Introduction. During revision surgery, the active electrode of an electrocautery device may get close to the implant, potentially provoking a flashover. Incidents have been reported, where in situ retained hip stems failed after isolated cup revision. Different sizes of discoloured areas, probably induced by electrocautery contact, were found at the starting point of the fracture. The effect of the flashover on the implant material is yet not fully understood. The aim of this study was to investigate the
Introduction. Laser marking of implants surfaces is necessary in order to provide traceability during revisions which will help identify product problems more quickly, better execute product recalls and improve patient safety. There are several methods of marking employed within the medical field such as chemical etching, electro pencil marking, mechanical imprinting, casting of markings, marking with vibratory type contact, ink jet, hot foil and screen printing. However, these methods have various drawbacks including marking durability or addition of potentially toxic chemical compounds. As a result laser marking has become the preferred identification process for orthopedic implants. Laser marking is known for its high visual quality, good reproducibility and precision. However there are concerns about the laser marking potential to affect fatigue life of a device. There is a limited number of research papers that studied the effect of laser marking on fatigue life of implants. The objective of the current study is to investigate the effects of laser marking on the fatigue life of titanium alloy material. Material and Methods. Two groups of four point bend specimens were used to investigate the effect of laser marking on the fatigue life. The first group comprised of the specimens without laser marking while the second group comprised of specimens with laser marking currently utilized for the implant surfaces. Prior to conducting the fatigue testing, a non-destructive X-ray diffraction (XRD) residual stress analysis was conducted to determine if the laser marking had introduced any residual stresses. Imaging analysis was also conducted to examine any potential surface damage on the test sample's surface. A servo-hydraulic test machine was used for the fatigue four point bend testing regime where the inner and outer spans were 30 mm and 90 mm respectively. All testing was conducted at a frequency of 10 Hz, a stress ratio R=0.1, and sine-wave loading in air. Testing was stopped at 10 Million cycles or at failure of the specimen. Results & Discussion. Figure 1 shows that laser marking process can create a fine network of surface cracks. Table 1 shows the results of residual stress measurements. Laser making introduced high tensile stresses on the components whereas “as machined” component without laser marking exhibited compressive stresses inherent due to machining. The result from the S-N curve testing is shown in Figure 2. The current laser marking components demonstrated 41% reduction in
Revision surgeries for orthopaedic infections are done in two stages – one surgery to implant an antibiotic spacer to clear the infection and another to install a permanent implant. A permanent porous implant, that can be loaded with antibiotics and allow for single-stage revision surgery, will benefit patients and save healthcare resources. Gyroid structures can be constructed with high porosity, without stress concentrations that can develop in other period porous structures [1] [2]. The purpose of this research is to compare the resulting bone and prosthesis stress distributions when porous versus solid stems are implanted into three proximal humeri with varying bone densities, using finite element models (FEM). Porous humeral stems were constructed in a gyroid structure at porosities of 60%, 70%, and 80% using computer-aided design (CAD) software. These CAD models were analyzed using FEM (Abaqus) to look at the stress distributions within the proximal humerus and the stem components with loads and boundary conditions representing the arm actively maintained at 120˚ of flexion. The stem was assumed to be made of titanium (Ti6Al4V). Three different bone densities were investigated, representing a healthy, an osteopenic, and an osteoporotic humerus, with an average bone shape created using a statistical shape and density model (SSDM) based on 75 cadaveric shoulders (57 males and 18 females, 73 12 years) [3]. The Young's moduli (E) of the cortical and trabecular bones were defined on an element-by-element basis, with a minimum allowable E of 15 MPa. The Von Mises stress distributions in the bone and the stems were compared between different stem scenarios for each bone density model. A preliminary analysis shows an increase in stress values at the proximal-lateral region of the humerus when using the porous stems compared to the solid stem, which becomes more prominent as bone density decreases. With the exception of a few mesh dependent singularities, all three porous stems show stress distributions below the
Introduction. The
Introduction. Porous scaffolds for bone ingrowth have numerous applications, including correcting deformities in the foot and ankle. Various materials and shapes may be selected for bridging an osteotomy in a corrective procedure. This research explores the performance of commercially pure Titanium (CPTi) and Tantalum (Ta) porous scaffold materials for use in foot and ankle applications under simplified compression loading. Methods. Finite element analysis was performed to evaluate von Mises stress in 3 porous implant designs: 1) a CPTi foot and ankle implant (Fig 1) 2) a similar Ta implant (wedge angle = 5°) and 3) a similar Ta implant with an increased wedge angle of 20°. Properties were assigned per reported material and density specifications. Clinically relevant axial compressive load of 2.5X BW (2154 N) was applied through fixtures which conform to ASTM F2077–11. Compressive yield and
BACKGROUND. This scientific work is a non-interventional, experimental and prospective comparative study of two very high-viscosity PMMA bone cements: DePuy CMW 2G and Palacos® fast R+G. Reference product: Palacos® R+G. Fast-setting PMMA bone cements are used in the endoprothetics of the patella and knee (in Australia) and are also used to cement an artificial acetabulum (in the UK). Are there any differences regarding the characteristics of the two fast-setting PMMA bone cements?. MATERIALS AND METHODS. All cements were mixed as specified by the manufacturer and analysed on the following parameters: handling properties (mixing, waiting, working and hardening phase), powder/liquid-ratio, mechanical properties (ISO 5833:2002 and DIN 53435),
Background. Titanium, in particular Ti6Al4V, is the standard material used in cementless joint arthroplasty. Implants are subjected to cyclic loading where fracture is the reason for re-operation in 1.5–2.4% of all revisions in total hip arthroplasty. In order to strengthen critical regions, surface treatments such as shot peening may be applied. A superficial titanium oxide layer is naturally formed on the surface as a protective film at ambient conditions. However, as its thickness is only in the range of several nanometers, it is prone to be destroyed by high loads - as present at the surface during bending - leading to an ‘oxidative wear’ in a corrosive environment [1]. The present study aims to evaluate the shot peening treatment on Ti6Al4V regarding its potential for cyclically loaded parts under a dry and a corrosive testing medium. Materials and Methods. Hour-glass shaped titanium specimens (Ti6Al4V) with a minimal diameter of 10 mm have been subjected to an annealing treatment at 620°C for 10h to remove initial residual stresses introduced during machining. Subsequently, a high-intensity shot peening treatment with cut wire followed by a low-intensity cleaning process with glass beads have been performed (Metal Improvement, Germany). Arithmetic mean roughness R. a. of the treated surfaces was measured (Mahr Perthometer M2, Germany). Residual stress depth profiles prior to and after shot peening have been measured by a Fe-filtered Co-K(alpha) radiation (GE Measurement&Control, USA) and calculated using the sin. 2. (psi) method.
INTRODUCTION. Since the early 2000s, highly cross-linked (HXL) UHMWPE's have become a popular option with multiple experimental and clinical studies showing that gamma or electron radiation doses between 50–100kGY reduce wear and potentially extend the bearing life of UHMWPE. However, the increased wear resistance came at a compromise to mechanical properties due to the cross-linking process. Vitamin E has been added to some HXL UHMWPE materials to offer a solution to the compromise by increasing oxidation resistance and maintaining sufficient
Distal neck modularity places a modular connection at a mechanically critical location, which is also the location that confers perhaps the greatest clinical utility. The benefits of increased clinical options at that location must be weighed against the potential risks of adding an additional junction to the construct. Those risks include prosthetic neck fracture, taper corrosion, metal hypersensitivity, and adverse local tissue reaction. Further, in-vitro testing of ultimate or
Distal neck modularity places a modular connection at a mechanically critical location which is also the location that confers perhaps the greatest clinical utility. Assessment of femoral anteversion in 342 of our total hip replacement (THR) patients by CT showed a range from −24 to 61 degrees. The use of monoblock stems in some of these deformed femurs therefore must result in a failure to appropriately reconstruct the hip and have increased risks of impingement, instability, accelerated bearing wear or fracture, and adverse local tissue reaction (ALTR). However, the risks of failing to properly reconstruct the hip without neck modularity must be weighed against the additional risks introduced by neck modularity. There are several critical design, material, and technique variables that are directly associated with higher or lower incidences of problems associated with modular neck femoral components. Unfortunately, in vitro testing of the
Introduction. Recently ventral plating implants made of carbon/PEEK composite material have been developed with apparently superior material properties in terms of implant fatigue and imaging suitability. In this study we assessed the outcome of the first clinical application of this new implant. Methods. Retrospective, single-center case series of 16 consecutive patients between 2011 and 2013 undergoing ventral stabilization surgery with a new carbon plating system (see figure 1). We collected data in terms of safety of the procedure (screw positioning, blood loss, operation time), quality and reliability of the implant (revisions, dislocations, screw loosening, fusion, adjacent segment degeneration), clinical outcome and biological tolerance (cervical pain / discomfort, dysphagia). Results. All patients were available for clinical and radiological follow up. Mean surgery time was 128 minutes, in 11 cases one in 5 cases 2 segments were treated. The clinical findings and patient's satisfaction were good in 14 and fair in two cases. All patients who completed the 6 months control had a radiographically confirmed interbody fusion; no implant loosening or failure and no infections were observed. (see figure 2). There was one implant related complication (dysphagia due to malpositioning of the plate which was removed 4 days after implant insertion) and one complication related to the approach (Horner's syndrome). Conclusion. In this retrospective study of 16 patients we found that the use of a carbon-composite plating system lead to results comparable to the “gold standard” metal plates in terms of safety / clinical outcome and reliability of the implant. There was one revision due to dysphagia. The MR imaging of the patients who have been operated with the carbon/PEEK system showed superior quality with reduced artifacts and improved diagnostical properties, especially when evaluating the neurogical structures. (see figure 3). The overall clinical outcome and patient acceptance of the implant was good. The radiologic findings on follow up of 2, 6 and 12 months have shown a high
Objective. The purpose of this study was to investigate how rim poly locking scallop cutting depth could affect the rigidity of acetabular cup. Materials and Methods. (11) generic FEA models including (5) 50mm OD Ti6Al4VELI hemispherical acetabular shells with thicknesses of 3.0, 3.5, 4.0, 4.5 and 5.0mm, and (6) 4mm thick hemispherical shells with standard rim poly indexing scallops varied in cutting depths from inner diameter of the cup in 1.0, 1.5, 2.0, 2.5, 3.0 and 3.5mm. All cups were analyzed in ANSYS® Workbench™ FEA software with a loading condition of 2000N applied to the cup rim per V15 ISO/TC 150/SC 4 N. Verification was carried out by the physical test of a same generic Ti6Al4VELI 50mmOD and 5mm thick solid hemispherical shell under 2000N rim directed load. The cup deformation was compared with FEA results. The maximum deformation of FEA scalloped cups were compared with that of solid hemispherical cups with different shell thickness. Results. The average value for physical test was 0.265(0.282/0.268) mm. The FEA result of the same 50mm OD and 5mm thick shell was 0.2464mm representing a 7% difference. (Figure 1) FEA results for solid hemisphere cups and scalloped shells are shown in Figure 2 and Figure 3 respectively. Conclusion and Discussion. Cup deformation increased in the average of 40% for every 0.5mm shell thickness decrease from 5mm to 3mm for 50mm OD solid cup. The increase of rim scallop depth from 0 to 2.5mm was equivalent to a 0.5mm shell thickness reduction for 4mm thick 50mm OD cup. The higher deformation reading in physical test was likely caused by the accumulations of the fixture deformations. Intraoperative acetabular cup deformation is a clinical issue. It increases the risk of ceramic liner fracture when the liner is inserted in the out of round cup. The increase of shell thickness is a simple and effective way to reduce the cup deformation. However it also reduces the poly thickness and that puts the adverse effects to the poly wear property and poly rim
Introduction. Dual modular hip prostheses were introduced to optimize the individual and intra-surgical adaptation of the implant design to the native anatomics und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear [1–2]. The purpose of this study was to characterize the metal ion release of a modular hip implant system with different modular junctions and material combinations in consideration of the corrosive physiological environment. Methods. One design of a dual modular hip prosthesis (Ti6Al4V, Metha®, Aesculap AG, Germany) with a high offset neck adapter (CoCrMo, CCD-angle of 130°, neutral antetorsion) and a monobloc prosthesis (stem size 4) of the same implant type were used to characterize the metal ion release of modular and non-modular hip implants. Stems were embedded in PMMA with 10° adduction and 9° flexion according to ISO 7206-6 and assembled with ceramic (Biolox® delta) or CoCrMo femoral heads (XL-offset) by three light impacts with a hammer. All implant options were tested in four different test fluids: Ringer's solution, bovine calf serum and iron chloride solution (FeCl3-concentration: 10 g/L and 114 g/L). Cyclic axial sinusoidal compressive load (Fmax = 3800 N, peak load level of walking based on in vivo force measurements [3]) was applied for 10 million cycles using a servohydraulic testing machine (MTS MiniBionix 370). The test frequency was continuously varied between 15 Hz (9900 cycles) followed by 1 Hz (100 cycles). The metal ion concentration (cobalt, chromium and titanium) of the test fluids were analysed using ICP-OES and ICP-MS at intervals of 0, 5·105, 2·106 and 10·106 cycles (measuring sensitivity < 1 µg/L). Results. Due to the additional modular interface between stem and neck adapter the total metal ion release of the modular hip endoprosthesis system increased significantly and is comparable to the coupling of a monobloc stem and a CoCrMo femoral head (Fig. 1). The application of ceramic femoral heads reduced the total cobalt and chromium release in the stem-head taper interface of non-modular and modular stems. In comparison between the four test fluids could be observed that lower pH-values and higher FeCl3-concentrations increased the metal ion release (Fig 2). In contrast, the use of bovine calf serum decreased the metal ion release of modular junctions due to the presence of proteins and other organic components. Discussion. For testing hip implants with proximal femoral modularity according to ISO and ASTM standards, sodium chloride solutions are frequently used to determine the
Prospective Randomised Control trial of 300 patients over a period of 3 years, 1 year post op follow up. Local ethic approval was attained for the study. Inclusion criteria: Age > 60, Consented to Participate in the study, Unstable Inter trochanteric fracture a) Sub trochanteric b) Medial Comminution c) Reverse Obliquity D)Severe Osteoporosis. Patients selected were randomized to Intra medullary Nail vs Hips screw. Variety of markers have been assessed: Pre OP: - Mechanism of injury, Mobility status, Pre OP ASA, Pre Op haemoglobin, living Conditions. Intra OP:- I.I Time, Time taken, Surgeon experience, Intra OP complications. Post OP:- Haemoglobin, mobility, radiographic analysis-Fracture stability and Tip Apex Distance, Thrombo embolic Complications. Follow up: - 6 weeks, 3,6,12 month follow up. There is considerable debate in literature regarding superiority of Compression Hip screw over Intra medullary nail for fixation of stable per trochanteric fractures of the femur. Biomechanical studies have shown superiority of Intra medullary device over a Compression Hip screw. Tenser et all showed an advantage over combined bending and compression failure. Mohammad et al found unstable subtrochanteric fractures with a gamma nail were stiffer. Kerush-Brinker showed that gamma nail had significantly greater
Ceramic-on-ceramic (COC) bearing surfaces have consistently demonstrated reliable clinical results with when coupled with appropriated designed femoral stems and acetabular shells. Ceramic bearing surfaces are highly wettable and display both boundary and hydrodynamic fluid-film lubrication modes, which lead to extremely low wear rates. Furthermore, COC bearing couples have been shown to exhibit virtually no risk of adverse biologic reaction and have not been associated with corrosion-induced adverse tissue reactions that occur with metal taper junctions, particularly head-neck taper junctions. The relative brittleness of ceramics initially was thought to be a major disadvantage; however, four decades of improvement in the manufacture of ceramics and rigorous proof testing has led an extremely low risk of fracture, perhaps lower than that for cross-linked polyethylene. More recently it has become increasing appreciated that nearly all revisions for squeaking have been restricted to specific designs and materials, including the use of a titanium elevated metal rim on the acetabular side, and more flexible femoral components made of a beta-titanium alloy (TMZF) which had thin necks and relative small tapers. Multiple clinical studies document excellent long-term survival of COC bearing couples in young patients with revision for any reason as the primary endpoint. Our own experience with 341 hips with 2 to 15 and average 9.1 year f/u demonstrates a 95% overall survivorship (revision for any reason) at 13 years in patients under 50 years of age at the time of surgery. By contrast, cross-linked polyethylene bearings have not been studied so carefully and have not been shown to be superior to ceramic-ceramic bearings in young patients. These bearing surfaces represent a very heterogeneous group of products, with varying degrees of cross-linking, post-irradiation processing methods, and additives. Cross-linked polyethylenes in general have a lower
Additive manufacturing (AM) techniques have gained attraction in orthopedic implant design with their ability to create unique shapes and structures. Depending on the application, there are different mechanical properties required. This study evaluated the mechanical properties of direct metal laser sintered (DMLS) Titanium alloy (Ti6Al4V) with and without hot isostatic pressure (HIP) treatment. Three dimensional computer modeling and the DMLS manufacturing assisted in building net or near-net samples for testing. The material testing consisted of uniaxial tension, Charpy impact, rotating beam fatigue (RBF), density, and hardness. Two sets of Ti6Al4V samples were created for testing using a DMLS process and stress relieved in a vacuum furnace prior to removal from the build platform. One set of samples were HIP treated. The two sets of samples were tested and the material properties of the non-HIP treated samples were compared to those with HIP treatment. Tension testing was conducted on fifteen (15) samples per treatment according to ASTM E8/E8M on as-built samples designed to a round specimen 3 per the standard. Fifteen (15) Charpy impact samples per treatment were built to near-net shapes. A low stress grind was performed on all surfaces and a notch was placed in the sample to comply with ASTM E23 and testing was performed in accordance with the standard. Fifteen (15) samples were built per treatment and machined for RBF per ISO 1143. RBF was performed on all samples at a frequency of 100 Hz with run out conditions of 10M cycles or failure. Density and hardness was measured on three (3) samples from each set using Archimedes' Principle and Rockwell hardness techniques respectively. The average (standard deviation) tensile strengths between the two groups were statistically different (p < 0.05). The non-HIP treated samples had an average ultimate strength of 956(10) MPa, yield strength of 896(13) MPa, and modulus of 118(2) GPa (Table 1). The HIP treated samples had an average ultimate strength of 909(4) MPa, yield strength of 832(9) MPa, and modulus of 112(3) GPa (Table 1). There was also statistical differences in the impact strength with the HIP treatment samples having a higher required force of 23.4(1.6) J compared to the non-HIP treated group of 19.8(1.8) J (Table 1). The
Distal neck modularity places a modular connection at a mechanically critical location. However, this is also the location that confers perhaps the greatest clinical utility. Assessment of femoral anteversion in 342 of our THR patients by CT showed a range from −24 to 61 degrees. The use of monoblock stems in some of these deformed femurs therefore must result in a failure to appropriately reconstruct the hip and have increased risks of impingement, instability, accelerated bearing wear or fracture, and adverse local tissue reaction (ATLR). However, the risks of failing to properly reconstruct the hip without neck modularity must be weighed against the additional risks introduced by neck modularity. There are several critical design, material, and technique variables that are directly associated with higher or lower incidences of problems associated with modular neck femoral components. These include modular neck length, design and material of both parts including the junction design, wall thickness of the receiving junction, assembly force, and bearing diameter and material. With regard to stem design and material, it has been clearly shown that the incidence of titanium neck fractures is higher in stems with a thinner wall-thickness of the receiving junction than in stems with a thicker wall-thickness. Moreover, titanium necks have been largely replaced with CoCr necks with significantly higher yield and
Introduction. Proper femoral stem and acetabular implant orientation is critical to the initial and long-term success of THA. Post-operative determination of cup and stem anteversion is important in cases of hip instability and planning isolated component revisions. At ISTA 2010 Dubai, we introduced a novel, simple stem modification that can be added to any stem design to help assess stem, and possibly cup anteversion with plain post-operative radiographs throughout the lifespan of the implant. [Figure 1] As the stem is rotated, the visible hole pattern changes. [Figure 2] This study was performed to further validate the accuracy and potential usefulness of this design. Methods. We prospectively reviewed 100 consecutive THA cases using the stem reference hole modification on rectangular tapered Zweymuller-type stems implanted from September 2010 to May 2012. Post-operative hip/femur CT scans were obtained to determine the true cup and stem orientation to validate and quanitify the precision of the reference holes. Intra-operative estimates of stem anteversion and combined anteversion (Ranawat Sign) were recorded. Post-operative radiograph measurement of stem anteversion (AP hip x-ray with leg in neutral rotation) was obtained and compared to the CT scan measurement referencing stem rotation relative to the knee epicondylar axis. [Figure 3] In addition, we compared the modified reference hole anteversion assessment to a control group of original unmodified stems assessed using the same methods. Results. All 100 patients had post-operative CT scans and ‘neutral’ rotation AP hip radiographs. The modified reference hole design was accurate to within 4.1 degrees compared to CT measurements. Estimates of stem anteversion in the control group (original Alloclassic or SL-Plus stems) was accurate to only 19.6 degrees with wide variablity as expected. The difference was statistically significant. Residual hip flexion contracture (2 patients) made the reference holes undetectable on radiographs. Morbid obesity did not decrease accuracy but required x-ray beam intensity modification. There was no statistical difference between standing and supine x-ray ‘neutral’ rotation radiograph measurements. The Ranawat combined stem and cup anteversion value could not predict cup anteversion reliably when subtracting the stem rotation. Two patients sustained post-operative THA dislocations that required closed reduction (occuring 2 months and 15 months after index THA). Conclusion. We conclude that hip stems with this pattern of modified anteversion reference holes provides an accurate and reliable method of determining stem component orientation post-operatively by using only simple plain radiographs. Initial finite element analysis of the modified stem hole pattern predicted that the
A flexed knee gait is common in patients with bilateral spastic
cerebral palsy and occurs with increased age. There is a risk for
the recurrence of a flexed knee gait when treated in childhood,
and the aim of this study was to investigate whether multilevel
procedures might also be undertaken in adulthood. At a mean of 22.9 months (standard deviation 12.9), after single
event multi level surgery, 3D gait analysis was undertaken pre-
and post-operatively for 37 adult patients with bilateral cerebral
palsy and a fixed knee gait.Aims
Patients and Methods