Quasi-static mechanical evaluation of canine cementless total hip replacement broaches: effect of tooth design on broach and stem insertion.

BACKGROUND: Biomedtrix BFX® cementless total hip replacement (THR) requires the use of femoral broaches to prepare a press-fit envelope within the femur for subsequent stem insertion. Current broaches contain teeth that crush and remove cancellous bone; however, they are not particularly well-suited for broaching sclerotic (corticalized) cancellous bone. In this study, three tooth designs [Control, TG1 (additional V-grooves), TG2 (diamond tooth pattern)] were evaluated with a quasi-static testing protocol and polyurethane test blocks simulating normal and sclerotic bone. To mimic clinical broaching, a series of five sequential broach insertions were used to determine cumulative broaching energy (J) and peak loads during broach insertion. To determine the effect of broach tooth design on THR stem insertion, a BFX® stem was inserted into prepared test blocks and insertion and subsidence energy and peak loads were determined. RESULTS: Broach tooth design led to significant differences in broaching energy and peak broaching loads in test blocks of both densities. In low density test blocks, TG1 required the lowest cumulative broaching energy (10.76 ±0.29 J), followed by Control (12.18 ±1.20 J) and TG2 (16.66 ±0.78 J) broaches. In high density test blocks, TG1 required the lowest cumulative broaching energy (32.60 ±2.54 J) as compared to Control (33.25 ±2.16 J) and TG2 (59.97 ±3.07 J).  During stem insertion and subsidence testing, stem insertion energy for high density test blocks prepared with Control broaches was 14.53 ± 0.81 J, which was significantly lower than blocks prepared with TG1 (22.53 ± 1.04 J) or TG2 (19.38 ± 3.00 J) broaches. For stem subsidence testing in high density blocks, TG1 prepared blocks required the highest amount of energy to undergo subsidence (14.49 ± 0.49 J), which was significantly greater than test blocks prepared with Control (11.09 ±0.09 J) or TG2 (12.57 ± 0.81 J) broaches. CONCLUSIONS: The additional V-grooves in TG1 broaches demonstrated improved broaching performance while also generating press-fit envelopes that were more resistant to stem insertion and subsidence. TG1 broaches may prove useful in the clinical setting; however additional studies that more closely simulate clinical broach impaction are necessary prior to making widespread changes to THR broaches.

Predictive estimation of ovine hip joint centers: A regression approach.

Estimation of the hip joint center in ovine biomechanical analysis is often overlooked or estimated using a marker on the greater trochanter which can result in large errors that propagate through subsequent analyses. The purpose of this study was to develop a novel method of estimating the hip joint centers in sheep to facilitate more accurate analysis of ovine biomechanics. CT scans from 16 sheep of varying ages, weight, sex, and phenotypes were acquired and the data was used to calculate the known hip joint center by sphere fitting the femoral head. Anatomical measurements and additional subject information were used to create a variety of regression models to estimate the hip joint centers in absence of CT data. The best regression equation created utilized markers placed on the tuber coxae and tuber ischii of the pelvis and resulted in a mean 3D Euclidean distance error of 6.43 ± 2.22 mm (mean ± standard deviation) between the known and estimated hip joint center. The regression models produced allow for more detailed, accurate and robust analysis of sheep biomechanics.

Methodology for performing biomechanical push-out tests for evaluating the osseointegration of calvarial defect repair in small animal models.

Push-out tests are frequently used to evaluate the bone-implant interfacial strength of orthopedic implants, particularly dental and craniomaxillofacial applications. There currently is no standard method for performing push-out tests on calvarial models, leading to a variety of inconsistent approaches. In this study, fixtures and methods were developed to perform push-out tests in accordance with the following design objectives: (i) the system rigidly fixes the explanted calvarial sample, (ii) it minimizes lateral bending, (iii) it positions the defect accurately, and (iv) it permits verification of the coaxial alignment of the defect with the push-out rod. The fixture and method was first validated by completing push-out experiments on 30 explanted murine cranial caps and two explanted leporine cranial caps, all induced with bilateral sub-critical defects (5.0 mm and 8.0 mm nominal diameter for the murine and leporine models, respectively). Defects were treated with an autograft (i.e., excised tissue flap), a shape memory polymer (SMP) scaffold, or a PEEK implant. Additional validation was performed on 24 murine cranial caps induced with a single, unilateral critically-sized defect (8.0 mm nominal diameter) and treated with an autograft or a SMP scaffold.•A novel fixture was developed for performing push-out mechanical tests to characterize the strength of a bone-implant interface in calvarial defect repair.•The fixture uses a 3D printed vertical clamp with mating alignment component to fix the sample in place without inducing lateral bending and verify coaxial alignment of push-out rod with the defect.•The fixture can be scaled to different calvarial defect geometries as validated with 5.0 mm bilateral and 8.0 mm single diameter murine calvarial defect model and 8.0 mm bilateral leporine calvarial defect model.

Evaluation of a self-fitting, shape memory polymer scaffold in a rabbit calvarial defect model.

Self-fitting scaffolds prepared from biodegradable poly(ε-caprolactone)-diacrylate (PCL-DA) have been developed for the treatment of craniomaxillofacial (CMF) bone defects. As a thermoresponsive shape memory polymer (SMP), with the mere exposure to warm saline, these porous scaffolds achieve a conformal fit in defects. This behavior was expected to be advantageous to osseointegration and thus bone healing. Herein, for an initial assessment of their regenerative potential, a pilot in vivo study was performed using a rabbit calvarial defect model. Exogenous growth factors and cells were excluded from the scaffolds. Key scaffold material properties were confirmed to be maintained following gamma sterilization. To assess scaffold integration and neotissue infiltration along the defect perimeter, non-critically sized (d = 8 mm) bilateral calvarial defects were created in 12 New Zealand white rabbits. Bone formation was assessed at 4 and 16 weeks using histological analysis and micro-CT, comparing defects treated with an SMP scaffold (d = 9 mm x t = 1 or 2 mm) to untreated defects (i.e. defects able to heal without intervention). To further assess osseointegration, push-out tests were performed at 16 weeks and compared to defects treated with poly(ether ether ketone) (PEEK) discs (d = 8.5 mm x t = 2 mm). The results of this study confirmed that the SMP scaffolds were biocompatible and highly conducive to bone formation and ingrowth at the perimeter. Ultimately, this resulted in similar bone volume and surface area versus untreated defects and superior performance in push-out testing versus defects treated with PEEK discs. STATEMENT OF SIGNIFICANCE: Current treatments of craniomaxillofacial (CMF) bone defects include biologic and synthetic grafts but they are limited in their ability to form good contact with adjacent tissue. A regenerative engineering approach using a biologic-free scaffold able to achieve conformal fitting represents a potential "off-the-shelf" surgical product to heal CMF bone defects. Having not yet been evaluated in vivo, this study provided the preliminary assessment of the bone healing potential of self-fitting PCL scaffolds using a rabbit calvarial defect model. The study was designed to assess scaffold biocompatibility as well as bone formation and ingrowth using histology, micro-CT, and biomechanical push-out tests. The favorable results provide a basis to pursue establishing self-fitting scaffolds as a treatment option for CMF defects.

Double Tension Slide Technique as a Novel Repair for Distal Biceps Tendon Tear: A Biomechanical Evaluation.

Background A comparative biomechanical analysis of two distal biceps tendon repair techniques was performed: a single suture tension slide technique (TST) and two suture double tension slide (DTS) technique. Methodology Ten matched pairs of fresh frozen human cadaveric elbows (20 elbows) were randomly separated into two cohorts for distal biceps tendon repair. One cohort underwent the TST, and the other underwent the DTS technique. The tendon was preconditioned with cyclic loading from 0° to 90° at 0.5 Hz for 3,600 cycles with a 50 N load. The specimens were then loaded to failure at a rate of 1 mm/s. The difference in the load to failure between the groups was analyzed using the Student's t test. The mode of failure was compared between groups using the chi-square test. All p-values were reported with significance set at p < 0.05. Results Overall, 77.8% of the included matched pairs demonstrated greater load to failure in the DTS group. The mean load to failure in the DTS group was 383.3 ± 149.3 N compared to 275.8 ± 98.1 N in the TST group (p = 0.13). The DTS specimens failed at the tendon (5/9), suture (3/9), and bone (1/9). The TST specimens failed at the tendon (4/9) and suture (5/9) only. There was no significant difference in failure type between groups (p = 0.76). Conclusions DTS demonstrates a similar to greater load to failure compared to TST with a trend towards statistical significance. The redundancy provided by the second suture has an inherent advantage without compromising the biomechanical testing.

A versatile biaxial testing platform for soft tissues.

Uniaxial testing remains the most common modality of mechanical analysis for biological and other soft materials; however, biaxial testing enables a more comprehensive understanding of these materials' mechanical behavior. In recent years, a number of commercially available biaxial testing systems designed for biological materials have been produced; however, there are common limitations that are often associated with using these systems. For example, the range of allowable sample geometries are relatively constrained, the clamping systems are relatively limited with respect to allowable configurations, the load and displacement ranges are relatively small, and the software and control elements offer relatively limited options. Due to these constraints, there are significant benefits associated with designing custom biaxial testing systems that meet the technical requirements for testing a broad range of materials. Herein we present a design for a biaxial testing system with capabilities that extend beyond those associated with typical commercially available systems. Our design is capable of performing uniaxial tests, traditional biaxial tests, and double lap shear (simple shear) tests, in either a displacement or load control mode. Testing protocols have been developed and proof-of-concept experiments have been performed on commercially available silicone membranes and rat abdominal skin samples.

A low-cost, novel endoscopic repeated-access port for small animal research.

Repeated endoscopic access to the abdominal cavity of animal models is useful for a variety of research applications. However, repeated surgical access may affect the welfare of the animal and compromise results. We present the design and benchtop manufacturing process for a self-sealing endoscopic port requiring surgical incision only at implantation. It can be used for repeated body cavity access over a long time period. This device reduces costs, animals required for a given study, and potential suffering for each animal. This novel endoscopic port is designed for low-cost benchtop manufacturing without expensive equipment such as injection molding facilities. Devices manufactured using the method described in this work have been implanted successfully in hen models for investigation of ovarian cancer for over two years. All work followed Texas A&M University institutional guidelines and was covered under Animal Use Protocol 2017-0172, approved by TAMU Animal Care and Use Committee (IACUC). This method can be translated to produce similar devices for use in other small animal models besides the galline model used in this work. This method can be used to produce devices for slightly different purposes than repeated endoscopic access, such as production of an entry port for surgical tools.

Distal Biceps Tendon Repair Using a Double Tension Slide Technique.

Distal biceps tendon ruptures are thought to be secondary to an acute forceful eccentric load on a degenerative tendon. Nonoperative treatment following rupture leads to significantly decreased forearm supination and elbow flexion strength. There are several techniques described in the literature for repair. This article describes, with video illustration, distal biceps tendon repair using a double tension slide technique with 2 No. 2 high-tension nonabsorbable composite sutures.

Clamping soft biologic tissues for uniaxial tensile testing: A brief survey of current methods and development of a novel clamping mechanism.

Biologic tissues are complex materials that come in many forms and perform a variety of functions. They vary widely in composition and mechanical properties, and determination of the mechanical properties of tissues is of interest to those trying to engineer tissues to restore missing function. In performing experiments to characterize the mechanical properties of biologic tissues, there is no single solution to clamping tissues or tissue engineered constructs for mechanical testing. Various clamping techniques have been developed over the past few decades to address the difficulty of imposing appropriate boundary conditions on particular soft tissues during mechanical testing. Two criteria for a successful clamping mechanism are (i) prevention of test specimen slippage, and (ii) prevention of test specimen failure outside the gage region. Herein we present a novel clamping mechanism design developed for the mechanical testing of abdominal wall tissue as an example. This design incorporates pins with serrated clamps to successfully decrease the occurrence of test sample slippage while reducing imposed stress concentrations at the clamping sites. This design was evaluated by performing 40 uniaxial tensile tests on rat abdominal wall muscles using strain rates of 1% per second or 10% per second. Load and displacement data were acquired at the grips. The clamping area on the tissue sample was marked with India ink to track potential slippage of the sample during testing. Ultimate tensile strength and the corresponding stretch were calculated when the maximum load was achieved. With fine-tuning of the torque applied to the clamping grips, the success rate of the tensile tests reached over 90%.

Characterizing the non-linear mechanical behavior of native and biomimetic engineered tissues in 1D with physically meaningful parameters.

It is common practice to evaluate the mechanical performance of a scaffold for tissue engineering using concepts from linear elasticity theory (i.e. Young's modulus), or variations thereof, and uniaxial testing data. In some cases the non-linear nature of tissue stress-strain behavior has prompted development of empirical approaches to obtain a more comprehensive description of the observed mechanical behavior. Such approaches constitute improvements over singular stiffness measures but the lack of an appropriate non-linear theoretical foundation renders them somewhat arbitrary and potentially incomplete. Recently, a constitutive model for non-linear tissues was developed based on first principles in physics. The Freed-Rajagopal 1-D Fiber Model incorporates physically meaningful parameters that provide a unique and comprehensive characterization of non-linear tissue behavior for the class of tissues with strain limiting behavior in 1D. The physical interpretation that these parameters provide suggests they may serve as useful design targets for tissue engineering applications. In this study, the Freed-Rajagopal model is employed with conventional uniaxial mechanical testing data obtained from experiments with collagen scaffolds for hernia repair grafts and the healthy native tissue counterpart. Results from the Freed-Rajagopal analysis revealed that tissue-engineered constructs that qualify as "biomimetic" according to linear elasticity theory, or variations thereof, are not truly biomimetic, as they do not mimic the non-linear mechanical behaviors observed in their native tissue counterparts. Most importantly, the Freed-Rajagopal model was easy to employ (it can be done using a standard uniaxial testing system, with minimal additional effort) and revealed specific design improvements that could be targeted to improve the biofidelity of these constructs. A performance comparison with conventional non-linear models (including Fung's 1D Law and a one-dimensionalized version of the Holzapfel, Gasser, Ogden model), was then conducted and revealed the Freed-Rajagopal model produced results that correlated exceptionally well with experimental data and better describes material behavior at low strains as compared to competing models.

Ballistic thermal phonons traversing nanocrystalline domains in oriented polyethylene.

Thermally conductive polymer crystals are of both fundamental and practical interest for their high thermal conductivity that exceeds that of many metals. In particular, polyethylene fibers and oriented films with uniaxial thermal conductivity exceeding 50 [Formula: see text] have been reported recently, stimulating interest into the underlying microscopic thermal transport processes. While ab initio calculations have provided insight into microscopic phonon properties for perfect crystals, such properties of actual samples have remained experimentally inaccessible. Here, we report the direct observation of thermal phonons with mean free paths up to 200 nm in semicrystalline polyethylene films using transient grating spectroscopy. Many of the mean free paths substantially exceed the crystalline domain sizes measured using small-angle X-ray scattering, indicating that thermal phonons propagate ballistically within and across the nanocrystalline domains; those transmitting across domain boundaries contribute nearly one-third of the thermal conductivity. Our work provides a direct determination of thermal phonon propagation lengths in molecular solids, yielding insights into the microscopic origins of their high thermal conductivity.

Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults.

BACKGROUND: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." METHODS: One hundred consecutive patients aged ≥18 years who presented with a chief complaint of pain were asked to record pain scores via a paper VAS and digitally via both the laptop computer and mobile phone. Ninety-eight subjects, 51 men (age, 44 ± 16 years) and 47 women (age, 46 ± 15 years), were included. A mixed-model analysis of covariance with the Bonferroni post hoc test was used to detect differences between the paper and digital VAS scores. A Bland-Altman analysis was used to test for instrument agreement between the platforms. The minimal clinically important difference was set at 1.4 cm (14% of total scale length) for detecting clinical relevance between the three VAS platforms. A paired one-tailed Student t-test was used to determine whether differences between the digital and paper measurement platforms exceeded 14% (P < 0.05). RESULTS: A significant difference in scores was found between the mobile phone-based (32.9% ± 0.4%) and both the laptop computer- and paper-based platforms (31.0% ± 0.4%, P < 0.01 for both). These differences were not clinically relevant (minimal clinically important difference <1.4 cm). No statistically significant difference was observed between the paper and laptop computer platforms. Measurement agreement was found between the paper- and laptop computer-based platforms (mean difference, 0.0% ± 0.5%; no proportional bias detected) but not between the paper- and mobile phone-based platforms (mean difference, 1.9% ± 0.5%; proportional bias detected). CONCLUSION: No clinically relevant difference exists between the traditional paper-based VAS assessment and VAS scores obtained from laptop computer- and mobile phone-based platforms.

Fabrication of macromolecular gradients in aligned fiber scaffolds using a combination of in-line blending and air-gap electrospinning.

Although a variety of fabrication methods have been developed to generate electrospun meshes with gradient properties, no platform has yet to achieve fiber alignment in the direction of the gradient that mimics the native tendon-bone interface. In this study, we present a method combining in-line blending and air-gap electrospinning to address this limitation in the field. A custom collector with synced rotation permitted fiber collection with uniform mesh thickness and periodic copper wires were used to induce fiber alignment. Two poly(ester urethane ureas) with different hard segment contents (BPUR 50, BPUR 10) were used to generate compositional gradient meshes with and without fiber alignment. The compositional gradient across the length of the mesh was characterized using a fluorescent dye and the results indicated a continuous transition from the BPUR 50 to the BPUR 10. As expected, the fiber alignment of the gradient meshes induced a corresponding alignment of adherent cells in static culture. Tensile testing of the sectioned meshes confirmed a graded transition in mechanical properties and an increase in anisotropy with fiber alignment. Finite element modeling was utilized to illustrate the gradient mechanical properties across the full length of the mesh and lay the foundation for future computational development work. Overall, these results indicate that this electrospinning method permits the fabrication of macromolecular gradients in the direction of fiber alignment and demonstrate its potential for use in interfacial tissue engineering. STATEMENT OF SIGNIFICANCE: The native tendon-bone interface contains a gradient of properties that ensures stability of the joint. Without this transition, failure can occur due to stress concentration at the bone insertion site. Electrospinning is a method commonly used to produce fibrous grafts with gradient properties; however, no current method allows for gradients in the direction of fiber alignment. This work details a novel electrospinning method to produce gradients in the direction of fiber alignment in order to better mimic transitional zones and improve regeneration of the tendon-bone interface. In addition to the biomechanical gradients demonstrated here, this method may also be used to generate gradients of macromolecular, biochemical, and cellular cues with broad potential utility in tissue engineering.

Biomimetic collagen/elastin meshes for ventral hernia repair in a rat model.

Ventral hernia repair remains a major clinical need. Herein, we formulated a type I collagen/elastin crosslinked blend (CollE) for the fabrication of biomimetic meshes for ventral hernia repair. To evaluate the effect of architecture on the performance of the implants, CollE was formulated both as flat sheets (CollE Sheets) and porous scaffolds (CollE Scaffolds). The morphology, hydrophylicity and in vitro degradation were assessed by SEM, water contact angle and differential scanning calorimetry, respectively. The stiffness of the meshes was determined using a constant stretch rate uniaxial tensile test, and compared to that of native tissue. CollE Sheets and Scaffolds were tested in vitro with human bone marrow-derived mesenchymal stem cells (h-BM-MSC), and finally implanted in a rat ventral hernia model. Neovascularization and tissue regeneration within the implants was evaluated at 6weeks, by histology, immunofluorescence, and q-PCR. It was found that CollE Sheets and Scaffolds were not only biomechanically sturdy enough to provide immediate repair of the hernia defect, but also promoted tissue restoration in only 6weeks. In fact, the presence of elastin enhanced the neovascularization in both sheets and scaffolds. Overall, CollE Scaffolds displayed mechanical properties more closely resembling those of native tissue, and induced higher gene expression of the entire marker genes tested, associated with de novo matrix deposition, angiogenesis, adipogenesis and skeletal muscles, compared to CollE Sheets. Altogether, this data suggests that the improved mechanical properties and bioactivity of CollE Sheets and Scaffolds make them valuable candidates for applications of ventral hernia repair. STATEMENT OF SIGNIFICANCE: Due to the elevated annual number of ventral hernia repair in the US, the lack of successful grafts, the design of innovative biomimetic meshes has become a prime focus in tissue engineering, to promote the repair of the abdominal wall, avoid recurrence. Our meshes (CollE Sheets and Scaffolds) not only showed promising mechanical performance, but also allowed for an efficient neovascularization, resulting in new adipose and muscle tissue formation within the implant, in only 6weeks. In addition, our meshes allowed for the use of the same surgical procedure utilized in clinical practice, with the commercially available grafts. This study represents a significant step in the design of bioactive acellular off-the-shelf biomimetic meshes for ventral hernia repair.

Processing-Structure-Property Relationships in Laser-Annealed PbSe Nanocrystal Thin Films.

As nanocrystal (NC) synthesis techniques and device architectures advance, it becomes increasingly apparent that new ways of connecting NCs with each other and their external environment are required to realize their considerable potential. Enhancing inter-NC coupling by thermal annealing has been a long-standing challenge. Conventional thermal annealing approaches are limited by the challenge of annealing the NC at sufficiently high temperatures to remove surface-bound ligands while at the same time limiting the thermal budget to prevent large-scale aggregation. Here we investigate nonequilibrium laser annealing of NC thin films that enables separation of the kinetic and thermodynamic aspects of nanocrystal fusion. We show that laser annealing of NC assemblies on nano- to microsecond time scales can transform initially isolated NCs in a thin film into an interconnected structure in which proximate dots "just touch". We investigate both pulsed laser annealing and laser spike annealing and show that both annealing methods can produce "confined-but-connected" nanocrystal films. We develop a thermal transport model to rationalize the differences in resulting film morphologies. Finally we show that the insights gained from study of nanocrystal mono- and bilayers can be extended to three-dimensional NC films. The basic processing-structure-property relationships established in this work provide guidance to future advances in creating functional thin films in which constituent NCs can purposefully interact.