Introduction. Dislocation continues to be a common complication of total hip arthroplasty (THA). Many factors affect the prevalence of dislocation after THA, including soft tissue laxity, surgical approach, component position, patient factors, and component design [1]. Achieving proper intraoperative soft tissue tension is one of the surgical goals to reduce the risk of the dislocation. However, reports of the intraoperative soft tissue tension measurements have not been enough yet. One way to quantify the intraoperative soft tissue tension is to measure joint forces using an instrumented prosthesis. Hence, we have developed a sensor-instrumented modular femoral head of THA to measure the soft-tissue tension intraoperatively. The goal of this study was to design and calibrate the sensor. Materials and Methods. The sensor-instrumented modular femoral head that we developed was made of polycarbonate with four linear strain gauges (BTM-1C, Tokyo Sokki Kenkyujo Co., Ltd., JP). To fabricate the sensor, four penetrant holes (1.6 millimeter in diameter), parallel to the coordinate axes were produced (Fig1). The strain gauges were embedded on inside wall of these holes. Finally, the holes were filled by epoxy resin (A-2 adhesive, Tokyo Sokki Kenkyujo Co., Ltd., JP). For calibration study, the sensor was fixed in a clamping block of an angle vice to permit change of force directions. The calibration jig with the angle vice was placed on top of a low-friction x-y translation table that eliminated horizontal constrains. Known forces (F. i. ) were applied by a standard material testing machine (Instron4204, INSTRON, Norwood, MA) through a polyethylene insert (Fig. 2). Two different series of forces were applied. One is that force values were increased from zero to 600 N on the z axis. And the other force pattern is 600 N forces were applied by changing force angles. The external force vector (F. i. ) can be expressed in terms of the strain gauge outputs as follows:. F. i. = T S. i. where T is a calibration matrix and S. i. corresponds to the outputs of the strain gauges. Calibration errors were calculated according to well-established methods [2]. Results. When the loads were applied on the z axis, the output strains of ε1 showed increases with increase of the force values (Fig.3). A coefficient of determination of least square linear regression between εz and the force values was 0.86. When the cone angle was decreased from 90˚ in the x-z plane, εz decreased and εx increased concurrently (Fig.4). The average absolute error of the force was 23.9%. Discussion. This device was connected to a data logger with wires. In order to remove these wires to diminish the risk of infection, we will use wireless system (nRF24LE1, Nordic Semiconductor, Inc., Norway). Although the calibration matrix and the errors were acquired, the error value was not good enough to calculate the applied forces yet. With more calibration results and wireless system, this system will be useful to permit optimized intraoperative soft tissue tension

Intraoperative planning of knee replacement components, targeting a desired functional outcome, requires a calibrated patient-specific model of the patient's soft-tissue anatomy and mechanics. Previously, a surgical technique was demonstrated for measuring knee joint kinematics and kinetics consistent with modern navigation systems in conjunction with the development of a patient-customizable knee model. A data efficient approach for the model calibration task was achieved utilizing the sensitivity of the model to simulated clinical hand manipulations of the knee joint requiring 85% less computations. For this numerical investigation a simplified knee joint model, based on the OpenKnee repository, consisting of bone (rigid), cruciate ligaments (single-bundle, nonlinear spring), collateral ligaments (multiple nonlinear springs), articular cartilage (rigid, pressure-over-closure relationship), and combined capsule/meniscus (linear springs) was created using a custom Matlab (MathWorks)-Abaqus (Dassault Systèmes) implicit finite element modeling framework (Figure 1). A sensitivity analysis was performed by applying constant loading along the anterior-posterior, medial-lateral, varus-valgus, and internal-external directions (30 N for forces and 3 Nm for moments) while perturbing each customizable parameter positively and negatively by 1 mm at 0, 25, 50, 75 and 100 degrees of flexion. A constant load of 150 N was maintained in compression. The change in static endpoint position was measured relative to the respective position without perturbation. Sensitivity results were then arranged by load direction and principal component analysis was subsequently performed (Table 1). First a single optimization task was simulated including all model parameters and all loading sequences with the goal of minimizing the kinematic differences between the reference model and a perturbed model (Figure 2). Second, a piecewise optimization task was designed using only the sensitive parameters for a spanning set of loads for the same perturbed model. Parameters 3 and 4 were tuned using internal and external endpoints. Then parameters 1 and 5 were tuned using the anterior endpoints. Similarly, parameters 2 and 7 were tuned using the posterior endpoints. Finally, parameter 8 was tuned using the varus endpoints. All loadings were observed to be insensitive to parameter 6 (ACL-Y). The number of model evaluations required were 2520 and 390 for the single and piecewise optimizations, respectively. The single simulation task recovered all parameters within 0.57 mm on average compared to 0.64 mm on average for the piecewise task. Kinematic errors due to the calibration technique were within 0.001 mm and 0.18 deg compared to 0.001 mm and 0.04 deg. Computational cost for the optimization task required to calibrate a patient-specific knee model was reduced while maintaining clinically relevant accuracy. This model reduction approach will further enable the rapid adoption of the technology for intraoperative planning of knee replacement components based on targeted functional outcomes

Several different algorithms attempt to estimate life expectancy for patients with metastatic spine disease. The Skeletal Oncology Research Group (SORG) has recently developed a nomogram to estimate survival of patients with metastatic spine disease. Whilst the use of the SORG nomogram has been validated in the international context, there has been no study to date that validates the use of the SORG nomogram in New Zealand. This study aimed to validate the use of the SORG nomogram in Aotearoa New Zealand. We collected data on 100 patients who presented to Waikato Hospital with a diagnosis of spinal metastatic disease. The SORG nomogram gave survival probabilities for each patient at each time point. Receiver Operating Characteristic (ROC) Area Under Curve (AUC) analysis was performed to assess the predictive accuracy of the SORG score. A calibration curve was also performed, and Brier scores calculated. A multivariate Cox regression analysis was performed. The SORG score was correlated with 30 day (AUC = 0.72) and 90-day mortality (AUC = 0.71). The correlation between the SORG score and 90-day mortality was weaker (AUC = 0.69). Using this method, the nomogram was correct for 79 (79%) patients at 30-days, 59 patients (59%) at 90-days, and 42 patients (42%) at 365-days. Calibration curves demonstrated poor forecasting of the SORG nomogram at 30 (Brier score = 0.65) and 365 days (Brier score = 0.33). The calibration curve demonstrated borderline forecasting of the SORG nomogram at 90 days (Brier score = 0.28). Several components of the SORG nomogram were not found to be correlated with mortality. In this New Zealand cohort the SORG nomogram demonstrated only acceptable discrimination at best in predicting life 30-, 90- or 356-day mortality in patients with metastatic spinal disease

Approximately 20% of patients feel unsatisfied 12 months after primary total knee arthroplasty (TKA). Current predictive tools for TKA focus on the clinician as the intended user rather than the patient. The aim of this study is to develop a tool that can be used by patients without clinician assistance, to predict health-related quality of life (HRQoL) outcomes 12 months after total knee arthroplasty (TKA). All patients with primary TKAs for osteoarthritis between 2012 and 2019 at a tertiary institutional registry were analysed. The predictive outcome was improvement in Veterans-RAND 12 utility score at 12 months after surgery. Potential predictors included patient demographics, co-morbidities, and patient reported outcome scores at baseline. Logistic regression and three machine learning algorithms were used. Models were evaluated using both discrimination and calibration metrics. Predictive outcomes were categorised into deciles from 1 being the least likely to improve to 10 being the most likely to improve. 3703 eligible patients were included in the analysis. The logistic regression model performed the best in out-of-sample evaluation for both discrimination (AUC = 0.712) and calibration (gradient = 1.176, intercept = -0.116, Brier score = 0.201) metrics. Machine learning algorithms were not superior to logistic regression in any performance metric. Patients in the lowest decile (1) had a 29% probability for improvement and patients in the highest decile (10) had an 86% probability for improvement. Logistic regression outperformed machine learning algorithms in this study. The final model performed well enough with calibration metrics to accurately predict improvement after TKA using deciles. An ongoing randomised controlled trial (ACTRN12622000072718) is evaluating the effect of this tool on patient willingness for surgery. Full results of this trial are expected to be available by April 2023. A free-to-use online version of the tool is available at . smartchoice.org.au.

External validation of machine learning predictive models is achieved through evaluation of model performance on different groups of patients than were used for algorithm development. This important step is uncommonly performed, inhibiting clinical translation of newly developed models. Recently, machine learning was used to develop a tool that can quantify revision risk for a patient undergoing primary anterior cruciate ligament (ACL) reconstruction (https://swastvedt.shinyapps.io/calculator_rev/). The source of data included nearly 25,000 patients with primary ACL reconstruction recorded in the Norwegian Knee Ligament Register (NKLR). The result was a well-calibrated tool capable of predicting revision risk one, two, and five years after primary ACL reconstruction with moderate accuracy. The purpose of this study was to determine the external validity of the NKLR model by assessing algorithm performance when applied to patients from the Danish Knee Ligament Registry (DKLR). The primary outcome measure of the NKLR model was probability of revision ACL reconstruction within 1, 2, and/or 5 years. For the index study, 24 total predictor variables in the NKLR were included and the models eliminated variables which did not significantly improve prediction ability - without sacrificing accuracy. The result was a well calibrated algorithm developed using the Cox Lasso model that only required five variables (out of the original 24) for outcome prediction. For this external validation study, all DKLR patients with complete data for the five variables required for NKLR prediction were included. The five variables were: graft choice, femur fixation device, Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life subscale score at surgery, years from injury to surgery, and age at surgery. Predicted revision probabilities were calculated for all DKLR patients. The model performance was assessed using the same metrics as the NKLR study: concordance and calibration. In total, 10,922 DKLR patients were included for analysis. Average follow-up time or time-to-revision was 8.4 (±4.3) years and overall revision rate was 6.9%. Surgical technique trends (i.e., graft choice and fixation devices) and injury characteristics (i.e., concomitant meniscus and cartilage pathology) were dissimilar between registries. The model produced similar concordance when applied to the DKLR population compared to the original NKLR test data (DKLR: 0.68; NKLR: 0.68-0.69). Calibration was poorer for the DKLR population at one and five years post primary surgery but similar to the NKLR at two years. The NKLR machine learning algorithm demonstrated similar performance when applied to patients from the DKLR, suggesting that it is valid for application outside of the initial patient population. This represents the first machine learning model for predicting revision ACL reconstruction that has been externally validated. Clinicians can use this in-clinic calculator to estimate revision risk at a patient specific level when discussing outcome expectations pre-operatively. While encouraging, it should be noted that the performance of the model on patients undergoing ACL reconstruction outside of Scandinavia remains unknown

The Step Holter is a software and mobile application that can be used to easily study gait analysis. The application can be downloaded for free on the App Store and Google Play Store for iOS and Android devices. The software can detect with an easy calibration the three planes to detect the movement of the gait. Before proceeding with the calibration, the smartphone can be placed and fixed with a band or stowed into a long sock with its top edge at the height of the joint line, in the medial side of the tibia. The calibration consists in bending the knee about 20 to 30 degrees and then making a rotation movement, leaving the heel fixed to the ground as a rotation fulcrum. After calibration, the program records data related to lateral flexion, rotation, and bending of the leg. This data can be viewed directly from the smartphone screen or transmitted via a web link to the Step Holter web page . www.stepholter.com. by scanning a personal QR code. The web page allows the users to monitor the test during its execution or view data for tests done previously. By pressing the play button, it is possible to see a simulation of the patient's leg and its movement. With the analyze button, the program is capable of calculating the swing and stance phase of every single step, providing a plot with time and percentages. Finally, with the Get Excel button, test data can be conveniently exported for more in-depth research. The advantage of this application is not only to reduce the costs of a machine for the study of gait analysis but also being able to perform tests quickly, without expensive hardware or software and be used in specific spaces, without specialized personnel. Furthermore, the application can collect important data concerning rotation that cannot be highlighted with the classic gait analysis. The versatility of a smartphone allows tests to be carried out not only during walking but also by climbing or descending stairs or sitting down or getting up from a chair. This software offers the possibility to easily study any kind of patients; Older patients, reluctant to leave their homes for a gait analysis can be tested at home or during an office control visit. Step Holter could be one small step for patients, one giant leap for gait study simplicity. For any figures or tables, please contact authors directly

Aim. Antibiotic concentration at the infected site is a relevant information to gain knowledge about deep-seated infections. The combination of antibiotic therapy and debridement is often indicated to treat these infections. At University Hospital Basel the most frequently administered antibiotic before debridement is amoxicillin in combination with clavulanic acid. Amoxicillin is a fragile beta-lactam antibiotic that brings multiple challenges for its quantification. As for many sample materials only little material is available, the aim of this work was to establish a sensitive and reliable quantification method for amoxicillin that only requires a small sample mass. We did not quantify clavulanic acid as we focused on the drug with antibiotic action. Method. Usually discarded sample material during debridement was collected and directly frozen. The thawed tissues were prepared using simple protein precipitation and manual homogenization with micro pestles followed by a matrix cleanup with online solid-phase extraction. Separation was performed by HPLC followed by heated electrospray ionization and tandem mass spectrometry. Results. During method development, amoxicillin showed partial formation of a covalent methanol adduct when performing protein precipitation. Furthermore, multiple in-source products of amoxicillin during ionization could be observed. Adding an aqueous buffer to the samples before protein precipitation and summing up the signals of amoxicillin and its in-source acetonitrile-sodium-adduct led to successful method validation for a calibration range of 1–51 mg/kg using 10 mg of each tissue sample. The imprecision was < 8% over the entire concentration range and the bias was ≤ 10 %. The quantitative matrix effect was < 6 % in six different tissue samples. Until now we measured amoxicillin in samples from nine patients with prosthetic joint infection, bursitis, or an abscess who obtained amoxicillin between 5 hours and 15 minutes before sampling and found concentrations between 1.4 and 35 mg/kg. Conclusions. With this method, we developed a fast, simple, and sensitive quantification assay for amoxicillin in tissue samples with little material that can now be applied to different study samples

Aim. Recurrence of bone and joint infection, despite appropriate therapy, is well recognised and stimulates ongoing interest in identifying host factors that predict infection recurrence. Clinical prediction models exist for those treated with DAIR, but to date no models with a low risk of bias predict orthopaedic infection recurrence for people with surgically excised infection and removed metalwork. The aims of this study were to construct and internally validate a risk prediction model for infection recurrence at 12 months, and to identify factors that predict recurrence. Predictive factors must be easy to check in pre-operative assessment and relevant across patient groups. Methods. Four prospectively collected datasets including 1173 participants treated in European centres between 2003 and 2021, followed up to 12 months after surgery for orthopaedic infections, were included in logistic regression modelling [1–3]. The definition of infection recurrence was identical and ascertained separately from baseline factors in three contributing cohorts. Eight predictive factors were investigated following a priori sample size calculation: age, gender, BMI, ASA score, the number of prior operations, immunosuppressive medication, glycosylated haemoglobin (HbA1c), and smoking. Missing data, including systematically missing predictors, were imputed using Multiple Imputation by Chained Equations. Weekly alcohol intake was not included in modelling due to low inter-observer reliability (mean reported intake 12 units per week, 95% CI for mean inter-rater error −16.0 to +15.4 units per week). Results. Participants were 64% male, with a median age of 60 years (range 18–95). 86% of participants had lower limb orthopaedic infections. 732 participants were treated for osteomyelitis, including FRI, and 432 for PJI. 16% of participants experienced treatment failure by 12 months. The full prediction model had moderate apparent discrimination: AUROC (C statistic) 0.67, Brier score 0.13, and reasonable apparent calibration. Of the predictors of interest, associations with failure were seen with prior operations at the same anatomical site (odds ratio for failure 1.51 for each additional prior surgery; 95% CI 1.02 to 2.22, p=0.06), and the current use of immunosuppressive medications (odds ratio for failure 2.94; 95% CI 0.89 to 9.77, p=0.08). Conclusions. This association between number of prior surgeries and treatment failure supports the urgent need to streamline referral pathways for people with orthopaedic infection to specialist multidisciplinary units

Pain and disability following wrist trauma are highly prevalent, however the mechanisms underlying painare highly unknown. Recent studies in the knee have demonstrated that altered joint contact may induce changes to the subchondral bone density and associated pain following trauma, due to the vascularity of the subchondral bone. In order to examine these changes, a depth-specific imaging technique using quantitative computed tomography (QCT) has been used. We've demonstrated the utility of QCT in measuring vBMD according to static jointcontact and found differences invBMD between healthy and previously injured wrists. However, analyzing a static joint in a neutral position is not necessarily indicative of higher or lower vBMD. Therefore, the purposeof this study is to explore the relationship between subchondral vBMDand kinematic joint contact using the same imaging technique. To demonstrate the relationship between kinematic joint contact and subchondral vBMDusing QCT, we analyzed the wrists of n = 10 participants (n = 5 healthy and n = 5 with previous wrist trauma). Participantsunderwent 4DCT scans while performing flexion to extension to estimate radiocarpal (specifically the radiolunate (RL) and radioscaphoid (RS)) joint contact area (JCa) between the articulating surfaces. The participantsalso underwent a static CT scan accompanied by a calibration phantom with known material densities that was used to estimate subchondral vBMDof the distal radius. Joint contact is measured by calculatinginter-bone distances (mm2) using a previously validated algorithm. Subchondral vBMD is presented using mean vBMD (mg/K2HPO4) at three normalized depths from the subchondral surface (0 to 2.5, 2.5 to 5 and 5 to 7.5 mm) of the distal radius. The participants in the healthy cohort demonstrated a larger JCa in the RS joint during both extension and flexion, while the trauma cohort demonstrated a larger JCa in the RL during extension and flexion. With regards to vBMD, the healthy cohort demonstrated a higher vBMD for all three normalized depths from the subchondral surface when compared to the trauma cohort. Results from our preliminary analysis demonstrate that in the RL joint specifically, a larger JCa throughout flexion and extension was associated with an overall lower vBMD across all three normalized layers. Potential reasoning behind this association could be that following wrist trauma, altered joint contact mechanics due to pathological changes (for example, musculoskeletal trauma), has led to overloading in the RL region. The overloading on this specific region may have led to a decrease in the underlying vBMD when compared to a healthy wrist. However, we are unable to conclude if this is a momentary decrease in vBMD that could be associated with the acute healing phase following trauma given that our analysis is cross-sectional. Therefore, future work should aim to analyze kinematic JCa and vBMD longitudinally to better understand how changes in kinematic JCa over time, and how the healing process following wrist trauma, impacts the underlying subchondral bone in the acute and longitudinal phases of recovery

Radiostereometric analysis (RSA) allows for precise measurement of interbody distances on X-ray images, such as movement between a joint replacement implant and the bone. The low radiation biplanar EOS imager (EOS imaging, France) scans patients in a weight-bearing position, provides calibrated three-dimensional information on bony anatomy, and could limit the radiation during serial RSA studies. Following the ISO-16087 standard, 15 double exams were conducted to determine the RSA precision of total knee arthroplasty (TKA) patients in the EOS imager, compared to the standard instantaneous, cone-beam, uniplanar digital X-ray set-up. At a mean of 5 years post-surgery, 15 TKA participants (mean 67 years, 12 female, 3 male) were imaged twice in the biplanar imager. To reduce motion during the scan, a support for the foot was added and the scan speed was increased. The voltage was also increased compared to standard settings for better marker visibility over the implant. A small calibration object was included to remove any remaining sway in post-processing. The 95% confidence interval precision was 0.11, 0.04, and 0.15 mm in the x, y, and z planes, respectively and 0.15, 0.20, and 0.14° in Rx, Ry, and Rz. Two participants had motion artifacts successfully removed during post-processing using the small calibration object. With faster speeds and stabilization support, this study found an in vivo RSA precision of ≤ 0.15 mm and ≤ 0.20° for TKA exams, which is within published uniplanar values for arthroplasty RSA. The biplanar imager also adds the benefits of weight bearing imaging, 3D alignment measurements, a lower radiation dose, and does not require a reference object due to known system geometry and automatic image registration

The purpose of this study was to quantify tibial tunnel enlargement at 3-, 6- and 12-months post-anterior cruciate ligament reconstruction (ACLR), and evaluate the magnitude of tunnel widening with use of a Poly (L-lactic Acid) interference screw (PLLA (Bioscrew XtraLok, Conmed, New York)) compared to a Poly (L-lactic Acid) + tricalcium phosphate interference screw (PLLA+TCP (GENESYS Matryx screw comprised of microTCP and 96L/4D PLA, Conmed, New York)). This was a prospective randomized controlled trial with two parallel groups. Eighty unilateral ACL-deficient participants awaiting ACLR surgery were recruited between 2013 and 2017 from the clinic of a sole fellowship trained orthopaedic surgeon. Patients had to be skeletally mature and less than 45 years old, with no concomitant knee ligament injuries requiring surgery, chondromalacia, or previous history of ipsilateral knee joint pathology, surgery or trauma to the knee. Participants were randomized intra-operatively into either the PLLA or PLLA+TCP tibial interference screw fixation group. Study time points were pre-, 3-, 6-, and 12-months post ACLR. Participants underwent x-rays with a 25 mm calibration ball, IKDC knee assessment, and completed the ACL-Quality of Life score (ACL-QOL) at each visit. Measurement (mm) of the most proximal and distal extents as well as the widest point of the tibial tunnel were taken using efilm (IBM Watson Health) and were standardized relative to the calibration ball. A contrast inverter was used to determine clear borders based on contrast between normal and drilled bone. In addition, a subjective evaluation of the tunnel was conducted looking for bowing of the borders of the tunnel or change in tunnel shape, categorizing the tunnel as widened or not widened. Differences between groups at each time point were evaluated using independent t-tests corrected for multiple comparisons. Tunnel width was also compared as a percentage of actual screw size at 12-months post-operative. Categorical data were compared using Fisher's Exact Test. Forty participants were randomized to each group with mean age (SD) of 29.7 (7.6) and 29.8 (9.1), for PLLA and PLLA+TCP, respectively. There were no differences between groups in age, gender or ACL-QOL. There were no differences found between groups at any time point in either tunnel width measurements or tunnel width as a percentage of actual screw size. The greatest difference between groups was noted in the measurement of the widest point on lateral x-ray view with a mean difference of 11%. Based on subjective evaluation of tunnel shape, three participants had visible widening in the PLLA group, and two in the PLLA+TCP group (p=NS). No differences in tunnel widening were identified between ACL reconstruction patients using a PLLA interference screw compared to a PLLA+TCP screw for tibial fixation up to 12-months post-operative

Background. Septic arthritis diagnostic is an emergency which implies a treatment with antibiotics and hospitalization. The diagnosis is based on the cytobacteriological examination of the synovial fluid (SF), but direct bacteriological examination is insensitive, and the result of the culture is obtained only after several days. Therefore, there is still a need for a rapid, simple and reliable method for the positive diagnosis of septic arthritis. Such method must allow avoiding both unrecognized septic arthritis leading to major functional consequences, and overdiagnosis that will induce unnecessary expensive hospitalization and unjustified treatment. Mid-infrared (MIR) spectroscopy, that gives a metabolic profiling of biological fluids, has been proposed for early and fast diagnosis. Objectives. To confirm the MIR spectroscopy to discriminate SF samples from patients with septic arthritis from other causes of joint effusion. Methods. Synovial fluids from 402 patients referred for suspected arthropathies were prospectively collected in six hospitals and stored at °80°C. The infrared absorption spectrum was acquired for each of the frozen samples using a chalcogenide fiber biosensor. The most informative spectral variables were selected and then used to develop an algorithm. Then, the algorithm has been validated on independent synovial fluids collected straight after arthrocentesis from 86 patients. Results. The calibration (n=402) and validation (n=86) cohorts consists of synovial fluid samples from patients exhibiting various etiologies. These samples (n=488), by using SF bacteriological analysis and culture and 16S PCR analysis were classified as septic arthritis (n=43) or non-septic arthritis (n=443). On the calibration cohort, the performances of the algorithm show a sensitivity of 90%, a specificity of 90%, a NPV of 99% and a PPV of 41%, the area under the ROC curve (AUROC) was 0.95. On the validation cohort, the performances of the algorithm show a sensitivity of 92%, a specificity of 81%, a NPV of 98% and a PPV of 46%, the area under the ROC curve (AUROC) was 0.90. Conclusions. This study confirms the diagnostic performances of MIR spectroscopy for the discrimination between septic and non-septic synovial fluids. The high negative predictive value and the very short time (within ten minutes) required to obtain the result makes it possible to quickly rule out an infection diagnosis

For a successful total knee arthroplasty (TKA) and long prosthesis lifespan, correct alignment of the implant components as well as proper soft tissue balancing are of major importance. In order to overcome weaknesses of existing imaging modalities for TKA planning such as radiation exposure and lack of soft tissue visualisation (X-ray and CT) and high cost, long acquisition times and geometric distortion (MRI), it is investigated if ultrasound (US) imaging is a suitable alternative. Currently, a reconstruction method of the bony knee morphology based on US imaging is developed at our research institute. For capturing the mechanical axis, being crucial for TKA planning, different approaches could be implemented. This work investigates whether a weight-bearing full leg X-ray registered with the local 3D-US knee dataset can be used for this purpose. Also, the impact of incorrect calibration data (i.e. uncalibrated X-rays) on the accuracy of the estimated mechanical axis is investigated. A 3D-2D projective, feature-based registration algorithm was used to spatially align the 3D US-based model to the 2D X-ray image before transferring the mechanical axis from the X-ray to the model. For validation, a CT-based local model and its projection were used and an initial error in translation and rotation was added. Also, calibration parameters such as the centre ray position and the source-to-image-detector distance were altered. The estimation error of the mechanical axis was less than 1°, the median error lower than 0.1° in the frontal plane. Even if the calibration data is not available, the accuracy remains sufficient for TKA planning. In this study, idealised 2D and 3D image information was used. In the future, this method should be tested using clinical X-ray images and 3D-US data

Background. Currently existing optical navigation systems have ergonomic disadvantages such as size, the “line of sight” problem and extended registration procedures. The operation room becomes crowded by additional installations and competitive supporting devices around the patient. These points reduce and limit the acceptance of navigation systems for further applications. But especially for surgical quality management, navigation systems have a high potential as objective measurement systems. Method. A miniaturised measuring and navigation system, which is directly fixed at the surgical tool, could overcome these limitations and fulfil the requirements demanded by current and future operation rooms. Minimising the distance between situ and camera promises an increased accuracy, a reduced “line of sight problem,” intuitive handling and one coordinate transformation (Tool2DRB) less. However, such a setting reduces the navigation working space available, needs a sterile system, a new marker design and special requirements for the cameras. The developed prototypes were tested in vitro using Synbones™ and ex vivo at anatomical specimen. Following surgical pilot applications were defined and considered during the studies: maxillofacial restoration osteotomy, hip replacement and unicondylar knee replacements (UKR). Special emphasis was placed on measured and recorded accuracy and miniaturised hardware. Results. Several miniaturised measuring system prototypes with high resolution cameras mounted directly onto a surgical instrument have been developed and tested. One prototype includes a laser device which is used in combination with the cameras to register 3D surfaces like the rotational centre of an acetabular cup from a prosthetic hip joint. Other prototypes demonstrate the miniaturising aspect of this development and their ergonomic advantages. Corresponding algorithm and software developments include calibration, marker identification, network components and surgical planning modules. Hard and software components have been tested for UKR application in an ex vivo study. Clinical trials for maxillofacial restoration osteotomy are prepared at the University Hospital Basel. The accuracy of the presented systems was evaluated in vitro with two setups. After intrinsic and extrinsic camera calibration with a 3D calibration specimen, the accuracy (RMS) of a single point of the 3D point coordinates of the calibration specimen could be determined with 0,020 mm in z-axis and 0,010 mm in x/y-axis. In another setup the accuracy was measured in 3D with a fixed camera system and two markers rigidly fixed together. The marker system was moved around working space. The repeat accuracy of the distances between the two markers was 0,025 mm (RMS). Discussion. The total development of the miniaturised measuring system, consisting of a video system, an optional laser scanner, calibration, image processing algorithms and planning modules was successful. The current prototype has proved to be accurate and usable. Users (surgeons) and suppliers of surgical implants, who have been exposed to the system, have expressed their keen interest, as it opens up new applications and fulfils their needs for improved ergonomics and smarter, cost reducing work flows. But of course there is still potential for improvements. In the next iteration of the development process, the usability and accuracy of the system could still be improved. The currently used optics limit the possible accuracy because the aperture of F = 2.8 is too large for photogrammetric applications and its optics distortions are too large. Therefore it will be exchanged by an optimised solution. Another optimisation target is the camera electronics. The currently used ones cannot be synchronised, which limits the usability, respectively reduces the accuracy, if it is moved during a measurement shot

INTRODUCTION. Over the last twenty years, image-guided interventions have been greatly expanded by the advances in medical imaging and computing power. A key step for any image-guided intervention is to find the image-to-patient transformation matrix, which is the transformation matrix between the preoperative 3D model of patient anatomy and the real position of the patient in the operating room. In this work, we propose a robust registration algorithm to match ultrasound (US) images with preoperative Magnetic Resonance (MR) images of the Humerus. MATERIALS AND METHODS. The fusion of preoperative MR images with intra-operative US images is performed through an NDI Spectra® Polaris system and a L12-5L60N TELEMED® ultrasound transducer. The use of an ultrasound probe requires a calibration procedure in order to determine the transformation between an US image pixel and its position according to a global reference system. After the calibration step, the patient anatomy is scanned with US probe. US images are segmented in real time in order to extract the desired bone contour. The use of an optical measurement system together with trackers and the previously-computed calibration matrix makes it possible to assign a world coordinate position to any pixel of the 2D US image. As a result, the set of US pixels extracted from the images results in a cloud of 3D points which will be registered with the 3D Humerus model reconstructed from MR images. The proposed registration method is composed of two steps. The first step consists of US 3D points cloud alignment with the 3D bone model. Then, the second step performs the widely-known Iterative Closest Point (ICP) algorithm. In order to perform this, we define the coordinate system of both the 3D Humerus model and the US points cloud. The frame directions correspond to the directions of the principal axes of inertia calculated from the matrices of inertia of both the preoperative 3D model and the US data obtained intra-operatively. Then, we compute the rotation matrix to estimate the transformation between the two coordinate systems previously calculated. Finally the translation is determined by evaluating the distance between the mass centres of the two 3D surfaces. RESULTS. In order to evaluate the performance of this registration method in terms of precision and accuracy, we performed the US/MRI fusion on 8 patients. The evaluation criterion used for the validation step was the fiducial registration error (FRE) estimation based on 8 anatomic fiducials detected on the Humerus of the patient. The mean, standard deviation, minimum and maximum values of the 8 Fiducial Registration Errors were 4.34, 2.20, 2.81 and 9.48 mm, respectively. DISCUSSIONS. In this work, we propose a robust registration method of MR and US data. Thanks to the optical system, this fusion will allow us for example to guide and assist surgeons in the positioning of the radiofrequency probe for bone tumor ablation. In addition to the fact that it is completely automatic, the proposed image-to-patient registration method is minimally invasive

Radiostereometric analysis (RSA) has become the gold standard technique for measuring implant migration and wear following joint replacement due to its high measurement precision and accuracy. However, RSA is conventionally performed using two oblique radiographic views with the presence of a calibration cage. Thus, a second set of radiographs must be acquired for clinical interpretation, for example anterior-posterior and cross-table lateral views following total hip arthroplasty (THA). We propose a modification to the RSA setup for examining THA, in which RSA measurements are performed from anterior-posterior and lateral views, with the calibration cage images acquired separately from the patient images. The objective of the current study was to compare the accuracy and precision of the novel technique to the conventional technique using a phantom. X-ray cassette holders were developed to enable simultaneous acquisition of anterior-posterior and cross-table lateral radiographs with the patient in a supine position in the RSA suite. A Sawbones phantom with total hip implant components was attached to a micrometer-driven stage. The femoral component was translated known distances relative to the acetabular cup in all planes, mimicking head penetration due to wear. Double RSA examinations were acquired for each increment using the traditional and novel radiograph orientations. Translations were measured from the radiographic images using RSA software. For both techniques, accuracy was calculated by comparing the measured translations to the known translation from the micrometer, and reported as the 95% confidence interval. Precision was measured by comparing the measured translations between the double exams, and reported as the standard deviation. Accuracy was greater for the conventional technique in the inferior-superior axis (p = 0.03), greater for the novel technique in the anterior-posterior axis (p = 0.01), and equivalent in the medial-lateral axis (p = 0.06). Overall accuracy for both the conventional and novel techniques was identical at ±0.022 mm. Precision was equivalent between both techniques for the medial-lateral (p = 0.68), inferior-superior (p = 0.14), and anterior-posterior axes (p = 0.86). Overall precision for the conventional technique was ±0.127 mm and for the novel technique was ±0.095 mm. Utilising standard clinical radiograph view angles within an RSA exam had no detrimental effect on wear measurement accuracy or precision. This reduces the barriers to implementing RSA imaging in routine follow-up of arthroplasty patients, potentially greatly increasing the numbers of patients that can have quantitative data on implant performance. Future applications can involve applying more clinically relevant radiograph view angles to RSA exams of the knee and shoulder

INTRODUCTION. To assess and compare the effect of new orthopedic surgical procedures, in vitro evaluation remains critical during the pre-clinical validation. Focusing on reconstruction surgery, the ability to restore normal kinematics and stability is thereby of primary importance. Therefore, several simulators have been developed to study the kinematics and create controlled boundary conditions. To simultaneously capture the kinematics in six degrees of freedom as outlined by Grood & Suntay, markers are often rigidly connected to the moving bone segments. The position of these markers can subsequently be tracked while their position relative to the bones is determined using computed tomography (CT) of the test specimen with the markers attached. Although this method serves as golden standard, it clearly lacks real-time feedback. Therefore, this paper presents the validation of a newly developed real-time framework to assess knee kinematics at the time of testing. MATERIALS & METHODS. A total of five cadaveric fresh frozen lower limb specimens have been used to quantitatively assess the difference between the golden standard, CT based, method and the newly developed real-time method. A schematic of the data flow for both methods. Prior to testing, both methods require a CT scan of the full lower limb. During the tests, the proximal femur and distal tibia are necessarily resected to fit the knees in the test setup, thus also removing the anatomical landmarks needed to evaluate their mechanical axis. Subsequently, a set of three passive markers are rigidly attached to the femur and tibia, referred to as M3F and M3T respectively. For the CT based method, the marker positions are captured during the tests and a second CT scan is eventually performed to link the marker positions to the knee anatomy. Using in-house developed software, this allowed to offline evaluate the knee kinematics in six degrees of freedom by combining both CT datasets with the tracked marker positions. For the newly developed real-time method, a calibration procedure is first performed. This calibration aims to link the position of the 3D reconstructed bone and landmarks with the attached markers. A set of bone surface points is therefore registered. These surface points are obtained by tracking the position of a pen while touching the bone surface. The pen's position is thereby tracked by three rigidly attached markers, denoted M3P. The position of the pen tip is subsequently calculated from the known pen geometry. The iterative closest point (ICP) algorithm is then used to match the 3D reconstructed bone to the registered surface points. Two types of 3D reconstructions have therefore been considered. First, the original reconstructions were used, obtained from the CT data. Second, a modified reconstruction was used. This modification accounted for the finite radius (r = 1.0 mm) of the registration pen, by shifting the surface nodes 1.0 mm along the direction of the outer surface normal. During the tests, the positions of the femur and tibia markers are tracked and streamed in real-time to an in-house developed, Matlab based software framework (MathWorks Inc., Natick, Massachussets, USA). This software framework simultaneously calculates the bone positions and knee kinematics in six degrees of freedom, displaying this information to the surgeons and operators. To assess the accuracy, all knee specimens have been subjected to passive flexion-extension movement ranging from 0 to 120 degrees of flexion. For each degree of freedom, the average root mean square (RMS) difference between both measurement methods has been evaluated during this movement. In addition, the distribution of the registered surface points has been assessed along the principal directions of the uniformly meshed 3D reconstructions (average mesh size of 1.0 mm). RESULTS. The root mean square difference between both measurements indicates a strong dependency on the variance of the registered points. This dependency is particularly pronounced when using the original 3D reconstructions in combination with the ICP algorithm, with an R. 2. = 0.76 and 0.85 for the translational and rotational degrees of freedom respectively. When using the modified 3D reconstructions, which compensates for the finite radius of the marker tip, this dependency becomes negligible (R. 2. = 0.10 and 0.05). Using this modified 3D reconstruction, the average difference between both measurements is also reduced to an average value of 1.20 degrees and 1.47 mm. DISCUSSION. The difference in kinematic parameters between both measurement techniques is an order of magnitude lower than the claimed accuracy of the motion tracking cameras. However, the difference is in line with the inter- and intra- observer variability when identifying bony landmarks around the knee. Since these landmarks are essential to calculate knee kinematics, it is understood that the proposed real-time system is sufficiently accurate to study these kinematics

Introduction. Dislocation continues to be a common complication of total hip arthroplasty (THA) [1]. Although many factors affect the prevalence of dislocation, achieving proper intraoperative soft tissue tension is one of the main surgical goals to reduce this risk. However, a sensor to measure the soft tissue of ball joints i.e. hip and shoulder has not yet been developed. The sensor enables surgeons to adjust the size or position of the implants depending on soft tissue tension. Hence, we have developed a sensor-instrumented modular femoral head for THA to measure soft-tissue tension intraoperatively [2]. This study demonstrates the possibility of a soft tissue tension and joint angle data connection using a wireless system. Materials and Methods. The sensor-instrumented modular femoral head that we developed was made of epoxy resin with linear strain gauges (BTM-1C, Tokyo Sokki, Japan) inside the head and a triple-axis gyroscope (MPU-6500). Strain outputs and angle data from the gyroscope were transferred to a computer via a 2.4 GHz wireless link (RN42, Bluetooth Module). Data logging was performed by a custom program using C++ (Microsoft Visual Studio 2012) via both wired and wireless link. The strain gauges were embedded inside the head. For the calibration study, the sensor was fixed in a clamping block of an angle vice to permit changes in the direction of force. The calibration jig with the angle vice was placed on top of a low-friction two-dimensional translation table that eliminated horizontal constraints. A constant vertical force was applied using a vertical die set. The experimental setup is shown in Fig. 1. Instead of a portable battery, a DC electric power supply is used (bottom left). A picture of the Gyroscope and the radio module is inserted (bottom right). The force values and applied angles were changed recording strain gauge and angle outputs. Results. When the loads were applied on the z axis (at θ = 0), the output strains of εz showed increases with increases of the force values. When the cone angle (θ) was decreased from 0˚, angle changes were measured by the gyro scope. Output angles of both wired and wireless data are plotted to be compared (Fig. 2). Although data from a wireless system have a worse signal to noise ratio, it could capture the angle changes. Strain outputs of εz were plotted changing the cone angles and force values. εz showed decreases with increasing of cone angles (Fig.3). Discussion. This device was connected to a data logger with a wireless system in order to diminish the risk of infection. Although the amount and quality of the data connection were not good enough, the possibility and the concept of intraoperative wireless measurement have been shown. With a more sophisticated sensor system, this will be useful to permit optimized intraoperative soft tissue tension. Acknowledgement. This study is supported by the Grant-in-Aid for Scientific Research (C) 26350511. To view tables/figures, please contact authors directly

Taylor Spatial Frame (TSF) is a six axis deformity correction frame and accuracy of correction depend on the accuracy of parameters input in to the web based software. There are various methods of obtaining frame and deformity parameters (13 in total) including the use of dedicated software known as SpatialCAD™. We tested the accuracy of SpatialCAD™ using a saw bone two ring frame construct of known parameters. We mounted a two-ring (155mm) frame on a saw bone tibia and fibula unit and worked out the accurate mounting and deformity parameters. Then we obtained orthogonal and nonorthogonal antero-posterior and lateral images of frame using a metallic sphere of known dimensions placed at the level of the bone, to aid calibration of x-ray images. We also obtained orthogonal and non-orthogonal images without a calibrating sphere. We then uploaded the images in to SpatialCAD™ software and obtained the mounting and deformity parameters and compared with the real parameters. SpatialCAD™ is capable of yielding measurements within 1–2mm of actual measurements when Calibrated orthogonal images were used. The software was inaccurate when frame hardware of known dimensions was used for calibration because the hardware was not in the same plane as the bone

Introduction. The release of metallic debris can promote many adverse tissue reactions, as metallosis, necrosis, pseudotumors and osteolysis . 1–3. This debris is mainly generated by the fretting-corrosion mechanism due to the geometric difference in the head-stem interface . 4. Retrieval and in silico analysis showed the roughness of the stem-head interface appears to play an important role in the volume of material lost and THA failure . 5–7. The technical standard ISO 7206-2 recommends the measurement of average roughness (Ra) and max height of the profile (Rz) to control the quality of the surface finish of articulating surfaces on THA implants. However, despite the importance of the trunnion roughness, there is no specific requirement for this variable on the referred technical standard. The present study carried out a surface finish analysis of the trunnion of hip stems from five distinct manufacturers. Methods. Four stems (n = 4) from five (5) distinct manufacturers (A, B, C, D, and E) were used to evaluate the roughness of the trunnion. All the stems are similar to the classical Exeter stem design, with a 12/14 taper and a polished body surface. The roughness of trunnions was evaluated according to ISO 4287 and ISO 13565-2. The total assessment length was 4.8 mm with 0.8 mm cut-off. The first and last 8.33% of assessment length were not considered. The measurements of all samples were made in a rugosimeter with 2 µm feeler ITP (Völklingen, Germany), the velocity of 0.5 mm.s. -1. , and a force of 1.5 mN. The calibration was made at 20 ºC and relative humidity at 50%. The Kruskal Wallis with post hoc Nemenyi test was used to evaluate the difference of Ra among the manufacturers. The confidence level was set at 5%. Results and Discussion. The analysis of surface finish revealed different roughness among the manufactures (p < 0.005), with Ra between 0.061 µm to 3.184 µm and Rz varying of 0.41 µm to 12.69 µm. The manufacturers A and E had a Ra (2.587±0.050 µm and 3.146±0.031µm) of the trunnion similar to founded by Panagiotidou et al (2013). Within such range, the trunnion has shown a high presence of pit . 8. The manufacturer C, on the other hand, had the best surface finish of the trunnion (Ra = 0.069±0.010 µm and Rz = 0.505 ± 0.076 µm). This more smooth surface might increase the taper strength, reduce the shear stress and the susceptibility to the fretting-corrosion damage . 4,8. . Conclusion. The results were worrying because there is great variability of roughness among the manufacturers with the occurrence of trunnions with roughness too high. Nevertheless, the ISO technical standard does not recommend any procedure or minimum parameters acceptable for the surface finish of the trunnion. The revision of ISO 7206-2 would guarantee better control of trunnion roughness to reduce the amount of metallic debris and increase the safety of THA implants. Additional research is needed to determine a target value for this variable. For any figures or tables, please contact authors directly