Do Stem Design and Surgical Approach Influence Early Aseptic Loosening in Cementless THA?

BACKGROUND: Some studies have revealed an increased risk of early aseptic loosening of cementless stems in THA when inserted through an anterior or anterolateral approach compared with a posterior approach, whereas approach does not appear to be a risk factor in others. Stem design, whether "anatomic" (that is, stems with a curved lateral profile or an obtuse angle at the proximal-lateral portion of the stem) or "shoulder" (that is, straight with a proximal shoulder), may also be associated with a differential risk of aseptic loosening in cementless THA depending on the surgical approach used, but if so, this risk is not well characterized. QUESTIONS/PURPOSES: In this national registry study, we investigated the association between surgical approach and early aseptic loosening of (1) cementless femoral stems with a proximal angular shape (shoulder); and (2) anatomically shaped femoral stems. METHODS: The Dutch Arthroplasty Registry is a nationwide population-based register recording data on primary and revision hip arthroplasty. We selected all primary THAs (n = 63,354) with a cementless femoral stem inserted through an anterior, anterolateral, or posterior approach from 2007 to 2013 with a minimal followup of 2 years. Femoral stems were classified as "anatomic," "shoulder," or "other" (that is, not classifiable as anatomic or shoulder). From the 47,372 THAs with an anatomic or shoulder stem (mean followup, 3.5 years; SD, 1.8 years), 340 (0.7%) underwent revision surgery as a result of aseptic loosening of the femoral stem, 1195 (2.5%) were revised for other reasons, and 1558 patients (3.3%) died. We used Cox proportional hazard models to determine hazard ratios for aseptic loosening of anatomic and shoulder stems for the anterolateral and anterior approaches compared with the posterior approach. RESULTS: After controlling for relevant confounding variables such as sex, American Society of Anesthesiologists score, previous surgery, and coating and material of the femoral stem, we found that there was a stem-approach interaction. Separate analysis showed that shoulder stems had a greater likelihood of early aseptic loosening when the anterolateral approach (hazard ratio [HR], 2.28; 95% confidence interval [CI], 1.43-3.63; p < 0.001) or anterior approach (HR, 10.47; 95% CI, 2.55-43.10; p = 0.001) was used compared with the posterior approach. Separate analysis of the anatomic stems yielded no association with approach (anterolateral: HR, 1.07, 95% CI, 0.70-1.63, p = 0.77; anterior: HR, 1.31, 95% CI, 0.91-1.89, p = 0.15). CONCLUSIONS: In THA, cementless femoral stems with a proximal shoulder are associated with early aseptic loosening when inserted through an anterior or anterolateral approach compared with a posterior approach. An anatomically shaped stem may be preferred with these approaches, although further analysis with larger registry volumes should confirm our results, in particular for shouldered stems when implanted through an anterior approach. LEVEL OF EVIDENCE: Level III, therapeutic study.

Flexing and downsizing the femoral component is not detrimental to patellofemoral biomechanics in posterior-referencing cruciate-retaining total knee arthroplasty.

PURPOSE: When downsizing the femoral component to prevent mediolateral overhang, notching of the anterior femoral cortex may occur, which could be solved by flexing the femoral component. In this study, we investigated the effect of flexion of the femoral component on patellar tendon moment arm, patellofemoral forces and kinematics in posterior-referencing CR-TKA. Our hypothesis was that flexion of the femoral component increases the patellar tendon moment arm, reduces the patellofemoral forces and provides stable kinematics. METHODS: A validated musculoskeletal model of CR-TKA was used. The flexion of the femoral component was increased in four steps (0°, 3°, 6°, 9°) using posterior referencing, and different alignments were analysed in combination with three implant sizes (3, 4, 5). A chair-rising trial was analysed using the model, while simultaneously estimating quadriceps muscle force, patellofemoral contact force, tibiofemoral and patellofemoral kinematics. RESULTS: Compared to the reference case (size 4 and 0° flexion), for every 3° of increase in flexion of the femoral component the patellar tendon moment arm increased by 1% at knee extension. The peak quadriceps muscle force and patellofemoral contact force decreased by 2%, the patella shifted 0.8 mm more anteriorly and the remaining kinematics remained stable, with knee flexion. With the smaller size, the patellar tendon moment arm decreased by 6%, the quadriceps muscle force and patellofemoral contact force increased by 8 and 12%, and the patellar shifted 5 mm more posteriorly. Opposite trends were found with the bigger size. CONCLUSION: Flexing the femoral component with posterior referencing reduced the patellofemoral contact forces during a simulated chair-rising trial with a patient-specific musculoskeletal model of CR-TKA. There seems to be little risk when flexing and downsizing the femoral component, compared to when using a bigger size and neutral alignment. These findings provide relevant information to surgeons who wish to prevent anterior notching when downsizing the femoral component.

Anterior referencing of tibial slope in total knee arthroplasty considerably influences knee kinematics: a musculoskeletal simulation study.

PURPOSE: In total knee arthroplasty (TKA), the posterior tibial slope is not always reconstructed correctly, and the knee ligaments may become too tight in flexion. To release a tight flexion gap, surgeons can increase the posterior tibial slope using two surgical resection techniques: the anterior tibial cortex (ACR) or the centre of tibial plateau (CPR) referencing. It is not known how this choice affects the knee laxity and function during activities of daily living. The aim of this study was to investigate the effect of tibial slope on knee laxity, kinematics and forces during a squatting activity using computer simulation techniques. We hypothesised that the effects depend on the referencing technique utilised. METHODS: A validated musculoskeletal model of TKA was used. Knee laxity tests were simulated in flexion and extension. Then, a squat motion was simulated to calculate: movement of the tibiofemoral joint (TFJ) contact points and patello-femoral joint (PFJ) contact force. All analyses were repeated with more anterior (-3°), neutral (0°), and more posterior tibial slope (+3°, +6°, +9°), and with two referencing techniques (ACR, CPR). RESULTS: Knee laxities increased dramatically with more posterior slope with the ACR technique (up to 400%), both in flexion and in extension. The CPR technique, instead, had much smaller effects (up to 42% variations). During squatting, more slope with the ACR technique resulted in larger movements of the TFJ contact point. The PFJ contact force decreased considerably with more slope with the CPR technique (12% body weight reduction every 3° more posterior slope), thanks to the preservation of the patellar height and quadriceps-femur load sharing. CONCLUSION: ACR technique alters considerably the knee laxity, both in flexion and extensions, and surgeons should be cautious about its use. More slope with CPR technique induces more favourable TFJ kinematics and loading of the knee extensor apparatus and does not substantially alter knee laxity. Preferably, the tibial slope resection should be pre-planned thoroughly and performed using CPR technique as accurately as possible. Surgeons can directly translate the results of this study into the clinical practice.

Biomechanical comparison of two different locking plates for open wedge high tibial osteotomy.

BACKGROUND: The purpose of this study was to compare the mechanical stability of a relatively thin locking plate (FlexitSystem implant) with a relatively firm locking plate (TomoFix implant), both used for opening wedge high tibial osteotomy. METHODS: Seven fresh frozen paired human cadaveric tibiae were used. The opening wedge high tibial osteotomies in the left tibiae were fixated with the FlexitSystem implant and in the right tibiae with the TomoFix implant. The tibiae were CT-scanned to determine the bone mineral density. Axial loading was applied in a cyclic fashion for 50,000 cycles. We compared throughout the loading history the relative motions between the proximal and distal tibia using roentgen stereophotogrammetry analysis at set intervals. Also the strength of the reconstructions was compared using a displacement-controlled compressive test until failure. RESULTS: One pair (with the lowest bone mineral density) failed during the preparation of the osteotomy. The FlexitSystem implant displayed a similar stability compared to the TomoFix implant, with low translations (mean 2.16 ± 1.02 mm vs. 4.29 ± 5.66 mm) and rotations (mean 3.17 ± 2.04° vs. 4.30 ± 6.78°), which was not significant different. Although on average the FlexitSystem reconstructions were slightly stronger than the Tomofix reconstructions (mean 4867 ± 944 N vs. 4628 ± 1987 N), no significant (p = 0.71) differences between the two implants were found. CONCLUSION: From a biomechanical point of view, the FlexitSystem implant is a suitable alternative to the TomoFix implant for a high tibial open wedge osteotomy.

Evaluation of a Surrogate Contact Model in Force-Dependent Kinematic Simulations of Total Knee Replacement.

Knowing the forces in the human body is of great clinical interest and musculoskeletal (MS) models are the most commonly used tool to estimate them in vivo. Unfortunately, the process of computing muscle, joint contact, and ligament forces simultaneously is computationally highly demanding. The goal of this study was to develop a fast surrogate model of the tibiofemoral (TF) contact in a total knee replacement (TKR) model and apply it to force-dependent kinematic (FDK) simulations of activities of daily living (ADLs). Multiple domains were populated with sample points from the reference TKR contact model, based on reference simulations and design-of-experiments. Artificial neural networks (ANN) learned the relationship between TF pose and loads from the medial and lateral sides of the TKR implant. Normal and right-turn gait, rising-from-a-chair, and a squat were simulated using both surrogate and reference contact models. Compared to the reference contact model, the surrogate contact model predicted TF forces with a root-mean-square error (RMSE) lower than 10 N and TF moments lower than 0.3 N·m over all simulated activities. Secondary knee kinematics were predicted with RMSE lower than 0.2 mm and 0.2 deg. Simulations that used the surrogate contact model ran on average three times faster than those using the reference model, allowing the simulation of a full gait cycle in 4.5 min. This modeling approach proved fast and accurate enough to perform extensive parametric analyses, such as simulating subject-specific variations and surgical-related factors in TKR.

Development of a fast curing tissue adhesive for meniscus tear repair.

Isocyanate-terminated adhesive amphiphilic block copolymers are attractive materials to treat meniscus tears due to their tuneable mechanical properties and good adhesive characteristics. However, a drawback of this class of materials is their relatively long curing time. In this study, we evaluate the use of an amine cross-linker and addition of catalysts as two strategies to accelerate the curing rates of a recently developed biodegradable reactive isocyanate-terminated hyper-branched adhesive block copolymer prepared from polyethylene glycol (PEG), trimethylene carbonate, citric acid and hexamethylene diisocyanate. The curing kinetics of the hyper-branched adhesive alone and in combination with different concentrations of spermidine solutions, and after addition of 2,2-dimorpholinodiethylether (DMDEE) or 1,4-diazabicyclo [2.2.2] octane (DABCO) were determined using FTIR. Additionally, lap-shear adhesion tests using all compositions at various time points were performed. The two most promising compositions of the fast curing adhesives were evaluated in a meniscus bucket handle lesion model and their performance was compared with that of fibrin glue. The results showed that addition of both spermidine and catalysts to the adhesive copolymer can accelerate the curing rate and that firm adhesion can already be achieved after 2 h. The adhesive strength to meniscus tissue of 3.2-3.7 N was considerably higher for the newly developed compositions than for fibrin glue (0.3 N). The proposed combination of an adhesive component and a cross-linking component or catalyst is a promising way to accelerate curing rates of isocyanate-terminated tissue adhesives.

Tibial component with and without stem extension in a trabecular metal cone construct.

PURPOSE: The purpose of this study was to investigate stability and strain distribution of a tibial plateau reconstruction with a trabecular metal cone while the tibial component is implanted with and without a stem, and whether prosthetic stability was influenced by bone mineral density. Trabecular metal cones are designed to fill up major bone defects in total knee arthroplasty. Tibial components can be implanted in combination with a stem, but it is unclear whether this is necessary after reconstruction with a trabecular metal cone. Implanting a stem can give extra stability, but may have negative side effects. METHODS: Tibial revision arthroplasties with trabecular metal cones were performed after reconstruction of a 2B bone defect according to the Anderson Orthopedic Research Institute classification. Components were implanted in seven pairs of cadaveric tibiae; one tibia of each pair was implanted with stem and the other without. All specimens were loaded to one bodyweight alternating between the medial and lateral tibial component. Implant-bone micro-motions, bone strains, bone mineral density and correlations were measured and/or calculated. RESULTS: Tibial components without a stem showed only more varus tilt [difference in median 0.14° (P < 0.05)], but this was not considered clinically relevant. Strain distribution did not differ. Bone mineral density only had an effect on the anterior/posterior tilt [ρ: -0.72 (P < 0.01)]. CONCLUSION: Tibial components, with or without a stem, which are implanted after reconstruction of major bone defects using trabecular metal cones produce very similar biomechanical conditions in terms of stability and strain distribution. If in vivo studies confirm that a stem extension is not mandatory, orthopaedic surgeons can decide not to implant a stem. LEVEL OF EVIDENCE: II.

The effect of surface morphology on the primary fixation strength of uncemented femoral knee prosthesis: a cadaveric study.

We investigated the effect of surface morphology on the mechanical performance of uncemented femoral knee prosthesis. Eighteen implants were implanted on nine paired femurs and then pushed-off (left legs: a novel surface morphology; right legs: Porocoat as baseline). Bone mineral density (BMD) and anteroposterior dimension were not significantly different between groups. The insertion force was not significantly different, however, the loosening force was significantly higher in the novel group (P=0.007). BMD had a direct relationship with the insertion and loosening force (P<0.001). The effect of surface morphology on implant alignment was very small. We conclude that the surface properties create a higher frictional resistance, thereby providing a better inherent stability of implants featuring the novel surface morphology.

The effect of periprosthetic bone loss on the failure risk of tibial total knee arthroplasty.

The effect of long-term periprosthetic bone loss on the process of aseptic loosening of tibial total knee arthroplasty (TKA) is subject to debate. Contradicting studies can be found in literature, reporting either bone resorption or bone formation before failure of the tibial tray. The aim of the current study was to investigate the effects of bone resorption on failure of tibial TKA, by simulating clinical postoperative bone density changes in finite element analysis (FEA) models and FEA models were created of two tibiae representing cases with good and poor initial bone quality which were subjected to a walking configuration and subsequently to a traumatic stumbling load. Bone failure was simulated using a crushable foam model incorporating progressive yielding. Repetitive loading under a level walking load did not result in failure of the periprosthetic bone in neither the good nor poor bone quality tibia at the baseline bone densities. When applying a stumble load, a collapse of the tibial reconstruction was noticed in the poor bone quality model. Incorporating postoperative bone loss led to a significant increase of the failure risk, particularly for the poor bone quality model in which subsidence of the tibial component was substantial. Our results suggest bone loss can lead to an increased risk of a collapse of the tibial component, particularly in case of poor bone quality at the time of surgery. The study also examined the probability of medial or lateral subsidence of the implant and aimed to improve clinical implications. The FEA model simulated plastic deformation of the bone and implant subsidence, with further validation required via mechanical experiments.

Quantification of long-term nonlinear stress relaxation of bovine trabecular bone.

The reliability of computational models in orthopedic biomechanics depends often on the accuracy of the bone material properties. It is widely recognized that the mechanical response of trabecular bone is time-dependent, yet it is often ignored for the sake of simplicity. Previous investigations into the viscoelastic properties of trabecular bone have not explored the relationship between nonlinear stress relaxation and bone mineral density. The inclusion of this behavior could enhance the accuracy of simulations of orthopedic interventions, such as of primary fixation of implants. Although methods to quantify the viscoelastic behavior are known, the time period during which the viscoelastic properties should be investigated to obtain reliable predictions is currently unclear. Therefore, this study aimed to: 1) Investigate the duration of stress relaxation in bovine trabecular bone; 2) construct a material model that describes the nonlinear viscoelastic behavior of uniaxial stress relaxation experiments on trabecular bone; and 3) implement bone density into this model. Uniaxial compressive stress relaxation experiments were performed with cylindrical bovine femoral trabecular bone samples (n = 16) with constant strain held for 24 h. Additionally, multiple stress relaxation experiments with four ascending strain levels with a holding time of 30 min, based on the results of the 24-h experiment, were executed on 18 bovine bone cores. The bone specimens used in this study had a mean diameter of 12.80 mm and a mean height of 28.70 mm. A Schapery and a Superposition model were used to capture the nonlinear stress relaxation behavior in terms of applied strain level and bone mineral density. While most stress relaxation happened in the first 10 min (up to 53 %) after initial compression, the stress relaxation continued even after 24 h. Up to 69 % of stress relaxation was observed at 24 h. Extrapolating the results of 30 min of experimental data to 24 h provided a good fit for accuracy with much improved experimental efficiency. The Schapery and Superposition model were both capable of fitting the repeated stress relaxation in a sample-by-sample approach. However, since bone mineral density did not influence the time-dependent behavior, only the Superposition model could be used for a group-based model fit. Although the sample-by-sample approach was more accurate for an individual specimen, the group based approach is considered a useful model for general application.

The effect of coating characteristics on implant-bone interface mechanics.

Successful osseointegration of press-fit implants depends on the initial stability, often measured by the micromotions between the implant and bone. A good primary stability can be achieved by optimizing the compressive and frictional forces acting at the bone-implant interface. The frictional properties of the implant-bone interface, which depend on the roughness and porosity of the implant surface coating, can affect the primary stability. Several reversible (elastic) and non-reversible (permanent) deformation processes take place during frictional loading of the implant-bone interface. In case of a rough coating, the asperities of the implant surface are compressed into the bone leading to mechanical interlocking. To optimize fixation of orthopaedic implants it is crucial to understand these complex interactions between coating and bone. The objective of the current study was to gain more insight into the reversible and non-reversible processes acting at the implant-bone interface. Tribological experiments were performed with two types of porous coatings against human cadaveric bone. The results indicated that the coefficient of friction depended on the coating roughness (0.86, 0.95, and 0.45 for an Ra roughness of 41.2, 53.0, and a polished surface, respectively). Larger elastic and permanent displacements were found for the rougher coating, resulting in a lower interface stiffness. The experiments furthermore revealed that relative displacements of up to 35 µm can occur without sliding at the interface. These findings have implications for micromotion thresholds that currently are assumed for osseointegration, and suggest that bone ingrowth actually occurs in the absence of relative sliding at the implant-bone interface.

The primary stability of a cementless PEEK femoral component is sensitive to BMI: A population-based FE study.

The use of polyetheretherketone (PEEK) for cementless femoral total knee arthroplasty (TKA) components is of interest due to several potential advantages, e.g. the use in patients with metal hypersensitivity. Additionally, the stiffness of PEEK closer resembles the stiffness of bone, and therefore, peri-prosthetic stress-shielding may be avoided. When introducing a new implant material for cementless TKA designs, it is important to study its effect on the primary fixation, which is required for the long-term fixation. Finite element (FE) studies can be used to study the effect of PEEK as implant material on the primary fixation, which may be dependent on patient factors such as age, gender and body weight index (BMI). Therefore, the research objectives of this study were to investigate the effect of PEEK vs cobalt-chrome (CoCr) and patient characteristics on the primary fixation of a cementless femoral component. 280 FE models of 70 femora were created with varying implant material and gait and squat activity. Overall, the PEEK models generated larger peak micromotions than the CoCr models. Distinct differences were seen in the micromotion distributions between the PEEK and CoCr models for both the gait and squat models. The micromotions of all femoral models significantly increased with BMI. Neither gender nor age of the patients had a significant effect on the micromotions. This population study gives insights into the primary fixation of a cementless femoral component in a cohort of FE models with varying implant material and patient characteristics.

The Effect of Patient-Related Factors on the Primary Fixation of PEEK and Titanium Tibial Components: A Population-Based FE Study.

Polyetheretherketone (PEEK) is of interest as implant material for cementless tibial total knee arthroplasty (TKA) components due to its potential advantages. One main advantage is that the stiffness of PEEK closely resembles the stiffness of bone, potentially avoiding peri-prosthetic stress-shielding. When introducing a new implant material for cementless TKA designs, it is essential to study its effect on the primary fixation. The primary fixation may be influenced by patient factors such as age, gender, and body mass index (BMI). Therefore, the research objectives of this finite element (FE) study were to investigate the effect of material (PEEK vs. titanium) and patient characteristics on the primary fixation (i.e., micromotions) of a cementless tibial tray component. A total of 296 FE models of 74 tibiae were created with either PEEK or titanium material properties, under gait and squat loading conditions. Overall, the PEEK models generated larger peak micromotions than the titanium models. Differences were seen in the micromotion distributions between the PEEK and titanium models for both the gait and squat models. The micromotions of all tibial models significantly increased with BMI, while gender and age did not influence micromotions.

The sensitivity of the stiffness and thickness of a titanium inlay in a cementless PEEK femoral component to the micromotions and bone strain energy density.

Polyetheretherketone (PEEK) has been proposed as alternative material for total knee arthroplasty implants due to its low stiffness, which may reduce stress-shielding. In cementless fixation, a proper primary fixation is required for long-term fixation. Previous research showed that the lower stiffness of a cementless PEEK femoral component results in larger micromotions at the implant-bone interface compared to a cobalt-chrome femoral component. A titanium inlay on the PEEK implant surface may improve the primary fixation while maintaining the favourable stiffness properties. Therefore, the effect of thickness and stiffness of a titanium inlay on the primary fixation and stress-shielding was investigated. A finite element model of the femur and femoral component was created with five titanium inlay variants. The micromotions and strain energy density (SED) were quantified as outcome measures. The distal thin - proximal thick variant showed the largest resulting micromotions (51.2 µm). Relative to the all-PEEK femoral component, the addition of a titanium inlay reduced the micromotions with 30 % to 40 % without considerably affecting the stress-shielding capacity (strain energy difference of 6 % to 10 %). Differences in micromotions (43.0-51.2 µm) and SED between the variants were relatively small. In conclusion, the addition of a titanium inlay could lead to a reduction of the micromotions without substantially affecting the SED distribution.

The application of an isotropic crushable foam model to predict the femoral fracture risk.

For biomechanical simulations of orthopaedic interventions, it is imperative to implement a material model that can realistically reproduce the nonlinear behavior of the bone structure. However, a proper material model that adequately combines the trabecular and cortical bone response is not yet widely identified. The current paper aims to investigate the possibility of using an isotropic crushable foam (ICF) model dependent on local bone mineral density (BMD) for simulating the femoral fracture risk. The elastoplastic properties of fifty-nine human femoral trabecular cadaveric bone samples were determined and combined with existing cortical bone properties to characterize two forms of the ICF model, a continuous and discontinuous model. Subsequently, the appropriateness of this combined material model was evaluated by simulating femoral fracture experiments, and a comparison with earlier published results of a softening Von-Mises (sVM) material model was made. The obtained mechanical properties of the trabecular bone specimens were comparable to previous findings. Furthermore, the ultimate failure load predicted by the simulations of femoral fractures was on average 79% and 90% for the continuous and discontinuous forms of the ICF model and 82% of the experimental value for the sVM material model. Also, the fracture locations predicted by ICF models were comparable to the experiments. In conclusion, a nonlinear material model dependent on BMD was characterized for human femoral bone. Our findings indicate that the ICF model could predict the femoral bone strength and reproduce the variable fracture locations in the experiments.

Length Changes of the Medial Patellofemoral Ligament During In Vivo Knee Motion: An Evaluation Using Dynamic Computed Tomography.

BACKGROUND: Medial patellofemoral ligament (MPFL) reconstruction is associated with high complication rates because of graft overloading from incorrect graft positioning. To improve clinical outcomes, it is crucial to gain a better understanding of MPFL elongation patterns. PURPOSE: To assess MPFL length changes in healthy knees from 0° to 90° of dynamic flexion and their relationship with anatomic parameters of the patellofemoral joint. STUDY DESIGN: Descriptive laboratory study. METHODS: Dynamic computed tomography scans of an active flexion-extension-flexion movement in 115 knees from 63 healthy participants were evaluated to construct knee joint models. Using these models, the MPFL length was measured as the shortest wrapping path from the Schöttle point on the femur to 3 insertion points on the superomedial border of the patella (proximal, central, and distal). MPFL length changes (%) relative to the length in full extension were calculated, and their correlations with the tibial tuberosity-trochlear groove distance, Caton-Deschamps index, and lateral trochlear inclination were analyzed. RESULTS: The proximal fiber was the longest in full extension and progressively decreased to a median length of -6.0% at 90° of flexion. The central fiber exhibited the most isometric pattern during knee flexion, showing a median maximal decrease of 2.8% relative to the full extension length and no evident elongation. The distal fiber first slightly decreased in length but increased at deeper flexion angles. The median overall length changes were 4.6, 4.7, and 5.7 mm for the proximal, central, and distal patellar insertion, respectively. These values were either not or very weakly correlated with the tibial tuberosity-trochlear groove distance, Caton-Deschamps index, and lateral trochlear inclination when the anatomic parameters were within the healthy range. CONCLUSION: The median MPFL length changed by approximately 5 mm between 0° and 90° of flexion. Proximally, the length continuously decreased, indicating slackening behavior. Distally, the length increased at deeper flexion angles, indicating tightening behavior. CLINICAL RELEVANCE: In MPFL reconstruction techniques utilizing the Schöttle point to establish the femoral insertion, one should avoid distal patellar insertion, as it causes elongation of the ligament, which may increase the risk for complications due to overloading.

Fully automatic extraction of knee kinematics from dynamic CT imaging; normative tibiofemoral and patellofemoral kinematics of 100 healthy volunteers.

BACKGROUND: Accurate assessment of knee kinematics is important in the diagnosis and quantification of knee disorders and to determine the effect of orthopaedic interventions. Despite previous studies showing the usefulness of dynamic imaging and providing valuable insights in knee kinematics, dynamic imaging is not widely used in clinics due to a variety of causes. In this study normative knee kinematics of 100 healthy subjects is established using a fully automatic workflow feasible for use in the clinic. METHODS: One-hundred volunteers were recruited and a dynamic CT scan was made during a flexion extension movement. Image data was automatically segmented and dynamic and static images were superimposed using image registration. Coordinate systems for the femur, patella and tibia were automatically calculated as well as their dynamic position and orientation. RESULTS: Dynamic CT scans weremade withan effective radiation dose of 0.08 mSv. The median tibial internal rotation was 4° and valgus rotation is 5° at full flexion. Femoral rollback of the lateral condyle was 7 mm versus 2 mm of the medial condyle. The median patella flexion reached 65% of tibiofemoral flexion and the median tilt and rotation were 5° and 0° at full flexion, respectively. The median mediolateral translation of the patella was 3 mm (medially) in the first 30° of flexion. CONCLUSION: The current study presents TF and PF kinematic data of 97 healthy individuals, providing a unique dataset of normative knee kinematics. The short scanning time, simple motion and, automatic analysis make the methods presented suitable for daily clinical practice.

The accuracy of navigated versus freehand curettage in bone tumors: a cadaveric model study.

PURPOSE: Navigation has been suggested to guide complex benign bone tumor curettage procedures, but the contribution of navigation to the accuracy of curettage has never been quantified. We explored the accuracy of navigated curettage in a cadaveric observational pilot study, comparing navigated to freehand curettage, performed independently by an expert and a novice user. METHODS: The expert performed curettage on 20 cadaveric bones prepared with a paraffin wax mixture tumor, 10 freehand and 10 navigated. We re-used 12 bones for the novice experiments, 6 freehand and 6 navigated. Tumor and curettage cavity volumes were segmented on pre- and post-cone-beam CT scans. Accuracy was quantified using the Dice Similarity Coefficient (DSC), and with remaining tumor volume, bone curettage volume, maximal remaining width and procedure times compared between navigation and freehand groups for both users. RESULTS: There were little differences in curettage accuracy between a navigated (DSC 0.59[0.17]) and freehand (DSC 0.64[0.10]) approach for an expert user, but there were for a novice user with DSC 0.67(0.14) and 0.83(0.06), respectively. All navigated and freehand procedures had some amount of remaining tumor, generally located in a few isolated spots with means of 2.2(2.6) cm3 (mean 20% of the tumor volume) and 1.5(1.4) cm3 (18%), respectively, for the expert and more diffusely spaced with means of 5.1(2.8) cm3 (33%) and 3.0(2.2) cm3 (17%), respectively, for the novice. CONCLUSIONS: In an explorative study on 20 cadaveric bone tumor models, navigated curettage in its current setup was not more accurate than freehand curettage. The amount of remaining tumor, however, confirms that curettage could be further improved. The novice user was less accurate using navigation than freehand, which could be explained by the learning curve. Furthermore, the expert used a different surgical approach than the novice, focusing more on removing the entire tumor than sparing surrounding bone.

1st EFORT European Consensus "Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices": Background, Delphi Methodology & Consensus process.

The objectives of the 1st EFORT European Consensus on 'Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices' were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745. Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 'Introduction of Innovation' recommendations and a related survey. A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements. A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge. The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities. For the first time, initiated by the EFORT IPSI (WG1 'Introduction of Innovation'), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.

Interface micromechanics of transverse sections from retrieved cemented hip reconstructions: an experimental and finite element comparison.

In finite element analysis (FEA) models of cemented hip reconstructions, it is crucial to include the cement-bone interface mechanics. Recently, a micromechanical cohesive model was generated which reproduces the behavior of the cement-bone interface. The goal was to investigate whether this cohesive model was directly applicable on a macro level. From transverse sections of retrieved cemented hip reconstructions, two FEA-models were generated. The cement-bone interface was modeled with cohesive elements. A torque was applied and the cement-bone interface micromotions, global stiffness and stem translation were monitored. A sensitivity analysis was performed to investigate whether the cohesive model could be improved. All results were compared with experimental findings. That the original cohesive model resulted in a too compliant macromechanical response; the motions were too large and the global stiffness too small. When the cohesive model was modified, the match with the experimental response improved considerably.