Introduction

Optimal orthopaedic implant placement is a major contributing factor to the long term success of all common joint arthroplasty procedures. Devices such as 3D printed bespoke guides and orthopaedic robots are extensively described in the literature and have been shown to enhance prosthesis placement accuracy. These technologies have significant drawbacks such as logistical and temporal inefficiency, high cost, cumbersome nature and difficult theatre integration. A radically new disruptive technology for the rapid intraoperative production of patient specific instrumentation that obviates all disadvantages of current technologies is presented.

Patient Specific Instruments (PSIs) are becoming an increasingly common method to provide surgeons with assistance in accurately performing procedures; however, to our knowledge, these new instruments have only been applied to traditional, highly invasive surgical approaches. However, PSIs have the potential to decreased surgical invasiveness by reducing the surgeon's need to clearly visualise anatomical landmarks. Therefore, we designed and evaluated a novel PSI for minimally invasive shoulder arthroplasty.

The proposed minimally invasive approach prevents en face access to the articular surfaces and thus the PSI was designed to guide the accurate placement of a trans-humeral bone tunnel which would permit surgical steps to be conducted. To accurately create this tunnel and place a guide pin in the glenoid, the PSI was designed as a two sided guide that incorporates unique anatomical features from both bones, which would lock the two bones in a predefined pose relative to one another. Proper registration of the PSI is aided by the joint's passive compression force, which is not disrupted due to the soft tissue sparing approach. Once the bones are locked together, a guide pin could be passed through the humeral head – creating a bone tunnel to guide later humeral bone preparation – and into the glenoid to guide reaming and drilling. By designing the guide in this way, it is possible to avoid the need to perform surgical steps with a clear en face view.

The PSI was created by loading 3D reconstructed CT models of the humerus and scapula into a CAD package, aligning the desired humeral and scapular guide axes such that the bones' relative pose is fully defined, and finally constructing the guide itself between and around the articular surfaces, such that sufficient anatomical features are incorporated to provide complete physical registration with the bones. This PSI was subsequently customised, based on a cadaveric specimen and fabricated using a 3D printer. The PSI's usability and accuracy in achieving the pre-operative plan were then assessed using optical tracking and surface based registration procedure.

Results of the evaluation demonstrated that the designed PSI is capable of accurately registering the two bones to within 5mm and 14° of the intended pre-operative plan, while also effectively reducing the invasiveness of the surgical procedure. Therefore, this novel PSI may represent a new avenue to improve the clinical impact of CAOS systems, by achieving good surgical accuracy, but with a greatly reduced invasiveness.

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.

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.

A major limiting factor for the accuracy in Computer Assisted Surgery (CAS) is the system’s positional knowledge of the patient’s anatomy, derived through the process of registration. In computer assisted Minimally Invasive Surgery (MIS) the registration process is made more difficult by the lack of direct access to a large portion of the surface to be registered. Current experience with a hands-on robotic surgery system, which uses a set of points measured with a mechanical digitiser on the exposed surface of the bone and a surface reconstructed from computer tomography (CT) data, has shown that accurate and robust registration is still possible through an MIS approach.

The registration method described here, which was originally developed for robotic assisted total knee arthroplasty (TKA), has successfully been adapted for robotic assisted unicompartmental knee arthroplasty (UKA) and computer assisted hip resurfacing (HR). Results show that good registration can be achieved by registering the bone surfaces through conventional surgical incisions, with two additional stab-wounds required for the UKA procedure. However, experimental results suggest that, because of the limited access resulting from a smaller incision, a good correspondence between the point-set and surface measurements (i.e., better than one millimeter) is necessary for registration accuracy better than two degrees and two millimeters. This degree of correspondence can be expected for a good surface model and an appropriate intra-operative setup, but poses an important constraint on the requirements for a system suitable for this type of procedure, if a registration method based on anatomical features is to be used without the need for additional access.

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.

Measurements of a patient’s anatomy are often made in two different forms, for instance from a computer tomography (CT) scan and by direct measurement of the anatomy, or when comparing a CT and a magnetic resonance imaging (MRI) scan or at different times. Therefore, it is almost inevitable that the patient will be measured in a different position each time, since the relative position between the patient and the measuring or scanning device will be different. To align the patient’s anatomy between these different measurement systems a process of registration is used. This is necessary in a number of fields including computer assisted navigation, robotic assisted surgery and diagnostics.

Computer assisted surgery (CAS) generally involves “patient to modality” registration, as, in any CAS application that involves planning, the relationship between the modeled space (where the procedure is planned) and the patient’s workspace (where the procedure is executed) needs to be established. Patient to modality registration involves the registration of patient-specific anatomy with an image acquired using one of many modalities. It is usually associated with intra-operative registration, where the actual patient’s position needs to be known with respect to a pre-operative or previously acquired image. Even though the acquisition of patient-specific information may itself involve the use of a modality, the purpose of the process is to register the patient’s position against the model. The two co-ordinate systems to be registered belong to the patient and to the modality used to acquire the registration image, respectively.

In “image-based” methods, identifiable features, such as fiducial marker screws or anatomical landmarks, are first extracted from the model, which is generally reconstructed from CT images, and then “sensed,” or located, in the operating theatre. This process provides the system with enough positional information for the model’s and patient’s spaces to be registered against a common co-ordinate system.

In recent years, the CAS community has seen a shift to “image-free” methods, where both the plan and registration process are carried out without any prior knowledge of the patient’s anatomy. The pre-operative image acquisition stage is avoided altogether, and the planning is executed intra-operatively during surgery. A complete functional model of the patient is reconstructed from anatomical landmarks sensed intra-operatively and, in some instances; intra-operatively acquired surface information is used to “morph” a standard anatomical atlas to resemble that of the patient.

Image-free methods offer the prospect of no pre-operative imaging or planning, however their value, in terms of intra-operative workflow and accuracy of outcome, has yet to be assessed when compared to image-based methods.

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.