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Objectives: Early identification of mechanical complications of total knee arthroplasties is of great importance to minimize the complexity and iatrogenicity of revision surgeries. There is therefore a critical need to use smart knee implants during intra or postoperative phases. Nevertheless, these devices are absent from commercialized orthopaedic implants, mainly due to their manufacturing complexity. We report the design, simulations and tests of a force and moments sensor integrated inside the tibial tray of a knee implant., Methods: By means of a "tray-pillar-membrane" arrangement, strain gauges and metal additive technology, our device facilitates the manufacturing and assembly steps of the complete system. We used finite element simulations to optimize the sensor and we compared the simulation results to mechanical measurements performed on a real instrumented tibial tray., Results: With a low power acquisition electronics, the measurements corroborate with simulations for low vertical input forces. Additionally, we performed ISO fatigue testings and high force measurements, with a good agreement compared to simulations but high non-linearities for positions far from the tray centre. In order to estimate the center of pressure coordinates and the normal force applied on the tray, we also implemented a small-size artificial neural network., Conclusion: This work shows that relevant mechanical components acting on a tibial tray of a knee implant can be measured in an easy to assemble, leak-proof and mechanically robust design while offering relevant data usable by clinicians during the surgical or rehabilitation procedures., Significance: This work contributes to increase the technological readiness of smart orthopaedic implants.

Background: The number of Total Knee Arthroplasty (TKA) procedures has been rising steadily for several decades in Europe and the USA. The increase varies in pace across countries, with a gradual climb in northern and central Europe, a slowing in the USA, and an exponential surge in the UK. In France, a 32.2% rise in the number of TKA and unicompartmental knee arthroplasty procedures was documented between 2012 and 2018. However, no study has focussed specifically on changes in both TKA procedures and the features of TKA patients. The objective of this study was to use the French national healthcare database to evaluate (1) increases in TKA procedures according to sex and age, (2) whether TKA is being performed at increasingly younger ages, (3) whether the comorbidity profile at TKA is changing, and (4) whether the TKA incidence rate will stabilise in the future, with a projection for 2050., Hypothesis: In France, the number of TKA procedures is rising in both males and females but the pace of the increases differs between sexes., Material and Method: This study used data collected in France in 2009-2019, separately for different age groups and for males and females, in the French national healthcare database (Système national des données de santé, SNDS) that collects information on all surgical procedures performed nationwide. Based on information about the TKA procedures, we determined (1) the TKA incidence rates with their time trends and (2) indirectly, the comorbidity profiles of the patients at TKA. Linear, Poisson, and logistic models were built to predict incidence rates in 2030, 2040, and 2050., Results: Between 2009 and 2019, the TKA incidence rate showed a steeper increase in males than in females (from 71.2 to 122.9 [+73%] vs. 124.2 to 181.0 [+46%], respectively). Although this increase was replicated in all age groups, it was sharper in patients younger than 65 years, in both males and females (from 20.9 to 37.9 [+82%] and 33.6 to 51.3 [+53%], respectively). During the study period, the number and proportion of patients increased in the group with mild comorbidities (from 40 093 to 67 430 TKAs, i.e., from 53.1% to 65.7% of all TKAs) but not in the other comorbidity groups. All projection models were validated. Nonetheless, the most likely scenario, provided by the logistic model, is a 33% rise by 2050 in both males and females (i.e., to 151 575 TKA procedures) with a plateau starting around 2030., Conclusion: Although the increase in TKA procedures is more marked in males than in females, the trends are similar in both sexes, with a sharper rise in the group younger than 65 years and a shift toward patients with milder comorbidities. In the longer term, incidence rate trends follow logistic dynamics, with a plateau starting around 2030. To meet the increasing demand, a corresponding development in relevant healthcare resources must be planned., Level of Evidence: IV, descriptive epidemiological study., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

The goal of this study was to assess and compare the precision and accuracy of nine and seven methods usually used in Computer Assisted Orthopedic Surgery (CAOS) to estimate respectively the Knee Center (KC) and the Frontal Plane (FP) for the determination of the HKA angle (HKAA). An in-vitro experiment has been realized on thirteen cadaveric lower limbs. A CAOS software application was developed and allowed the computation of the HKAA according to these nine KC and seven FP methods. The precision and the accuracy of the HKAA measurements were measured. The HKAA precision was highest when the FP is determined using the helical method. The HKAA accuracy was highest using the helical approach to determine the FP and either the notch or the tibial spines to determine the KC. This study shows that the helical approach to determine the FP and either the notch or the middle of tibia spines are the combinations that provide both a good enough accuracy and precision to estimate the HKA.

Purpose: A new approach is proposed to localise surgical instruments for Computer Assisted Orthopaedic Surgery (CAOS) that aims at overpassing the limitations of conventional CAOS solutions. This approach relies on both a depth sensor and a 6D pose estimation algorithm., Methods: The Point-Pair Features (PPF) algorithm was used to estimate the pose of a Patient-Specific Instrument (PSI) for Total Knee Arthroplasty (TKA). Four depth sensors have been compared. Three scores have been computed to assess the performances: The Depth Fitting Error (DFE), the Pose Errors, and the Success Rate., Results: The obtained results demonstrate higher performances for the Microsoft Kinect Azure in terms of DFE. The Occipital Structure core shows better behavior in terms of Pose Errors and Success Rate., Conclusion: This comparative study presents the first depth-sensor based solution allowing the intraoperative markerless localization of surgical instruments in orthopedics., (© 2021 John Wiley & Sons Ltd.)

Estimating in vivo the life span of a total knee replacement prosthesis is currently done by estimating the polyethylene (PE) wear rate from measurement of the femorotibial distance using X-ray photographies. This efficient method requires, however, waiting for few years to obtain a readout. This letter proposes using another metric that can be obtained within a couple of months of surgery, namely the center of pressure (COP). This metric represents the point, where the axial force applies the most onto the tibial tray. The displacement of the COP with respect to its ideal position can be used to estimate the wear and the life span of the PE. This requires the implant to be fitted with a telemetry system described briefly. The proposed method is supported by measures and simulations.

In-vivo measurement of tibiofemoral forces transmitted through Total Knee Replacement (TKR) during normal walking allows the early detection of postoperative complications such as the tibiofemoral misalignment and soft-tissue imbalance. In addition, the in-vivo data can help to improve the design of TKR in order to reduce polyethylene wear and consequently to increase the lifespan of knee implant. A self-powered custom-designed tibial implant instrumented with four piezoceramics has been developed in order to detect the aforementioned complications by measuring the relative change in pressure center (COP) position for different levels of eccentric compressive loading. Moreover, the energy harvested by the piezoceramics can be used to power a transmission system located at the stem of knee implant to wirelessly transmit the in-vivo data outside the implant for further processing and display.

Patellar maltracking after total knee arthroplasty often results in complications, including anterior knee pain, instability and impingement, and is therefore better resolved intraoperatively. Many factors can affect patellar kinematics during knee replacement, including component position, implant design, joint alignment, and soft tissue tensions. However, to our knowledge, the impact of arthroplasty on patellar kinematics has not been previously reported in vivo. A computer-assisted surgery (CAS) system was developed to measure the pre-arthroplasty patellar kinematics, display the distance between this path and the surface of the planned femoral component, and compare the post-arthroplasty path to the pre-arthroplasty path. Three surgeons from three centers used this CAS system to measure the in vivo pre- and post-arthroplasty kinematics of 18 patients. There was a small, but consistent, proximal shift in the tibial joint lines (mean: 4.2 mm), resulting in pseudo patella-baja, i.e., relatively more distal contact of the patella on the femoral component. This led to significant changes in proximodistal and anteroposterior patellar positioning as well as patellar flexion following arthroplasty (p < 0.008). Mediolateral shift, tilt and internal/external spin had the greatest magnitudes of change (mean: 4.1 mm, 4.6 degrees and 4.6 degrees, respectively) relative to their mean pre-arthroplasty ranges (averaging 2.1 mm, 5.8 degrees and 5.8 degrees, respectively); however, these changes were distributed almost equally medially and laterally, indicating no surgical bias in any one direction. Female patients had more lateral tilt on average than male patients throughout flexion (p < 0.004 post-arthroplasty, p < 0.03 pre-arthroplasty, in later flexion), as well as other kinematic differences; there may therefore be potential for improving overall kinematic results by focusing on gender differences during research, design and surgery. This study demonstrated the feasibility of using a CAS system to measure patellofemoral kinematics. Intraoperative awareness of patellar tracking, including knowledge of the tibiofemoral joint line, could have an impact on the surgical plan and thereby improve the postoperative outcome.

Objective: This study analyzed the influence of the acquisition method in image-free computer-assisted total knee arthroplasty (CAS-TKA), and the reproducibility of implant planning using BoneMorphing, a 3D morphometric model obtained by a 3D-to-3D elastic registration of statistical models to sparse point clouds acquired directly on the bone surface with a pointer., Materials and Methods: Five surgeons (one expert, four trainees) each performed a CAS-TKA hybrid protocol based on morphometric models and landmarks on a cadaveric knee 10 times. In addition, several additional landmarks were digitized during each acquisition. The reproducibility of the implant positioning and sizing, as determined by an implant planning algorithm with morphometric models, was compared to direct digitization accuracy., Results: Femoral and tibial implant positioning parameters with the hybrid protocol resulted in intra-surgeon standard deviations (SDs) of less than+/-1.4 degrees for rotation and 1.9 mm for translation for all surgeons in all directions except for tibial axial rotation (the only parameter determined by a digitized landmark and not recomputed in the 3D model). The variability in individual landmark digitization varied from 2 to 5 mm SD for certain landmarks, with ranges of 15-25 mm across all surgeons. The comparison study showed an improvement in femoral rotation reproducibility with the morphometric model when using the posterior condylar axis. Tibial implant reproducibility for each method was comparable, with the morphometric model giving better results in well-digitized areas such as the tibial plateau., Conclusion: A CAS-TKA protocol based on a deformed statistical model offers reproducible implant positioning. Some landmarks, such as distal condyles, show sufficient reproducibility in the direction of interest, while others, such as the anterior tibial tubercle, can lead to hazardous implant positioning. This should be taken into consideration when designing a CAS-TKA system with bony landmarks. In areas where a sufficient number of points have been digitized with good coverage, such as on the distal and posterior femoral condyles or the tibial plateau areas, the information derived from the 3D model is more accurate and reproducible than that derived from digitization. Good training and a guiding user interface are essential to guarantee coverage quality.

Objective: The clinical outcome of a total knee arthroplasty (TKA) is mainly determined by the accuracy of the surgical procedure itself. To improve the final result, one must take into account (a) the alignment of the prosthesis with respect to the mechanical axis, and (b) the balance of the soft tissues. Therefore, morphologic data (such as the shape of the epiphysis) and geometric data are essential. We present a new method for performing TKA based on morphologic and geometric data without preoperative images., Materials and Methods: The global method is based on the digitization of points with an optical 3D localizer. For the morphologic acquisitions, we use a method based on the registration of sparse point data with a 3D statistical deformable model. To build the mechanical axis, we use a kinematics method for the hip center and digitization of anatomical landmarks for the ankle centers. The knee center is not determined by digitization or kinematics of the knee, as this would not be accurate. The surgical planning relies totally on the soft-tissue balance, which is the key issue for a good kinematics result., Results: We have used this system for 6 months in a randomized clinical trial involving 35 patients to date. For the first 11 patients that could be measured in the navigation group, the postoperative frontal alignment was within the range of 180 +/- 3 degrees. Fluoroscopic assessment of the soft-tissue balancing will be performed at the conclusion of an extended 2-year study to evaluate the results from a functional point of view., Conclusion: Bone Morphing is an accurate, fast, and user-friendly method that can provide morphologic as well as geometric data. We have introduced the important notion of soft-tissue balancing into the intraoperative planning step to optimize the kinematics as well as the anatomy. Therefore, this method should be considered as an alternative to the CT-based method., (Copyright 2002 Wiley-Liss, Inc.)