Roentgen Stereophotogrammetric Analysis (RSA) is the gold standard for measuring implant micromotion thereby predicting implant loosening. Early migration has been associated with the risk of long-term clinical failure. We used RSA to assess the stability of the Australian designed cementless hip stem (Paragon TM) and now report our 5-year results. Fifty-three patients were prospectively and consecutively enrolled to receive a Paragon hip replacement. Tantalum beads were inserted into the bone as per RSA protocol and in the implant. RSA x-rays were taken at baseline 1–4 days post-surgery, at 6 weeks, 6 months, 12 months, 2 years, and 5 years. RSA was completed by an experienced, independent assessor. We reported the 2-year results on 46 hips (ANZJS 91 (3) March 2021 p398) and now present the 5-year results on 27 hips. From the 2-year cohort 5 patients had died, 8 patients were uncontactable, 1 patient was too unwell to attend, 5 patients had relocated too far away and declined. At 5 years the mean axial subsidence of the stem was 0.66mm (0.05 to 2.96); the mean rotation into retroversion was 0.49˚ (−0.78˚ to 2.09˚), rotation of the stem into valgus was −0.23˚ (−0.627˚ to 1.56˚). There was no detectable increase in subsidence or rotation between 6 weeks and 5 years. We compared our data to that published for the Corail cementless stem and a similar pattern of migration was noted, however greater rotational stability was achieved with the Paragon stem over a comparable follow-up period. The RSA results confirm that any minor motion of the Paragon cementless stem occurs in the first 6 weeks after which there is sustained stability for the next 5 years. The combination of a bi-planar wedge and transverse rectangular geometry provide excellent
Aim. Debridement and implant retention (DAIR) is a valuable option for treating periprosthetic joint infection (PJI), provided that the criteria of the Infectious Diseases Society of America guidelines are fulfilled. The inflammation caused by infection and the surgical impact of DAIR may influence
Patients undergoing revision surgery of a primary total hip arthroplasty often exhibit bone loss and poor bone quality, which make achieving stable fixation and osseointegration challenging. Implant components coated in porous metals are used clinically to improve mechanical stability and encourage bone in-growth. We compared ultra-porous titanium coatings, known commercially as Gription and Porocoat, in an intra-articular model by press-fitting coated cylindrical implants into ovine femoral condyles and evaluating bone in-growth and fixation strength 4, 8 and 16 weeks post-operatively. Bilateral surgery using a mini-arthrotomy approach was performed on twenty-four Dorset-Rideau Arcott rams (3.4 ± 0.8 years old, 84.8 ± 9.3 kg) with Institutional Animal Care Committee approval in accordance with the Canadian Council on Animal Care. Cylindrical implants, 6.2 mm in diameter by 10 mm in length with surface radius of curvature of 35 mm, were composed of a titanium substrate coated in either Porocoat or Gription and press-fit into 6 mm diameter recipient holes in the weight-bearing regions of the medial (MFC) and lateral (LFC) femoral condyles. Each sheep received 4 implants; two Gription in one stifle (knee) and two Porocoat in the contralateral joint. Biomechanical push-out tests (Instron ElectroPuls E10000) were performed on LFCs, where implants were pushed out relative to the condyle at a rate of 2 mm/min. Force and displacement data were used to calculate force and displacement at failure, stiffness, energy, stress, strain, elastic modulus, and toughness. MFCs were fixed in 70% ethanol, processed undecalcified, and polished sections, approximately 70 µm thick (Exakt Micro Grinding system) were carbon-coated. Backscattered electron images were collected on a scanning electron microscope (Hitachi SU3500) at 5 kV and working distance of 5 mm. Bone in-growth within the porous coating was quantified using software (ImageJ). Statistical comparisons were made using a two-way ANOVA and Fisher's LSD post-hoc test (Statistica v.8). Biomechanical evaluation of the bone-implant interface revealed that by 16 weeks, Gription-coated implants exhibited higher force (2455±1362 N vs. 1002±1466 N, p=0.046) and stress (12.60±6.99 MPa vs. 5.14±7.53 MPa, p=0.046) at failure, and trended towards higher stiffness (11510±7645 N/mm vs. 5010±8374 N/mm, p=.061) and modulus of elasticity (591±392 MPa vs. 256±431 MPa, p=0.61). Similarly, by 16 weeks, bone in-growth in Gription-coated implants was approximately double that measured in Porocoat (6.73±3.86 % vs. 3.22±1.52 %, p=0.045). No statistically significant differences were detected at either 4 nor 8 weeks, however, qualitative observations of the exposed bone-implant interface, made following push-out testing, showed more bony material consistently adhered to Gription compared to Porocoat at all three time points. High variability is attributed to implant placement, resulting from the small visual window afforded during surgery, unique curvatures of the condyles, and presence of the extensor digitorum longus tendon which limited access to the LFC. Ultra-porous titanium coatings, know commercially as Gription and Porocoat, were compared for the first time in a challenging intra-articular ovine model. Gription provided superior fixation strength and bone in-growth, suggesting it may be beneficial in hip replacement surgeries where bone stock quality and quantity may be compromised.
Glenoid bone grafting in reverse total shoulder arthroplasty (RTSA) has emerged as an effective method of restoring bone stock in the presence of complex glenoid bone loss, yet there is limited published evidence on efficacy. The aim of this study was to conduct an analysis of clinical and radiographic outcomes associated with glenoid bone grafting in primary RTSA. Patients who underwent a primary RTSA with glenoid bone grafting were retrospectively identified from the databases of two senior shoulder surgeons. Inclusion criteria included minimum of 12 months clinical and/or radiographical follow up. Patients underwent preoperative clinical and radiographic assessment. Graft characteristics (source, type, preparation), range of movement (ROM), patient-reported outcome measures (Oxford Shoulder Scores [OSS]), and complications were recorded. Radiographic imaging was used to analyse
Gram-negative prosthetic joint infections (GN-PJI) present unique challenges in management due to their distinct pathogenesis of biofilm formation on implant surfaces. To date, there are no animal models that can fully recapitulate how a biofilm is challenged in vivo in the setting of GN-PJI. The purpose of this study is to establish a clinically representative GN-PJI in vivo model that can reliably depict biofilm formation on titanium implant surface. We hypothesized that the biofilm formation on the implant surface would affect the ability of the implant to be osseointegrated. The model was developed using a 3D-printed, medical-grade titanium (Ti-6Al-4V), monoblock, cementless hemiarthroplasty hip implant. This implant was used to replace the femoral head of a Sprague-Dawley rat using a posterior surgical approach. To induce PJI, two bioluminescent Pseudomonas aeruginosa (PA) strains were utilized: a reference strain (PA14-lux) and a mutant strain that is defective in biofilm formation (DflgK-lux). PJI development and biofilm formation was quantitatively assessed in vivo using the in vivo imaging system (IVIS), and in vitro using the viable colony count of the bacterial load on implant surface. Magnetic Resonance Imaging (MRI) was acquired to assess the involvement of periprosthetic tissue in vivo, and the field emission scanning electron microscopy (FE-SEM) of the explanted implants was used to visualize the biofilm formation at the bone-implant interface. The
Introduction. Gram-negative prosthetic joint infections (GN-PJI) present unique challenges in management due to their distinct pathogenesis of biofilm formation on implant surfaces. The purpose of this study is to establish a clinically representative GN-PJI model that can reliably recapitulate biofilm formation on titanium implant surface in vivo. We hypothesized that biofilm formation on an implant surface will affect its ability to osseointegrate. Methods. The model was developed using 3D-printed titanium hip implants, to replace the femoral head of male Sprague-Dawley rats. GN-PJI was induced using two bioluminescent Pseudomonas aeruginosa strains: a reference strain (PA14-lux) and a mutant biofilm-defective strain (ΔflgK-lux). Infection was monitored in real-time using the in vivo imaging system (IVIS) and Magnetic Resonance Imaging (MRI). Bacterial loads on implant surface and in periprosthetic tissues were quantified utilizing viable-colony-count. Field-emission scanning-electron-microscopy of the explanted implants was used to visualize the biofilm formation at the bone-implant-interface. The
Introduction. Loosening of the baseplate is one of the most common causes of failure in Reverse Shoulder Arthroplasty. To allow osteo-integration to occur and thus provide long-term stability, initial screws fixation plays a pivotal role. In particular, tightening torque and force of nonlocking screws are two parameters that are considered to have a clear impact on
Implant loosening is one of the primary mechanisms of failure for hip, knee, ankle and shoulder arthroplasty. Many established implant fixation surfaces exist to achieve
Introduction. The fixation of press-fit orthopaedic devices depends on the mechanical properties of the bone that is in contact with the implants. During the press-fit implantation, bone is compacted and permanently deformed, finally resulting in the mechanical interlock between implant and bone. For the development and design of new devices, it is imperative to understand these non-linear interactions. One way to investigate primary fixation is by using computational models based on Finite Element (FE) analysis. However, for a successful simulation, a proper material model is necessary that accurately captures the non-linear response of the bone. In the current study, we combined experimental testing with FE modeling to establish a Crushable Foam model (CFM) to represent the non-linear bone biomechanics that influences implant fixation. Methods. Mechanical testing of human tibial trabecular bone was done under uniaxial and confined compression configurations. We examined 62 human trabecular bone samples taken from 8 different cadaveric tibiae to obtain all the required parameters defining the CFM, dependent on local bone mineral density (BMD). The derived constitutive rule was subsequently applied using an in-house subroutine to the FE models of the bone specimens, to compare the model predictions against the experimental results. Results. The crushable foam model provided an accurate simulation of the experimental compression test, and was able to replicate the ultimate compression strength measured in the experiments [Figure 1]. The CFM was able to simulate the post-failure behavior that was observed in the experimental specimens up to strain levels of 50% [Figure 2]. Also, the distribution of yield strains and permanent displacement was qualitatively very similar to the experimental deformation of the bone specimens [Figure 3]. Conclusion. The crushable foam model developed in the current study was able to accurately replicate the mechanical behavior of the human trabecular bone under compression loading beyond the yield point. This advanced bone model enables realistic simulations of the primary fixation of orthopaedic devices, allowing for the analysis of the influence of interference fit and frictional properties on
Introduction. Although cementless press-fit femoral total knee arthroplasty (TKA) components are routinely used in clinical practice, the effect of the interference fit on primary stability is still not well understood. Intuitively, one would expect that a thicker coating and a higher surface roughness lead to a superior fixation. However, during implant insertion, a thicker coating can introduce more damage to the underlying bone, which could adversely influence the primary fixation. Therefore, in the current study, the effect of coating thickness and roughness on primary stability was investigated by measuring the micromotions at the bone-implant interface with experimental testing. Methods. A previous experimental set-up was used to test 6 pairs of human cadaveric femurs (47–60 years, 5 females) implanted with two femoral component designs with either the standard e.motion (Total Knee System, B. Braun, Germany) interference fit of 350 µm (right femurs) or a novel, thicker interference fit of 700 µm (left femurs). The specimens were placed in a MTS machine (Figure 1) and subjected to the peak loads of normal gait (1960N) and squat (1935N), based on the Orthoload dataset for Average 75. Varus/valgus moments were incorporated by applying the loads at an offset relative to the center of the implants, leading to a physiological mediolateral load distribution. Under these loads, micromotions at the implant-bone interface were measured using Digital Image Correlation (DIC) at different regions of interest (ROIs – Figure 1). In addition, DIC was used to measure opening and closing of the implant-bone interface in the same ROIs. Results. After comparing the micromotions and opening of the two implant designs, we found no significant differences between the standard and novel coating. Loading was a significant factor for both opening (P<0.0001) and micromotions (P=0.019), where the squat produced higher micromotions than gait. Opening was seen anteriorly (MA, LA), and was higher during squat. Closing was noticed distally (MD, LD), particularly during gait (Figure 2). During gait (Figure 3), the highest micromotions were found in the posterior condyles (CM, MP), followed by the medial anterior region (MA). For squat, the largest micromotions were in the anterior flange (ANT), followed by the distal regions (LD, MD). Discussion. In the current study, the primary stability of the same implant with two different coating thicknesses was evaluated. The results demonstrate that increasing the coating thickness does not automatically influence the primary stability of a femoral TKA component. This is likely due to abrasion and damage of the underlying trabecular during implant insertion, which also was observed in previous experiments. The exact relation between coating thickness or interference fit and primary
Introduction. Trabecular Titanium is a biomaterial characterized by a regular three-dimensional hexagonal cell structure imitating trabecular bone morphology. Components are built via Electron Beam Melting technology in aone- step additive manufacturing process. This biomaterial combines the proven mechanical properties of Titanium with the elastic modulus provided by its cellular solid structure (Regis 2015 MRS Bulletin). Several in vitro studies reported promising outcomes on its osteoinductive and osteoconductive properties: Trabecular Titanium showed to significantly affect osteoblast attachment and proliferation while inhibiting osteoclastogenesis (Gastaldi 2010 J Biomed Mater Res A, Sollazzo 2011 ISRN Mater Sci); human adipose stem cells were able to adhere, proliferate and differentiate into an osteoblast-like phenotype in absence of osteogenic factors (Benazzo 2014 J Biomed Mater Res A). Furthermore, in vivo histological and histomorphometric analysis in a sheep model indicated that it provided bone in-growth in cancellous (+68%) and cortical bone (+87%) (Devine 2012 JBJS). A multicentre prospective study was performed to assess mid-term outcomes of acetabular cups in Trabecular Titanium after Total Hip Arthroplasty (THA). Methods. 89 patients (91 hips) underwent primary cementless THA. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age and BMI of 67 (57–70) years and 26 (24–29) kg/m2, respectively. Diagnosis was mostly primary osteoarthritis in 80 (88%) cases. Radiographic and clinical evaluations (Harris Hip Score [HHS], SF-36) were performed preoperatively and at 7 days, 3, 6, 12, 24 and 60 months. Bone Mineral Density (BMD) was determined by dual-emission X-ray absorptiometry (DEXA) according to DeLee &Charnley 3 Regions of Interest (ROI) postoperatively at the same time-points using as baseline the measureat 1 week. Statistical analysis was carried out using Wilcoxon test. Results. Median (IQR) HHS and SF-36 improved significantly from 48 (39–61) and 49 (37–62) preoperatively to 99 (96–100) and 76 (60–85) at 60 mo. (p≤0.0001). Radiographic analysis showed evident signs of bone remodelling and biological fixation, with presence of superolateral and inferomedial bone buttress, and radial trabeculae in ROI I/II. All cups resulted radiographically stable without any radiolucent lines. The macro-porous structure of this biomaterial generates a high coefficient of friction (Marin 2012 Hip Int), promoting a firm mechanical interlocking at the implant-bone interface which could be already observed in the operating room. BMD initially declined from baseline at 7 days to 6 months. Then, BMD slightly increased or stabilized in all ROIs up to 24 months, while showing evidence of partial decline over time with increasing patient' age at 60 months, although without any clinical significance in terms of patients health status or
Initial stability of cementless components in bone is essential for longevity of Total Hip Replacements. Fixation is provided by press-fit: seating an implant in an under-reamed bone cavity with mallet strikes (impaction). Excessive impaction energy has been shown to increase the risk of periprosthetic fracture of bone. However, if implants are not adequately seated they may lack the stability required for bone ingrowth. Ideal fixation would maximise
Recent introduction of short femoral implants has produced inconsistent outcomes. There have been reports of early aseptic failure as high as 30% within 2 years of implantation. This is in spite of the fact that these short components are shortened versions of existing successful non-cemented designs. The mode of initial fixation in non-cemented implants has been investigated. It has been demonstrated that long term survivability is dependent upon osseous integration; and that osseous integration requires secure initial implant fixation. Traditional non-cemented implants achieve initial fixation analogous to that of a nail in a piece of wood: friction and displacement (with resultant hoop stress). Initial fixation, of a traditional non-cemented femoral component, is directly proportional to surface area contact between the implant and endosteal bone and/or three point fixation. By reducing stem length, contact area may be significantly reduced, thereby increasing stresses over a smaller area of contact. The result of this is to potentially compromise fixation/
INTRODUCTION. The restoration of the anatomical hip rotation center (HRC) has a major influence on the longevity of hip prostheses. Deviations from the HRC of the anatomical joint after total hip arthroplasty (THA) can lead to increased hip joint forces, early wear or loosening of the implant. The contact conditions of acetabular press-fit cups after implantation, including the degree of press-fit, the existence of a polar gap and cup orientation, may affect the HRC restoration, and therefore
Proximal humeral fractures occur frequently, with fixed angle locking plates often being used for their treatment. However, the failure rate of this fixation is high, ranging between 10 and 35%. Numerous variables are thought to affect the performance of the fixation used, including the length and configuration of screws used and the plate position. However, there is currently limited quantitative evidence to support concepts for optimal fixation. The variations in surgical techniques and human anatomy make biomechanical testing prohibitive for such investigations. Therefore, a finite element osteosynthesis test kit has been developed and validated - SystemFix. The aim of this study was to quantify the effect of variations in screw length, configuration and plate position on predicted failure risk of PHILOS plate fixation for unstable proximal humerus fractures using the test kit. Twenty-six low-density humerus models were selected and osteotomized to create a malreduced unstable three-part fracture AO/OTA 11-B3.2 with medial comminution which was virtually fixed with the PHILOS plate. In turn, four different screw lengths, twelve different screw configurations and five plate positions were simulated. Each time, three physiological loading cases were modelled, with an established finite element analysis methodology utilized to evaluate average peri-screw bone strain, this measure has been previously demonstrated to predict experimental fatigue fixation failure. All three core variables lead to significant differences in peri-screw strain magnitudes, i.e. predicted failure risk. With screw length, shortening of 4 mm in all screw lengths (the distance of the screw tips to the joint surface increasing from 4 mm to 8 mm) significantly (p < 0 .001) increased the risk of failure. In the lowest density bone, every additional screw reduced failure risk compared to the four-screw construct, whereas in more dense bone, once the sixth screw was inserted, no further significant benefit was seen (p=0.40). Screw configurations not including calcar screws, also demonstrated significant (p < 0 .001) increased risk of failure. Finally, more proximal plate positioning, compared to the suggested operative technique, was associated with reduced the predicted failure risk, especially in constructs using calcar screws, and distal positioning increased failure risk. Optimal fixation constructs were found when placing screws 4 mm from the joint surface, in configurations including calcar screws, in plates located more proximally, as these factors were associated with the greatest reduction in predicted fixation failure in 3-part unstable proximal humeral fractures. These results may help to provide practical recommendations on the implant usage for improved primary
Introduction. Total Hip Arthroplasty (THA) is currently one of the most widely performed surgical procedures in clinical orthopaedic practice. Despite the recorded number of uncemented implants has steadily increased in recent years, cemented fixation still remains the benchmark in THA, accounting for most of the procedures performed nowadays. The Friendly Short is a novel cemented short-stem that grants a less invasive and more bone conservative approach due to its shortened height and innovative cementing technique. It is indicated to treat elderly patients with the aim of preserving bone diaphysis while decreasing postoperative recovery times. Its instrument set allows to optimize the cement mantle thickness via an improved pressurization and stem centralization system. Objectives. Aim of this prospective study was to evaluate functional recovery and
This is a minimum 15 year follow up of a cohort of 58 patients (30 men and 28 women) who underwent 62 non-cemented THR between 1998–2000 (54 unilateral, 4 bilateral), in whom an off-the-shelf “lateral flare” femoral component was implanted. These surgeries were performed by a single surgeon and have been followed continuously by that same surgeon. The mean age at the time of surgery was 60.4 yrs (52–74). There were no exclusions for osteoporosis or type “C” femoral geometry. Although some patients have deceased during these 15 years, there have been no stem failures, revisions or impending stem revisions at the time of follow up or at the time of death in those who have passed. Two patients have undergone revision of their acetabular liner for poly wear. There have been no complaints of thigh pain; and like the results seen in other series employing this stem design, there has been no evidence of bone loss due to stress shielding or subsidence of the femoral component in any of these patients. This mid-term follow up re-affirms the dynamic tension band model of hip biomechanics, upon which the “lateral flare” design is predicated. This model predicts that the proximal lateral femur can experience compression during the gait cycle and as such can be utilized as an additional base of support upon which the femoral component can rest. Rather than relying upon a traditional “press fit” technique to achieve initial
Background. Cementless acetabular cups rely on press-fit fixation for initial stability; an essential pre-requisite to implant longevity. Impaction is used to seat an oversized implant in a pre-prepared bone cavity, generating bone strain, and ‘grip’ on the implant. In certain cases (such as during revision) initial fixation is more difficult to obtain due to poorer bone quality. This increases the chance of loosening and instability. No current study evaluates how a surgeon's impaction technique (mallet mass, mallet velocity and number of strikes) may be used to maximise cup fixation and seating. Questions/purposes. (1) How does impaction technique affect a) bone strain & fixation and b) seating in different density bones? (2) Can an impaction technique be recommended to minimize risk of implant loosening while ensuring seating of the acetabular cup?. Methods. A custom drop tower was used to simulate surgical strikes, seating acetabular cups into a synthetic bone model (Fig. 1). Strike velocity (representing surgeon strike level) and drop mass (representing mallet mass) were varied through representative low, medium and high levels. Polar gap between the implant and bone was measured using optical tracking markers. Strain gauges were used to measure acetabular rim strain. Following seating, cup pushout force was measured in a materials testing machine. Both measurements were used to quantify the level of fixation of the implant for two conditions: For the first, the cup was optimally seated (moving no more than 0.1mm on the previous strike, representing ideal conditions); For the second the cup was impacted 10 times (excessively impacted). Repeats (N = 5) were conducted in low and high density bone; a total of 180 tests. Results. For ideally impacted cups, increasing mallet mass and velocity improved fixation and reduced polar gap. However a phenomenon of bone strain deterioration was identified if an excessive number of strikes were used to seat a cup, resulting in loss of implant fixation. This effect was most severe in low density bone (Fig. 2). For high strike velocity and mallet mass, each excessive strike halved the measured bone strain (78 ± 7 με/strike). This reduced fixation strength from 630 ± 65 N (optimally seated) to just 49 ± 6 N at 10 strikes (Fig. 3). Discussion. These results identify a possible mechanism of loss of
Purpose. Although the use of stems in revision total knee arthroplasty (RTKA) enhances survival by improving the
Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications.Aims
Methods