Effect of intramedullary nail stiffness on load-sharing in tibiotalocalcaneal arthrodesis: A patient-specific finite element study.

Tibiotalocalcaneal (TTC) arthrodesis is a procedure to treat severe ankle and subtalar arthropathy by providing pain free and stable fusion using IM nails. These nails can be manufactured with multiple materials and some feature the ability to dynamize the arthrodesis construct. However, the impact of IM nail material and nail dynamization on load-sharing and in the setting of bone resorption have not been quantified. This work utilized a patient-specific finite element analysis model of TTC arthrodesis to investigate IM nails with differing material moduli and the impact of nail dynamization on load-sharing and intersegmental compression in the setting of bone resorption. Each nail was virtually inserted into a patient-specific model of a hindfoot, which was segmented into the three bones of the TTC complex and assigned material properties based on the densitometry of the bone. Compression, amount of load-sharing, and stress distributions after simulated bone resorption were quantified and compared between the varying IM nails. Simulations revealed that bone segments were only subjected to 17% and 22% of dynamic gait forces in the titanium and carbon fiber nail constructs, whereas the pseudoelastic NiTi nail constructs allowed for 67% of the same. The titanium and carbon fiber nails lost all initial compression in less than 0.13mm of bone resorption, whereas the NiTi nail maintained compression through all simulated values of bone resorption. These data highlight the poor load-sharing of static nail TTC arthrodesis constructs and the ability of a pseudoelastic IM nail construct to maintain intersegmental compression when challenged with bone resorption.

Effect of Arthrodesis Device Type and Trajectory on Subtalar Joint Compression.

The use of subtalar arthrodesis procedures has been widely implemented to relieve hindfoot issues after failure of conservative treatments; however, fusion failures persist in some patients with certain risk factors. Currently, surgeons utilize cannulated screws in these arthrodesis procedures to immobilize the subtalar joint. Recent clinical studies have demonstrated improved fusion outcomes in at-risk patients using sustained dynamic compression devices in the tibiotalocalcaneal complex. These devices utilize pseudoelastic nitinol which enables sustained dynamic compression when faced with postoperative bone resorption, joint settling, and bone relaxation. While the clinical success of these devices has been established in the tibiotalocalcaneal complex, the ability of sustained dynamic compression devices to apply joint compression in the subtalar joint has not been quantified. As such, the goals of this study were to (1) compare the ability of static compression devices and sustained dynamic compression devices to apply joint compression and (2) assess the impact of device trajectory on joint compression. A custom mechanical testing fixture was utilized to test the compression applied across the subtalar joint by one sustained dynamic compression device (in anterior and posterior trajectories) as compared to 2 cannulated screws (in both parallel and diverging trajectories). Testing revealed the sustained dynamic compression devices generated 53% greater compression as compared to the static compression devices, despite single versus dual device usage, respectively. Additionally, both types of devices applied joint compression forces in an insertion trajectory-independent manner. These data illustrate the ability of a single SDC device to maintain significantly improved joint compressive forces as compared to 2 static cannulated screws, regardless of insertion trajectory. These SDC devices may be of particular interest for at-risk patients or in revision cases.

Effect of Simulated Bone Resorption on the Biomechanical Performance of Intramedullary Devices for Foot and Ankle Arthrodesis.

Midfoot and subtalar arthrodesis surgeries are performed to correct foot deformities and relieve arthritic pain. These procedures often employ intramedullary (IM) devices. The aim of the present study was to evaluate the biomechanical performance of a sustained dynamic compression (SDC) IM device compared to mechanically static devices in withstanding the effects of simulated bone resorption. Mechanically static and SDC IM devices were implanted in simulated bone blocks (n = 5/device). Compressive loads were measured with a custom-made mechanism to simulate bone resorption. The construct bending stiffness was determined from a 4-point bend test. Resorption was simulated by cutting a 1 mm or 2 mm gap in the midpoint of each construct and repeating the loading (n = 6/device). Initial compressive loads after device insertion were greater in the SDC IM devices when compared to the static devices (p < .01). The SDC device was able to sustain compression from 2 mm to 5.5 mm of simulated resorption depending upon device length, while the static devices lost compression within 1 mm of simulated resorption regardless of implant length (p < .001). In the 4-point bend test, the SDC device maintained its bending stiffness during simulated resorption whereas the static device displayed a significant loss in bending stiffness after 1 mm of simulated resorption (p < .001). The SDC device exhibited a significantly higher bending stiffness than the static device (p < .001). The SDC IM device demonstrated superior biomechanical performance during simulated resorption compared to static devices (p < .001). In conclusion, the ability of SDC IM devices to maintain construct stability and sustain compression across the fusion site while adapting to bone resorption may lead to greater fusion rates and overall quicker times to fusion than static IM devices. Surgeons who perform midfoot and subtalar arthrodesis procedures should be aware of a device's ability to sustain compression, especially in cases where bone resorption and joint settling are prevalent postoperatively.

Effect of Bone Quality and Leg Depth on the Biomechanical Performance of a Nitinol Staple.

The use of Nitinol compression staples has increased in foot and ankle procedures due to their ease of delivery and ability to offer sustained, dynamic compression. Prior biomechanical studies have predominantly examined mechanical performance in healthy bone models without investigating the effect of unicortical versus bicortical fixation. The purpose of this study was to examine the effect of bone quality and staple leg depth on the biomechanical performance of Nitinol staples in a bicortical bone model. Two-legged Nitinol staples were implanted in bicortical sawbone of 2 densities. Two different leg depths were tested to simulate unicortical versus bicortical fixation. Interfacial compressive forces, interfacial compression area, torsional strength, and shear strength were measured for each group. The effect of leg depth was minimal compared to the effect of sawbone density on the mechanical performance of Nitinol staples. Interfacial compressive force and interfacial compression areas were greater in the low density bone model, while torsional strength and shear strength were greater in the normal density bone model. Nitinol staple's mechanical performance is highly dependent upon bone quality and less dependent on whether staple legs terminate in cancellous versus cortical bone. Low density bone allows for a higher compressive interfacial area to be imparted by the staple. Staples in normal density bone are able to resist torsion and shear deformation more readily than staples in low density bone. Bone density may have a greater effect on the Nitinol staple's stability and compressive capability in vivo as compared to unicortical versus bicortical leg fixation.

Effects of Surface Topography and Chemistry on Polyether-Ether-Ketone (PEEK) and Titanium Osseointegration.

STUDY DESIGN: An in vivo study examining the functional osseointegration of smooth, rough, and porous surface topographies presenting polyether-ether-ketone (PEEK) or titanium surface chemistry. OBJECTIVE: To investigate the effects of surface topography and surface chemistry on implant osseointegration. SUMMARY OF BACKGROUND DATA: Interbody fusion devices have been used for decades to facilitate fusion across the disc space, yet debate continues over their optimal surface topography and chemistry. Though both factors influence osseointegration, the relative effects of each are not fully understood. METHODS: Smooth, rough, and porous implants presenting either a PEEK or titanium surface chemistry were implanted into the proximal tibial metaphyses of 36 skeletally mature male Sprague Dawley rats. At 8 weeks, animals were euthanized and bone-implant interfaces were subjected to micro-computed tomography analysis (n = 12), histology (n = 4), and biomechanical pullout testing (n = 8) to assess functional osseointegration and implant fixation. RESULTS: Micro-computed tomography analysis demonstrated that bone ingrowth was 38.9 ±â€Š2.8% for porous PEEK and 30.7 ±â€Š3.3% for porous titanium (P = 0.07). No differences in fixation strength were detected between porous PEEK and porous titanium despite titanium surfaces exhibiting an overall increase in bone-implant contact compared with PEEK (P < 0.01). Porous surfaces exhibited increased fixation strength compared with smooth and rough surfaces regardless of surface chemistry (P < 0.05). Across all groups both surface topography and chemistry had a significant overall effect on fixation strength (P < 0.05), but topography accounted for 65.3% of the total variance (ω = 0.65), whereas surface chemistry accounted for 5.9% (ω = 0.06). CONCLUSIONS: The effect of surface topography (specifically porosity) dominated the effect of surface chemistry in this study and could lead to further improvements in orthopedic device design. The poor osseointegration of existing smooth PEEK implants may be linked more to their smooth surface topography rather than their material composition. LEVEL OF EVIDENCE: N/A.

Fatigue behavior of As-built selective laser melted titanium scaffolds with sheet-based gyroid microarchitecture for bone tissue engineering.

Selective laser melting (SLM) has enabled the production of porous titanium structures with biological and mechanical properties that mimic bone for orthopedic applications. These porous structures have a reduced effective stiffness which leads to improved mechanotransduction between the implant and bone. Triply periodic minimal surfaces (TMPS), specifically the sheet-based gyroid structures, have improved compressive fatigue resistance due lack of stress concentrations. Sheet-based gyroid microarchitectures also have high surface area, permeability, and zero mean curvature. This study examines the effects of the gyroid microarchitectural design in parallel with SLM parameters on structure and function of as-built titanium alloy (Ti6Al4V ELI) scaffolds. Scaffold design was varied by varying unit cell size and wall thickness to produce scaffolds with porosity within the range of trabecular bone (50-90%). Manufacturer's default and refined laser parameters were used to examine the effect of input energy density on mechanical properties. Scaffolds exhibited a stretching-dominated deformation behavior under both compressive and tensile loading, and porosity dependent stiffness and strength. Internal void defects were observed within the walls of the gyroids structure, serving as sites for crack initiation leading to failure. Refinement of laser parameters resulted in increased compressive and tensile fatigue behavior, particularly for thicker walled gyroid microarchitectures, while thinner walls showed no significant change. The observed properties of as-built gyroid sheet microarchitectures indicates that these structures have potential for use in bone engineering applications. Furthermore, these results highlight the importance of parallel design and processing optimization for complex sheet-based porous structures produced via SLM. STATEMENT OF SIGNIFICANCE: Selective laser melting (SLM) is an additive manufacturing technology which produces complex porous scaffolds for orthopedic applications. Titanium alloy scaffolds with novel sheet-based gyroid microarchitectures were produced via SLM and evaluated for mechanical performance including fatigue behavior. Gyroid structures are function based topologies have been hypothesized to be promising for tissue engineering scaffolds due to the high surface area to volume ratio, zero mean curvature, and high permeability. This paper presents the effects of scaffold design and processing parameters in parallel, a novel study in the field on bone tissue scaffolds produced via additive manufacturing. Additionally, the comparison of compressive and tensile behavior of scaffolds presented is important in characterizing behavior and failure mechanisms of porous metals which undergo complex loading in orthopedic applications.

The effect of surface topography and porosity on the tensile fatigue of 3D printed Ti-6Al-4V fabricated by selective laser melting.

Additive manufacturing (3D printing) is emerging as a key manufacturing technique in medical devices. Selective laser melted (SLM) Ti-6Al-4V implants with interconnected porosity have become widespread in orthopedic applications where porous structures encourage bony ingrowth and the stiffness of the implant can be tuned to reduce stress shielding. The SLM technique allows high resolution control over design, including the ability to introduce porosity with spatial variations in pore size, shape, and connectivity. This study investigates the effect of construct design and surface treatment on tensile fatigue behavior of 3D printed Ti-6Al-4V. Samples were designed as solid, solid with an additional surface porous layer, or fully porous, while surface treatments included commercially available rotopolishing and SILC cleaning. All groups were evaluated for surface roughness and tested in tension to failure under monotonic and cyclic loading profiles. Surface treatments were shown to reduce surface roughness for all sample geometries. However, only fatigue behavior of solid samples was improved for treated as compared to non-treated surfaces Irrespective of surface treatment and resulting surface roughness, the fatigue strength of 3D printed samples containing bulk or surface porosity was approximately 10% of the ultimate tensile strength of identical 3D printed porous material. This study highlights the relative effect of surface treatment in solid and porous printed samples and the inherent decrease in fatigue properties of 3D printed porous samples designed for osseointegration.

Porous PEEK improves the bone-implant interface compared to plasma-sprayed titanium coating on PEEK.

Polyether-ether-ketone (PEEK) is one of the most common materials used for load-bearing orthopaedic devices due to its radiolucency and favorable mechanical properties. However, current smooth-surfaced PEEK implants can lead to fibrous encapsulation and poor osseointegration. This study compared the in vitro and in vivo bone response to two smooth PEEK alternatives: porous PEEK and plasma-sprayed titanium coatings on PEEK. MC3T3 cells were grown on smooth PEEK, porous PEEK, and Ti-coated PEEK for 14 days and assayed for calcium content, osteocalcin, VEGF and ALP activity. Osseointegration was investigated by implanting cylindrical implants into the proximal tibiae of male Sprague Dawley rats for 8 weeks. Bone-implant interfaces were evaluated using µCT, histology and pullout testing. Cells on porous PEEK surfaces produced more calcium, osteocalcin, and VEGF than smooth PEEK and Ti-coated PEEK groups. Bone ingrowth into porous PEEK surfaces was comparable to previously reported porous materials and correlated well between µCT and histology analysis. Porous PEEK implants exhibited greater pullout force, stiffness and energy-to-failure compared to smooth PEEK and Ti-coated PEEK, despite Ti-coated PEEK exhibiting a high degree of bone-implant contact. These results are attributed to increased mechanical interlocking of bone with the porous PEEK implant surface. Overall, porous PEEK was associated with improved osteogenic differentiation in vitro and greater implant fixation in vivo compared to smooth PEEK and Ti-coated PEEK. These results suggest that not all PEEK implants inherently generate a fibrous response and that topography has a central role in determining implant osseointegration.

Effect of porous orthopaedic implant material and structure on load sharing with simulated bone ingrowth: A finite element analysis comparing titanium and PEEK.

Osseointegration of load-bearing orthopaedic implants, including interbody fusion devices, is critical to long-term biomechanical functionality. Mechanical loads are a key regulator of bone tissue remodeling and maintenance, and stress-shielding due to metal orthopaedic implants being much stiffer than bone has been implicated in clinical observations of long-term bone loss in tissue adjacent to implants. Porous features that accommodate bone ingrowth have improved implant fixation in the short term, but long-term retrieval studies have sometimes demonstrated limited, superficial ingrowth into the pore layer of metal implants and aseptic loosening remains a problem for a subset of patients. Polyether-ether-ketone (PEEK) is a widely used orthopaedic material with an elastic modulus more similar to bone than metals, and a manufacturing process to form porous PEEK was recently developed to allow bone ingrowth while preserving strength for load-bearing applications. To investigate the biomechanical implications of porous PEEK compared to porous metals, we analyzed finite element (FE) models of the pore structure-bone interface using two clinically available implants with high (> 60%) porosity, one being constructed from PEEK and the other from electron beam 3D-printed titanium (Ti). The objective of this study was to investigate how porous PEEK and porous Ti mechanical properties affect load sharing with bone within the porous architectures over time. Porous PEEK substantially increased the load share transferred to ingrown bone compared to porous Ti under compression (i.e. at 4 weeks: PEEK = 66%; Ti = 13%), tension (PEEK = 71%; Ti = 12%), and shear (PEEK = 68%; Ti = 9%) at all time points of simulated bone ingrowth. Applying PEEK mechanical properties to the Ti implant geometry and vice versa demonstrated that the observed increases in load sharing with PEEK were primarily due to differences in intrinsic elastic modulus and not pore architecture (i.e. 4 weeks, compression: PEEK material/Ti geometry = 53%; Ti material/PEEK geometry = 12%). Additionally, local tissue energy effective strains on bone tissue adjacent to the implant under spinal load magnitudes were over two-fold higher with porous PEEK than porous Ti (i.e. 4 weeks, compression: PEEK = 784 ± 351 microstrain; Ti = 180 ± 300 microstrain; and 12 weeks, compression: PEEK = 298 ± 88 microstrain; Ti = 121 ± 49 microstrain). The higher local strains on bone tissue in the PEEK pore structure were below previously established thresholds for bone damage but in the range necessary for physiological bone maintenance and adaptation. Placing these strain magnitudes in the context of literature on bone adaptation to mechanical loads, this study suggests that porous PEEK structures may provide a more favorable mechanical environment for bone formation and maintenance under spinal load magnitudes than currently available porous 3D-printed Ti, regardless of the level of bone ingrowth.

Impaction durability of porous polyether-ether-ketone (PEEK) and titanium-coated PEEK interbody fusion devices.

BACKGROUND CONTEXT: Various surface modifications, often incorporating roughened or porous surfaces, have recently been introduced to enhance osseointegration of interbody fusion devices. However, these topographical features can be vulnerable to damage during clinical impaction. Despite the potential negative impact of surface damage on clinical outcomes, current testing standards do not replicate clinically relevant impaction loading conditions. PURPOSE: The purpose of this study was to compare the impaction durability of conventional smooth polyether-ether-ketone (PEEK) cervical interbody fusion devices with two surface-modified PEEK devices that feature either a porous structure or plasma-sprayed titanium coating. STUDY DESIGN/SETTING: A recently developed biomechanical test method was adapted to simulate clinically relevant impaction loading conditions during cervical interbody fusion procedures. METHODS: Three cervical interbody fusion devices were used in this study: smooth PEEK, plasma-sprayed titanium-coated PEEK, and porous PEEK (n=6). Following Kienle et al., devices were impacted between two polyurethane blocks mimicking vertebral bodies under a constant 200 N preload. The posterior tip of the device was placed at the entrance between the polyurethane blocks, and a guided 1-lb weight was impacted upon the anterior face with a maximum speed of 2.6 m/s to represent the strike force of a surgical mallet. Impacts were repeated until the device was fully impacted. Porous PEEK durability was assessed using micro-computed tomography (µCT) pre- and postimpaction. Titanium-coating coverage pre- and postimpaction was assessed using scanning electron microscopy (SEM) and energy dispersive X-ray spectroscopy. Changes to the surface roughness of smooth and titanium-coated devices were also evaluated. RESULTS: Porous PEEK and smooth PEEK devices showed minimal macroscopic signs of surface damage, whereas the titanium-coated devices exhibited substantial visible coating loss. Quantification of the porous PEEK deformation demonstrated that the porous structure maintained a high porosity (>65%) following impaction that would be available for bone ingrowth, and exhibited minimal changes to pore size and depth. SEM and energy dispersive X-ray spectroscopy analysis of titanium-coated devices demonstrated substantial titanium coating loss after impaction that was corroborated with a decrease in surface roughness. Smooth PEEK showed minimal signs of damage using SEM, but demonstrated a decrease in surface roughness. CONCLUSION: Although recent surface modifications to interbody fusion devices are beneficial for osseointegration, they may be susceptible to damage and wear during impaction. The current study found porous PEEK devices to show minimal damage during simulated cervical impaction, whereas titanium-coated PEEK devices lost substantial titanium coverage.

Getting PEEK to Stick to Bone: The Development of Porous PEEK for Interbody Fusion Devices.

Interbody fusion cages are routinely implanted during spinal fusion procedures to facilitate arthrodesis of a degenerated or unstable vertebral segment. Current cages are most commonly made from polyether-ether-ketone (PEEK) due to its favorable mechanical properties and imaging characteristics. However, the smooth surface of current PEEK cages may limit implant osseointegration and may inhibit successful fusion. We present the development and clinical application of the first commercially available porous PEEK fusion cage (COHERE®, Vertera, Inc., Atlanta, GA) that aims to enhance PEEK osseointegration and spinal fusion outcomes. The porous PEEK structure is extruded directly from the underlying solid and mimics the structural and mechanical properties of trabecular bone to support bone ingrowth and implant fixation. Biomechanical testing of the COHERE® device has demonstrated greater expulsion resistance versus smooth PEEK cages with ridges and greater adhesion strength of porous PEEK versus plasma-sprayed titanium coated PEEK surfaces. In vitro experiments have shown favorable cell attachment to porous PEEK and greater proliferation and mineralization of cell cultures grown on porous PEEK versus smooth PEEK and smooth titanium surfaces, suggesting that the porous structure enhances bone formation at the cellular level. At the implant level, preclinical animal studies have found comparable bone ingrowth into porous PEEK as those previously reported for porous titanium, leading to twice the fixation strength of smooth PEEK implants. Finally, two clinical case studies are presented demonstrating the effectiveness of the COHERE® device in cervical spinal fusion.

Deformation and fatigue of tough 3D printed elastomer scaffolds processed by fused deposition modeling and continuous liquid interface production.

Polyurethane (PU) based elastomers continue to gain popularity in a variety of biomedical applications as compliant implant materials. In parallel, advancements in additive manufacturing continue to provide new opportunities for biomedical applications by enabling the creation of more complex architectures for tissue scaffolding and patient specific implants. The purpose of this study was to examine the effects of printed architecture on the monotonic and cyclic mechanical behavior of elastomeric PUs and to compare the structure-property relationship across two different printing approaches. We examined the tensile fatigue of notched specimens, 3D crosshatch scaffolds, and two 3D spherical pore architectures in a physically crosslinked polycarbonate urethane (PCU) printed via fused deposition modeling (FDM) as well as a photo-cured, chemically-crosslinked, elastomeric PU printed via continuous liquid interface production (CLIP). Both elastomers were relatively tolerant of 3D geometrical features as compared to stiffer synthetic implant materials such as PEEK and titanium. PCU and crosslinked PU samples with 3D porous structures demonstrated a reduced tensile failure stress as expected without a significant effect on tensile failure strain. PCU crosshatch samples demonstrated similar performance in strain-based tensile fatigue as solid controls; however, when plotted against stress amplitude and adjusted by porosity, it was clear that the architecture had an impact on performance. Square shaped notches or pores in crosslinked PU appeared to have a modest effect on strain-based tensile fatigue while circular shaped notches and pores had little impact relative to smooth samples. When plotted against stress amplitude, any differences in fatigue performance were small or not statistically significant for crosslinked PU samples. Despite the slight difference in local architecture and tolerances, crosslinked PU solid samples were found to perform on par with PCU solid samples in tensile fatigue, when appropriately adjusted for material hardness. Finally, tests of samples with printed architecture localized to the gage section revealed an effect in which fatigue performance appeared to drastically improve despite the localization of strain.

Local deformation behavior of surface porous polyether-ether-ketone.

Surface porous polyether-ether-ketone has the ability to maintain the tensile monotonic and cyclic strength necessary for many load bearing orthopedic applications while providing a surface that facilitates bone ingrowth; however, the relevant deformation behavior of the pore architecture in response to various loading conditions is not yet fully characterized or understood. The focus of this study was to examine the compressive and wear behavior of the surface porous architecture using micro Computed Tomography (micro CT). Pore architectures of various depths (~0.5-2.5mm) and pore sizes (212-508µm) were manufactured using a melt extrusion and porogen leaching process. Compression testing revealed that the pore architecture deforms in the typical three staged linear elastic, plastic, and densification stages characteristic of porous materials. The experimental moduli and yield strengths decreased as the porosity increased but there was no difference in properties between pore sizes. The porous architecture maintained a high degree of porosity available for bone-ingrowth at all strains. Surface porous samples showed no increase in wear rate compared to injection molded samples, with slight pore densification accompanying wear.

Thermo-mechanical behavior and structure of melt blown shape-memory polyurethane nonwovens.

New processing methods for shape-memory polymers allow for tailoring material properties for numerous applications. Shape-memory nonwovens have been previously electrospun, but melt blow processing has yet to be evaluated. In order to determine the process parameters affecting shape-memory behavior, this study examined the effect of air pressure and collector speed on the mechanical behavior and shape-recovery of shape-memory polyurethane nonwovens. Mechanical behavior was measured by dynamic mechanical analysis and tensile testing, and shape-recovery was measured by unconstrained and constrained recovery. Microstructure changes throughout the shape-memory cycle were also investigated by micro-computed tomography. It was found that increasing collector speed increases elastic modulus, ultimate strength and recovery stress of the nonwoven, but collector speed does not affect the failure strain or unconstrained recovery. Increasing air pressure decreases the failure strain and increases rubbery modulus and unconstrained recovery, but air pressure does not influence recovery stress. It was also found that during the shape-memory cycle, the connectivity density of the fibers upon recovery does not fully return to the initial values, accounting for the incomplete shape-recovery seen in shape-memory nonwovens. With these parameter to property relationships identified, shape-memory nonwovens can be more easily manufactured and tailored for specific applications.

Impact of surface porosity and topography on the mechanical behavior of high strength biomedical polymers.

The ability to control the surface topography of orthopedic implant materials is desired to improve osseointegration but is often at the expense of mechanical performance in load bearing environments. Here we investigate the effects of surface modifications, roughness and porosity, on the mechanical properties of a set of polymers with diverse chemistry and structure. Both roughness and surface porosity resulted in samples with lower strength, failure strain and fatigue life due to stress concentrations at the surface; however, the decrease in ductility and fatigue strength were greater than the decrease in monotonic strength. The fatigue properties of the injection molded polymers did not correlate with yield strength as would be traditionally observed in metals. Rather, the fatigue properties and the capacity to maintain properties with the introduction of surface porosity correlated with the fracture toughness of the polymers. Polymer structure impacted the materials relative capacity to maintain monotonic and cyclic properties in the face of surface texture and porosity. Generally, amorphous polymers with large ratios of upper to lower yield points demonstrated a more significant drop in ductility and fatigue strength with the introduction of porosity compared to crystalline polymers with smaller ratios in their upper to lower yield strength. The latter materials have more effective dissipation mechanisms to minimize the impact of surface porosity on both monotonic and cyclic damage.

Compressive cyclic ratcheting and fatigue of synthetic, soft biomedical polymers in solution.

The use of soft, synthetic materials for the replacement of soft, load-bearing tissues has been largely unsuccessful due to a lack of materials with sufficient fatigue and wear properties, as well as a lack of fundamental understanding on the relationship between material structure and behavior under cyclic loads. In this study, we investigated the response of several soft, biomedical polymers to cyclic compressive stresses under aqueous conditions and utilized dynamic mechanical analysis and differential scanning calorimetry to evaluate the role of thermo-mechanical transitions on such behavior. Studied materials include: polycarbonate urethane, polydimethylsiloxane, four acrylate copolymers with systematically varied thermo-mechanical transitions, as well as bovine meniscal tissue for comparison. Materials showed compressive moduli between 2.3 and 1900MPa, with polycarbonate urethane (27.3MPa) matching closest to meniscal tissue (37.0MPa), and also demonstrated a variety of thermo-mechanical transition behaviors. Cyclic testing resulted in distinct fatigue-life curves, with failure defined as either classic fatigue fracture or a defined increased in maximum strain due to ratcheting. Our study found that polymers with sufficient dissipation mechanisms at the testing temperature, as evidenced by tan delta values, were generally tougher than those with less dissipation and exhibited ratcheting rather than fatigue fracture much like meniscal tissue. Strain recovery tests indicated that, for some toughened polymers, the residual strain following our cyclic loading protocol could be fully recovered. The similarity in ratcheting behavior, and lack of fatigue fracture, between the meniscal tissue and toughened polymers indicates that such polymers may have potential as artificial soft tissue.

Use of 3D Printed Bone Plate in Novel Technique to Surgically Correct Hallux Valgus Deformities.

Three-dimensional (3-D) printing offers many potential advantages in designing and manufacturing plating systems for foot and ankle procedures that involve small, geometrically complex bony anatomy. Here, we describe the design and clinical use of a Ti-6Al-4V ELI bone plate (FastForward™ Bone Tether Plate, MedShape, Inc., Atlanta, GA) manufactured through 3-D printing processes. The plate protects the second metatarsal when tethering suture tape between the first and second metatarsals and is a part of a new procedure that corrects hallux valgus (bunion) deformities without relying on doing an osteotomy or fusion procedure. The surgical technique and two clinical cases describing the use of this procedure with the 3-D printed bone plate are presented within.

Solvent-driven temperature memory and multiple shape memory effects.

Thermally-activated temperature memory and multiple shape memory effects have been observed in amorphous polymers with a broad glass transition. In this work, we demonstrate that the same shape recovery behaviors can also be achieved through solvent absorption. We investigate the recovery behaviors of programmed Nafion membranes in various solvents and compare the solvent-driven and temperature-driven shape recovery response. The results show that the programming temperature and solvent type have a corresponding strong influence on the shape recovery behavior. Specifically, lower programming temperatures induce faster initial recovery rates and larger recovery, which is known as the temperature memory effect. The temperature memory effect can be used to achieve multi-staged and multiple shape recovery of specimens programmed at different temperatures. Different solvents can also induce different shape recovery, analogous to the temperature memory effect, and can also provide a mechanism for multi-staged and multiple shape memory recovery.

Extraluminal distraction enterogenesis using shape-memory polymer.

PURPOSE: Although a few techniques for lengthening intestine by mechanical stretch have been described, they are relatively complex, and the majority involve placement of an intraluminal device. Ideally, techniques applicable to humans would be easy to perform and extraluminal to avoid the potential for mucosal injury. This study of distraction enterogenesis used an extraluminal, radially self-expanding shape-memory polymer cylinder and a simple operative approach to both elongate intestine and grow new tissue. METHODS: Young Sprague Dawley rats (250-350 g) underwent Roux-en-Y isolation of a small intestinal limb and were divided in three groups: no further manipulation (Control 1, C1); placement of a nonexpanding device (Control 2, C2); or placement of a radially expanding device by the limb (Experimental, Exp). For C2 and Exp animals, the blind end of the limb was wrapped around the radially expanding cylindrical device with the limb-end sutured back to the limb-side. Bowel length was measured at operation and at necropsy (14 days) both in-situ and ex-vivo under standard tension (6g weight). Change in length is shown as mean ± standard deviation. A blinded gastrointestinal pathologist reviewed histology and recorded multiple measures of intestinal adaptation. The DNA to protein ratio was quantified as a surrogate for cellular proliferation. Changes in length, histologic measures, and DNA:protein were compared using analysis of variance, with significance set at P<0.05. RESULTS: The length of the Roux limb in situ increased significantly in Exp animals (n=8, 29.0 ± 5.8mm) compared with C1 animals (n=5, -11.2 ± 9.0mm, P<0.01). The length of the Roux limb ex vivo under standard tension increased in the Exp group (25.8 ± 4.2mm) compared with the C2 group (n=6, -4.3 ± 6.0, P<0.01). There were no differences in histologic measures of bowel adaptation between the groups, namely villous height and width, crypt depth, crypt density, and crypt fission rate (all P ≥ 0.08). Muscularis mucosal thickness was also not different (P=0.25). There was no difference in DNA:protein between groups (P=0.47). CONCLUSION: An extraluminally placed, radially expanding shape-memory polymer cylinder successfully lengthened intestine, without damaging mucosa. Lack of difference in muscularis thickness and a constant DNA:protein ratio suggests that this process may be related to actual growth rather than mere stretch. This study demonstrated a simple approach that warrants further study aiming at potential clinical applicability.