Purpose: Surgical techniques must be evaluated before proceeding with widespread use. The evaluation system is usually copied after that used for drugs, relying on randomised trials. This system fails however to assess one dimension, i.e. quality control. The purpose of the present study was to demonstrate the usefulness of an evaluation technique taking into account the capacity to control the quality of a surgical procedure and determine the reliability, reproducibility, and controllability of the technique. This method of evaluation was applied to
Orthopaedic surgery residents typically learn total knee arthroplasty (TKA) through an apprenticeship-type model, which is a necessarily slow process. If residents could learn the required technical and cognitive skills more quickly, they could make better use of reduced hours in the operating room, surgeons could teach at a higher level, patients could have shorter operating times with better outcomes, and the healthcare system would have reduced costs and better-trained surgeons. Surgical skills courses, using artificial bones, have been shown to improve technical and cognitive skills significantly within a couple of days.
Introduction and Aims:
The clinical success and long-term outcomes of total knee arthroplasty (TKA) depend not only on the accuracy of femoral and tibial components positioning, but also on the restoration of a proper mechanical axis (MA). Coronal and rotational mal-alignment may affect significantly the final result of a knee replacement. Patient specific cutting guides and intra-operative
Malalignment of total knee arthroplasty components may affect implant function and lead to decreased survival, regardless of preferred alignment philosophy – neural mechanical axis restoration or kinematic alignment. A common technique is to set coronal alignment prior to adjusting slope. If the guide is not maintained in a neutral position, adjustment of the slope may alter coronal alignment. Different implant systems recommend varying degrees of slope for ideal function of the implant, from 0–7°. The purpose of this study was to quantify the change in coronal alignment with increasing posterior tibial slope comparing two methods of jig fixation. Prospective consecutive series of 100 patients undergoing total knee arthroplasty using computer navigation. First cohort of 50 patients had extramedullary cutting jig secured distally with ankle clamp and proximally with one pin and a second cohort of 50 patients with the jig secured distally with ankle clamp and proximally with two pins. The change in coronal alignment was recorded with each degree of increasing posterior slope from 0–7° using computer navigation. Mean coronal alignment and change in coronal alignment was compared between the two cohorts.Introduction
Methods
Acquiring adaptive soft-tissue balance is one of the most important factors in total knee arthroplasty (TKA). However, there have been few reports regarding to alteration of tolerability of varus/valgus stress between before and after TKA. In particular, there is no enough data about mid-flexion stability. Based on these backgrounds, it is hypothesized that alteration of varus/valgus tolerance may influence post-operative results in TKA. The purpose of this study is an investigation of in vivo kinematic analyses of tolerability of varus/valgus stress before and after TKA, comparing to clinical results. A hundred knees of 88 consecutive patients who had knees of osteoarthritis with varus deformity were investigated in this study. All TKAs (Triathlon, Stryker) were performed using computer assisted navigation system. The kinematic parameters of the soft-tissue balance, and amount of coronal relative movement between femur and tibia were obtained by interpreting kinematics, which display graphs throughout the range of motion (ROM) in the navigation system. Femoro-tibial alignments were recorded under the stress of varus and valgus before the procedure and after implantation of all components. In each ROM (0, 30, 60, 90, 120 degrees), the data of coronal relative movement between femur and tibia (tolerability) were analyzed before and after implantation. Furthermore, correlations between tolerability of varus/valgus and clinical improvement revealed by ROM and Knee society score (KSS) were analyzed by logistic regression analysis.Introduction
Materials and Methods
Computer assisted surgery (CAS) is used in trauma surgery to reduce radiation and improve accuracy but it is time consuming. Some trials for navigation in small bone fractures were made, but they are still experimental. One major problem is the fixation of the dynamic reference base for navigation. We evaluated the benefit of a new image based guidance-system (Surgix®, Tel Aviv, Israel) for fracture treatment in scaphoid bones compared to the conventional method without navigation. The system consists of a workstation and surgical devices with embedded radio opaque markers. These markers as well as the object of interest must be on the same C-arm shot. If a tool is detected in an image by the attached workstation additional information such as trajectories are displayed in the original fluoroscopic image to serve the surgeon as aiming device. The system needs no referencing and no change of the workflow. For this study 20 synthetic hand models (Synbone®, Malans, Switzerland) were randomised in two groups. Aim of this study was a central guide-wire placement in the scaphoid bone, which was blindly measured by using postoperative CT-scans. Significant distinctions related to the duration of surgery, emission of radiation, radiation dose, and trials of guide-wire positioning were observed. By using the system the surgery duration was with 50 % shortened (p = 0.0054) compared to the conventional group. One reason might be the significant reduction of trials to achieve a central guide-wire placement in the bone (p = 0.0032). Consequently the radiation exposure for the surgeon and the patient could be shortened by reduction of radiation emission (p = 0.0014) and radiation dose (p = 0.0019). By using the imaged based guidance system a reduction of surgery duration, radiation exposure for the patient and the surgeon can be achieved. By a reduced number of trials for achieving a central guide-wire position the risk of weakening the bone structure can be minimised as well by using the system. The system seems helpful where navigation is not applicable up to now. The surgical workflow does not have to be chanced.
Mean pain score improved 39.4 points, Knee Score improved 47.8 points, and the functional component improved 17.1 points. The pain score improvement for CAS was 39.2 compared to 33.0 for conventional knees (p<
0.002). The Knee Score improvement for CAS was 48.3 compared to 41.4 for conventional knees (p<
0.013). The functional component improvement was not significant between CAS and conventional TKA. When CAS is utilized along with the spring loaded tensioning device for ligament balancing, manipulation rates dropped to 7% (p<
0.01). There were a total of thirteen infections, three deep infections (0.3%) and ten superficial infections (1%). There were no fractures from the pin sites, and no patients were revised for instability.
Numerous studies have reported the importance of acetabular component positioning in decreasing dislocation rates, the risk of liner fractures, and bearing surface wear in total hip arthroplasty (THA). The goal of improving acetabular component positioning has led to the development of computer-assisted surgical (CAS) techniques, and several studies have demonstrated improved results when compared to conventional, freehand methods. Recently, a computed tomography (CT)-based robotic surgery system has been developed (MAKO™ Robotic Arm Interactive Orthopaedic System, MAKO Surgical Corp., Fort Lauderdale, FLA, USA), with promising improvements in component alignment and surgical precision. The purpose of this study was to compare the accuracy in predicting the postoperative acetabular component position between the MAKO™ robotic navigation system and an imageless, CAS system (AchieveCAS, Smith and Nephew Inc., Memphis, TN, USA). 30 THAs performed using the robotic navigation system (robotic cohort) were available for review, and compared to the most recent 30 THAs performed using the imageless, CAS system (CAS cohort). The final, intraoperative reading for acetabular abduction and anteversion provided by each navigation system was recorded following each THA. Einsel-Bild-Roentgen analysis was used to measure the acetabular component abduction and anteversion based on anteroposterior pelvis radiographs obtained at each patient's first, postoperative visit (Figure 1). Two observers, blinded to the treatment arms, independently measured all the acetabular components, and the results were assessed for inter-observer reliability. Comparing the difference between the final, intraoperative reading for both acetabular abduction and anteversion, and the radiographic alignment calculated using EBRA analysis, allowed assessment of the intraoperative predictive capability of each system, and accuracy in determining the postoperative acetabular component position. In addition, the number of acetabular components outside of the “safe zone” (40° + 10° of abduction, 15° + 10° of anteversion), as described by Lewinnek et al., was assessed. Lastly, the operative time for each surgery was recorded.Background:
Materials and Methods:
In recent years, some attempts have been made to develop a method that generates finite element (FE) models of the femur and pelvis using CT. However, due to the complex bone geometry, most of these methods require an excessive amount of CT radiation dosage. Here we describe a method for generating accurate patient-specific FE models of the total hip using a small number of CT scans in order to reduce radiation exposure. A previously reported method for autogenerating patient-specific FE models of the femur was extended to include the pelvis. CT osteodensitometry was performed on 3 patients who had hip replacement surgery and patient-specific FE models of the total hip were generated. The pelvis was generated with a new technique that incorporated a mesh morphing method called ‘host mesh fitting’. It used an existing generic mesh and then morphed it to reflect the patient specific geometry. This can be used to morph the whole pelvis, but our patient dataset was limited to the acetabulum. An algorithm was developed that automated all the procedures involved in the fitting process. Average error between the fitted mesh and patient specific data sets for the femur was less than 1mm. The error for the pelvis was about 2.5mm. This was when a total 18 CT scans with 10mm gap were used – 12 of the femur, and 6 of the pelvis. There was no element distortion and a smooth element surface was achieved. Previously, we reported a new method for automatically generating a FE model of the femur with as few CT scans as possible. Here we describe a technique that customizes a generic pelvis mesh to patient-specific data sets. Thus we have developed a novel hybrid technique which can generate an accurate FE model of the total hip using significantly less CT scans. An automated method of generating FE models for the total hip with reduced CT radiation exposure will be a valuable clinical tool for surgeons.
The Bernese periacetabular osteotomy (PAO) described by Ganz, et al. is a commonly used surgical intervention in hip dysplasia. PAO is being performed more frequently and is a viable alternative to hip arthroplasty for younger and more physically active patients. The procedure is challenging because pelvic anatomy is prohibitive to visibility and open access and requires four X-ray guided Diagnosis and the decision for surgical intervention is currently based upon patient symptoms, use of two-dimensional (2D) radiographic measurements, and the intrinsic experience of the surgeon. With the advent of new technologies allowing three-dimensional reconstructions of hip anatomy, previous two-dimensional X-ray definitions have created much debate in standardizing numerical representations of hip dysplasia. Recent work done by groups such as Arminger et al. have combined and expanded two-dimensional measurements such as Center-Edge (CE) angle of Wiberg, Vertical-Center-Anterior margin (VCA) angle, Acetabular Anteversion (AcetAV) and applied them to three-dimensional CT rendering of hip anatomy. Further, variability in pelvic tilt is a confounding factor and has further impeded measurement translatability. Computer assisted surgery (CAS) and navigation also called image-guided surgery (IGS) has been used in clinical cases of PAO with mixed results. The first appearing study of CAS/IGS in PAO was conducted by Langlotz, et. al 1997 and reported no clinical benefit to using CAS/IGS. However, they did conclude that the use of CAS/IGS is undoubtedly useful for surgeons starting this technically demanding procedure. This is supported by a more recent study done by Hsieh, et. al 2006 who conducted a two year randomised study of CAS/IGS in PAO and concluded its feasibility to facilitate PAO, but there was not an additional benefit when conventional PAO is done by an experienced surgeon. A study done by Peters, et. Al 2006 studying the learning curve necessary to become proficient at PAO found that “The occurrence of complications demonstrates a substantial learning curve” and thus makes a compelling argument for the use of CAS/IGS. A major obstacle to navigation and CAS/IGS revolves around consistency, intra-operative time and ease of use. Custom made guides and implants may help circumvent these limitations. The use of CAS/CAM in developing custom made guides has been proven very successful in areas of oral maxillofacial surgery, hip arthroplasty, and knee replacement surgeries. Additionally, a significant study in the development of rapid prototyping guides in the treatment of dysplastic hip joints was done by Radermacher et. al 1998. They describe a process of using CAS/CAM within the operational theatre using a desktop planning station and a manufacturing unit to develop what they termed as “templates” to carry out a triple osteotomy. Our group is evaluating and developing strategies in PAO using CAS/IGS and more recently using CAS and computer aided modeling (CAM) to develop custom made guides for acetabular positioning. Our first study (Burch et al.) focused on CAS/IGS in PAO using cadavers and yielded small mean cut (1.97± 0.73mm) and CE angle (4.9± 6.0) errors. Our recent study used full sized high-resolution foam pelvis models (Sawbones The APG we developed was to demonstrate the concept of using a positioning guide to obtain accurate rotation of the acetabular fragment. For a clinical application a refined and sleeker design would be required. Further, because working space within the pelvis is extraordinary constrained, once fitted the APG would need to remain and serve as an implantable cage capable of holding bone graft. A potential material is polyetheretherketone (PEEK). Customised PEEK implants and cages have been established in the literature and is a potential option for PAO. The benefits of an implant not only serve to constrain the acetabular fragment in the Though CAS/IGS is a proven viable option, we envision a potentially simpler method for PAO, the use of a cut guide and an acetabular positioning implant. Using customized guides and implants could potentially circumvent the need for specialised intra-operative equipment and the associated learning curves, by providing guides that incorporate the pre-operational plan within the guide, constraining the surgeon to the desired outcome.
Recently, several preliminary reports have been issued on the application of computer assistance to bone tumour surgery. Surgical navigation systems can apply three-dimensional images such as CT and MR images to intraoperative visualization. Although CT is better at describing cortical bone status, MRI is considered the best method for defining the extent of marrow involvement for bone tumours and for planning surgical resection in bone tumour surgery. There have been a few reports on the application of MR imaging to navigation-assisted bone tumour surgery through CT–MR image fusion. However, the CT–MRI fusion technique requires additional costs and exposure of the patient to radiation from the preoperative CT, as well as additional time for image fusion. Above all, the image fusion process is a kind of registration (image to image registration) that inevitably leads to registration error. Herein we describe a new method for the direct application of MR images to navigation-assisted bone tumour surgery as an alternative to CT–MRI fusion. Six patients with an orthopaedic malignancy were employed for this method during navigation-assisted tumour resection. Resorbable pin placement and rapid 3-dimensional spoiled gradient echo sequences made the direct application of MR images to
The hip centre (HC) in Computer Assisted Orthopedic Surgery (CAOS) can be determined either with anatomical (AA) or functional approaches (FA). AA is considered as the reference while FA compute the hip centre of rotation (CoR). Four main FA can be used in CAOS: the Gammage, Halvorsen, pivot, and least-moving point (LMP) methods. The goal of this paper is to evaluate and compare with an in-vitro experiment (a) the four main FA for the HC determination, and (b) the impact on the HKA. The experiment has been performed on six cadavers. A CAOS software application has been developed for the acquisitions of (a) the hip rotation motion, (b) the anatomical HC, and (c) the HKA angle. Two studies have been defined allowing (a) the evaluation of the precision and the accuracy of the four FA with respect to the AA, and (b) the impact on the HKA angle. For the pivot, LMP, Gammage and Halvorsen methods respectively: (1) the maximum precision reach 14.2, 22.8, 111.4 and 132.5 mm; (2) the maximum accuracy reach 23.6, 40.7, 176.6 and 130.3 mm; (3) the maximum error of the frontal HKA is 2.5°, 3.7°, 12.7° and 13.3°; and (4) the maximum error of the sagittal HKA is 2.3°, 4.3°, 5.9°, 6.1°. The pivot method is the most precise and accurate approach for the HC localisation and the HKA computation.
A number of advantages of unicondylar arthroplasty (UKA) over total knee arthroplasty in patients presenting osteoarthritis in only a single compartment have been identified in the literature. However, accurate implant positioning and alignment targets, which have been shown to significantly affect outcomes, are routinely missed by conventional techniques. Computer Assisted Orthopaedic Surgery (CAOS) has demonstrated its ability to improve implant accuracy, reducing outliers. Despite this, existing commercial systems have seen extremely limited adoption. Survey indicates the bulk, cost, and complexity of existing systems as inhibitive characteristics. We present a concept system based upon small scale head mounted tracking and augmented reality guidance intended to mitigate these factors. A visible-spectrum stereoscopic system, able to track multiple fiducial markers to 6DoF via photogrammetry and perform semi-active speed constrained resection, was combined with a head mounted display, to provide a video-see-through augmented reality system. The accuracy of this system was investigated by probing 180 points upon a 110×110×50 mm known geometry and performing controlled resection upon a 60×60×15 mm bone phantom guided by an overlaid augmented resection guide that updated in real-time. The system produced an RMS probing accuracy and precision of 0.55±0.04 and 0.10±0.01 mm, respectively. Controlled resection resulted in an absolute resection error of 0.34±0.04 mm with a general trend of over-resection of 0.10±0.07 mm. The system was able to achieve the sub-millimetre accuracy considered necessary to successfully position unicondylar knee implants. Several refinements of the system, such as pose filtering, are expected to increase the functional volume over which this accuracy is obtained. The presented system improves upon several objections to existing commercial CAOS UKA systems, and shows great potential both within surgery itself and its training. Furthermore, it is suggested the system could be readily extended to additional orthopaedic procedures requiring accurate and intuitive guidance.
Despite being demonstrably better than conventional surgical techniques with regards to implant alignment and outlier reduction, computer navigation systems have not faced widespread adoption in surgical operating rooms. We believe that one of the reasons for the low uptake stems from the bulky design of the optical tracker assemblies. These trackers must be rigidly fixed to a patient's bone and they occupy a significant portion of the surgical workspace, which makes them difficult to use. In this study we introduce the design for a new optical tracker system, and subsequently we evaluate the tracker's performance. The novel tracker consists of a set of low-profile flexible pins that can be placed into a rigid body and individually deflect without greatly affecting the pose estimation. By relying on a pin's stiff axial direction while neglecting lateral deviations, we can gain sufficient constraint over the underlying body. We used an unscented Kalman filter based algorithm as a recursive body pose estimator that can account for relative marker displacements. We assessed our tracker's performance through a series of simulations and experiments inspired by a total knee arthroplasty. We found that the flexible tracker performs comparably to conventional trackers with regards to accuracy and precision, with tracking errors under 0.3mm for typical operating conditions. The tracking error remained below 0.5mm during pin deflections of up to 40mm. Our algorithm ran at computation speeds greater than real-time at 30Hz which means that it would be suitable for use in real-time applications. We conclude that this flexible pin concept provides sufficient accuracy to be used as a replacement for rigid trackers in applications where its lower profile, its reduced invasiveness and its robustness to deflection are desirable characteristics.