Introduction

In clinical routine surgeons depend largely on 2D x-ray radiographs and their experience to plan and evaluate surgical interventions around the knee joint. Numerous studies have shown that pure 2D x-ray radiography based measurements are not accurate due to the error in determining accurate radiography magnification and the projection characteristics of 2D radiographs. Using 2D x-ray radiographs to plan 3D knee joint surgery may lead to component misalignment in Total Knee Arthroplasty (TKA) or to over- or under-correction of the mechanical axis in Lower Extremity Osteotomy (LEO).

Recently we developed a personalized X-ray reconstruction-based planning and post-operative treatment evaluation system called “iLeg” for TKA or LEO. Based on a patented X-ray image calibration cage and a unique 2D–3D reconstruction technique, iLeg can generate accurate patient-specific 3D models of a complete lower extremity from two standing X-rays for true 3D planning and evaluation of surgical interventions at the knee joint. The goal of this study is to validate the accuracy of this newly developed system using digitally reconstructed radiographs (DRRs) generated from CT data of cadavers.

Recently we developed a personalised X-ray reconstruction-based planning and post-operative treatment evaluation system called iLeg for total knee arthroplasty or lower extremity osteotomy. Based on a patented X-ray image calibration cage and a unique 2D-3D reconstruction technique, iLeg can generate accurate patient-specific 3D models of a complete lower extremity from two standing X-rays for true 3D planning and evaluation of surgical interventions at the knee joint. The goal of this study is to validate the accuracy of this newly developed system using digitally reconstructed radiographs (DRRs) generated from CT data of 12 cadavers (24 legs). Our experimental results demonstrated an overall reconstruction accuracy of 1.3±0.2mm.

Tracked B-mode ultrasound (US) potentially provides a non-invasive and radiation-free alternative to percutaneous pointer digitization for intra-operative determination of the anterior pelvis plane (APP). However, most of the published approaches demand a direct access to the corresponding landmarks, which can only be presumed for surgical approaches with the patient in supine position. In order to avoid any change of the clinical routine for total hip arthroplasties (THAs), we propose a new method to determine the pelvic orientation, which could be performed in lateral position.

Our proposed method is based on the acquisition of ultrasound images of the ipsilateral hemi-pelvis, namely the posterior superior iliac spines (PSISs) and iliac crest region. The US images are tracked by a navigation system and further processed to extract three-dimensional point clouds. As only one side of the pelvis is accessible, we estimate the symmetry plane (midsagittal plane) of the pelvis based on additionally digitized bilateral anterior superior iliac spine (ASIS) landmarks. This symmetry plane is further used to mirror the ipsilateral US-derived points to the contralateral side of the pelvis and to register and instantiate a pelvic SSM constructed from 30 CT-scans.

The proposed registration method was evaluated using two plastic pelvis models and two cadaveric pelvises together with special custom-made silicone phantoms to simulate the missing soft-tissue. In each trial, the required data were collected with the pelvis rigidly fixed in lateral decubitus position together with ground truth APP landmarks. A registration error of 3.48° ± 1.10° was found for the anteversion angle, while the inclination angle could be reconstructed with a mean error of 1.26° ± 1.62°.

The performed in-vitro experiments showed reasonably good results, taking the sparsity of the input point clouds into consideration.

Bone fixation plates are routinely used in corrective and reconstructive interventions. Design of such implants must take into consideration not only good surface fit, but also reduced intra-operative bending and twisting of the implant itself. This process increases mechanical stresses within the implant and affects its durability and the functional outcome of the surgery. Wound exposure and anaesthesia times are also reduced. Current population-based designs consider the average shape of a target bone as a template to pre-shape the implant. Other studies try to enhance the average design by optimising surface metrics in a statistical shape space. This could ensure a low mean distance between the implant and any bone in the population, but does not reduce neither the maximum possible distances nor directly the mechanical forces needed to fit the implant to the specific patient. We propose a population-based study that considers the bending and torsion forces as metrics to be minimised for the design of enhanced fixation plates. Our aim is to minimise the necessary intra-operative deformations of the plates.

In our approach, we first propose to represent a fixation plate by dividing it into discrete sections lengthwise and fitting a plane to each section. The number of sections depends on the size of the implant and anatomical location. It should be small enough to capture the anatomical curvatures, but large enough not to be affected by local noise in the surface.

Surface patches corresponding to common locations for plate fixations are extracted from 200 segmented computed tomography (CT) images. In this work, distal lateral femoral patches are considered. A statistical shape model of the patches is then computed and a large population of 2,197 instances is generated, evenly covering the natural statistical variation within the initial population. These instances are considered as both bone surfaces and potential new designs of the contact surface of the fixation plate.

The key formulation of our solution is to examine the effect of deforming each section of the implant on the rest of the sections and compute the amount of bending and torsion needed to shape one patch to another.

Each instance of the population is fitted to all others and the maximum bending and torsion angles are recorded. A similar process was applied for the mean of the population. The goal is to pick from the population the shape that simultaneously minimises the bending and torsion angles.

The maximum required bending was reduced from 25.3® to 19.3® (24.72% reduction), whereas the torsion component was reduced from 12.4® to 6.2® (50% reduction).

The method proposed in this abstract enhances the current state-of-the-art in orthopaedic implant design by considering the mechanical deformations applied to the implant during the surgery. The obtained results are promising and indicate a noticeable improvement over the standard pre-contouring to the population mean. We plan to further validate the method and as a future outlook, we intend to test the approach in real surgical scenarios.

The integration of statistical shape models (SSMs) for generating a patient-specific model from sparse data is widely spread. The SSM needs to be initially registered to the coordinate-system in which the data is acquired and then be instantiated based on the point data using some regressing techniques such as principal component analysis (PCR). Besides PCR, partial least squares regression (PLSR) could also be used to predict a patient-specific model. PLSR combines properties of PCR and multiple linear regression and could be used for shape prediction based on morphological parameters.

Both methods were compared on the basis of two SSMs, each of them constructed from 30 surface models of the proximal femur and the pelvis, respectively. Thirty leave-one-out trials were performed, in which one surface was consecutively left out and further used as ground truth surface model. Landmark data were randomly derived from the surface models and used together with the remaining 29 surface models to predict the left-out surface model based on PCR and PLSR, respectively. The prediction accuracy was analysed by comparing the ground truth model with the corresponding predicted model and expressed in terms of mean surface distance error.

According to their obtained minimum error, PCR (1.62 mm) and PLSR (1. 63 mm) gave similar results for a set of 50 randomly chosen landmarks. However PLSR seems to be more susceptible to a wrong selection of number of latent vectors, as it has a more variation in the error.

Although both regression methods gave similar results, decision needs to be done, how to select the optimal number of regressors, which is a delicate task. In order to predict a surface model based on morphological parameters using PLSR, the choice of the parameters and their optimal number needs to be carefully selected.

The goal of this study was to validate accuracy and reproducibility of a new 2D/3D reconstruction-based program called “HipRecon” for determining cup orientation after THA. “HipRecon” uses a statistical shape model based 2D/3D deformable registration technique that can reconstruct a patient-specific 3D model from a single standard AP pelvic X-ray radiograph. Required inputs include a digital radiograph, the pixel size, and the film-to-source distance. No specific calibration of the X-ray, or a CAD (computer-assisted design) model of the implant, or a CT-scan of the patient is required. Cup orientation is then calculated with respect to the anterior pelvic plane that is derived from the reconstructed 3D-model.

The validation study was conducted on datasets of 29 patients (31 hips). Among them, there were 15 males and 14 females. Each dataset has one post-operative X-ray radiograph and one post-operative CT-scan. The post-operative CT scan for each patient was used to establish the ground truth for the cup orientation. Radiographs with deep centering (7 radiographs), or of pelvises with fractures (2 radiographs), or with both (1 radiograph), or of non-hemispherely shaped cup (1 radiograph) were assessed separately from the radiographs without above mentioned phenomena (18 radiographs) to estimate a potential influence on the 2D/3D reconstruction accuracy. To make the description easier, we denote those radiographs with above mentioned phenomena as non-normal cases and those without as normal cases. The cup anteversions and inclinations that were calculated by “HipRecon” were compared to the associated ground truth. To validate the reproducibility and the reliability, one observer conducted twice measurements for each dataset using “HipRecon”.

The mean accuracy for the normal cases was 0.4° ± 1.8° (−2.6° to 3.3°) for inclination and 0.6° ± 1.5° (−2.0° to 3.9°) for anteversion, and the mean accuracy for the non-normal cases was 2.3° ± 2.4° (−2.1° to 6.3°) for inclination and 0.1° ± 2.8° (−4.6° to 5.1°) for anteversion. Comparing the measurement from the normal radiographs to those from the non-normal radiographs using the Mann-Whitney U-test, we found a significant difference in measuring cup inclination (p = 0.01) but not in measuring cup anteversion (p = 0.3). Bland-Altman analysis of those measurements from the normal cases indicated that no systematical error was detected for “HipRecon,” as the mean of the measurement pairs were spread evenly and randomly for both inclination and anteversion. “HipRecon” showed a very good reproducibility for both parameters with an intraclass correlation coefficient (ICC) for inclination of 0.98 (95% Confidence Limits (CL): 0.96–0.99) and for anteversion of 0.96 (95% CL: 0.91–0.98).

Accurate assessment of the acetabular cup orientation is important for evaluation of outcome after THA, but the inability to measure acetabular cup orientation accurately limits one's ability to determine optimal cup orientations, to assess new treatment methods of improving acetabular cup orientation in surgery, and to correlate the acetabular cup orientation to osteolysis, wear, and instability. In this study, we showed that “HipRecon” was an accurate, consistent, and reproducible technique to measure cup orientation from post-operative X-ray radiographs. Furthermore, our experimental results indicated that the best results were achieved with the radiographs of non-fractured pelvises that included the anterior superior iliac spines and the cranial part of the non-fractured pelvis. Thus, it is recommended that these landmarks should be included in the radiograph whenever the 2D/3D reconstruction-based method will be used

The existing image-free Total Hip Arthroplasty (THA) navigation systems conventionally utilise the patient-specific Anterior Pelvic Plane (APP) as the reference to calculate orientations of the implanted cup, e.g. anteversion and inclination angles. The definition of APP relies on the intra-operative digitisation of three anatomical landmarks, the bilateral Anterior Superior Iliac Spine (ASIS) and the pubicum.

Due to the presence of the thick soft tissue around the patient's pubic region, however, the landmark on pubic area is hard to be digitised accurately. A novel reference plane called Intra-operative Reference Plane (IRP) was proposed by G. Zheng et al to address this issue. To determine the IRP, bilateral ASIS and the cup center of the operating side instead of the pubicum are digitised intra-operatively. It avoids the error-prone digitisation of pubicum, and the angle between the patient-specific APP and the suggested IRP can be computed pre-operatively by a single X-ray radiograph-based 2D/3D reconstruction approach developed by G. Zheng et al. Based on this angle, the orientation of the APP can be intra-operatively estimated from that of the IRP such that all measurements with respect to IRP can be transformed to measurements with respect to APP.

In order to implement and validate this new reference plane for image-free navigation of acetabular cup placement, we developed an IRP-based image-free THA navigation system. All cup placement instruments were mounted with passive markers whose positions could be traced by a NDI Polaris® infrared camera (Northern Digital Inc, Ontario, Canada). The cup center was obtained by first pivoting a tracked impactor with appropriate size of the mounted trial cup and then calculating the pivoting center through a least-squares fitting. The bilateral ASIS landmarks were acquired through the percutaneous pointer-based digitisation.

We tested this new IRP-based image-free THA navigation system in our laboratory by conducting twelve studies on two dry cadaver pelvises and two plastic pelvises. The ground truth for each study was established using the conventional APP-based method, i.e., in addition to those landmarks required by our IRP-based method, we also digitised the pubicum on respective pelvic bones and calculated cup orientations on the basis of the digitised APP.

The mean and standard deviation of differences between the proposed IRP-based anteversion measurement and the ground truth are 1.0 degree and 0.7 degree, while the maximal and minimal differences are 2.1 degree and 0.3 degree respectively.

The mean and standard deviation of differences between the proposed IRP-based inclination measurement and the ground truth are respective 0.2 degree and 0.2 degree. Moreover, the maximum of differences is 0.5 degree and the minimum is 0.0 degree.

Our laboratory experimental results demonstrate that the new IRP-based image-free navigation system is accurate enough for acetabular cup placement. In comparison to existing image-free navigation systems that use APP as the reference plane, the newly developed system employs IRP as the reference plane, which has the advantage to eliminate the digitisation of landmarks around the pubic region. The successful validation with the laboratorial study has led us to the next step of clinical trials. We expect to report preliminary clinical cases in the near future.

Ligament balancing in total knee arthroplasty is believed to have an important influence on the joint stability and prosthesis lifetime. In order to provide quantitative information and assistance during the ligament balancing phase, a device that intra operatively measures knee joint forces and moments has been developed.

Thanks to its small thickness (6mm), the developed device fits after a tibial precut entirely in the tibio-femoral gap with thepatella in its anatomical place. The device measures the tibio-femoral contact force amplitude and location, thus allowing the computation of the net varus-valgus moment, which characterizes the ligamentous balance. Following an accuracy study, the device was validated with a plastic knee joint model equipped with spring-ligaments, which allowed the application of various degrees of ligamentous imbalance. Finally, the device was tested ina cadaver experiment by an experienced surgeon.

During the accuracy study, the absolute force amplitude and location error were respectively 1.4 N and 0.6 mm, which corresponds to a 3%relative error on the active measurement range. The expected linear relationship between the varus-valgus moments and the spring forces in the plastic bone experiment was experimentally verified and the slope corresponded effectively to the lever arm within 12%, which attests the device’s suitability for the purpose of ligament balancing. The cadaver experiment demonstrated the adequacy of the measurement scale (0–500N) as well as the consistency between the acquired data and the surgeon’s perception.

The design and first prototype of the proposed device has been experimentally validated. In a near future, the benefit of using such a device will be examined by a series of cadaver experiments.

Information regarding the axes of motion or centers of rotation of the normal cervical spine are necessary to evaluate the similarity of the motion allowed by cervical total disc replacement designs to the natural cervical spine. However, little data has been presented previously regarding the three-dimensional axes of motion of the cervical spine for the three primary motions of flexion/extension, lateral bending and axial rotation. The objective of this study was to measure the three-dimensional axes of motion (Helical axis of Motion) in the natural sub-axial cervical spine using ex-vivo human cadaveric cervical spines.

To measure the Helical Axes of Motion (HAM) for the sub-axial cervical spine under flexion/extension, lateral bending and axial torsion moments and evaluate the effect of a physiologic axial preload on the axes locations and orientations.

This study demonstrated the feasibility of calculating the HAM in the cervical spine using an ex-vivo experimental protocol.

The HAM is a three-dimensional analogue to the two-dimensional center of rotation. The data presented here can be used to evaluate the similarity of the motion allowed by total disc replacement designs to the natural cervical spine. They can also be applied for the characterization of spinal trauma, pathology, instability or surgical devices.

The orientation and locations of the HAMs for axial torsion loading are presented in Figure 1. In flexion/extension the HAM penetrated the sagittal plane near the posterior aspect of the vertebral body and near the cranial endplate. The lateral bending results were similar to the axial torsion results. The addition of axial preload had little effect on the position and orientation of the HAM.

Sub-axial (level C2-C7) cadaveric cervical spine functional spinal units (n=7) were subjected to pure moments of 1 Nm. Specimens were tested with and without axial preloads of 200 N. Vertebral kinematics were measured using an optoelectronic motion analysis system. These data are particularly applicable to the evaluation and design of “motion-retaining” devices such as total disc replacements, facet joint replacement systems or flexible stabilization systems.

Please contact author for figures and diagrams.

A novel CT-free image-guided navigation system for acetabular cup placement has been designed, implemented and evaluated in laboratory and clinical environments. The most common postoperative complications for total hip arthroplasty (THA), subluxation and dislocation, is directly related to acetabular component orientation. Recent developments in the area of CT-based cup navigation have proven to be a valuable aid. However, a CT scan often unwarranted and has a significant impact on the total cost of treatment.

The method proposed in this paper utilizes reference coordinates from the anterior pelvic plane (APP) to compute the angular orientation of the cup. The APP is aligned to a vertical plane of a standing patient defined by the two anterior superior iliac spines and the pubic tubercles. A hybrid strategy for the acquisition of these landmarks has been introduced involving percutaneous pointer-based digitization with the possibility of non-invasive bi-planar landmark reconstruction using multiple registered fluoroscopy images. An intuitive graphical user interface, combined with a sterile virtual keyboard control, effectively support the navigation of acetabular preparation and cup placement.

A detailed validation of the system was performed in a laboratory setting. Seven full body human specimens were used to confirm the APP reference concept using custom made software to simulate worst case scenarios.

System usability was evaluated throughout an early clinical trial involving 25 patients. A postoperative study of all patients found that the accuracy was better than 4° inclination and 5° anteversion under standard clinical conditions. This implies that there is no significant difference in performance from the established CT-based navigation methods.

Background: Successful total knee arthroplasty requires component alignment according to the mechanical axes and restoration of ideal knee kinematics. This requires adequate ligament balancing, stable tibia-femoral and patello-femoral joints, and a non-restricted range of motion.

We developed a computer assisted total knee arthroplasty system to help the surgeon achieving more intra-operative accuracy.

Material and methods: An OPTOTRAK camera is used to track relative motions between femur, tibia, and instruments. In contrast to other systems we avoid fixation of reference bases onto acetabulum and foot. The surgeon generates a representation of the patient’s anatomy using the technique of “surgeon defined anatomy”. Based on recorded landmarks the system calculates the femoral and tibial mechanical axes, the position of the knee joint line, the level of the defects on femoral and tibial side, the anatomically best fitting femoral component size, the femoral ventral level, and the natural tibial rotation. These values enable an initial planning situation, which features alignment of the tibial and femoral distal resection planes according to the mechanical axes as well as the definition of the anterior and posterior femoral resection planes with respect to the ventral cortex and the prosthesis design. To consider soft-tissue behaviour the surgeon loads both collateral ligaments in extension and flexion, a

Results: During a clinical study we performed thirteen total knee arthroplasties. Postoperatively passive extension was 0.8-4.2° (mean 1.9°) in the coronal plane and 0.2-3.9° (mean 1.8°) in the sagittal plane. Varus-valgus instability was 7.2°. The results of the subsequent patients of this ongoing study will be available during the conference.

The most common reason for possible complications after total hip replacement (THR) surgery is improper positioning of the implant components within the hip joint. Systems for computer assisted planning and navigation during THR have been developed. However, these established modules focus on the acetabular implant component only; disrespecting the fact that proper implant functioning relies upon correct placement of both components relative to each other. Therefore, we developed an extension to the existing CT-based SurgiGATE-Prosthetics system (Medivision, Oberdorf, Switzerland) for planning and placing of the acetabular component to give the surgeon a tool, which can help him/her to also plan and insert the femoral implant.

Preoperatively, the appropriate size and position as well as the orientation of both implants components were planned. Following navigated cup placement a dynamic reference base (DRB) was fixed to the thighbone and the registration procedure was executed. For the preparation of the femoral cavity a modular PPF rasp system (Biomet-Merck, Darmstadt, Germany) was developed. All surgical action was visualised graphically within the patient’s image data. In addition, the surgeon was provided with real-time information about the depth of tool insertion, antetorsion angle, varus/valgus deviation, and the postoperative change in leg length and lateralisation of the hip joint.

After extensive validation and accuracy analyses performed on plastic models the presented system was used during one operation. An extended clinical study is currently being started.

We expect that the developed application will help the surgeon to better plan the appropriate size and position of the both parts of a hip endoprosthesis and will supply intraoperative feedback of the position of the surgical instruments relative to the patients’ anatomy and to the preoperative plan. Safer and more accurate placement of the implants components during free-hand THR surgery may be expected from this technology.

After experimental and preclinical evaluation (HAP Paul Award 2001) of a CT-free image guided surgical navigation system for acetabular cup placement, the system was introduced into clinical routine. The computation of the angular orientation of the cup is based on reference coordinates from the anterior pelvic plane concept. A hybrid strategy for pelvic landmark acquisition has been introduced involving percutaneous pointer-based digitisation with the non-invasive bi-planar landmark reconstruction using multiple registered fluoroscopy images.

From January 2001 to May 2002 a total of 118 consecutive patients (mean age 68 years, 82 male, 36 female, 62 left and 56 right hip joints) were operated on with the hybrid CT-free navigation system. During each operation the angular orientation of the inserted implant was recorded.

To determine the placement accuracy of the acetabular components the first 50 consecutive patients underwent a CT scan seven to ten days postoperatively to analyse the cup position related to the anterior pelvic plane. This was done blinded with commercial planning software. There was no significant learning curve observed for the use of the system.

Mean values for postoperative inclination read 43° (SD 3.0, range 37 to 49) and anteversion 19° (SD 3.9, range 10 to 28). The resulting system accuracy, i.e., the difference between intraoperatively calculated cup orientation and postoperatively measured implant position shows a maximum error of 5° for the inclination (mean 1.5°, SD 1.1) and 6° for the anteversion (mean 2.4°, SD 1.3).

An accuracy of better than 5° inclination and 6° ante-version was achieved under clinical conditions, which implies that there is no significant difference in performance from the established CT-based navigation methods. Image guided CT-free cup navigation provides a reliable solution for future THA.

Orthopaedic surgeons are often found with critical procedures in trauma surgery that involve precise action on the underlying bony fragments without direct surgical access. This is exemplified by the intramedullary nailing technique, which is successfully used in many orthopaedic and trauma departments. Besides surgical actions on the surrounding soft tissues it involves fracture reduction as well as control of leg length and antetorsion angle. Distal locking of the inserted nail provides secure fixation to the bone fragments. To date accurate and safe performance of these steps remains a challenge in particular for the less experienced surgeon and can often only be achieved with extensive use of the image intensifier.

We have recently proposed a novel computer based technique, which was achieved combining intraoperative fluoroscopy based imaging using widely available C-arm technology with modern freehand surgical navigation. Modules were developed to automate digital X-ray image registration, which allows the real-time image interactive navigation of surgical tools based on one single registered X-ray image with no further image updates. Furthermore, the system allows the acquisition and real-time use of multiple registered images, which provides an advanced pseudo 3D control. Projection parameters were used effectively for intraoperative measurements on the patient’s anatomy, e.g. to determine bone axes, anatomic angles (e.g. femoral antetorsion), distances (e.g. leg length).

The system has been adapted to intramedullary nailing through the development of special stereotactic instruments and appropriate graphical user interfaces. A detailed validation of the prototype system was performed in laboratory settings and throughout early clinical trials. Currently the system is in routine use in various European clinics. Based on the resulting data the novel technique holds promises for improved accuracy and safety.

At present, multi-modality medical imaging including x-ray, fluoroscopy, ultrasound, CT, MRI, etc. allows to efficiently diagnose and plan for the majority of surgical interventions. So far, the resulting preoperative set of diagnostic and planning information could not be directly transformed to the real situation in the operating theatre. Additionally, there is a need to improve the accuracy and safety of surgical actions.

In the past few years a novel area of research and development – Computer Assisted Orthopaedic Surgery (CAOS) – has been established. Its primary goal is to provide a direct link between preoperative planning and intraoperative surgical action through advanced image-interactive surgical navigation. In addition, the use of computer hard- and software is promoted to enhance patient treatment and care pre- and postoperatively and to provide improved education and training of surgeons as well as advanced case documentation.

In this presentation an overview of the state of the art in CAOS research and development is given. Initial focus will be on image-interactive navigation based on preoperatively acquired three-dimensional tomographic image data sets. These techniques require intraoperatively a surgeon-generated transformation between the surgical object and the associated image based virtual object, the so-called registration procedure. Medical robots or free-hand navigation systems are then used to image-interactively perform various surgical actions. In addition, a novel approach to computer assisted orthopaedic surgery will be described, in which intraoperative images, such as ultrasound, endoscopy and fluoroscopy or ‘surgeon-defined anatomy’ complement or replace preoperatively acquired three-dimensional tomographic image data. Various applications for both strategies will be presented in different anatomical areas, such as spine, hip, shoulder, and knee. Surgical interventions ranging from joint reconstruction and replacement to trauma treatment will be covered.