Problem

Total hip replacement (THA) is among the most common and highest total spend elective operations in the United States. However, up to 7% of patients have 90-day complications after surgery, most frequently joint dislocation that is related to poor acetabular component positioning. These complications lead to patient morbidity and mortality, as well as significant cost to the health system. As such, surgeons and hospitals value navigation technology, but existing solutions including robotics and optical navigation are costly, time-consuming, and complex to learn, resulting in limited uptake globally.

Introduction

Total Hip Arthroplasty has been shown to have excellent long term outcomes, yet early reoperation remains a risk. The current study assesses the incidence, causes, and cost associated with early revision following elective primary THA in the US Medicare population.

Aims

The practice of alternating operating theatres has long been used to reduce surgeon idle time between cases. However, concerns have been raised as to the safety of this practice. We assessed the payments and outcomes of total knee arthroplasty (TKA) performed during overlapping and nonoverlapping days, also comparing the total number of the surgeon’s cases and the total time spent in the operating theatre per day.

Background

Defining optimal coronal alignment in Total Knee Replacement (TKR) is a controversial and poorly understood subject. Tibial bone density may affect implant stability and functional outcomes following TKR. Our aim was to compare the bone density profile at the implant-tibia interface following TKR in mechanical versus kinematic alignment.

Tibial bone density may affect implant stability and functional outcomes following total knee replacement (TKR). Our aim was to characterise the bone density profile at the implant-tibia interface following TKR in mechanical versus kinematic alignment. Pre-operative computed tomography scans for 10 patients were obtained. Using surgical planning software, tibial cuts were made for TKR either neutral (mechanical) or 3 degrees varus (kinematic) alignment. Signal intensity, in Hounsfield Units (HU), was measured at 25,600 points throughout an axial slice at the implant-tibia interface and density profiles compared along defined radial axes from the centre of the tibia towards the cortices. From the tibial centre towards the lateral cortex, trabecular bone density for kinematic and mechanical TKR are similar in the inner 50% but differ significantly beyond this (p= 0.012). There were two distinct density peaks, with peak trabecular bone density being higher in kinematic TKR (p<0.001) and peak cortical bone density being higher in mechanical TKR (p<0.01). The difference in peak cortical to peak trabecular signal was 43 HU and 185 HU respectively (p<0.001). On the medial side there was no significant difference in density profile and a linear increase from centre to cortex. In the lateral proximal tibia, peak cortical and peak trabecular bone densities differ between kinematic TKR and mechanical TKR. Laterally, mechanical TKR may be more dependent upon cortical bone for support compared to kinematic TKR, where trabecular bone density is higher. This may have implications for surgical planning and implant design.

Background

The accurate positioning of the total knee arthroplasty affects the survival of the implants(1). Alignment of the femoral component in relation to the native knee is best determined using pre- and post-operative 3D-CT reconstruction(2). Currently, the scans are visualised on separate displays. There is a high inter- and intra-observer variability in measurements of implant rotation and translation(3). Correct alignment is required to allow a direct comparison of the pre- and post-operative surfaces. This is prevented by the presence of the prostheses, the bone shape alteration around the implant, associated metal artefacts, and possibly a segmentation noise.

BACKGROUND

Trochlear geometry of modern femoral implants is designed for the mechanical alignment (MA) technique for Total Knee Arthroplasty (TKA). The biomechanical goal is to create a proximalised and more valgus trochlea to better capture the patella and optimize tracking. In contrast, Kinematic alignment (KA) technique for TKA respects the integrity of the soft tissue envelope and therefore aims to restore native articular surfaces, either femoro-tibial or femoro-patellar. Consequently, it is possible that current implant designs are not suitable for restoring patient specific trochlea anatomy when they are implanted using the kinematic technique. This could cause patellar complications, either anterior knee pain, instability or accelerated wear or loosening. The aim of our study is therefore to explore the extent to which native trochlear geometry is restored when the Persona^® implant (Zimmer, Warsaw, USA) is kinematically aligned.

BACKGROUND

Conventional TKA surgery attempts to restore patients to a neutral alignment, and devices are designed with this in mind. Neutral alignment may not be natural for many patients, and may cause dissatisfaction [1]. To solve this, kinematical alignment (KA) attempts to restore the native pre-arthritic joint-line of the knee, with the goal of improving knee kinematics and therefore patient's function and satisfaction [1].

Proper prosthetic trochlea alignment is important to prevent patella complications such as instability or loosening. However, available TKA components have been designed for mechanical implantation, and concerns remain relating the orientation of the prosthetic trochlea when implants are kinematically positioned. The goal of this study is to investigate how a currently available femoral component restores the native trochlear geometry of healthy knees when virtually placed in kinematic alignment.

Trochlear geometry of modern femoral implants is designed for mechanical alignment (MA) technique for TKA. The biomechanical goal is to create a proximalised and more valgus trochlea to better capture the patella and optimize tracking. In contrast, Kinematic alignment (KA) technique for TKA respects the integrity of the soft tissue envelope and therefore aims to restore native articular surfaces, either femoro-tibial or femoro-patellar. Consequently, it is possible that current implant designs are not suitable for restoring patient specific trochlea anatomy when they are implanted using the kinematic technique, this could cause patellar complications, either anterior knee pain, instability or accelerated wear or loosening. The aim of our study is therefore to explore the extent to which native trochlear geometry is restored when the Persona^®implant (Zimmer, Warsaw, USA) is kinematically aligned.

A retrospective study of a cohort of 15 patients with KA-TKA was performed with the Persona^®prosthesis (Zimmer, Warsaw, USA). Preoperative knee MRIs and postoperative knee CTs were segmented to create 3D femoral models. MRI and CT segmentation used Materialise Mimics and Acrobot Modeller software, respectively. Persona^®implants were laser scanned to generate 3D implant models. Those implant models have been overlaid on the 3D femoral implant model (generated via segmentation of postoperative CTs) to replicate, in silico, the alignment of the implant on the post-operative bone and to reproduce in the computer models the features of the implant lost due to CT metal artefacts. 3D models generated from post-operative CT and pre-operative MRI were registered to the same coordinate geometry. A custom written planner was used to align the implant, as located on the CT, onto the pre-operative MRI based model. In house software enabled a comparison of trochlea parameters between the native trochlea and the performed prosthetic trochlea. Parameters assessed included 3D trochlear axis and anteroposterior offset from medial facet, central groove, and lateral facet. Sulcus angle at 30% and 40% flexion was also measured. Inter and intra observer measurement variabilities have been assessed.

Varus-valgus rotation between the native and prosthetic trochleae was significantly different (p<0.001), with the prosthetic trochlear groove being on average 7.9 degrees more valgus. Medial and lateral facets and trochlear groove were significantly understuffed (3 to 6mm) postoperatively in the proximal two thirds of the trochlear, with greatest understuffing for the lateral facet (p<0.05). The mean medio-lateral translation and internal-external rotation of the groove and the sulcus angle showed no statistical differences, pre and postoperatively.

Kinematic alignment of Persona^®implants poorly restores native trochlear geometry. Its clinical impact remains to be defined.

Conventional TKA surgery attempts to restore patients to a neutral alignment, and devices are designed with this in mind. Neutral alignment may not be natural for many patients, and may cause dissatisfaction. To solve this, kinematical alignment (KA) attempts to restore the native pre-arthritic joint-line of the knee, with the goal of improving knee kinematics and therefore patient's function and satisfaction.

Proper prosthetic trochlea alignment is important to prevent patella complications such as instability or loosening. However, available TKA components have been designed for mechanical implantation, and concerns remain relating the orientation of the prosthetic trochlea when implants are kinematically positioned. The goal of this study is to investigate how a currently available femoral component restores the native trochlear geometry of healthy knees when virtually placed in kinematic alignment.

The healthy knee OAI (Osteoarthritis Initiative) MRI dataset was used. 36 MRI scans of healthy knees were segmented to produce models of the bone and cartilage surfaces of the distal femur. A set of commercially available femoral components was laser scanned. Custom 3D planning software aligned these components with the anatomical models: distal and posterior condyle surfaces of implants were coincident with distal and posterior condyle surfaces of the cartilage; the anterior flange of the implant sat on the anterior cortex; the largest implant that fitted with minimal overhang was used, performing ‘virtual surgery’ on healthy subjects.

Software developed in-house fitted circles to the deepest points in the trochlear grooves of the implant and the cartilage. The centre of the cartilage trochlear circle was found and planes, rotated from horizontal (0%, approximately cutting through the proximal trochlea) through to vertical (100%, cutting through the distal trochlea) rotated around this, with the axis of rotation parallel to the flexion facet axis. These planes cut through the trochlea allowing comparison of cartilage and implant surfaces at 1 degree increments. Trochlear groove geometry was quantified with (1) groove radial distance from centre of rotation cylinder (2) medial facet radial distance (3) lateral facet radial distance and (4) sulcus angle, along the length of the trochlea. Data were normalised to the mean trochlear radius. The orientation of the groove was measured in the coronal and axial plane relative to the flexion facet axis. Inter- and intra-observer reliability was measured.

In the coronal plane, the implant trochlear groove was oriented a mean of 8.7° more valgus (p<0.001) than the normal trochlea. The lateral facet was understuffed most at the proximal groove between 0–60% by a mean of 5.3 mm (p<0.001). The medial facet was understuffed by a mean of 4.4 mm between 0–60% (p<0.001).

Despite attempts to design femoral components with a more anatomical trochlea, there is significant understuffing of the trochlea, which could lead to reduced extensor moment of the quadriceps and contribute to patient dissatisfaction.

The accurate positioning of the total knee arthroplasty affects the survival of the implants(1). Alignment of the femoral component in relation to the native knee is best determined using pre- and post-operative 3D-CT reconstruction(2). Currently, the scans are visualised on separate displays. There is a high inter- and intra-observer variability in measurements of implant rotation and translation(3). Correct alignment is required to allow a direct comparison of the pre- and post-operative surfaces. This is prevented by the presence of the prostheses, the bone shape alteration around the implant, associated metal artefacts, and possibly a segmentation noise.

The aim is to create a novel method to automatically register pre- and post-operative femora for the direct comparison of the implant and the native bone.

The concept is to use post-operative femoral shaft segments free of metal noise and of surgical alteration for alignment with the pre-operative scan. It involves three steps. Firstly, using principal component analysis, the femoral shafts are re-oriented to match the X axis. Secondly, variants of the post-operative scan are created by subtracting 1mm increments from the distal femoral end. Thirdly, an iterative closest point algorithm is applied to align the variants with the pre-operative scan.

For exploratory validation, this algorithm was applied to a mesh representing the distal half of a 3D scanned femur. The mesh of a prosthesis was blended with the femur to create a post-operative model. To simulate a realistic environment, segmentation and metal artefact noise were added. For segmentation noise, each femoral vertex was translated randomly within +−1mm,+−2mm,+−3mm along its normal vector. To create metal artefact random noise was added within 50 mm of the implant points in the planes orthogonal to the shaft. The alignment error was considered as the average distance between corresponding points which are identical in pre- and post-operative femora.

These preliminary results obtained within a simulated environment show that by using only the native parts of the femur, the algorithm was able to automatically register the pre- and post-operative scans even in presence of the implant. Its application will allow visualisation of the scans on the same display for the direct comparison of the perioperative scans.

This method requires further validation with more realistic noise models and with patient data. Future studies will have to determine if correct alignment has any effect on inter- and intra-observer variability.

Patellofemoral joint (PFJ) arthroplasty is traditionally performed using mechanical jigs to align the components, and it is hard to fine tune implant placement for the individual patient. These replacements have not had the same success rate as other forms of total or partial knee replacement surgery1.

Our team have developed a computer assisted planning tool that allows alignment of the implant based on measurements of the patient's anatomy from MRI data with the aim of improving the success of patellofemoral joint arthroplasty.

When planning a patellofemoral joint arthroplasty, one must start from the premise that the original joint is either damaged as a result of osteoarthritis, or is dysplastic in some way, deviating from a normal joint. The research aimed to plan PFJ arthroplasty using knowledge of the relationship between a normal PFJ (trochlear groove, trochlea axis and articular surfaces) and other aspects of the knee2, allowing the plan to be estimated from unaffected bone surfaces, within the constraints of the available trochlea.

In order to establish a patient specific trochlea model a method was developed to automatically compute an average shape of the distal femur from normal distal femur STL files (Fig.1). For that MRI scans of 50 normal knees from osteoarthritis initiative (OAI) study were used. Mimics and 3-matic software (Materialise) packages were used for segmentation and analysis of 3D models. Spheres were fitted to the medial and lateral flexion facets for both average knee model and patient knee model. The average knee was rescaled and registered in order to match flexion facet axis (FFA) distance and FFA midpoint of the patient (Fig.2). The difference between the patient surface and the average knee surface allow to plan the patella groove alteration.

The Patella cut is planned parallel to the plane fitted to the anterior surface of the patella. The patella width/thickness ratio (W/T=2) is used to predict the post reconstruction thickness3. The position of the patella component (and its orientation if a component with a median ridge is used) is also planned.

The plan is next fine-tuned to achieve satisfactory PFJ kinematics4 (Fig.3). This will be complemented by intraoperative PFJ tracking which assists with soft tissue releases. PFJ kinematics is evaluated in terms of patella shift, tilt and deviation from the previously described circular path of the centre of the patella.

The effect of preoperative planning on PFJ tracking and soft tissue releases is being examined. Additional study is needed to evaluate whether planning and intraoperative kinematic measurements improve the clinical outcome of PFJ arthroplasty.

Introduction

The trochlea of a typical patellofemoral replacement or anterior flange of a total knee replacement usually extends past the natural trochlea and continues onto the femoral anterior cortex. One reason for this is that it allows a simple patella button to be permanently engaged in the trochlea groove in an attempt to ensure stability. On the natural patella, the apex helps to guide it into the trochlea groove as the knee moves from full extension into flexion.

The aim is to study whether a generalised patella can be created that is close in form to a healthy patella.

Introduction

Patient Specific Instrumentation (PSI) has the potential to allow surgeons to perform procedures more accurately, at lower cost and faster than conventional instrumentation. However, studies using PSI have failed to convincingly demonstrate any of these benefits clinically. The influence of guide design on the accuracy of placement of PSI has received no attention within the literature.

Our experience has suggested that surgeons gain greater benefit from PSI when undertaking procedures they are less familiar with. Lateral unicompartmental knee replacement (UKR) is relatively infrequently performed and may be an example of an operation for which PSI would be of benefit. We aimed to investigate the impact on accuracy of PSI with respect to the area of contact, the nature of the contact (smooth or studded guide surfaces) and the effect of increasing the number of contact points in different planes.

Introduction

We report 10-year clinical outcomes of a prospective randomised controlled study on uni-compartmental knee arthroplasty using an active constraint robot.

Measuring the clinical impact of CAOS systems has generally been based around surrogate radiological measures with currently few long-term functional follow-up studies reported. We present 10 year clinical follow up results of robotic vs conventional surgery in UKA.

Large heads offer substantial advantages over small ones in hip arthroplasty, as they are far less likely to dislocate. This feature is of particular benefit in very dysplastic females who often have a degree of joint laxity making dislocation a real possibility. Large metal heads have a range of problems, so registries report that they are now being substituted by large ceramic heads, typically reducing in diameter by 15% or more from the native size.

All current designs of the femoral ball heads, whether for resurfacing of replacement share a unique design characteristic: a subtended angle of 120° defining the proportion of a sphere that the head represents. A novel design has recently been proposed that might reduce conflict between the femoral ball head rim and the iliopsoas tendon. This paper explains the problem of iliopsoas impingement on femoral heads of native diameter, and the consequences.

Outcome measures are an essential element of our industry: comparing a novel procedure against an established one requires a reliable set of metrics that are comprehensible to both the technologist and the layman.

We surmised that a detailed assessment of function before and after knee arthroplasty, combined with a detailed set of personal goals would enable us to test the hypothesis that less invasive joint and ligament preserving operations could be demonstrated to be more successful, and cost effective. We asked the simple question: how well can people walk following arthroplasty, and can we measure this?

INTRODUCTION:

The 3D shape of the normal proximal femur is poorly described in current designs of proximal femur prosthesis. Research has shown that in current implant designs with small diameter femoral heads the moment arm of the ilio-psoas tendon is reduced causing weakness in full extension, while large femoral heads cause psoas tendon impingement on the femoral head neck junction [1]. The femoral head-neck junction thus directly influences the hip flexor muscles' moment arm. Mathematical modeling of proximal femoral geometry allowed a novel proximal femur prosthesis to be developed that takes into account native anatomical parameters. We hypothesized that it is possible to fit a quadratic surface (e.g. sphere, cylinder…) or combinations of them on different bone surfaces with a relatively good fit.

Introduction:

Varus alignment of the knee is common in patients undergoing unicondylar knee replacement. To measure the geometry and morphology of these knees is to know whether a single unicondylar knee implant design is suitable for all patients, i.e. for patients with varus deformity and those without. The aim of this study was to identify any significant differences between normal and varus knees that may influence unicondylar implant design for the latter group.

Introduction:

Cam type femoroacetabular impingement (FAI) may lead to osteoarthritis (OA)[1]. In 2D studies, an alpha angle greater than 55° was considered abnormal however limitations of 2D alpha angle measurement have led to the development of 3D methods [2–4]. Failure to completely address the bony impingement lesions during surgery has been the most common reason for unsuccessful hip arthroscopy surgery [5]. Robotic technology has facilitated more accurate surgery in comparison to the conventional means. In this study we aim to assess the potential application of robotic technology in dealing with this technically challenging procedure of cam sculpting surgery.

Acetabular and pelvic fractures are amongst the most challenging to treat, still requiring major open surgery. The operations to reduce and fix them entail lengthy operative time, significant blood loss and use of ionising radiation.

We report on the initial stages of developement of a minimally invasive method for navigated reduction and percutaneous fixation of acetabular fractures (NRFA). A commercial navigation platform (Acrobot Ltd.) will be adapted for use with this technique. CT based planning will be used to identify the correct realignment of the the bone fragments, which will then be reduced percutaneously with the aid of two tracked arms attached to the navigation system. Schanz pins, which are inserted in pre-operatively planned sites in each fragment using safe trajectories, are handled as joysticks to manipulate the fracture under computer assistance. Registration of the fragments after insertion of the joysticks will be carried out by means of fluoroscopic images of the AP and Judet views of the fractured acetabulum. Once reduction is achieved by following on-screen instructions, the joysticks are held in place by a custom clamping system connected to one of the arms, while the other is used for percutaneous insertion of column screws.

This technique is potentially suitable for a number of acetabular fractures which include transverse, anterior column, posterior column, T-fractures and some associated both columns fractures. These constitute over 50% of Letournel’s and 60% of Matta’s original series of acetabular fractures. Furthermore, this percutaneous technique could reduce bleeding, wound complications, hospital stay and cost of treatment. Intra operative ionising radiation would be greatly reduced for both patients and the surgeons.

Adequate training with the use of this software may provide a greater number of surgeons the capability to surgically treat these complex fractures.

A Prospective, randomised controlled trial demonstrates superior outcomes using an active constraint robot compared with conventional surgical technique in unicompartmental knee arthroplasty (UKA). Computer assistance should extinguish outliers in arthroplasty, with robotic systems being able to execute the preoperative plan with millimetre precision.

We used the Acrobot system to deliver tailor made surgery for each individual patient. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly assigned to have the operation performed either with the assistance of the Acrobot or conventionally. CT scans were obtained with coarse slices through hips and ankles and fine slices through the knee joint. Preoperative 3D plans were made and transferred to the Acrobot system in theatre, or printed out as a conventional surgical aid. Accurate co-registration was confirmed, prior to the surfaces of the femur and tibia being milled. The outcome parameters included measurements of the American Knee Society (AKS) score and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. These measurements were performed pre-operatively and at six, 18 weeks, and 18 months post-operatively. After 18 months two UKA out of the conventional trial (n =15) had been revised into a total knee replacement (TKA), whereas there were no revisions in the Acrobot trial group (n = 13).

Using an active constrained robot to assist the surgeon was significantly more accurate than the conventional surgical technique. This study has shown a direct correlation between accuracy and improvement in knee scores at 6, 18 weeks and 18 months after surgery. At 18 months there continues to be a significant improvement in the knee scores with again a marked correlation between radiological accuracy and clinical outcome with higher accuracy leading to better function based on the WOMAC and American Knee Society Score.

Whilst computer assistance enables more accurate arthroplasty to be performed, demonstrating this is difficult. The superior results of CAOS systems have not been widely appreciated because accurate determination of the position of the implants is impossible with conventional radiographs for they give very little information outside their plane of view.

We report on the use of low dose (approximately a quarter of a conventional pelvic scan), low cost CT to robustly measure and demonstrate the efficacy of computer assisted hip resurfacing. In this study we demonstrate 3 methods of using 3D CT to measure the difference between the planned and achieved positions in both conventional and navigated hip resurfacing.

The initial part of this study was performed by imaging a standard radiological, tissue equivalent phantom pelvis. The 3D surface models extracted from the CT scan were co-registered with a further scan of the same phantom. Subsequently both the femoral and acetabular components were scanned encased in a large block of ice to simulate the equivalent Hounsfield value of human tissue. The CT images of the metal components were then co-registered with their digital images provided by the implant manufactures. The accuracy of the co-registration algorithm developed here was shown to be within 0.5mm.

This technique was subsequently used to evaluate the accuracy of component placement in our patients who were all pre-operatively CT scanned. Their surgery was digitally planned by first defining the anterior pelvic plane (APP), which is then used as the frame of reference to accurately position and size the wire frame models of the implant. This plan greatly aids the surgeon in both groups and in the computer assisted arm the Acrobot Wayfinder uses this pre-operative plan to guide the surgeon.

Following surgery all patients, in both groups were further CT scanned to evaluate the achieved accuracy. This post-operative CT scan is co-registered to the pre-operative CT based plan. The difference between the planned and achieved implant positions is accurately computed in all three planes, giving 3 angular and 3 translational numerical values for each component.

Further analysis of the CT generated results is used to measure the implant intersection volume between the pre-operatively planned and achieved positions. This gives a single numerical value of placement error for each component. These 3D CT datasets have also been used to quantify the volume of bone resected in both groups of patients comparing the simulated resection of the planned position of the implant to that measured on the post-operative CT.

This study uses 3D CT as a surrogate outcome measure to demonstrate the efficacy of CAOS systems.

Last year at CAOS UK we reported on the development of the Acrobot® Navigation System for accurate computer-assisted hip resurfacing surgery. This paper describes the findings of using the system in the clinical setting and includes the improvements that have been made to expedite the procedure. The aim of our system is to allow accurate planning of the surgery and precise placement of the prosthesis in accordance with the plan, with a zero intra-operative time penalty in comparison to the standard non-navigated technique.

The system uses a pre-operative CT-based plan to allow the surgeon to have full 3D knowledge of the patient’s anatomy and complete control over the sizes and positions of the components prior to surgery.

At present the navigation system is undergoing final clinical evaluation prior to a clinical study designed to demonstrate the accuracy of outcome compared with the conventional technique. Whilst full results are not yet available, this paper describes the techniques that are being used to evaluate accuracy by comparing pre-operative CT-based plans with post-operative CT scans, and gives initial results.

This approach provides a true measure of procedure outcome by measuring what was achieved against what was planned in 3D. The measure includes all the sources of error present within the procedure protocol, therefore these results represent the first time that the outcome of a navigated orthopaedic procedure has been measured accurately.

Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image.

There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area.

By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant position on outcome with greater precision.

We used computer tomography (CT) to measure the outcome of knee-arthroplasty in our prospective double-blind randomised controlled study of our active constraint robotic system ACROBOT.

All patients in our trial had pre-operative CT scan and proprietary software used to plan the size, position and orientation of the implants. Post operatively a further CT scan was performed and measurement studies performed using 3 different methods of manipulating the CT dicom data.

Method 1, a quick and simple method of implant assessment that measures the varus-valgus orientation of the implants relative to the axes of the long bones

Two landmarks each are used to define the individual mechanical axis for both the femur and tibia, for consistency these landmarks are the very ones used in the planning stage on the pre-operative CT.

Landmarks are then placed on the implants in order to measure their tilt relative to the mechanical axes. An appropriate Hounsfield threshold (2800) was used to image the metal components. The angle between the individual mechanical axis and the prosthetic component was calculated.

Method 2, detailed and accurate comparisons between the planned and achieved component positions in 3D are made. Co-registration of the precisely planned CT based models with surface models from the post-op scan gives real measurements of implant position enabling the measurement of the accuracy of component in an all six degrees of freedom giving both translation and rotation errors in all three planes.

The process of alignment was achieved by surface-to-surface registration. An implementation of the iterative closest point algorithm was used to register matching surfaces on the objects to be registered. A polygon mesh of the implant, provided by the manufacturer, defined the surface shape of each size of implant. This was used both to define the planned position and to register to the post-operative scan. Method 3, in this study we quantified post-operative error in knee arthroplasty using one value for each component whilst retaining 3D perspective.

The position of the prosthetic components in the post-op scan is calculated and individual transformation matrix computed which is matched to the transformation matrices for the planned components.

The pre-operative CT based component positions were co-registered to the post-operative CT scan and values for the intersection (volumetric) between the digitised images (both planned and achieved) were calculated. Both the co-registered femoral and tibial component’s intersection was quantified with software packages supporting Boolean volume analysis

Method 1, the sum of the two, independently measured, angles allows an estimate of the post-operative alignment of the load bearing axes in the two bones.

Method 2, 3D CT allows precise measurements of the achieved position for each component in all three planes. Six values, three angular and three translational, define the achieved component position relative to the planned position.

Method 3, the greater the percentage intersection between the planned and achieved images, the greater the accuracy of the surgery. Owing to the shape of the components (large articular surface) large intersections demonstrate more accurate reconstruction of the joint line.

In the recent past the lack of a sufficiently accurate tool to plan and measure the accuracy of component placement has resulted in an inability to detect and study radiological and functional outliers and hence the hypnotised relationship between prosthetic joint placement and outcome has been difficult to prove.

CT offers us the ability to accurately describe the actual position and deviation from plan of component placement in knee arthroplasty. Whilst X-ray has the intrinsic problems of perspective distortion magnification errors and orientation uncertainties CT can be used to define ‘true’ planes for two dimensional (2D) measurements and permits the comparison in three dimensions (3D) between the planned and achieved component positions.

Hip resurfacing has advantages over hip replacement for younger, more active patients. However, it requires that surgeons learn new techniques for correctly cutting bone and positioning the components. Pre-operative planning systems exist for conventional hip replacement. Planning software for hip resurfacing is described, with the resulting plans available as a visual aid during surgery, or transferred to the Acrobot^® Navigation system for intra-operative guidance.

CT data is acquired from the top of the pelvis to immediately above the acetabulae in 4 mm slices, and from there down to just below the lesser trochanter in one mm slices. This keeps radiation doses low while providing high image quality in the important regions for planning. This is segmented semi-automatically, and bone surface models are generated.

Frames of reference are generated for the pelvis and femur, and the acetabular and femoral head positions are computed relative to these.

Prosthesis components are initially positioned and sized to match the computed anatomy. They can then be adjusted as required by the surgeon. While adjusting their positions, he is able to visualize their fit onto the bone to ensure good placement without problems such as femoral neck notching.

Twenty one hip resurfacings have been planned including two navigated cases. In addition, visualization of hip geometry for osteotomy and impingement debridement has been performed on 14 cases, giving the surgeon a good understanding of hip geometry prior to surgery. Initial evidence indicates surgeons find the planner useful, particularly when the anatomy is not straightforward.

Accurately planning the intervention and precisely measuring outcome in computer assisted orthopaedic surgery (CAOS) is essential for it permits robust analysis of the efficacy of these systems.

We demonstrate the use of low dose computer tomography (CT) radiation for both the planning and outcome measurement of robotic and conventionally performed knee arthroplasty.

Studies were initially performed on a human phantom pelvis and lower limb. The mAs (milliampere seconds) were varied from 120 to 75 at the pelvis and from 100 to 45 for both the knee and ankle whilst keeping the kV (kilovolt) between 120 and 140. Image quality was evaluated at the different doses.

The volumes scanned were defined on the scout film; they included the whole femoral head (0.5cm above and below the head), 20cm at the knee (10cm on either side of the joint line) and 5cm at the ankle (the distal tibia and the talus). Effective dose (mSv) was calculated using two commercially available software packages. This protocol was subsequently used to image patients in our prospective double-blind randomised controlled study of our active constraint robotic system ACRO-BOT.

With the reduction in the mA and scanned volume the effective dose was reduced to 0.761 mSv in females and 0.497 mSv in males whilst maintaining a sufficient image resolution for our purposes. We found that a mAs of 80 for the hip joint, 100 for the knee and 45 for the ankle was sufficient for imaging in both pre-op planning and pos-operative assessment in knee arthroplasty. This contributed on an average effective dose to the hip of 0.61 mSv, the knee 0.120 mSv and to the ankle 0.0046 mSv.

The results of our study show that we have considerably reduced the effective dose (0.8 mSv) to one third of the Perth Protocol (2.5mSv) by reducing the areas of the body scanned and adjusting the mA for the various parts of the body whist maintaining the x, y and z axis throughout the scan. The areas between the knee, hip and ankle that were not exposed to radiation are not strictly necessary for the planning of knee arthroplasty, but it is essential that the leg does not move during the scanning process. In order to prevent this leg was placed in a radiolucent splint. For post op three dimensional (3D) assessments only the knee component of the protocol is necessary.

This paper presents initial results of the Acrobot® Navigation System for Minimally Invasive (MI) Hip Resurfacing (HR) which addresses the problems of conventional HR. The system allows true MI HR – mini-mising the incision and tissue retraction required, and conservation of bone in contrast to other MI total hip procedures.

Pre-operative CT-based software allows the surgeon to plan the operation accurately. Use of CT gives the greatest accuracy, and is the only method which can give an accurate assessment of procedure outcome (planned versus achieved implant position). Intra-operatively, the bones are registered by touching points using a probe connected to a digitising arm. Next a series of tools is connected so that bone preparation and implant insertion is performed using on-screen guidance.

The accuracy of the registration probe is within 0.6mm, inside the acceptable margin for optical tracker systems. We have validated this acceptability using registration simulations leading to a protocol which restricts registration errors to within 1.5mm and three degree. These error margins are within those in the literature for acetabular component placement using optical tracker based systems (five degree inclination, six degree anteversion). No comparable data could be found regarding the accuracy of femoral component placement during computer-assisted HR.

The system is currently undergoing clinical tests at one alpha site, with three further beta sites planned for early 2006. The methods described by Henckel et al (CAOS International Proceedings 1994, pp. 281–282) are being used to evaluate the performance of the system, comparing pre-operative to post-operative CTs to obtain a true, accurate measure of performance.

The primary objective of this study was to evaluate the performance of the Acrobot^® Sculptor system in achieving a surgical plan for implantation of unicompartmental knee prostheses, compared with conventional surgery. The Acrobot^® Sculptor is a novel hands-on medical device, consisting of a high speed cutter mounted on a robotic device which the surgeon holds and directs.

A prospective, randomised, double-blind (patient and evaluator), controlled versus conventional surgery study was undertaken and has been fully reported in Journal of Bone and Joint Surgery (British), 88-B.

All (13 out of 13) of the Acrobot^® cases were implanted with tibio-femoral alignment in the coronal plane within ±2° of the planned position, while only 40% (six out of 15) of the conventionally performed cases achieved this level of accuracy.

There was also a significant enhancement in the extent of post-operative improvement, as measured by American Knee Society (AKS) Scores at six weeks, in the cases implanted with the Acrobot^®. The difference between type of surgery is statistically significant (p=0.004, Mann-Whitney U test). Operating time (skin to skin) is higher in Acrobot treated subjects, but the difference between the two types of surgery fails to reach significance.

The Acrobot^® System was found to significantly improve both accuracy and short term outcome in this investigation. By permitting the creation of bone surfaces that can be machined by means other than an oscillating saw, the Acrobot^® System paves the way for novel implant designs to be developed, facilitating bone conserving arthroplasty in the knee, hip and spine with a new generation of even less invasive but more reliable procedures.

We performed a prospective, randomised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly allocated to have the operation performed conventionally or with the assistance of the Acrobot. The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane, measured by CT. Other secondary parameters were evaluated and are reported.

All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2° of the planned position, while only 40% of the conventional group achieved this level of accuracy. While the operations took longer, no adverse effects were noted, and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months. The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages.

The accuracy of prosthesis implantation is closely related to their function and longevity; we report the development of an active constraint robot for minimally invasive unicompartmental knee arthroplasty (UKA) using CT and knee scoring.

Method: Pre and postoperative CT scans are performed. Pre-op scan CT scans were used to plan the precise position of implants on the bones. The femoral and tibial bone cuts were then generated, together with the software boundaries that constrain the surgeon. This plan was then used to define the cutting planes of the ‘Acrobot’ active constraint device that we have developed.

The Postoperative CT scan was compared with the preoperative plan. The distance of the joint line from the hip and ankle joint, and its angulation and rotation were compared to the preoperative plan. In addition, the position of the implants relative to their planned position has been computed.

Results: No significant complications have been encountered. Using the postoperative CT scans, in no case is the implant more than 2mm or 2 degrees from the planned position.

Conclusions: The Acrobot system for UKA has completed its preliminary trial satisfactorily. It provides a hands-on operation but with robotic levels of accuracy, through a minimally invasive approach. By abolishing outliers, it improves outcomes in UKA replacement.

The Acrobot®, an active constraint “hands-on” robotic system, gives navigation cues to the surgeon, and also assists him in the surgery, using active software constraints if he tries to depart from the preoperative plan. It has just entered clinical trials. We report the first 5 cases.

The Acrobot® system for precision total knee arthroplasty comprises the following components:

1. A CT-based planning system

a gross positioning device with separate brakes and encoders, locked off for safety during the procedure,

4. The Acrobot’s software which:

imports the preoperative plan,

Each patient’s knee scores were monitored and postoperative CT scan was compared with the preoperative plan.

Seven robot assisted arthroplasties have been performed. No significant complications have been encountered. The Knee and Womac Scores show that the procedure is safe and comparable to conventional surgery in the early postoperative period. The envelope of error on postoperative CT scans has been within the accuracy of the method of measurement, at < 1 mm and < 10 without the outliers which haunt every clinical series.

The Acrobot® system for total knee arthroplasty has completed its preliminary trial satisfactorily. It provides a handson operation but with robotic levels of accuracy. It is suitable for conventional open surgery, but its real place will be in the arena of minimally invasive unicondylar knee arthroplasty, hip arthroplasty and resurfacing, and in the spine, where active constraint will prevent potentially dangerous surgical errors.