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
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
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
Surgical drill-bits are used in a raft of procedures, from trauma, joint reconstruction to Arthroplasty. Drilling of bone is associated with the conversion of mechanical work energy into shear failure of bone and heat generation, causing a transient rise in temperature of hard and soft tissues. Thermal insults above 47°C sustained for one minute or more may cause osteonecrosis, reduced osteogenic potential, compromise fixation and influence tolerances with cutting blocks. Drill design parameters and operational variables have marked effects on cutting performance and heat generation during drilling. Dulling and wear of the cutting surfaces sustained through repeated usage can significantly reduce drill bit performance. Deterioration of cutting performance substantially increases the axial thrust force required to propel the cutting face through bone, compromising surgeon control during drilling and increasing the likelihood of uncontrolled plunging, cortical breakthrough and improper placement of holes as well as other jigs. The drilling accuracy and skiving of 2.8 mm 3-fluted SurgiBit (Orthopedic Innovation (OI), Sydney, Australia) (Figure 1) was compared with a standard 2-fluted drill (Synthes) at 15, 30 and 45 degrees using a 4th generation Sawbone as well as bovine cortical bone. A surgical handpiece was mounted in a servo-hydraulic testing machine and the motion of the drill-bit confined to 2 degrees of freedom. The lateral force and skiving distance was measured (n=6 per drill per angle per testing medium). A new drill was used for each test. Wear performance over multiple drilling episodes (1, 10 and 100) was performed in bovine cortical bone. The surface characteristics of the cutting faces of the drills were assessed optically at 10x magnification and at higher magnifications (50, 100 and 500x) using an environmental electron microscope.Introduction
Methods
Initial stability of the tibial component influences the success of uncemented total knee arthroplasty. In uncemented components, osseointegration provides long-term fixation which is particularly important for the tibial component. Osseointegration is facilitated by minimising bone-implant interface micromotion to within acceptable limits. To investigate initial stability, this study compares the micromotion and initial seating of two uncemented hydroxyapatite-coated tibial components, the Genesis II and Profix. This is the first stability comparison of two hydroxyapatite-coated tibial components. Six components of each type were implanted into synthetic tibias by a single orthopaedic surgeon. Good coverage was achieved. No screws or articular inserts were used. Initial seating was measured using ImageJ software at five areas on each tibia. Tibias were transected and their proximal section implanted into a molten alloy parallel to horizontal. Dynamic mechanical testing was performed using a hydraulic 858-Bionix machine. Prostheses underwent unilateral axial point-loading of 700N cyclically applied four times. The load was applied to three locations approximating femoral loading points. The loading cycle was repeated six times at each point, allowing micromotion to be recorded at three contralateral locations. Micromotion was measured by optical lasers. After dynamic testing, two tibial components of each type were removed with claw pliers while measuring the force required on the 858-Bionix machine. Implant under-surfaces were photographed for wear.Introduction
Methods
Implant contamination prior to cement application has the potential to affect the cement-implant bond. the consequences of implant contamination were investigated Fifty Titanium alloy (Ti-6Al-4V) dowels were prepared with two surface finishes comparable to existing stems. The roughness (Ra and Rq) of the dowel surface was measured before and after the pushout test. Four contaminants (Phosphate Buffered Saline (PBS), ovine marrow, ovine blood, olive oil) were prepared and heated to 37°C. Each contaminant was smeared on the dowel surface completely and uniformly approximately 4 minutes prior to implantation. Samples were separated into ten groups (n=5 per group) based on surface roughness and contaminant. Titanium alloy dowels was placed in the center of Polyvinyl chloride (PVC) tubes with bone cement, and equilibrated at 37°C in PBS for 7 days prior to mechanical testing. The push out test was performed at 1 mm per minute. The dowel surface and cement mantel were analyzed using a Scanning Electron Microscopy (SEM) to determine the distribution and composition of any debris and contaminates on the surface.Introduction
Methods
Cementless prosthesis is one of the major bone-implant interface fixation methods in total joint replacement. Grit blasted surface, hydroxyapatite coated surface and plasma sprayed metallic porous coating have been popularly used. The latter has demonstrated higher bone implant mechanical stability in previous laboratory study in early and middle stages. However, question remains what the mechanism is to make it performing better and how to improve them further. This study is designed to examine the mode of failure in bone-implant interface in a sheep model. Plasma sprayed porous coated (TiPL); hydroxyapatite (HA) coated and and grit blasted (TiGB) titanium implants were examined in the study. Each type has 36 specimens. Implants were inserted into cortical bones in a press-fit fashion in a total of 22 sheep bilateral hind limbs. Specimens were retrieved at 4 weeks and 12 weeks. Push- out testing was performed to just reach ultimate failure. Failed bone-implant interface were investigated by histology and BSEM. The percentage of failure at bone-coating interface, bone itself fracture, coating itself failure, and coating-substrate dissociation were measured by BSEM.Aim
Method
This study was performed to compare the mechanism of bone-implant integration and mechanical stability among three popularly used cementless implant surfaces. Plasma sprayed porous surface (TiPL), grit-blasted rough surface (TiGB), and hydroxyapatite coated implant surface (HA) were tested in a sheep model at 4 and 12 weeks. The integration patterns were investigated using histology, histomorphometry, and mechanical strength by push-out test. All three groups demonstrated early bone ongrowth on their surfaces, with much of the ongrowth resembling contact osteogenesis. TiPL group showed bone anchorage into porous coating with new bone ingrowth into the pores. HA group revealed small cracks at its coating at 12 weeks time point. Plasma sprayed porous surface also demonstrated its superior mechanical stability maybe reinforced by its bone anchorage, whearas, HA surface exhibited higher osteoconductivity with highest ongrowth rate.
The need for regeneration and repair of bone presents itself in a variety of clinical situations. The current gold standard of treatment is autograft harvested from the iliac crest or local bone. Inherent disadvantages associated with the use of autogenous bone include limited supply, increased operating time and donor site morbidity. This study utilized a challenging model of posterolateral fusion to evaluate the in vivo response of an engineered collagen carrier combined with nano-structured hydroxyapatite (NanOss Bioactive 3D, Pioneer Surgical) compared to a collagen porous beta-tricalcium phosphate bone void filler (Vitoss BA, Orthovita). A single level posterolateral fusion was performed in 72 adult rabbits at 6, 12 and 26 weeks (8 per group per time point). Group 1: nanOss Bioactive 3D + bone marrow aspirate (BMA) + autograft, Group 2: Vitoss BA + BMA and Group 3: Autograft + BMA were compared were compared using radiographic (X-ray and Micro-computed tomography (μCT), biomechanics (manual palpation and tensile testing at 12 and 26 weeks) and histology.Introduction
Materials and Methods
The marriage of rapid prototyping technologies with Arthroplasty has resulted in the fabrication and use of cutting jigs and guides which are tailored to a patients' individual anatomy. These disposable cutting blocks are designed based on input parameters obtained from pre-operative CT and MRI scans and manufactured using 3-D printers. Indirect benefits include a reduction in inventory and a decrease in the burden for central sterilising units. This approach is advantageous for the surgeon in the attainment of ideal mechanical alignment, which is known to be associated with an improved clinical outcome and implant longevity. This study evaluated the postoperative alignment parameters from a single surgeon series of patients following TKA with the Signature (Biomet) system. The postoperative alignment of a single surgeon series of 60 consecutive patients receiving a Vanguard cruciate retaining TKR (Biomet) using the Signature patient-specific surgical positioning guides was performed. Postoperative CT and preoperative templating MRI scans were imported into Mimics 14.0 (Materialise, Belgium) where specific bony landmarks were identified in both data sets. A subset of these points was used to transform the MRI data into the CT coordinate frame to enable the computation of femoral mechanical alignment in the absence of a full-length lower limb CT scan. CT and transformed MRI landmarks were then imported into ProEngineer (PTC, MA) where angular measurements were made by projecting axes onto anotomical planes. Flexion, rotation, valgus/varus of the femoral component and posterior slope, rotation and valgus/varus of the tibial component were computed. Femoral rotation was referenced to the trans-epicondylar axis as opposed to Whiteside's line. Overall limb alignment was determined based on individual component position.Introduction
Methods and Materials
Shape memory staples have several uses in both hand and foot and ankle surgery. There is relatively little data available regarding the biomechanical properties of staples, in terms of both the compression achieved and potential decay of mechanical advantage with time. An understanding of these properties is therefore important for the surgeon. Two blocks of synthetic polyurethane mimicking properties of cancellous bone were fixed in jigs to both the actuator and 6 degree-of-freedom load cell of an MTS servohydraulic testing machine. With the displacement between the blocks held constant the peak value and subsequent decay in compressive force applied by both the smooth and barbed version of the nitinol OSStaple (Biomedical Enterprises), Easyclip (LMT), Herbert Bone Screws (Martin) and the Headless Compression Screw (Synthes) was measured. Nitinol staples were energised once only. A second experiment was conducted to assess the effects of repeated energisation on these parameters. The Easyclip staples achieved a mean peak force of 5.2N, whilst the smooth and barbed OSStaples achieved values of 9.3N and 5.7N, respectively. The Herbert screws achieved a mean peak force of 9N and the headless compression screws 23.9N. The mean peak force achieved with 2 Easyclip staples in parallel was 8.1N. Following the application of a single energisation the OSStaples exhibited a significant reduction in compressive load, losing up to approximately 70% of the peak value attained. The repeated energisation of these nitinol staples produced progressive increases in both peak and trough loads, the positive effects exhibited a plateau with time. Performance of both OSStaples was comparable to the Herbert screw with regard to reduction load applied across a simulated fracture plane. The maximum load applied by the OSStaples diminished with time. Staples provide fixation without violating the fracture plane which has the potential to offer some benefits from a healing perspective.
Thermal damage to bone related to the exothermic polymerisation of bone cement (PMMA) remains a concern. A series of studies were conducted to examine PMMA bone interface during cemented arthroplasty. In vitro and in vivo temperature distributions were performed in the laboratory and human and animal surgery. In vivo (10 patients) measurements of cement temperature during cementing of BHR femoral prosthesis using thermocouples. Intra-operative measurement of cement temperature in BHR in the presence of femoral head cysts was examined in patients. The BHR femoral heads were sectioned to assess cement mantle as well as position of thermocouples. An additional study was performed in sheep with PMMA implanted into cancellous defects. Thermocouples were used to monitor temperature in the cement as well as adjacent bone. Histology and CT was used to assess any thermal damage. The exothermic reaction of PMMA during polymerization does indeed result in an increase in temperature at the interface with bone. The in vivo study recorded a maximum temperature of 49.12C for approximately three minutes in the cancellous bone underneath the BHR prosthesis. This exposure is probably not sufficient to cause significant injury to the femoral head. The maximum temperature of the cement on the surface of the bone was 54.12C, whereas the maximum recorded in the cement in the mixing bowl was 110.2C. In the presence of artificial cysts within the bone, however, temperatures generated within the larger cysts, and even at the bone-cement interface of these cysts, reached levels greater than those previously shown to be harmful to bone. This occurred in one case even in the 1 cc cyst. Routine histology revealed a fibrous layer at the cement bone interface in the sheep study. Fluorescent microscopy demonstrated bone label uptake adjacent to the defect site. Histology did not reveal thermal necrosis in the defects in terms of bony necrosis. CT data was used to measure the amount of PMMA placed into each defect. This analysis revealed a range of volumes that did not seem to influence the histology. The heat of cement polymerisation in resurfacing as performed in our study is not sufficient to cause necrosis. This may reflect the ability of the body to rapidly conduct heat away by acting as a heat sink. The temperature-conducting properties of the metal prosthesis are also likely to be important.
The transosseous equivalent/Suture Bridge or TOE/SB repair has received much attention in recent years as more shoulder surgeons transition to all arthroscopic rotator cuff repairs. The purpose of this study was to compare the biomechanical behaviour of several variants of the Suture Bridge repair performed by the authors. Four different Suture Bridge constructs were performed six times on 24 sheep infraspinatus tendon humerus constructs. The first group was a standard Suture Bridge with two medial mattress stitches with knots (KSSB4). The second group had four medial mattress stitches with knots and was called KDSB8. The third group had two medial mattress stitches without knots and was called USBFT4. These first three repairs used two medial 5.5 mm Bio-Corkscrew FT Anchors and two lateral 3.5 mm PushLock Anchors (Arthrex). The fourth repair had two medial mattress stitches without knots and used all Pushlocks and was called USBP4. The repairs were then analysed for failure force, cyclic creep and stiffnessafter. Cycling was performed from 10 to 100 N at 1 Hz for 500 cycles. Following cyclic testing a single cycle pull to failure at 33 mm/sec was performed. The constructs were also observed for failure mechanism and gap formation using digital video recording. The KDSB8 repair with a mean failure force of 456.9N was significantly stronger than the USBP4 repair at 299.7N (P=0.023), the KSSB4 repair at 295.4N (P=0.019) and lastly the USBFT4 repair at 284.0N (P=0.011). There was no statistical difference between the measured failure force for the two mattress stitch KSSB4 repair with knots and the knotless two mattress stitch repairs USBFT4 and USBP4. There was not a statistical difference between any of the repairs for measured stiffness and cyclic creep. However, the KDSB8 repair showed no discernable gap formation or movement at the footprint during cyclic testing. The KSSB4, USBFT4 and USBP4 repairs demonstrated bursal sided gap formation in the range of 1 to 3 mm. Based on the results of this study the transosseous equivalent/Suture Bridge repair with four stitches tied in the medial row and maximal lateral suture strand utilization (KDSB8 TOE/SB) is the strongest. The KDSB8 also appeared to show less bursal sided gap formation and greater footprint stability than the other Suture Bridge constructs tested.
Infrapatellar Contracture Syndrome describes a postoperative complication characterised by a vertical migration of the patella due to Patella Tendon (PT) shortening and/or PT adhesion (PTA) formation. We investigated how removal of the central one-third of the PT influences both PT length (LP) and in vitro knee kinematics in 18 sheep divided into 3, 6, 12 and 24 week groups. At time of sacrifice the pelvis-lower extremities complexes were left in a supine position until rigor mortis set in. Limbs were CT-scanned (0.5mm) whilst frozen and LP measured (ProEngineer, PTC, MA). Specimens were fixed into a loading frame with 50N applied to the rectus femoris and knee kinematics obtained (Polhemus, VT). Bones and associated registration block portions of the receiver assemblies were CT-scanned (0.5mm), reconstructed, and imported into ProEngineer where coordinate systems were created in accordance with the Joint Coordinate System (JCS). Registration was accomplished by aligning models of the receiver assemblies with the reconstructed surfaces. Post-processing and statistical analysis (ANOVA) was performed using Matlab (MathWorks, MA) and data referenced to the contralateral controls. No significant changes in LP were observed. The mean PT length ratio (LP/LC) in the 3 week group was 1.0028±0.004 (mean±SD). In the 6 week group this ratio had increased to 1.0282±0.0246, returning to 1.005±0.0035 at 12 weeks and back to 1.0159±0.0217 at 24 weeks. No PTA’s were observed. A significant proximal shift of the patella reflecting the increase in LP was observed which correlated well with a retardation of patellar flexion (r = 0.880, p<
0.001). A significant decrease in medial patellar tilt was also observed but was not coupled with changes in tibial rotation. Proximal and lateral tibial shifts were also detected. The results of this study seem to suggest that the changes in knee kinematics and LP induced by removal of the central one-third of the PT do not recover 24 weeks post-operatively.
