Biphasic calcium phosphate (BCP) with a characteristic needle-shaped submicron surface topography (MagnetOs) has attracted much attention due to its unique bone-forming ability which is essential for repairing critical-size bone defects such as those found in the posterolateral spine. Previous in vitro and ex-vivo data performed by van Dijk LA and Yuan H demonstrated that these specific surface characteristics drive a favorable response from the innate immune system. This study aimed to evaluate and compare the in vivo performance of three commercially-available synthetic bone grafts, (1) i-FACTOR Putty®, (2) OssDsign® Catalyst Putty and (3) FIBERGRAFT® BG Matrix, with that of a novel synthetic bone graft in a clinically-relevant instrumented sheep posterolateral lumbar spine fusion (PLF) model. The novel synthetic bone graft comprised of BCP granules with a needle-shaped submicron surface topography (MagnetOs) embedded in a highly porous and fibrillar collagen matrix (MagnetOs Flex Matrix). Four synthetic bone grafts were implanted as standalone in an instrumented sheep PLF model for 12 weeks (n=3 bilateral levels per group; levels L2/3 & L4/5), after which spinal fusion was determined by manual palpation, radiograph and µCT imaging (based on the Lenke scale), range-of-motion mechanical testing, and histological and histomorphological evaluation. Radiographic fusion assessment determined bilateral robust bone bridging (Lenke scale A) in 3/3 levels for MagnetOs Flex Matrix compared to 1/3 for all other groups. For µCT, bilateral fusion (Lenke scale A) was found in 2/3 levels for MagnetOs Flex Matrix, compared to 0/3 for i-FACTOR Putty®, 1/3 for OssDsign® Catalyst Putty and 0/3 for FIBERGRAFT® BG Matrix. Fusion assessment for MagnetOs Flex Matrix was further substantiated by histology which revealed significant graft resorption complemented by abundant bone tissue and continuous bony bridging between vertebral transverse processes resulting in bilateral spinal fusion in 3/3 implants. These results show that MagnetOs Flex Matrix achieved better fusion rates compared to three commercially-available synthetic bone grafts when used as a standalone in a clinically-relevant instrumented sheep PLF model.
Recent clinical data suggest improvement in the fixation of tibia trays for total knee arthroplasty when the trays are additive manufactured with highly porous bone ingrowth structures. Currently, press-fit TKA is less common than press-fit THA. This is partly because the loads on the relatively flat, porous, bony apposition area of a tibial tray are more demanding than those same porous materials surrounding a hip stem. Even the most advanced additive manufactured (AM) highly porous structures have bone ingrowth limitations clinically as aseptic loosening still remains more common in press-fit TKA vs. THA implants. Osseointegration and antibacterial properties have been shown In this At 4 weeks, a 42% increase in average pull-out shear strength between nanotube treated specimens and non-nanotube treated specimens was shown. A 21% increase in average pull-out shear strength between nanotube treated specimens and hydroxyapatite-coated specimens was shown. At 12 weeks, all specimens had statistically similar pull-out values. Bone labels demonstrated new bone formation into the porous domains on the materials as early as 2 weeks. A separate These
The prevention of surgical-site infection (SSI) is of great importance. Airborne particulate correlates with microbial load and SSI. There are many potential sources of airborne particulates in theatre and from an experimental point of view impossible to control. We evaluated the effectiveness of a novel air decontamination-recirculation system (ADRS) in reducing airborne particles in a laboratory environment and controlled the introduction of particulate using diathermy. Airborne particles were measured with and without activation of the ADRS in PC2 laboratory to provide a baseline. Particles were generated in a controlled manner utilising electrocautery ablation of porcine skin tissue. Ablation was performed at 50W power (Cut) for 60 seconds at a constant rate with and without the ADRS operating in the PC2 laboratory. Particles were measured continuously in 30s intervals at two sites 0.5m and 3m from the site of diathermy. Adequate time was allowed for return to baseline between each repetition. Each experiment was repeated 10 times.Aim
Methods
Calcium sulfate and phosphate have a long clinical history of use as bone-void fillers (BVF) with established biocompatibility and resorption profiles. It has been widely reported that the addition of ‘impurity’ elements such as Silicon, Strontium and Zinc to calcium phosphate is advantageous, resulting in an improved bone healing response. This study examined the in vivo response of two formulations of calcium sulfate, as 3mm diameter hemispherical beads, in critical sized defects created in cancellous bone of distal femur and proximal tibia (10mm diameter × 13mm depth) in adult sheep; beads prepared from recrystallised pharmaceutical grade calcium sulfate (RPCS, Stimulan, Biocomposites Ltd, UK) and a lower purity medical grade material containing 1% strontium (SrCS). The animals were sacrificed at 3, 6 and 12 weeks post implantation and the surgical sites analysed using microCT and decalcified histology.Background
Methods
Cementless devices can be designed with varying surface treatments with the hope of achieving osseointegration. The surface finish dictates the interaction, adhesion and growth of bone therefore it is an important parameter that be measured and compared. The surface topography of a material can be viewed both microscopically and macroscopically. Surface microtopography focuses on the peaks and valleys where deviations in the characteristics of the size and spacing of these features determine the variability between surface topography. The most common parameter used worldwide to describe surface roughness is the arithmetic average height (Ra). The definition of Ra is the absolute deviation of the surface irregularities from a mean line across the sampling length given by the equation shown in figure 1. Many techniques can be used to relate to surface characteristics of materials, with the common two options revolving around contact and non-contact methods. These techniques are expensive and are limited in detecting the interaction of implantable devices at a macroscopic level. This study sought to develop a method to determine the surface roughness and characterise implants based on cross sectional images and scanning electron microscopy. The profile of 6 trunnions from a total hip replacement was obtained in x and y coordinates along a set length using a profilometer. A custom program to calculate the Ra of the material was created using a mathematical program (MATLAB). Each material profile was inputted into a mathematical program to provide the surface roughness of the material. The surface parameters were initially obtained from a surface analyser to determine the accuracy of the program.Introduction
Method
Biological fixation of arthroplasty devices through osseointegration via ingrowth or ongrowth can be achieved with a numerous surface treatments and technologies. Surface roughness and topography have evolved to include sintered bead, calcium phosphate coatings and more recently additive manufacturing techniques. Regardless of the technique employed, the clinical goal has always been directed at improving osseointegration and achieve rapid, stable and long-term implant fixation without compromising the mechanical properties of the device. Pre-clinical models provide insight into the in-vivo efficacy. The in vivo results of a wide range of technologies over the past 20 years have been examined by our laboratory using an adult ovine cortical and cancellous implantation model. This paper will present a twenty year experience of pre-clinical evaluation of bone ingrowth and ongrowth surfaces used for arthroplasty device fixation. The endpoints as well as understanding of the dynamic nature of the bone-implant interface continues to evolve as advanced manufacturing moves forward and the demands on the interface due to patient and surgeon expectations increase.
Bone marrow stimulation has been a successful treatment option in cartilage repair and microfracture was the procedure of choice since the late 1980s. Despite its success in young and active patients, microfracture has inherent shortcomings such as shallow channels, wall compression, and non-standardized depth and diameter. This in vitro study assessed bone marrow access comparing microfracture, 1 and 2mm K-Wires, 1mm drill, and a recently introduced standardized subchondral bone needling procedure (Nanofracture) that creates 9mm deep and 1mm wide channels. An adult ovine model was used to assess access to bone the marrow spaces as well as effects on bone following microfracture, nanofracture, K-wire, and drilling following ethical clearance. All bone marrow stimulation techniques were conducted on a full thickness articular cartilage defect on the medial femoral condyles by the same surgeon. The same groups were repeated in vitro in 4 paired ovine distal femurs. MicroCT (Inveon Scanner, Siemens, Germany) was performed using 3D reconstruction and 25 micron slice analysis (MIMICS, Materialise, Belgium).Introduction
Methods
Modern hip replacements all have encapsulated the design concept of proximal modularity. The factors contributing to the increased wear and corrosion at the taper junction are trunnion geometry, surface characteristics, head size, impaction forces, and material coupling. This study maps the inferior and superior region of the trunnion and bore to provide a visual identification of the corrosion severity. The corrosion/wear generated inferiorly and superiorly at the bore and trunnion will be quantified to understand how corrosion is affected by mechanical stresses in relation to anatomical orientation. Three neck tapers generated from bar stock containing a threaded trunnion Ti-6Al-4V and 3× 32mm femoral heads (Co-Cr-Mo) with a +4 offset manufactured by Signature Orthopaedics were used within this study. Rectangular Rozzette strain gauges (Tokyo Sokki Kenkyujo Co., Ltd.) were adhered onto the inferior and superior sections of the neck section. The tapers were fatigued in accordance to ISO 7206 at 5Hz for 5 million cycles at 37 degrees Celsius in phosphate buffered saline. The tapers were sectioned from the center of the femoral head to split both trunnion and bore into superior and inferior components. SEM imaging of all surface areas for each component, per taper (4) was done under ×100 magnification. The images were used to quantify the corrosion present across the surface area using a MATLAB based program called Histomorph. To obtain a visual observation of the variation of corrosion across the bore and trunnion the proximal, medial, and distal regions were mapped together for both the superior and inferior sections.Introduction
Methodology
The possibility of corrosion at the taper junction of hip replacements was initially identified as a concern of generating adverse reactions in the late 1980s. Common clinical findings of failure are pain, clicking, swelling, fluid collections, soft tissue masses, and gluteal muscle necrosis identified intra operatively. The joint replacement surgery was performed utilizing a posterior approach to the hip joint. The data from all surgical, clinical and radiological examinations was prospectively collected and stored in a database. Patients were separated into two groups based on bearing material, where group 1 had a CoC bearing and ABG modular stem whilst group 2 had a MoM bearing and SROM stem, with each group having 13 cases. Pre-operative revision surgery and post-operative blood serum metal ion levels we collected. Cup inclination and anteversion was measured using the Ein-Bild-Roentgen-Analyse (EBRA) software. A range of 2–5 tissue sections was examined per case. 2 independent observers that were blinded to the clinical patient findings scored all cases. The tissue grading for the H&E tissue sections were graded based on the presence of fibrin exudates, necrosis, inflammatory cells, metallic deposits, and corrosion products. The corrosion products were identified into 3 groups based on visible observation and graded based on abundance. A scanning electron microscope (SEM) Hitachi S3400 was used to allow for topographic and compositional surface imaging. Unstained tissue sections were used for imaging and elemental analysis. X-Ray diffraction was the analytical technique used for the taper debris that provided identification on the atomic and molecular structure of a crystal.Introduction
Methodology
A thorough understanding of wear patterns and failure mechanisms of TKA components in the context of pre-revision knee kinematics is advantageous for component designers, manufacturers and surgeons alike. Traditional gait analysis provides an experimental technique to determine in vivo kinematics but is often limited by its cumbersome nature, infrastructure intensiveness and time. The recent introduction of the KneeKG (Emovi Inc, Canada) as a stand-alone knee motion tracking system which uses infrared technology provides a great opportunity to quickly, easily and routinely monitor patients at the clinical level, especially those being revised for component failure. This pilot study was conducted to examine pre-revision knee kinematics and subsequent wear patterns and failure mechanisms observed on the UHMWPE inserts upon retrieval in a cohort of TKA revision patients. We hypothesize that motion patterns can provide surgeons a unique insight into the status of the UHMWPE insert and implant longevity. Patients requiring revision due to failure of the UHMWPE insert were recruited in this study after institutional ethical approval and written informed consent of the patients was obtained. Motion of the affected knee was quantified using a stand-alone infrared tracking system (KneeKG, Emovi Inc, Canada) whilst the patient was walking on a treadmill. All analyses were conducted within our institutional Physiotherapy Department. The KneeKG system is composed of passive motion sensors fixed on a validated knee harness, an infrared motion capture system (Polaris Spectra, Northern Digital Inc, USA) and a computer equipped with the Knee3D software suite (Emovi). Following application of the KneeKG trackers a calibration procedure was performed to identify joint centres and define a coordinate system on each body segment. After a treadmill habituation period of between 6 and 10 min, a trial was then conducted at the patient's comfortable treadmill gait speed over 45 sec. Averaged clinical rotations and translations of the tibia as a function of gait cycle were output by the system, and a report highlighting and detailing biomechanical deficiencies as compared to a database of normal controls automatically generated. Following the scheduled revision surgery the retrieved components were formalin-fixed and brought to our laboratory for a routine retrieval workup. All revisions were performed by a single surgeon. Components were analysed using optical and scanning electron microscopy techniques for regions of polishing, burnishing, pitting, delamination, deformation, scratching and embedded debris. Wear maps and scores were generated and correlated with pre-revision kinematics for each patient.Introduction
Methods
Biological fixation through bone ingrowth and ongrowth to implants can be achieved with a variety of surface treatments and technologies. This study evaluated the effect of two different three dimensional surface coatings for CoCr where porosity was controlled through the use of different geometry of CoCr beads in the sintering process. Test specimens in Group A were coated with conventional spherical porous-bead technology. The porous coating technology used on Group B was a variation of the conventional porous-bead technology. Instead of spherical beads, cobalt-chromium particles in irregular shapes were sieved for a particular size range, and were sintered onto the specimen substrate using similar process as Group A. The geometry and the size variation of the particles resulted in a unique 3D porous structure with widely interconnected pores. Three implants were placed bicortically in the tibia. Two implants were placed in the cancellous bone of the medial distal femur and proximal tibia bilaterally with 4 implantation conditions (2 mm gap, 1 mm gap line-to-line, and press fit). Animals were euthanized at 4 or 12 weeks for standard mechanical, histological and histomorphometric endpoints.Introduction
Methods
Timing for the application and use of fentanyl patches for pre-emptive analgesia and sedation is crucial to obtain good clinical outcomes. Placement and timing is important to maximise clinical effect and apparent levels of analgesia. The use of sheep as preclinical models for the investigation of orthopaedic conditions is gaining momentum, the control of their pain is a significant ethical issue. The daily need for injecting non-steroidal anti-inflammatory drugs (NSAIDs) and/or the shorter acting opioids increases the demand for handling post-operatively which can increase animal distress and risk of human injury. NSAIDs can have a negative effect on bone healing, complicating results. Opioid analgesics have no impact on bone healing. Fentanyl patches have become another option for use in pain management. Pre-emptive analgesia helps reduce the demand on post-operative analgesic use. Fentanyl has the added benefit of producing mild sedation. This study evaluated the pharmacokinetics of fentanyl patches in sheep in an effort to maximise pre and post-surgical analgesia.Summary
Introduction
Supercritical fluid (SCF) sterilization produces clean and osteoconductive allograft bone capable of healing a critical-sised bony defect. SCF treated graft induces an increased anabolic response and decreased catabolic reponse compared to gamma irradiated graft. Clinically, allogeneic bone graft is used extensively because it avoids the donor site morbidity associated with autograft. However, there are concerns over the optimal sterilization method to eliminate immunological risks whilst maintaining the biological efficacy of the graft. This study compared the effect of Supercritical fluid (SCF) sterilization and gamma irradiation on the osteoconductivity of allograft bone in a bilateral critical-sised defect rabbit model.Summary Statement
Introduction
An autologous thrombin activated 3-fold PRP, mixed with a biphasic calcium phosphate at a 1mL:1cc ratio, is beneficial for early bone healing in older age sheep. The management of bone defects continues to present challenges. Upon activation, platelets secrete an array of growth factors that contribute to bone regeneration. Therefore, combining platelet rich plasma (PRP) with bone graft substitutes has the potential to reduce or replace the reliance on autograft. The simple, autologous nature of PRP has encouraged its use. However, this enthusiasm has failed to consistently translate to clinical expediency. Lack of standardisation and improper use may contribute to the conflicting outcomes reported within both pre-clinical and clinical investigations. This study investigates the potential of PRP for bone augmentation in an older age sheep model. Specifically, PRP dose is controlled to provide clearer indications for its clinical use.Summary Statement
Introduction
Demineralised bone matrix augmented tendon-bone fixations in the animal model show less scar tissue and an enthesis morphology closer to the physiologic one which may lead to a more resistant repair construct. Rotator cuff repair is one of the most common operative procedures in the shoulder. Yet despite its prevalence recurrent tear rates of up to 94% have been reported in the literature. High failure rates have been associated with tendon detachment from bone at the tendon – bone interface. Exogenous agents as biological strategies to augment tendon – bone healing in the shoulder represent a new area of focus to improve patient outcomes. Demineralised bone matrix (DBM) contains matrix bound proteins, exposed through acid demineralization step of DBM manufacture, and has long been recognised for its osteoinductive and osteoconductive properties. We hypothesised that DBM administered to the bone bed prior to the reattachment of the tendon, will upregulate healing and result in enhanced tissue morphology that more closely resembles that of a normal enthesis. An established ovine transosseous equivalent rotator cuff model was used.Summary Statement
Introduction
In order to emulate normal knee kinematics more closely and thereby potentially improve wear characteristics and implant longevity the Medial Pivot type knee replacement geometry was designed. In the current study the clinical and radiographic results of 50 consecutive knee replacements using a Medial Pivot type knee replacement are reported; results are compared to the Australian Orthopaedic Associations National Joint Replacement Registry. The patients' data were crossed checked against the registry to see if they had been revised elsewhere. After a mean follow-up of 9.96 years results show that the Medial Pivot Knee replacement provides good pain relief and functional improvement according to KSS and Womac scores and on subjective patient questionnaires. There was one minor revision; insertion of a patella button at 6.64 years FU. There were no major revisions; all implants appeared to be well fixed on standard radiographic examination. While the revision rate for the Medial Pivot knee according to the Australia Joint Registry results is higher compared to all other types of knee replacements in the registry, and to what is reported in the literature on the medial pivot knee, it is not in the current series. Revision rate was similar to what is reported on in the literature, but after a longer follow-up period. However, long term follow-up is required to draw definitive conclusions on the longevity of this type of implant.
Mechanical stabilization following periprosthetic fractures is challenging. A variety of cable and crimping devices with different design configurations are available for clinical use. This study evaluated the mechanical performance of 5 different cable systems in vitro. The effect of crimping device position on the static failure properties were examined using a idealized testing set up. Five cable systems were used in this study; Accord (Smith & Nephew), Cable Ready (Zimmer), Dall-Miles (Stryker), Osteo Clage (Acumed) and Control Cable (DePuy). Cables were looped over two 25 mm steel rods. Cable tension was applied to the maximum amount using the manufactures instrumentation. Devices were crimped by orthopaedic surgeon according to instructions. Crimping device/sleeve was secured in two different positions; 1. Long axis in-line with the load; 2. Long axis perpendicular to the load (Fig 1). Four constructs were tested for each cable system at each position. All constructs were tested following equilibration in phosphate buffered saline at 37 degrees Celsius using a servohydraulic testing machine (MTS 858 Bionix Testing Machine, MTS Systems) at a displacement rate of 10 mm per minute until failure. The failure load, stiffness and failure model (cable failure or slippage) was determined for all samples. Data was analysed using a two way analysis of variance (ANOVA) followed by a Games Howell post hoc test. One sample of each cable – crimping construct was embedded in PMMA and sectioned to examine the crimping mechanism.Introduction
Materials and Methods
The use of polymethyl methacrylate based cement for the fixation of joint replacements although commonly applied, is still limited by interfacial weakness. This study aims to document the effects of a variety of surface treatments on implant/cement bonding and link them to their surface properties. Thirty seven femoral implant analogues of Ti6Al4V rods were given one of six different surface treatments: traditional grit blasting, wet and dry Vaquasheening, acid etching in concentrated sulphuric and hydrochloric acid, anodisation at 150V, and a combination of acid etching and anodisation, before being embedded into a commercially available poly(methyl methacrylate) bone cement. The interfacial strength, energy and stiffness were measured through pushout testing. Surface analysis included examination with scanning electron microscopy, wettability tests and roughness analysis. Results were analysed with a one-way ANOVA with post hoc tests. Overall, the coarse blasted surface created the strongest interface, followed by both etched then anodised, acid etched only, wet Vaquasheened, anodised only and finally dry vaquasheened. While anodised samples showed a weaker bond than etched samples, the combination of etching and anodisation was not different to etching alone. In addition, six different types of interface failure modes were observed, and theories as to explain their mechanism, using experimental evidence were outlined. Coarse blasted surfaces showed the strongest bonding, while other surface modifications may encourage tissue ingrowth and other biological responses, these surface treatments do not strengthen bonding for cemented fixation.
Loading of the implant/cement bond during polymerization is possible when a joint is put through passive range of motion shortly after implantation. This may adversely affect the integrity of the cement – implant interface. The aim of this study was to evaluate the effect of implant motion during cement polymerization on the mechanical properties of the cement – implant interface. Simulated titanium tibial trays (15 mm dial tray, 15 mm keel) were used in this study and implanted in cellular rigid polyurethane foam (12.5 pcf) (Sawbones Vashon, WA, USA). Surface roughness (Ra) of implants was verified as 3.60μm with a 2μm tip at 0.5 mm/s over a length of 1.6 mm (SurfAnalyzer, MAHR Federal Inc., Providence, RI, USA). Palacos cement (Heraeus Medical, Wehrheim, Germany) was mixed for 2 minutes followed by implantation and one of 3 motion regimes at two time points. Six groups were tested. Motion was applied at three minutes for three groups. This motion was 1)axial micromotion for 20 cycles at 100 microns and 0.5 Hz, 2)rotational of 20 cycles at +/− 1.5 degrees and 0.5 Hz, or 3)both motions sumultaneously. An additional three groups were tested at 6 minutes under the same conditions. Motion was applied using calibrated mechanical testing equipment (MTS systems, Eden Prarie, MN, USA). Implants were tested in tension to failure at 0.5 mm/min, 24 hrs after implantation. The peak load, stiffness and energy were determined for each sample. Data was analysed using an Analysis of Variance and a Games Howell post hoc tests where appropriate.Introduction
Methods
Appropriate, well characterized animal models remain essential for preclinical research. This study investigated a relevant animal model for cancellous bone defect healing. Three different defect diameters of fixed depth were compared in both skeletally immature and mature sheep. This ovine model allows for the placement of four confined cancellous defects per animal. Defects were surgically created and placed in the cancellous bone of the medial distal femoral and proximal tibial epiphyses (See Figure 1). All defects were 25 mm deep, with defect diameters of 8, 11, and 14 mm selected for comparison. Defects sites were flushed with saline to remove any residual bone particulate. The skeletally immature and mature animals corresponded to 18 month old and 5 year old sheep respectively. Animals were euthanized at 4 weeks post-operatively to assess early healing. Harvested sites were graded radiographically. The percentage of new bone volume within the total defect volume (BV/TV) was quantified through histomorphometry and μ-CT bone morphometry. Separate regions of interest were constructed within the defect to assess differences in BV/TV between periosteal and deep bone healing. Defect sites were PMMA embedded, sectioned, and stained with basic fuschin and methylene blue for histological evaluation.INTRODUCTION
METHODS
