Study Aim. Femoral components used in total knee arthroplasty (TKA) are primarily designed on the basis of kinematics and ease of fixation. This study considers the stress-strain environment in the distal femur due to different implant internal geometry variations (based on current industry standards) using finite element (FE) analyses. Both two and three dimensional models are considered for a range of physiological loading scenarios – from full extension to deep flexion. Issues associated with micro-motion at the bone-implant interface are also considered. Materials and methods. Two (plane strain) and three dimensional finite element analyses were conducted to examine implant micro-motions and stability. The simple 2D models were used to examine the influence of anterior-posterior (AP) flange angle on implant stability. AP slopes of 3°, 7° and 11° were considered with contact between bone and implant interfaces being modeled using the standard coulomb friction model. The direction and region of loading was based on loading experienced at full extension, 90° flexion and 135° flexion. Three main model variations were created for the 3D analyses, the first model represented an intact distal femur, the second a primary implanted distal femur and the third a distal femur implanted with a posterior stabilising implant. Further each of the above 3D model sets were divided into two group, the first used a frictional interface between the bone and implant to characterise the behavior of uncemented implants post TKA and the second group assumed 100% osseointegration had already taken place and focused on examining the subsequent stress/strain environment in the femur with respect to different femoral component geometries relative the intact distal femur model. Results and Discussion. Analyses indicate a trend relating the slope of the anterior-posterior (AP) flange to implant loosening at high flexion angles for uncemented components. Once cemented, this becomes less important. Results from the 3D analyses show that the posterior stabilising implant causes stress concentrations which can lead to bicondylar fatigue fracture. All femoral components cause stress shielding in cancellous bone particularly when they are fully bonded. Investigations into implant micromotion show that revision implants with box sections provided more resistance to micromotion than the pegged primary implants. However for the gait cycle tested the maximum recorded micromotion of both implants was well within acceptable levels for osseointegration to occur

In vitro femoral studies have demonstrated the addition of hydroxyapatite (HA), to morcellised bone graft (MBG) decreases femoral prosthesis subsidence. However, with an increased risk of femoral fracture during the impaction of a MBG:HA mixture, possibly due to greater force transmission to the femoral cortex via the HA. The aim was to compare the hoop strains and subsidence of a 1:1 mixture of MBG:HA with pure bone allograft during impaction and subsequent endurance testing in a revision hip arthroplasty model.

Materials and methods Large Sawbone femurs were prepared to represent a femur with bone loss (Sawbones, Sweden). 12 uniaxial strain gauges were attached to each femur at 0, 90, 180 and 270 degrees, at distal, midshaft, proximal points to measure hoop strain. Impaction grafting was performed using X-Change 2 instruments and an Instron servohydaulic machine for 2 distal impactions and 4 proximal impactions for 60 impactions each.

Primary implant stability is critical for osseointegration and subsequent implant success. Small displacements on the screw/bone interface are necessary for implant success, however, larger displacements can propagate cracks and break anchorage points which causes the screw to fail. Limited information is available on the progressive degradation of stability of an implanted bone screw since most published research is based on monotonic, quasi-static loading [1]. This study aims to address this gap in knowledge. A total of 100 implanted trabecular screws were tested using multi-axial loading test set-up. Screws were loaded in cycles with the applied force increasing 1N in each load cycle. In every load cycle, Peak forces, displacements, and stiffness degradation (calculated in the unloading half of the cycle) where recorded. 10 different loading configurations where tested. The damage vs displacement shows a total displacement at the point of failure between 0.3 and 0.4 mm while an initial stiffness reduction close to 40%. It is also shown that at a displacement of ~0.1 mm, the initial stiffness of every sample had degraded by 20% (or more) meaning that half of the allowable degradation occurred in the first 25-30% of the total displacement. Other studies on screw overloading [1] suggests similar results to our concerning initial stiffness degradation at the end of the loading cycle. Our results also show that the initial stiffness degrades faster with relatively small deformations suggesting that the failure point of an implanted screw might occur before the common failure definition (pull-out force, for example). These results are of great significance since primary implant stability is better explained by the stiffness of the construct than by its failure point

3D-printed orthopedic implants have been gaining popularity in recent years due to the control this manufacturing technique gives the designer over the different design aspects of the implant. This technique allows us to manufacture implants with material properties similar to bone, giving the implant designer the opportunity to address one of the main complications experienced after total hip arthroplasty (THA), i.e. aseptic loosening of the implant. To restore proper function after implant loosening, the implant needs to be replaced. During these revision surgeries, some extra bone is removed along with the implant, further increasing the already present defects, and making it harder to achieve proper mechanical stability with the revision implant. A possible way to limit the increasing loss of bone is the use of biodegradable orthopedic implants that optimize long-term implant stability. These implants need to both optimize the implant such that stress shielding is minimized, and tune the implant degradation rate such that newly formed bone is able to replace the degrading metal in order to maintain a proper bone-implant contact. The hope is that such (partly) degradable implants will lead to a reduction in the size of the bone defects over time, making possible future revisions less likely and less complex. We focused on improving the long-term implant stability of patient-specific acetabular implants for large bone defects and the modeling of their biodegradable behavior. To improve long-term implant stability we implemented a topology optimization approach. A patient-specific finite element model of the hip joint with and without implant was derived from CT-scans to evaluate the performance of the designs during the optimization routine. To evaluate the biodegradation behavior, a quantitative mathematical model was developed to assess the degradation rates of the biodegradable part of the implant. Currently, the biodegradation model has been implemented for magnesium (Mg) implants as a first proof of concept. For a first test case, an optimized implant was found with stress shielding levels below 20% in most regions. The highest stress shielding levels were found at the bone implant interface. The biodegradation model has been validated using experimental data, which includes immersion tests of simple scaffolds created from Commercial Pure Mg. The mass loss of the scaffold is about 0.8 mg/cm. 2. for the first day of immersion in simulated body fluid (SBF) solution. After the formation of a protective film on the surface of the simple scaffold, the degradation rate starts to slow down. Initial results presented serve as a proof of concept of the developed computational framework for the implant optimization and the implant biodegradation behavior. Currently, timing calibration, benchmarking and validation are taking place. Reducing implant-induced stress shielding, obtaining a better implant integration and reduction of bone defects, by allowing for bone to partially replace the implant over time, are crucial design factors for large bone defect implants. In this research, we have developed in-silico models to investigate these factors. Once validated and coupled, the models will serve as an important tool to find the appropriate biodegradable implant designs and biodegradable metal properties for THA applications, that improve current implant lifetime while ensuring proper mechanical functioning

Abstract. Objectives. Obesity is prevalent with nearly one third of the world's population being classified as obese. Total knee arthroplasty (TKA) is an effective treatment option for high BMI patients achieving similar outcomes to non-obese patients. However, increased rates of aseptic loosening in patients with a high BMI have been reported. In patients with high BMI/body mass there is an increase in strain placed on the implant fixation interfaces. As such component fixation is a potential concern when performing TKA in the obese patient. To address this concern the use of extended tibial stems in cemented implants or cementless fixation have been advocated. Extend tibial stems are thought to improve implant stability reducing the micromotion between interfaces and consequently the risk of aseptic loosening. Cementless implants, once biologic fixation is achieved, effectively integrate into bone eliminating an interface. This retrospective study compared the use of extended tibial stems and cementless implants to conventional cemented implants in high BMI patients. Methods. From a prospectively maintained database of 3239 primary Attune TKA (Depuy, Warsaw, Indiana), obese patients (body mass index (BMI) >30 kg/m²) were retrospectively reviewed. Two groups of patients 1) using a tibial stem extension [n=162] and 2) cementless fixation [n=163] were compared to 3) a control group (n=1426) with a standard tibial stem cemented implant. All operations were performed by or under the direct supervision of specialist arthroplasty surgeons. Analysis compared the groups with respect to class I, II, and III (BMI >30kg/m², >35 kg/m², >40 kg/m²) obesity. The primary outcome measures were all-cause revision, revision for aseptic loosening, and revision for tibial loosening. Kaplan-Meier survival analysis and Cox regression models were used to compare the primary outcomes between groups. Where radiographic images at greater than 3 months post-operatively were available, radiographs were examined to compare the presence of peri-implant radiolucent lines. Results. The mean follow-up of 4.8, 3.4, and 2.5 years for cemented, stemmed, and cementless groups respectively. In total there were 34 all-cause revisions across all the groups with revision rates of 4.55, 5.50, and 0.00 per 1000-implant-years for cemented, stemmed, and cementless groups respectively. Survival Analysis did not show any significant differences between the three groups for all-all cause revision. There were 6 revisions for aseptic loosening (5 tibial and 1 femoral); all of which were in the standard cemented implant group. In contrast there were no revisions in the stemmed or cementless implant groups, however, this was not significant on survival analysis. Analysis looking at class I, II, and III obesity also did not show any significant differences in survival for all cause revision or aseptic loosening. Conclusion. This retrospective analysis showed that there were no revisions required for aseptic loosening when either a cemented stemmed or cementless implant were used in obese patients. These findings are in line with other studies showing that cementless fixation or extended stem implants are a reasonable option in obese patients who represent an increasing cohort of patients requiring TKR. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

To date, the fixation of proximal humeral fractures with angular stable locking plates is still insufficient with mechanical failure rates of 18% to 35%. The PHILOS plate (DePuy Synthes, Switzerland) is one of the most used implants. However, this plate has not been demonstrated to be optimal; the closely symmetric plate design and the largely heterogeneous bone mineral density (BMD) distribution of the humeral head suggest that the primary implant stability may be improved by optimizing the screw orientations. Finite element (FE) analysis allows testing of various implant configurations repeatedly to find the optimal design. The aim of this study was to evaluate whether computational optimization of the orientation of the PHILOS plate locking screws using a validated FE methodology can improve the predicted primary implant stability. The FE models of nineteen low-density (humeral head BMD range: 73.5 – 139.5 mg/cm3) left proximal humeri of 10 male and 9 female elderly donors (mean ± SD age: 83 ± 8.8 years) were created from high-resolution peripheral computer tomography images (XtremeCT, Scanco Medical, Switzerland), using a previously developed and validated computational osteosynthesis framework. To simulate an unstable mal-reduced 3-part fracture (AO/OTA 11-B3.2), the samples were virtually osteotomized and fixed with the PHILOS plate, using six proximal screws (rows A, B and E) according to the surgical guide. Three physiological loading modes with forces taken from musculoskeletal models (AnyBody, AnyBody Technology A/S, Denmark) were applied. The FE analyses were performed with Abaqus/Standard (Simulia, USA). The average principal compressive strain was evaluated in cylindrical bone regions around the screw tips; since this parameter was shown to be correlated with the experimental number of cycles to screw cut-out failure (R2 = 0.90). In a parametric analysis, the orientation of each of the six proximal screws was varied by steps of 5 in a 5×5 grid, while keeping the screw head positions constant. Unfeasible configurations were discarded. 5280 simulations were performed by repeating the procedure for each sample and loading case. The best screw configuration was defined as the one achieving the largest overall reduction in peri-screw bone strain in comparison with the PHILOS plate. With the final optimized configuration, the angle of each screw could be improved, exhibiting significantly smaller average bone strain around the screw tips (range of reduction: 0.4% – 38.3%, mean ± SD: 18.49% ± 9.56%). The used simulation approach may help to improve the fixation of complex proximal humerus fractures, especially for the target populations of patients at high risk of failure

Introduction. Achieving an appropriate primary stability after implantation is a prerequisite for the long-term viability of a dental implant. Virtual testing of the bone-implant construct can be performed with finite element (FE) simulation to predict primary stability prior to implantation. In order to be translated to clinical practice, such FE modeling must be based on clinically available imaging methods. The aim of this study was to validate an FE model of dental implant primary stability using cone beam computed tomography (CBCT) with ex vivo mechanical testing. Method. Three cadaveric mandibles (male donors, 87-97 years old) were scanned by CBCT. Twenty-three bone samples were extracted from the bones and conventional dental implants (Ø4.0mm, 9.5mm length) were inserted in each. The implanted specimens were tested under quasi-static bending-compression load (cf. ISO 14801). Sample-specific homogenized FE (hFE) models were created from the CBCT images and meshed with hexahedral elements. A non-linear constitutive model with element-wise density-based material properties was used to simulate bone and the implant was considered rigid. The experimental loading conditions were replicated in the FE model and the ultimate force was evaluated. Result. The experimental ultimate force ranged between 67 N and 789 N. The simulated ultimate force correlated better with the experimental ultimate force (R. 2. =0.71) than the peri-implant bone density (R. 2. =0.30). Conclusion. The developed hFE model was demonstrated to provide stronger prediction of primary stability than peri-implant bone density. Therefore, hFE Simulations based on this clinically available low-radiation imaging modality, is a promising technology that could be used in future as a surgery planning tool to assist the clinician in evaluating the load-bearing capacity of an implantation site. Acknowledgements. Funding: EU's Horizon 2020 grant No: 953128 (I-SMarD). Dental implants: THOMMEN Medical AG

Introduction and Objective. The patients with a total hip arthroplasty is growing in world manly in Europe and USA, and this solution present a high success at 10years in several orthopaedic registers. The application of total press-fit hip fixation presents the most used solution, but presents some failures associated to the acetabular component fixation, associated to the load transfer and bone loss at long term. The aim of this work is to investigate the influence of different acetabular bone loss in the strain distribution in iliac bone. To evaluate implant fixation, an experimental study was performed using acetabular press-fit component simulating different acetabular bone loss and measuring the strain distribution. Materials and Methods. The experimental samples developed was based in an iliac bone model of Sawbones supplier and a acetabular component Titanium (Stryker) in a condition press-fit fixation and was implanted according surgical procedure with 45º inclination angle and 20º in the anteversion angle. Were developed five models with same initial bone, one with intact condition simulating the cartilage between bones and four with different bone loss around the acetabular component. These four models representing the evolution of bone support of acetabular components presented in the literature. The evolution of bone loss was imposed with a CAD CAM process in same iliac bone model. The models were instrumented with 5 rosettes in critical region at the cortical bone to measure the strain evolution along the process. Results. The results of strain gauges present the influence of acetabular component implantation, reducing the bone strains and presented the effect of the strain shielding. The acetabular component works as a shield in the load transfer. The critical region is the posterior region with highest principal strains and the strain effect was observed with different bone loss around acetabular component. The maximum value of principal strain was observed in the intact condition in the anterior region, with 950μ∊. In the posterior superior region, the effect of bone loss is more important presenting a reduction of 500% in the strains. The effect of bone loss is presented in the strains induced with acetabular implantation, in the first step of implantation the maximum strain was 950μ∊ and in the last model the value was 50μ∊, indicating lower press-fit fixation. Conclusions. The models developed allows study the effect of bone loss and acetabular implant fixation in the load transfer at the hip articulation. The results presented a critical region as the anterior-superior and the effect of strain shielding was observed in comparison with intact articulation. The results of press-fit fixation present a reduction of implant stability along bone loss. The process of bone fixation developed present some limitation associated to the bone adhesion in the interface, not considered. Acknowledgement. This work was supported by POCI-01-0145-FEDER-032486,– FCT, by the FEDER, with COMPETE2020 - (POCI), FCT/M

Abstract. Objective. To compare the periprosthetic fracture mechanics between a collared and collarless fully coated cementless femoral stem in a composite femur. Methods. Two groups of six composite femurs (‘Osteoporotic femur’, SawBones, WA USA) were implanted with either a collared (collared group) or collarless (collarless group) cementless femoral stem which was otherwise identical by a single experienced surgeon. Periprosthetic fractures of the femur were simulated using a previously published technique. High speed video recording was used to identify fracture mechanism. Fracture torque and angular displacement were measured and rotational work and system stiffness were estimated for each trial. Results were compared between collared and collarless group and the comparison was evaluated against previously published work using fresh frozen femurs and the same protocol. Results. In composite femur testing median fracture torque (IQR) was greater with a collared versus collarless implant (48.41 [42.60 to 50.27] Nm versus 45.12 [39.13 to 48.09] Nm, p= 0.4). Median rotational displacement (IQR) was less with a collared versus collarless implant (0.29 [0.27 to 0.31] radians versus 0.33 [0.32 to 0.34] radians, p= 0.07). Estimated rotary work was similar between groups (5.76 [4.92 to 6.64] J versus 5.21 [4.25 to 6.04] J, p= 0.4). Torsional stiffness was greater with a collared versus collarless implant (158.36 [152.61, 163.54] Nm per radian versus 138.79 [122.53, 140.59] Nm per radian, p= 0.5). Collarless stems were seen to move independently of the femur and fracture patterns originated at the calcar. Conclusions. Testing with composite femurs using an established protocol produced similar results to previously published studies using human femurs, but the difference between collared and collarless stems was smaller. The internal homogenous foam material in composite femurs does not accurately represent the heterogeneous cancellous bone which supports a femoral stem in vivo and may lead to overestimation of implant stability. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

Pulsed electromagnetic fields (PEMFs) have been considered a potential treatment modality for fracture healing. As bone fracture healing and osseointegration share the same biological events, the application of PEMF stimulation to facilitate the osseointegration process of orthopedic implants has been suggested. However, the mechanism of their action remains unclear. Mammalian target of rapamycin (mTOR) signaling may affect osteoblast proliferation and differentiation. This study aimed to assess the osteogenic differentiation of mesenchymal stem cells (MSCs) under PEMF stimulation and the potential involvement of mTOR signaling pathway in this process. PEMFs were generated by a novel miniaturized electromagnetic device (MED). Potential changes in the expression of mTOR pathway components, including receptors, ligands and nuclear target genes, and their correlation with osteogenic markers and transcription factors were analyzed. PEMF exposure increased cell proliferation, adhesion and osteogenic commitment of MSCs. Osteogenic-related genes were over-expressed following PEMF treatment. Our results confirm that PEMFs contribute to activation of the mTOR pathway via upregulation of the proteins AKT, MAPP kinase, and RRAGA, suggesting that activation of the mTOR pathway is required for PEMF-stimulated osteogenic differentiation. In summary, the findings of the present study revealed that MED-generated PEMFs stimulate osteogenic differentiation and the maturation of the adipose tissue-derived MSCs via activation of the mTOR pathways. Even though further research is required to determine an optimal stimulation timing and flux density both in-vitro and in-vivo, this study results may serve a source for an adjuvant therapy to improve orthopedic implant stability, longevity and enhance fracture healing

Orbital floor (OF) fractures are commonly treated by implanting either bioinert titanium or polyethylene implants, or by autologous grafts. A personalized implant made of biodegradable and osteopromotive poly(trimethylene carbonate) loaded with hydroxyapatite (PTMC-HA) could be a suitable alternative for patients where a permanent implant could be detrimental. A workflow was developed from the implant production using stereolithography (SLA) based on patient CT scan to the implantation and assessment its performance (i.e. implant stability, orbit position, bone formation) compared to personalised titanium implants in a repair OF defect sheep model. Implants fabrication was done using SLA of photo-crosslinkable PTMC mixed with HA [1–3]. Preclinical study: (sheep n=12, ethic number 34_2016) was conducted by first scanning the OF bone of each sheep in order to design and to fabricate patient specific implants (PSI) made of PTMC-HA. The fabricated PSI was implanted after creating OF defect. Bone formation and defect healing was compared to manually shaped titanium mesh using time-laps X-ray analyses, histology (Giemsa-Eosin staining) and sequential fluorochrome staining over 3-months. Additionally, the osteoinductive property of the biomaterials was assessed by intramuscular implantation (IM). In this study, we showed that the composite PTMC-HA allowed for ectopic bone formation after IM implantation, without requiring any biotherapeutics. In addition, we could repair OF defect on sheep using SLA-fabricated PTMC-HA with a good shape fidelity (compared to the virtual implant) and a better bone integration compared to the titanium mesh. This study opens the field of patient-specific implants made of degradable and osteoinductive scaffolds fabricated using additive manufacturing to replace advantageously autologous bone and titanium implants

Tibial bone density may affect implant stability and functional outcomes following total knee replacement (TKR). Our aim was to characterise the bone density profile at the implant-tibia interface following TKR in mechanical versus kinematic alignment. Pre-operative computed tomography scans for 10 patients were obtained. Using surgical planning software, tibial cuts were made for TKR either neutral (mechanical) or 3 degrees varus (kinematic) alignment. Signal intensity, in Hounsfield Units (HU), was measured at 25,600 points throughout an axial slice at the implant-tibia interface and density profiles compared along defined radial axes from the centre of the tibia towards the cortices. From the tibial centre towards the lateral cortex, trabecular bone density for kinematic and mechanical TKR are similar in the inner 50% but differ significantly beyond this (p= 0.012). There were two distinct density peaks, with peak trabecular bone density being higher in kinematic TKR (p<0.001) and peak cortical bone density being higher in mechanical TKR (p<0.01). The difference in peak cortical to peak trabecular signal was 43 HU and 185 HU respectively (p<0.001). On the medial side there was no significant difference in density profile and a linear increase from centre to cortex. In the lateral proximal tibia, peak cortical and peak trabecular bone densities differ between kinematic TKR and mechanical TKR. Laterally, mechanical TKR may be more dependent upon cortical bone for support compared to kinematic TKR, where trabecular bone density is higher. This may have implications for surgical planning and implant design

Modular femoral stems for total hip arthroplasty (THA) were introduced to allow additional options for surgeons in controlling leg lengths, offset, and implant stability. This option is widely used in Region Emilia Romagna, Italy, where the study was conducted, having a modular neck stem nearly 35% of primary THA in 2013. Great majority of modular neck is made of Titanium alloy. The study was designed as a retrospective descriptive case series of 67 hips in patients who underwent revision of a THA. All had a Titanium modular neck. In 44 cases revision was due to breakage of the neck, in the remaining 23 it was due to different reasons unrelated to modular neck such as bone fracture, breakage of a ceramic component, cup loosening. Mean follow up was 3.5 yrs. For all patients excised capsule and surrounding tissue were graded for presence of necrosis, inflammatory exudate, lymphocytes, and wear particles using light microscopy of routine paraffin sections stained with hematoxylin and eosin. The retrieved modular neck-body and head-neck junctions were examined for evidence of fretting and corrosion. For some patient dosage of circulating Titanium was obtained. Approval was obtained from institutional review board. It resulted that a variable amount of wear was observed in the first group of patients, with no evidence of lymphocytic reaction, but with variable notes of necrosis. Broken necks showed different patterns of damage, with different degree of corrosion, beside the fatigue fracture. In the second group wear was less evident or absent and negativity of lymphocyte reaction was substantially confirmed. Circulating Titanium ions were one order of magnitude higher in first group (mean 35 micrograms /litre). It can be concluded that fracture of Titanium modular necks occurs progressively, wear does not induce lymphocytic reaction and circulating ions increase. Level of Evidence. III retrospective, comparative study. Acknowledgments. The research was funded by Ministry of Health, grant ‘Early diagnosis of pending failure…’RF 20091472961

Background. Implant stability and is an important factor for adequate bone remodelling and both are crucial in the long-term clinical survival of total hip arthroplasty (THA). Assessment of early bone remodelling on X-rays during the first 2 years post-operatively is mandatory when stepwise introduction of a new implant is performed. Regardless of fixation type (cemented or cementless), early acetabular component migration is usually the weakest link in THA, eventually leading to loosening. Over the past years, a shift towards uncemented cup designs has occurred. Besides the established hydroxyapatite (HA) coated uncemented cups which provide ongrowth of bone, new uncemented implant designs stimulating ingrowth of bone have increased in popularity. These cups initiate ingrowth of bone into the implant by their open metallic structure with peripheral pores, to obtain a mechanical interlock with the surrounding bone, thereby stabilising the prosthesis in an early stage after implantation. This retrospective study assessed bone remodelling, osseointegration and occurrence of radiolucency around a new ingrowth philosophy acetabular implant. Methods. In a retrospectively, single centre cohort study all patients whom underwent primary THA with a Tritanium acetabular component in 2011 were included. Bone remodelling, osseointegration and occurrence of radiolucency were determined by two reviewers from X-ray images that were made at 6 weeks, 3–6-12 and 24 months post-operatively. Bone contact % was calculated based on the original Charnley and DeLee zones. According to Charnley and DeLee the outer surface of an acetabular cup is divided into 3 zones (1-2-3). For our analysis the original 3 zones were further divided into 2 producing 6 zones 1A to 3B. Each of these 6 zones were then further divided into 4 equal sections. We attributed 25 points per section in which complete bone contact without lucency was observed. If lucency was observed no points were attributed to the section. A fully osteointegrated cup in all 24 sections could therefore attain 600 points. The total of each section and zone was subsequently tallied and recalculated to produce the percentage of bone contact on a 1–100% score. Results. In 2011 131 patients; 54 male and 76 female with average age of 60.83 (SD 12.42) and 60.57 (SD 12.11) year respectively underwent primary THA at our institution and all where included in our study cohort. Majority of this cohort underwent primary THA due to osteoarthrosis and most patients were classified ASO I (18%) or ASA II (65%). At two year clinical follow-up two revision were performed. One constituted a femur and acetabulum revision due to leg length difference and a snapping hip phenomenon. Complications included 3 dislocations (all treated policlinic), 4 deep infections (all treated with Genta PMMA beads with prosthesis in situ and healed) and 1 removal of hematoma. In another patient the femoral component was revised due to a peri-prosthetic fracture. Mean bone contact % values for all Charnley and DeLee zones combined were calculated and improved from 68,18% (SD 22,36) at 6 weeks to 73,61% SD (16,26) at 3 months to 84,21% (SD 19,02) at 6 months to 86,90% (SD 16,0) at 1 year to 92,19% (SD 12,74) at two year follow-up. When analysing the bone contact % per individual zone a remarkable difference was found for zones 2A-B. In contrast to zone 1A-B and 3A-B the initial bone contact % was clearly although not significantly lower until two year follow-up. Conclusions. In this study, the bone apposition around Tritanium actebular component was retrospectively assessed until two year clinical. Our results show excellent bone apposition that continues to improve over time (at least until two year clinical follow-up) suggesting that the open trabecular Ti structure of the Tritanium has a positive effect on cup osseointegration. However, some recent reports have shown the development of reactive lines around cups with porous/trabecular metal surfaces, of which the meaning is still unclear. Our analysis indicated that especially acetabular zone 2A-B according to Charnley&DeLee needs time to establish a direct contact of the implant surface and the surrounding bone tissues. Perhaps this might be explained by reaming technique (underreaming vs line to line reaming) resulting in suboptimal seating of the cup. Therefore, careful follow-up of this new implant technology will remain necessary and continued in this study. We aim to improve cohort size and establish results at longer follow-up times. Furthermore we aim to correlate these results to RSA component migration analysis

Summary. Despite high revision rates, the mean two year migration of the ASR. TM. cup is within an acceptable threshold. Slightly higher migration rates found for the M2a- Magnum™ Porous Coated Acetabular Component but longer follow up is needed to establish if this implant is at risk. Introduction. RSA can detect the migration of an implant, and continuous migration is a predictor for failure (1). The ASR. TM. resurfacing implant was withdrawn from the marked due to excessive failure rate but showed initial femoral component stability. The aim of this study was to investigate the initial implant stability for the ASR cup as a possible explanation for the high revision rate, and to compare it to another metal on metal (MoM) cup. Patients and Methods. 36 patients with primary osteoarthritis from a RCT received either an ASR. TM. (n=19) or an M2a-Magnum Cup. TM. (n=17) without markers. Ten 0.8mm tantalum markers were injected in the periacetabular bone. Using a UmRSA® 43Calibration Cage™ (RSA Biomedical, Sweden), supine RSA images were obtained within 3 days of surgery, at 8 w, 6 m, 1 and 2 years. A model based RSA system using an EGS Hemi-sphere model (Medis specials, Leiden) calculated migration. For the 2 year analysis 16 and 15 sets of images were available. ANOVA with repeated measurements analysed movement over time for each type of implant as well as difference between implants. Results. Mean translations in the medial –lateral (X), proximal-distal (Y) and anterior-posterior (Z) direction are depicted. Initial movement was noted, especially for the M2a-Magnum cup, where the 2 year mean (sd) X translation was −0.307 (0.53)mm (p = 0.01), Y translation was 0.282 (0.36)mm (p < 0.001) and Z translation was −0.343 (0.63)mm p = (0.03). After 2 years the ASR cup displayed a mean X translation of −0.115 (0.60) mm (p = 0.82), Y translation of 0.075 (0.14)mm (p = 0.01) and Z translation of 0.438 (0.88)mm (p = 0.04). The implants had a similar pattern for X and Y with slightly more movement for M2a-Magnum in the X translations (p < 0.01) On the Z axis the implants displayed movement in opposite directions (p=<0.001). At two years 4 ASR and 5 M2aMagnum displayed movement above 1 mm in one axis . Discussion/Conclusion. The early migration of both cups were low. The ASR implant is slightly higher than a competing implant with better survival rates on the Z axis, but low at particularly the Y axis, where the mean 0.075 mm is well below the limit of 0.2mm recently suggested as an acceptable threshold. The M2a-Magnum cup has migration rates just above that, but longer clinical follow up is needed to establish if this cup has greater risk of revision. We will continue to monitor our patients to establish if the individual patient with excess migration is at risk. Continuous migration is not likely to explain failure of neither the cup nor the femoral side of the ASR hip

The osteo-regenerative properties of allograft have recently been enhanced by addition of autogenous skeletal stem cells to treat orthopaedic conditions characterised by lost bone stock. There are however, multiple disadvantages to allograft, including cost, availability, consistency and potential for disease transmission, and trabecular tantalum represents a potential alternative. Tantalum is already in widespread orthopaedic use, although in applications where there is poor initial implant stability, or when tantalum is used in conjunction with bone grafting, loading may need to be limited until sound integration has occurred. Development of enhanced bone-implant integration strategies will improve patient outcomes, extending the clinical applications of tantalum as a substitute for allograft. The aim of this study was to examine the osteoconductive potential of trabecular tantalum in comparison to human allograft to determine its potential as an alternative to allograft. Human bone marrow stromal cells (500,000 cells per ml) were cultured on blocks of trabecular tantalum or allograft for 28 days in basal and osteogenic media. Molecular profiling, confocal and scanning electron microscopy, as well as live-dead staining and biochemical assays were used to characterise cell adherence, proliferation and phenotype. Cells displayed extensive adherence and proliferation throughout trabecular tantalum evidenced by CellTracker immunocytochemistry and SEM. Tantalum-cell constructs cultured in osteogenic conditions displayed extensive matrix production. Electron microscopy confirmed significant cellular growth through the tantalum to a depth of 5mm. In contrast to cells cultured with allograft in both basal and osteogenic conditions, cell proliferation assays showed significantly higher activity with tantalum than with allograft (P<0.01). Alkaline phosphatase (ALP) assay and molecular profiling confirmed no significant difference in expression of ALP, Runx-2, Col-1 and Sox-9 between cells cultured on tantalum and allograft. These studies demonstrate the ability of trabecular tantalum to support skeletal cell growth and osteogenic differentiation comparable to allograft. Trabecular tantalum represents a good alternative to allograft for tissue engineering osteo-regenerative strategies in the context of lost bone stock. Such clinical scenarios will become increasingly common given the ageing demographic, the projected rates of revision arthroplasty requiring bone stock replacement and the limitations of allograft. Further mechanical testing and in vivo studies are on-going

Long term, secondary implant fixation of Total Disc Replacements (TDR) can be enhanced by hydroxyapatite or similar osseo-conductive coatings. These coatings are routinely applied to metal substrates. The objective of this in vivo study was to investigate the early stability and subsequent bone response adjacent to an all polymer TDR implant over a period of six months in an animal model. Six skeletally mature male baboons (Papio annubis) were followed for a period of 6 months. Using a transperitoneal exposure, a custom-sized Cadisc L device was implanted into the disc space one level above the lumbo-sacral junction in all subjects. Radiographs of the lumbar spine were acquired prior to surgery, and post-operatively at intervals up to 6 months to assess implant stability. Flourochrome markers (which contain molecules that bind to mineralization fronts) were injected at specified intervals in order to investigate bone remodeling with time. Animals were humanely euthanized six months after index surgery. Test and control specimens were retrieved, fixed and subjected to histological processing to assess the bone-implant-bone interface. Fluorescence microscopy and confocal scanning laser microscopy were utilized with BioQuant image analysis to determine the bone mineral apposition rates and gross morphology. Radiographic evaluation revealed no loss of disc height at the operative level or adjacent levels. No evidence of subsidence or significant migration of the implant up to 6 months. Heterotopic ossification was observed to varying degrees at the operated level. Histology revealed the implant primary fixation features embedded within the adjacent vertebral endplates. Flourochrome distribution revealed active bone remodeling occurring adjacent to the polymeric end-plate with no evidence of adverse biological responses. Mineral apposition rates of between 0.7 and 1.7 microns / day are in keeping with literature values for hydroxyapatite coated implants in cancellous sites of various species. Radiographic assessment demonstrates that the Cadisc L implant remains stable in vivo with no evidence of subsidence or significant migration. Histological analysis suggests the primary fixation features are engaged, and in close apposition with the adjacent vertebral bone. Flourochrome markers provide evidence of a positive bone remodelling response in the presence of the implant

Summary Statement. Magnesium has a number of qualities suitable for bioresorbable metallic implants. However, high corrosion rate and formation of hydrogen gas can compromise its performance. Combining magnesium with calcium phosphate improves magnesium's biocompatibility by decreasing gas formation and increasing bone remodeling. Introduction. Clinical problems like risk of postoperative infection and increased incidence of pediatric trauma requiring surgical intervention raised the need for temporary orthopedic implants that would resorb after the bone healing is complete. This would decrease high costs associated with repeated surgeries, minimise recovery times, decrease the risk of postoperative infections, and thus promote higher quality of life to the patients. The specific requirement for orthopedic implants, aside from being bioresorbable, is the ability to bear high loads. Magnesium was suggested as a suitable material for these purposes because it is biocompatible; has excellent mechanical properties; is natural for human body, and seems to stimulate new bone formation. However, an important problem with magnesium is high corrosion rate with consistent hydrogen gas formation on contact with fluids. This in vivo study focuses on investigation of new magnesium-based implants specifically designed to minimise hydrogen gas formation. Methods. Four types of degradable magnesium-based materials were tested for biocompatibility in this study: Magnesium-Hydroxyapatite implants (Mg-HA); Magnesium-Calcium Phosphate Cement (Mg-CPC); alloy of 96% Magnesium and 4% Yttrium (W4); and 99.95% pure magnesium which was a control group. Biomaterials were operated into 33 male New Zealand white rabbits. The animals were sacrificed after 6 and 12 weeks after which the samples were embedded into Epon, paraffin and Technovit resin. The staining was done with TRAP, hematoxylin eosin and toluidine blue. Additionally, TEM and immunohistochemical analysis were performed. The data was analysed both qualitatively and quantitatively by Statistical Package for the Social Sciences (SPSS, v18, SPSS Inc, Chicago, IL). Results. Mg-CPC showed the best performance in this study. New bone formation was significantly more prevalent in Mg-CPC group while gas formation was significantly less comparing to the other materials. Mg-HA had the worst properties due to extremely fast degradation already at 6 weeks, the least amount of new bone formation, and the lowest amount of osteoclasts and multinucleated cells in the implantation site. Pure magnesium and W4 had similar properties: both were surrounded with corrosion layer, and the gas volumes were significantly higher in these two groups compared to other materials. Discussion/Conclusion. New bone was seen forming either in direct contact to implants or around the gas bubbles. The later can be interpreted as body's reaction to protect from gas spreading. Mg-HA's degradation rate was far too fast and this is unacceptable for orthopedic fractures which often require several months to heal and that experience much load. Pure magnesium and W4 although maintained their integrity, were surrounded by corrosion layer and gas bubbles that were bigger in diameter than in the other groups. These findings could compromise implant stability. Mg-CPC was the most biocompatible; it showed significantly higher amount of osteoclasts which is a first sign of bone remodeling. It had also significantly less gas production than other groups. These results show that magnesium's biocompatibility could be improved by combining it with other suitable materials, such as calcium phosphate

Introduction. The treatment of osteonecrosis of the femoral head (ONFH) in young and active patients remains a challenge. The purpose of this study was to determine and compare the clinical and radiographic results of the two different hip resurfacing systems; hemi-resurfacing and metal-on-metal total hip resurfacing in patients with ONFH. Methods. This study was a retrospective review of 20 patients with 30 hips who had ONFH and underwent hemi-resurfacing or total hip resurfacing between November 2002 and February 2006. We mainly performed hemi-resurfacing for early stage ONFH, and total hip resurfacing for advanced stages. Fifteen hips in 11 patients had a hemi-resurfacing component (Conserve, Wright Medical Co) with a mean age at operation of 50 years and an average follow-up of 5.5 years. Fifteen hips in 10 patients had a metal-on-metal total hip resurfacing component (Birmingham hip resurfacing, Smith & Nephew Co.) with a mean age at operation of 40 years and an average follow-up years. Results. The average postoperative Japanese Orthopaedic Association (JOA) hip scores were 86 points in hemi-resurfacing and 96 points in total hip resurfacing. The difference of pain score was a main factor to explain the difference of total JOA hip score in the two groups. Both implants were radiographically stable, but radiolucent lines around the metaphyseal stem were more frequent in total hip resurfacing. In hemi-resurfacing patients, ten of 15 hips had groin pain or groin discomfort and three hips were revised to total hip arthroplasties (THA) because of femoral neck fracture, acetabular protrusio, and osteoarthritic changes, respectively. In total hip resurfacing patients, there were no revisions and no groin pain observed. Conclusion. In the prosthetic treatment of young active patients with ONFH, it is theoretically desirable to choose an implant with a conservative design in anticipation of the future revision surgery. Hemi-resurfacing hip arthroplasty is the most conservative implant for the treatment of ONFH. However, the results of hemi-resurfacing in this study have been disappointing due to high revision rates and insufficient pain relief despite of the good implant stability. However, the pain relief and implant survivorship after total hip resurfacing were superior to the results of hemi-resurfacing, although the usages of the total hip resurfacing were for more advanced cases. These results suggest that total hip resurfacing was a more valuable treatment option for active patients with ONFH than hemi-resurfacing

Summary Statement. In young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, crosslinked polyethylene liners and either titanium or tantalum shells. Introduction. Early femoral implant stability is essential to long-term success in total hip replacement. Radiostereometric analysis (RSA) provides precise measurements of micromotion of the stem relative to the femur that are otherwise not detectable by routine radiographs. This study characterised micromotion of a tapered, cementless femoral stem and tantalum porous-coated vs. titanium acetabular shells in combination with highly cross-linked UHMWPE or conventional polyethylene liners using radiostereometric analysis (RSA) for 5 years following THR. Patients and Methods. This IRB-approved, prospective, double randomised, blinded study, involved 46 patients receiving a primary THR by a single surgeon. Each patient was randomised to receive a titanium (23) (Trilogy, Zimmer) or tantalum (23) (Modular Tantalum shell, Zimmer) uncemented hemispheric shell and either a highly-crosslinked or conventional polyethylene liner. Tantalum RSA markers were implanted in each patient. All patients had a Dorr A or B femoral canal and received a cementless, porous-coated titanium tapered stem (M/L Taper, Zimmer). All final femoral broaches were stable to rotational and longitudinal stress. RSA examinations, Harris Hip, UCLA, WOMAC, SF-12 scores were obtained at 10 days, 6 months, and annually through 5 years. Results. All patients demonstrated statistically significant improvement in Harris Hip, WOMAC, and SF-12 PCS scores post-operatively. Evaluation of polyethylene wear demonstrated that median penetration measurements were significantly greater in the conventional compared to the HXPLE liner cohorts at 1 year through 5 years follow-up (p<0.003). At 5 years, conventional liners showed 0.38 ± 0.05mm vertical wear whereas HXLPE liners showed 0.08 ± 0.02mm (p<0.003). Evaluation of the femoral stems demonstrated that the rate of subsidence was highest in the first 6 months (0.09mm/yr), with no other detectable motion through 5 years. Two outlying patients had significantly higher stem subsidence values at 6 months (0.7 mm and 1.0mm). One stem stabilised without further subsidence after 6 months (0.7mm), and the other stem stabilised at 1 year (1.5mm). Neither patient has clinical evidence of loosening. Evaluation of acetabular shells demonstrated less median vertical translation in tantalum than titanium shells at each time-point except at 3-years follow-up, however due to large standard errors, there was no significant difference between the two designs (p>0.05). These large standard errors were predominantly caused by two outliers, neither of which had clinical evidence of loosening. Discussion/Conclusion. In this RSA study of young THR patients, cementless tapered femoral stems, highly crosslinked polyethylene liners, and tantalum or titanium acetabular shells all demonstrated excellent performance through 5 years follow-up. Highly crosslinked polyethylene liners demonstrated significantly less wear than conventional liners. The femoral stem showed excellent stability through 5 years, with no clinical or radiologic episodes of failure. The small amount of micromotion seen is less than that previously reported for similar tapered, cementless stems and approaches the accuracy of RSA (0.05mm). Both acetabular shells demonstrated excellent stability with minimal micromotion at 5 years without significant differences in migration. All patients demonstrated significant clinical improvement in pain and function and additional RSA evaluation of these patients is planned