in vitro potentiodynamic corrosion system to analyze pitting corrosion for small metallic medical devices.

Background Polyetheretherketone (PEEK) has a wide range of clinical applications but does not directly bond to bone. Bulk incorporation of osteoconductive materials including hydroxyapatite (HA) into the PEEK matrix is a potential solution to address the formation of a fibrous tissue layer between PEEK and bone and has not been tested. Questions/purposes Using in vivo ovine animal models, we asked: (1) Does PEEK-HA improve cortical and cancellous bone ongrowth compared with PEEK? (2) Does PEEK-HA improve bone ongrowth and fusion outcome in a more challenging functional ovine cervical fusion model? Methods The in vivo responses of PEEK-HA Enhanced and PEEK-OPTIMA® Natural were evaluated for bone ongrowth in the form of dowels implanted in the cancellous and cortical bone of adult sheep and examined at 4 and 12 weeks as well as interbody cervical fusion at 6, 12, and 26 weeks. The bone-implant interface was evaluated with radiographic and histologic endpoints for a qualitative assessment of direct bone contact of an intervening fibrous tissue later. Gamma-irradiated cortical allograft cages were evaluated as well. Results Incorporating HA into the PEEK matrix resulted in more direct bone apposition as opposed to the fibrous tissue interface with PEEK alone in the bone ongrowth as well as interbody cervical fusions. No adverse reactions were found at the implant–bone interface for either material. Radiography and histology revealed resorption and fracture of the allograft devices in vivo. Conclusions Incorporating HA into PEEK provides a more favorable environment than PEEK alone for bone ongrowth. Cervical fusion was improved with PEEK-HA compared with PEEK alone as well as allograft bone interbody devices. Clinical Relevance Improving the bone–implant interface with a PEEK device by incorporating HA may improve interbody fusion results and requires further clinical studies.

Studies on the effects of cement augmentation or vertebroplasty on multi-level spine after vertebral compression fractures are lacking. This paper seeks to establish a 3-vertebrae ovine model to determine the impact of compression fracture on spine biomechanics, and to discover if cement augmentation can restore mechanical stability to fractured spine.Five lumbar spine segments (L1-L3) were obtained from 5-year-old female Merino sheep. Standardized wedge-compression fractures were generated in each L2 vertebra, and then augmented with polymethyl methacrylate (PMMA) cement mixed with 30% barium sulphate powder. Biomechanical pure moment testing in axial rotation (AR), flexion/extension (FE) and lateral bending (LB) was carried out in the intact, fractured and repaired states. Range of motion (ROM) and neutral zone (NZ) parameters were compared, and plain radiographs taken at every stage.Except for a significant increase in ROM between the intact and fractured states in AR between L1 and L2 (P0.05), there were no other significant differences in ROM or NZ between the other groups. There was a trend towards an increase in ROM and NZ in all directions after fracture, but this did not reach significance. Normal biomechanics was only minimally restored after augmentation.Results suggest that cement augmentation could not restore mechanical stability of fractured spine. Model-specific factors may have had a role in these findings. Caution should be exercised when applying these results to humans.

Background The field of orthopaedics is a constantly evolving discipline. Despite the historical success of plates, pins and screws in fracture reduction and stabilisation, there is a continuing search for more efficient and improved methods of fracture fixation. The aim of this study was to evaluate shape-memory staples and to compare them to a currently used implant for internal fracture fixation. Multi-plane bending stability and interfragmentary compression were assessed across a simulated osteotomy using single and double-staple fixation and compared to a bridging plate. Methods Transverse osteotomies were made in polyurethane blocks (20 × 20 × 120 mm) and repairs were performed with one (n = 6), or two (n = 6) 20 mm nitinol staples, or an eight-hole 2.7 mm quarter-tubular plate (n = 6). A pressure film was placed between fragments to determine contact area and compressive forces before and after loading. Loading consisted of multi-planar four-point bending with an actuator displacement of 3 mm. Gapping between segments was recorded to determine loads corresponding to a 2 mm gap and residual post-load gap. Results Staple fixations showed statistically significant higher mean compressive loads and contact areas across the osteotomy compared to plate fixations. Double-staple constructs were superior to single-staple constructs for both parameters (p

Anterior lumbar interbody fusion (ALIF) is a common procedure for patients with degenerative pathologies of the lumbar spine. In this study, the clinical and radiological outcomes of a combination titanium/polyetheretherketone (Ti/PEEK) ALIF cages in one, two and three-level surgery were evaluated. Over an 18-month time period, a prospective single surgeon series of 20 implants (15 patients) were included in the study, with minimum 10-months follow-up. From these 15 patients, two were supplemented with posterior percutaneous pedicle screw fixation for additional stability. Radiological follow-up with fine cut CT scan at 9-12months was performed to evaluate early fusion rates, and integration of the Titanium/PEEK cage at the endplate junction. 20 implants were followed for a minimum of 10months, and a mean of 15months. A 95% (19/20 implants) fusion rate with no implant related complications was achieved at the mean 15-month postoperative mark. Patients experienced statistically significant improvement in pain and functional outcomes (SF12 and ODI) compared to their pre-operative status. A single patient with a non-union at L5/S1 (smoker) did not experience any improvement in symptoms. A Ti-PEEK cage, with allograft and BMP-2 to achieve interbody fusion is an effective implant for use in anterior lumbar surgery with high fusion rates, no lucency around the titanium endplates at follow-up, and with promising early results.

Bone is an anisotropic non-homogenous composite material composed of inorganic bone mineral embedded in an organic matrix. The mechanical behaviour of bone is governed by the volume fraction of these constituents, their mechanical properties, the degree of crystallite-collagen orientation and the bonding between phases. This study aims to evaluate the mechanical role of these constituents in the expression of anisotropy by using gamma irradiation to alter the mineralised collagen fibrils. Bovine cortical cubes were prepared, treated and mechanically tested in uniaxial compression in the axial, radial and tangential orientations. Ultimate stress, ultimate strain, energy to failure and stiffness were evaluated. This study confirmed deleterious effect of gamma irradiation on the axial compressive properties of cortical bone with a dose dependent decrease in ultimate stress of 6% (P=0.231) and 16% (P=0.001) at 15 and 25 kGy respectively. This corresponded to a 39% (P=0.058) and 30% (P=0.167) reduction in energy to failure. In the radial orientation there was also a dose dependant decrease in ultimate stress which was consistent with a statistically significant decline in ultimate strain (31% (P=0.003) and 36% (P=0.000)) and energy to failure (36% (P=0.053) and 45% (P=0.008)) at both doses. In the tangential orientation there was a significant 22% (P=0.01) and 23% (P=0.02) decrease in stiffness; though these changes did not alter ultimate stress considerably. This study provides valuable insights into the role of collagen in the radial and tangential orientation when loaded in compression; while also building on the body of work related to the use of gamma irradiation for load bearing bone allografts.

Patella alta is associated with adverse cartilage adaptations, patellofemoral pain, and instability. It is defined by a relatively long patellar tendon and patella positioned in a more proximal location within the patellar groove of the femur. This study used the ovine stifle joint model to investigate the effect of patellar tendon lengthening on the 3D passive kinematics of the patellofemoral and tibiofemoral joints. Eight patellar tendons were lengthened in 2 mm increments up to a maximum of 12 mm (20%) using a device placed in series with the transected patellar tendon. Three-dimensional kinematics were measured in the intact joint and at each increment of patellar tendon length (L(T)) during passively induced tibiofemoral flexion. Patellar flexion angle was linearly correlated with tibial flexion angle in the intact joint, and this correlation persisted after tendon lengthening (R = 0.897-0.965, p 9%. In contrast, when patellofemoral kinematics were expressed as a function of patellar flexion angle they were not significantly altered by increases in L(T). Tibiofemoral kinematics were not affected by the L(T) increases. These results demonstrate that for a given tibial flexion angle, patellar tendon lengthening alters the patellar flexion angle. However, for a given patellar flexion angle, the orientation of the patella in the remaining five degrees of freedom is unchanged, implying a repeatable path of patellar motion.

While the Lapidus procedure is a widely accepted technique for treatment of hallux valgus, the optimal fixation method to maintain joint stability remains controversial. The purpose of this study is to evaluate the biomechanical properties of new shape memory alloy (SMA) staples arranged in different configurations in a repeatable first tarsometatarsal arthrodesis model. Ten sawbones models of the whole foot (n = 5 per group) were reconstructed using a single dorsal staple or two staples in a delta configuration. Each construct was mechanically tested non-destructively in dorsal four-point bending, medial four-point bending, dorsal three-point bending, and plantar cantilever bending with the staples activated at 37°C. The peak load (newton), stiffness (newton per millimeter), and plantar gapping (millimeter) were determined for each test. Pressure sensors were used to measure the contact force and area of the joint footprint in each group. There was a statistically significant increase in peak load in the two staple constructs compared to the single staple constructs for all testing modalities with P values range from 0.016 to 0.000. Stiffness also increased significantly in all tests except dorsal four-point bending. Pressure sensor readings showed a significantly higher contact force at time zero (P = 0.037) and contact area following loading in the two staple constructs (P = 0.045). Both groups completely recovered any plantar gapping following unloading and restored their initial contact footprint. The biomechanical integrity and repeatability of the models was demonstrated with no construct failures due to hardware or model breakdown. SMA staples provide fixation with the ability to dynamically apply and maintain compression across a simulated arthrodesis following a range of loading conditions.

The addition of large amounts of antibiotics to bone cement provides a convenient local delivery, but may influence the compressive properties of the cement. Flucloxacillin and vancomycin were added to Simplex P (Stryker, Limerick, Ireland) and VersaBond (Smith & Nephew) cements. Tripling the antibiotic dose from 2 to 6 g had little effect on the static compressive properties 24 hours after curing. After 4 weeks in phosphate-buffered saline, there was marked decrease in properties with the addition of antibiotics. Compressive strength of cements with 6 g of antibiotic was reduced to near or below the ASTM and ISO minimum of 70 MPa after 4 weeks in phosphate-buffered saline. Microcomputer tomography revealed increased porosity and clumping of the radiopacifier with the addition of antibiotics.