Introduction

The mechanical classical method of knee surgical instrumentation by alignment is based on built-in compromises and is considered insufficient to ensure consistent success. Soft tissue balancing is thus now seen as necessary for optimal functional outcomes and patient satisfaction. (Matsuda 2005, Winemaker 2002). The authors have previously demonstrated that balancing can be achieved through specific strategic moves. In this study, the goal was to determine the efficacy of a given surgical algorithm and to define predictors of improved outcome. The surgical target is equilibrium of contact loads. The mechanical axis remains in neutral, however subtle variation in the joint line obliquity and posterior slope are tolerated within the literature established boundaries of +/− 3 degrees and less than 10 degrees respectively.

PURPOSE

Soft tissue balancing can be achieved by using spacer blocks, by distractors which measure tensile forces, or by instrumented devices which measure the forces on the lateral and medial condyles. However there is no quantitative method for assessment of balancing at clinical follow-up; to address this, we developed a Smart Knee Fixture (SKF) which measured the varus and valgus angles for a moment of 10 Nm. Our purpose was to determine if varus and valgus angles measured at clinical follow-up, was equivalent to the balancing parameters of distraction forces or contact forces measured at surgery. METHODS: The SKF, which measured VV angles using stretch sensors on each side of the knee, was validated by cadaver studies, fluoroscopy, and emg. The balancing parameters were:

A force analysis, and measurements on 101 surgical cases & clinical follow-up in an IRB study, were carried out to determine the relationship between these parameters.

INTRODUCTION

The major loss of articular cartilage in medial osteoarthritis occurs in a central band on the distal femur, and in the center of the tibial plateau (Figure). This is consistent with varus deformity due to cartilage loss and meniscal degeneration, together with the sliding regions in walking. Treatment at an early stage such as KL grade 2 or 3, has the advantages of little bone deformity and cruciate preservation, and could be accomplished by resurfacing only the arthritic areas with Early Intervention (EI) components. Such components would need to be geometrically compatible with the surrounding bearing surfaces, to preserve continuity and stability. However because of the relatively small surface area covered, compared with total knees and even unicompartmentals, it is hypothesized that EI components will be an accurate fit on a population of knees with only a small number of sizes, and that accuracy can be maintained without requiring right-left components. We examined this hypothesis using unique design and methodology.

Introduction

The role of soft tissue balancing in optimising functional outcome and patient satisfaction after total knee arthroplasty surgery is gaining interest. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery. Based on free body diagram theory, compressive load equilibrium should be correlated with ligamentous equilibrium between the medial and lateral collateral ligaments. The authors propose to use the Collateral Ligaments Strain Ratio (CLSR) as a functional tool to quantify and track the effectuated surgical change in laxity of the medial and lateral collateral ligaments and correlate this ratio to validated functional scores and patient reported outcomes. The relationship with intra-operative balancing of compartmental loads can then be scrutinised.

Introduction

Balancing at surgery is important for clinical outcome in terms of pain relief, flexion range, and function. The methodology usually involves making bone cuts to achieve correct leg alignment, and then obtaining equal gaps in extension and flexion using spacer blocks or tensor devices. In this study, we describe a method for quantifying balancing throughout the flexion range and show the effect of different surgical corrections from an unbalanced to a balanced state. In this way, we quantified how accurately balancing could be achieved within the practical time frame of a surgical procedure.

Introduction

Evaluation of post-operative soft tissue balancing outcomes after Total Knee Arthroplasty (TKA) and other procedures can be measured by stability tests, with Anterior-Posterior (AP) drawer tests and Varus-Valgus (VV) ligamentous laxity tests being particularly important. AP stability can be quantified using a KT1000 device; however there is no standard way of measuring VV stability. The VV test relies on subjective force application and perception of laxity. Therefore we sought to develop and validate a device and method for quantifying knee balancing by analyzing VV stability.

The use of smart trial components is now allowing a better assessment of soft tissue balancing at the time of total knee replacement surgery. A balanced knee can be defined as one that possesses symmetry, ie. equal and centered lateral and medial forces through the full range of flexion. There is still a need for a standard reproducible surgical test to quickly confirm optimized balancing at surgery with such devices. The Heel Push test is the established standard, by pushing the foot in a cephalad direction while supporting the thigh and keeping the leg stable in the vertical plane. A common variation of this test is the Thigh Pull test where the foot is actively assisted during the cephalad pull of the thigh through deep flexion. The test is an open chain test. The Thigh Pull test may be an improvement since the weight of the leg is alleviated and no supplemental compressive forces are introduced. The directional changes of the lower extremity are thus a result of ligamentous tension and balances. The purpose of this study is to compare the two tests using a standard testing methodology and observe the variation in kinetic parameters in a controlled biomechanical setting.

A custom l rig was developed, which independently controls all six degrees of freedom about the knee joint. In addition a commercial navigation system was used to derive instantaneous alignment values and flexion angles between the tibia and femur. The pelvis was fixed to the table and the foot was fitted onto a low friction carriage along a slide rail. The knee design used was cruciate retaining. The pressure mapping system was a wireless tibial trial that provided magnitude of load per compartment.

The study is a preliminary cadaveric study reporting the data from two. In this experiment the leg was then tested with the Heel Push and Thigh Pull tests after obtaining optimum soft tissue balance of the cadaveric specimen. From this standard neutral state a series of single surgical variables were introduced to mimic common intra-operative surgical corrections. This was achieved through custom tibial liner and angle shims.

The results defied theoretical anticipation. Though the total contact forces with heel push were generally higher than with thigh pull, the relative load distribution between compartments did not follow a trend (see Figure 1). Furthermore in deeper flexion the persistence of relatively high contact pressures would suggest that ligaments still generate intra-articular forces despite the much weaker gravitational effect. The clinical relevance lies in the asymmetry of the load distribution between medial and lateral compartment for the two methods tested. The load asymmetry as tested by the Thigh Pull test may correspond to an open chain in swing phase. This asymmetry would force some axial rotation and tibial femoral alignment deviation that can significantly affect the forces at the time of heel strike. The Heel Push test would be more representative of the compressive forces in a closed chain mode as seen during the stance phase of gait.

Soft tissue balancing in total knee replacement may well be the determining factor in raising the fair patient satisfaction. The development of intelligent implants allows quantification of reactive loads to applied pressures. This can be tested in dynamic mode such as heel push test at surgery, or in static mode such as when testing for varus/valgus (VV) laxity of the collateral ligaments of the knee. We postulate that a well-balanced knee will have comparable if not equal load distribution across compartments in dynamic loading. When tested for laxity, we anticipate an equal or comparable response to VV applied loads under physiologic load range of 10–50N. This study sought to analyze the relationship between the kinematic (joint motion) and kinetic (force) effects to VV testing in the 0–15 degrees range of flexion. One goal was to demonstrate that testing the knee in locked extension (Screw Home effect) is unreliable and should be abandoned in favor of the more reliable VV testing at 10–15 degrees of flexion.

This is a preliminary cadaveric study utilizing data from two hemibodies. The pelvis was fixed in a custom test rig with open or closed chain lower leg testing capability along a sliding rail with foot VV translational. Forces were applied at the malleoli with a wireless hand held dynamometer. Kinematic analysis of the hip-knee-ankle (HKA) tibiofemoral angle was derived from a commercial navigation system with mounted infrared trackers. Kinetic analysis was derived from a commercially available sensor imbedded in a tibial trial liner. Balance was optimized by conventional methods with the use of the sensor feedback until loads were roughly symmetrical and VV testing yielded symmetrical rise in opposite compartments. The VV testing was then performed with the knees locked at the femoral side in axial rotation and translational motion in any plane. Sagittal flexion was pre-set at 0, 10, and 15 degrees and progressive load was applied.

There are many different approaches to achieving balancing in total knee surgery. The most frequently used method is to obtain correctly aligned bone cuts, and then carry out necessary soft tissue releases to achieve equal flexion and extension gaps. In some techniques, the bone cuts themselves are determined by the prevailing soft tissue status or the kinematics during flexion-extension. Navigation can provide quantitative data during these processes but so far, navigation is used in only in a minority of cases. However in recent years, new technologies have been introduced with lower cost and implementation time, allowing for more widespread use. Early studies have indicated that more reproducible balancing can be obtained, and that balancing has a positive effect on clinical outcomes. However the ability to measure balancing quantitatively during surgery, has raised the questions of the most systematic method for implementation during surgery, and the relative influence of various correcting factors. Further, the ideal balancing parameters with respect to varus-valgus ratios and the magnitudes during a full flexion range, have yet to be defined. Even if normative data is the target, there is scant data on this topic.

In our own laboratory, we carried out experiments on knee specimens where the various surgical variables were systematically investigated for their effect on varus-valgus balancing. Different tests were developed including the ‘Heel Push Test’ where lateral and medial contact forces were plotted as a function of flexion. Imbalances were achieved with either bone cut adjustments or soft tissue releases. The major finding was that adjustments of only 2 mms or 2 degrees could correct most imbalances. This was considered to be due to two effects; the pretension in the ligaments bringing the structure to the stiff part of the load-elongation curve, and the high values of the stiffness itself. Medial-lateral equality was the goal in this work, but recognizing that this may not be the situation in the normal knee. To answer this question, we developed a method for measuring the varus-valgus balancing in normal subjects, using a ‘Smart Knee Fixture’ with embedded stretch sensors. We validated this device using cadaveric specimens, and normal volunteers using fluoroscopy and electromyography. We are now applying the method in an IRB study to both normals and post-operative knee replacement cases. For the latter, the relation between operative data, and post-operative balancing will be studied, as well as the relation of balancing to functional outcomes.

This overall subject of balancing at surgery, and the post-operative effects, is open to extensive experimental research, and is predicted to result in improved outcomes.

Total Knee Arthroplasty (TKA), has now become a reliable, successful, and widely used treatment for osteoarthritis. Numerous reports indicate that for the majority of patients, the TKA lasts a lifetime with pain relief and the ability to perform most everyday activities. However there are a number of ways in which the procedure can be further improved, the focus here being on function. One of the problems in evaluating function is that it depends upon the inherent ability, motivation, and expectation of the patients. There are several well-used questionnaire systems which capture functional ability objectively. In the effort to simplify evaluation, a ‘forgotten knee’ evaluation has been introduced, the concept being that ‘the ideal TKA design’ would feel and function like a normal knee. Such a measure would include factors such as surgical technique, alignment, and rehabilitation, as well as the TKA design itself. Another approach to evaluation is to measure biomechanical parameters, such as in gait analysis and fluoroscopy, which evaluate kinematic or kinematic parameters, using normal controls for comparison. Nevertheless, such evaluations still include factors other than the TKA design itself, and do not apply to new designs.

The approach taken here for the evaluation of a new TKA design independent of other factors, is to measure the neutral path of motion and the laxity boundaries of the loaded knee on the application of shear and torque over a full range of flexion. The benchmark is the same kinematic data from the normal intact knee. The rationale has some analogy to the ‘forgotten knee’ in that if the laxity response of a design of TKA is the same as that of the anatomic knee itself, the behavior of that implanted knee in any functional condition will be indistinguishable from that of the anatomic knee itself. Such a testing concept has some similarities to the constraint test described in the ASTM standard. In this paper, a novel design algorithm is proposed for creating different design concepts. First, a general morphological form is formulated for each design concept, a Cam-Post PS, a Saddle-Ramp, and a Converging Condyle, all with overall anatomic-like surfaces. Each femoral component is then designed, which is then moved through the normal neutral path and laxity paths, which creates the tibial surface. The concepts are evaluated using a Desktop Knee Machine configured to move the knee dynamically through full flexion while applying combinations of compression, shear and torque; kinematic data being captured optically and plotted using custom software. The normal benchmark was obtained from 10 normal knee specimens, which showed the restraint of the medial femoral condyle to anterior displacement and the overall rollback and laxity laterally. Compared with standard CR and PS designs, the Guided Motion designs were seen to more closely resemble normal. It is proposed that this approach can result in designs which will more likely reproduce a ‘forgotten knee’ and achieve the optimal function for a given patient.

Balancing in total knee replacement is generally carried out using the feel and experience of the surgeon, using spacer blocks or distractors. However, such a method is not generally applicable to all surgeons and nor does it provide quantitative data of the balancing itself. One approach is the use of instrumented distractors, which have been used to monitor soft tissue releases or indicate a flexion cut for equal lateral and medial forces. More recently an instrumented tibial trial has been introduced which measures and displays the magnitude and location of the loads on the lateral and medial plateaus, during various manoeuvres carried out at surgery. The data set is then used by the surgeon to determine options, whether soft tissue releases or bone cut adjustments, to achieve lateral-medial equality.

The testing method consisted of mounting the femoral component rigidly in a fixture on the vertical arm of an MTS machine. The tibial component was fixed on to a platform which allowed varus-valgus correction, and where the component could be displaced or rotated in a horizontal plane. Two of each size times 4 sizes of production components were tested. Compressive forces from 0–400N in steps of 50N were applied and the readings taken. There were strong correlations between applied and measured forces with mean Pearson's Correlation Coefficient of 0.958.

The special tests under different conditions did not have any effect on the output values. The output data proved to be repeatable under Central Loading with a maximum standard deviation of ± 15.36N at the highest applied force of 400N. “Low battery” did not adversely affect the data. Applying the load steadily to maximum versus load-unload-zero tests produced similar results. Lubrication versus no lubrication tests produced no changes to the results. There was no cross talk of the electronics within the device when loaded on one condyle. For both central and anterior-posterior loading, the contact points were centered medial-lateral on the GUI display, and tracked contact point translation appropriately.

Anterior-posterior loading did create output load variance at the extremes. However, it enabled the validation of the relationship of the femur on the trial surface. In addition, malrotation would be indicated by the femur riding up on the anterior or posterior tibial edges, important for soft tissue tension in all flexion angles.

In conclusion, the sensors provided data which was accurate to well within a practical range for surgical conditions. In our separate experiments on 10 cadaveric leg specimens, even the same test under controlled conditions could produce variations of up to ± 30N. Hence the sensor outputs indicated whether or not the knee was balanced to that level of tolerance, while the contact point data would indicate contacts too close to the anterior or posterior of the tibial surface.

The purpose of balancing in total knee surgery is to achieve smooth tracking of the knee over a full range of flexion without excessive looseness or tightness on either the lateral or medial sides. Balancing is controlled by the alignment of the bone cuts, the soft tissue envelope, and the constraint of the total knee. Recently, Instrumented Tibial Trials (OrthoSensor) which measure and display the location and magnitude of the forces on the lateral and medial condyles, have been introduced, offering the possibly of predictive and quantitative balancing. This paper presents the results of experiments on 10 lower limb specimens, where the effects of altering the bone cuts or the femoral component size were measured.

A special leg mounting rig was fixed to a standard operating table. A boot was strapped to the foot, and the boot tracked along a horizontal rail to allow flexion-extension. The initial bone cuts were carried out by measured resection using a navigation system. The trial femoral component and the instrumented tibial trial were inserted, and the following tests carried out:

Sag Test; foot lifted up, the trial thickness chosen to produce zero flexion.

Heel Push Test; heel moved towards body to maximum flexion.

Varus-Valgus Test, AP and IXR Tests were also carried out, but not discussed here.

For an initial state of the knee, close to balanced, the lateral and medial contact forces were recorded for the full flexion range. The mean value of the contact forces per condyle was 77.4N, the mean in early flexion (0–60 deg) was 94.2N, and the mean in late flexion (60–120 deg) was 55.7N. The difference was due to the effect of the weight of the leg. One of the following Surgical Variables was then implemented, and the contact forces again recorded. 1.

Distal femoral cut; 2 mm resection (2 mm increase in insert thickness to preserve extension)

The differences between the condyle force readings before and after the Surgical Variable were calculated for low and high angular ranges. The mean values for the 10 knees of the differences of the above Surgical Variables from the initial balanced state are shown in the chart.

From literature data, the mean tension increase in one collateral ligament is close to 25N/mm up to the toe of the load-elongation graph, and 50N/mm after the toe. Hence in the initial balanced state, the collateral ligaments were elongated by 2–4 mm producing pretension. From the Surgical Variables data, up to 2 mm/2 deg change in bone cuts (or 3 mm femcom change), and collateral ligament releases up to 2 mm, would correct from any unbalanced state to a balanced state.

This data provides useful guidelines for the use of the Instrumented Tibial Trials at surgery, in terms of bone cut adjustments and ligament releases.

In different contemporary posterior-stabilized (PS) total knees, there are considerable variations in condylar surface radii and cam-post geometry. This is expected to result in differences in kinematics and functional outcomes in patients. The hypotheses of our study were: 1. Current PS design will show symmetric motion which is different from anatomic motion, and 2. An asymmetric PS design will produce motion closer to normal anatomic motion than symmetric designs.

A special machine was constructed which could implement the ASTM standard test on constraint, by measuring the laxities. The rational for the test is to predict functional laxity ranges which will affect the kinematics in vivo. The machine set the knee at the required flexion angles and applied combinations of compressive, shear, and torque forces, to represent a range of everyday activities. The femorotibial contact points, the neutral path of motion, and the AP and internal-external laxities were used as the motion indicators. The benchmark was the motion data from anatomic knee specimens tested under the same conditions.

Four contemporary PS designs with a range of geometries was selected for the tests, together with a design where the medial side was more constrained, the lateral side was less constrained, and the post was rounded. The output motions were compared between themselves, while all designs were compared with the anatomic data. The PS designs showed major differences in motion characteristics among themselves including the neutral path of motion and the AP and rotational laxities. These differences were related to the constraints of the condyles, and the cam-post designs. The four PS designs showed motion different from anatomic, including symmetric mediolateral motion, susceptibility to excessive AP medial laxity, and reduced laxity in high flexion. The asymmetric Guided Motion design alleviated some but not all of the abnormalities; in particular, while the lateral rollback with flexion and the near-constant position of the medial femoral condyle resembled anatomic behaviour, the rotational laxity was still limited in high flexion. The latter ws observed to be due to the ‘entrapment’ of the femoral condyles between the upwards posterior lip of the tibial plastic, and the posterior of the cam-post, a phenomenon seen on all designs.

The conclusion of the study is that an asymmetric PS design may provide a path to achieving a closer match to anatomic kinematics. This may improve functional outcomes, and even provide a better ‘feel’ to the patient. However, there are still inherent challenges in PS design to closely achieve this goal. Other design configurations have also been formulated which could even more closely reproduce anatomic motion. However a pre-clinical testing method such as presented here, is one method for evaluation and can be used hand-in-hand with computational methods to produce an optimal design. The importance of the benchmark of the anatomic knee and the identification of the important parameters of the ASTM standard, notably the neutral path of motion and the laxity about the neutral path, are important aspects of the design methodology.

Published investigations with custom short stems have reported very encouraging results (Walker, et al, 1). However, off-the-shelf (OTS) versions of shorter length prostheses has not met with the same success.

Several basic questions must be addressed. First, what is the purpose of a stem? Second, can stem length be reduced and if so by how much can this be safely done. Third, what are the effects of stem shortening and are there other design criteria which must take on greater importance in the absence of a stem to protect against implant aseptic failure.

To examine these issues a testing rig was constructed which attempts to simulate the in vivo loading situation of a hip, Fig. 1 (Walker, et, al.). Fresh cadaveric femora were tested with the femora intact and then with femoral components of varying stem length implanted to examine the distribution of stresses within the femur under increasing loads as a function of stem length. This was correlated with observations of prospective DEXA measurement of proximal femoral bone mass and implant migration following THR (Leali, 3). We then initiated a prospective multi-center study of a specific short stem design which included three geometric features to ensure initial implant stability. This report documents that after 2 years, in the first 200 stems implanted, this design has been shown to provide stability against subsidence, flexion/extetnsion and rotational forces. This is consistent with the findings of the in-vitro studies and identical to the previously published clinical results of a similarly designed full length version of this same stem.

Our studies indicated that a stem is not an absolute requirement in order to achieve a well functioning, stable implant. Initial stability can be achieved in the absence of a stem, by a “rest fit,” if adequate design features are incorporated. These studies also demonstrated that simply reducing the length of an existing implant to accommodate changes in surgical techniques may not be a reasonable or safe design change. Such shortened versions of existing stem designs must undergo rigorously in-vitro testing and clinical validation before being released for implantation.

Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The OrthoSensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. SURGICAL TESTS were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, matching the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

SURGICAL VARIABLES were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10 mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

Testing was carried out on 10 full leg specimens. The Sag Test was the basic test for determining the thickness of the tibial insert. The Heel Push Test was then implemented from which force data throughout flexion was determined; followed by the Varus-Valgus Test. In a surgical case, this data will be used in a decision tree to identify which Surgical Variable required correction. In the experiments, by obtaining the above data for each SURGICAL VARIABLE in turn, we were able to determine a SIGNATURE for each SURGICAL VARIABLE. It was found that there was considerable variation in the force magnitudes between knees. However the SIGNATURES were sufficient to point to the specific SURGICAL VARIABLE requiring correction. In some knees, although there was a dominant SURGICAL VARIABLE, even after correcting for that, there was still an imbalanced state, requiring a second correction.

This research provided the fundamental principles and data for: 1.

Defining tests to be carried out at surgery, to obtain force data to determine the SURGICAL VARIABLE to correct.

Tibial component loosening is an important failure mode in unicompartmental knee arthroplasty (UKA) which may be due to the 6–8 mm of bone resection required or the limited surface area. To address component loosening and fixation, a new Early Intervention (EI) design is proposed which reverses the traditional material scheme between femoral and tibial components. That is, the EI design consists of a plastic inlay component for the distal femur and a thin metal plate for the proximal tibia. With this reversed materials scheme, the EI design requires minimal tibial bone resection compared to traditional UKA to preserve the dense and stiff bone in the proximal tibia. This study investigated, by means of finite element (FE) simulations, the potential advantages of a thin metal tibial component compared with traditional UKA tibial components, such as an all-plastic inlay or a metal-backed onlay. We hypothesized that an EI component would produce comparable stress, strain, and strain energy density characteristics to an intact knee and more favorable values than UKA components. Indeed, the finite element results showed that an EI design reduced stresses, strains and strain energy density in the underlying support bone compared to an all-plastic UKA component. Analyzed parameters were similar for an EI and a metal-backed onlay, but the EI component had the advantage of minimal resection of the stiffest bone.

INTRODUCTION:

The purpose of this study was to determine if a short femoral stem (Lima Corporate, Udine, Italy) would result in a strain distribution which mimicked the intact bone better than a traditional length stem, thereby eliminating the potential for stress-shielding.

Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The Orthosensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop the algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. Surgical Tests were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, to match the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

Surgical Variables were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

In an actual surgical case, having obtained readings from the Surgical Tests, the data will be compared with the signatures of the Surgical Variables. This will then identify the Variable which needed correction. The Surgical Tests will be repeated and the readings should be closer to balanced. Further correction of another Variable is carried out if necessary. In early clinical cases, it was found that this method allowed for identification of how to reach a balanced state, and achieved soft tissue balancing in a quantitative way.

In order to emulate normal knee kinematics more closely and thereby potentially improve wear characteristics and implant longevity the Medial Pivot type knee replacement geometry was designed. In the current study the clinical and radiographic results of 50 consecutive knee replacements using a Medial Pivot type knee replacement are reported; results are compared to the Australian Orthopaedic Associations National Joint Replacement Registry. The patients' data were crossed checked against the registry to see if they had been revised elsewhere. After a mean follow-up of 9.96 years results show that the Medial Pivot Knee replacement provides good pain relief and functional improvement according to KSS and Womac scores and on subjective patient questionnaires. There was one minor revision; insertion of a patella button at 6.64 years FU. There were no major revisions; all implants appeared to be well fixed on standard radiographic examination. While the revision rate for the Medial Pivot knee according to the Australia Joint Registry results is higher compared to all other types of knee replacements in the registry, and to what is reported in the literature on the medial pivot knee, it is not in the current series. Revision rate was similar to what is reported on in the literature, but after a longer follow-up period. However, long term follow-up is required to draw definitive conclusions on the longevity of this type of implant.

In the large majority of cases of knee osteoarthritis (OA), total knee replacement (TKA) is the selected treatment, due to its proven durability, satisfactory function and familiarity of surgeons. However in recent years there has been an increase in the numbers of uni-compartmental knees used (UKA), due to more favorable follow-up, improved designs and techniques, quicker and better patient recovery, and less hospitalization costs. Designs have been produced for even lesser invasive components than UKA, including simple spacers, with mixed results. Recently, several studies have been carried out on the wear patterns on the femoral and tibial condyles in OA, showing that the main areas of cartilage loss occur on the distal end of the femur, that area engaged in walking activities, and over a large proportion of the tibial plateau. A study we carried out on the bone pieces resected at TKA surgery showed that no less than 22% of the cases could have been done with a device which resurfaced only the medial side. That figure would have been higher if the patients had been treated earlier, before cartilage wear and deformation had progressed. In a more recent study, we showed the progress of the wear of OA by analyzing MRI scans of 50 patients at various stages of OA. The cartilage wear occurred on areas which were initially the thickest on both the femur and the tibia. This was evidently associated with excessive contact stresses, while the menisci, if they had previously been spreading the load over a large area of the cartilage surfaces, were no longer functional. In this paper it is proposed that the treatment modality of OA could be carried out on a sliding scale, based on MRI analysis together with clinical factors including pain and disability. Early Intervention devices, including UKA, could be used much more frequently if the surgical technique was developed to be reliable, simple and reproducible. Specifically there is space for an Early Intervention device (EI) where only the distal end of the femur and the tibial surface are resurfaced. A design has been produced where a pocket is milled into the distal end of the femur to house a plastic runner, and a thin layer is resected from the proximal tibia for a metal plate with a special keel design. The advantages of such a design are ease of exposure, accurate and simple surgery, minimal tibial resection for long term fixation, reduced wear, and ease of restoration of the original joint line. The wear is assessed using a custom-made wear machine, while fixation is evaluated using FEA. It is proposed that such a device would add a valuable option for the treatment of symptomatic early OA where the functional level of the patient can be maintained, and the progress of OA possibly arrested.