INTRODUCTION

Understanding the biomechanics of the anatomical knee is vital to innovations in implant design and surgical procedures. The anterior – posterior (AP) laxity is of particular importance in terms of functional outcomes. Most of the data on stability has been obtained on the unloaded knee, which does not relate to functional knee behavior. However, some studies have shown that AP laxity decreases under compression (1) (2). This implies that while the ligaments are the primary stabilizers under low loads, other mechanisms come into play in the loaded knee. It is hypothesized this decreased laxity with compressive loads is due to the following: the meniscus, which will restrain the femur in all directions; the cartilage, which will require energy as the femur displaces across the tibial surface in a plowing fashion; and the upwards slope of the anterior medial tibial plateau, which stabilizes the knee by a gravity mechanism. It is also hypothesized that the ACL will be the primary restraint for anterior tibial translation.

INTRODUCTION

Most total knees today are CR or PS, with lateral and medial condyles similar in shape. There is excellent durability, but a shortfall in functional outcomes compared with normals, evidenced by abnormal contact points and gait kinematics, and paradoxical sliding. However unicondylar, medial pivot, or bicruciate retaining, are preferred by patients, ascribed to AP stability or retention of anatomic structures (Pritchett; Zuiderbaan). Recently, Guided Motion knees have been shown to more closely reproduce anatomic kinematics (Walker; Willing; Amiri; Lin; Zumbrunn). As a design approach we proposed Design Criteria: reproduce the function of each anatomic stabilizing structure with bearing surfaces on the lateral and medial sides and intercondylar; resected cruciates because this is surgically preferred; avoid a cam-post because of central femur bone removal, soft tissue entrapment, noises, and damage (Pritchett; Nunley). Our hypothesis was that these criteria could produce a Guided Motion design with normal kinematics.

Introduction

The major function of the medial meniscus has been shown to be distribution of the load with reduction of cartilage stresses, while its role in AP stability has been found to be secondary. However several recent studies have shown that cartilage loss in OA occurs in the central region of the tibia while the meniscus is displaced medially. In a lab study (Arno, Hadley 2013) it was confirmed that the AP laxity was greatly reduced with a compressive force across the knee, while the femur shifted posteriorly and the AP laxity was increased after a partial meniscetomy of the posterior horn. It is therefore possible that under load, the compression of the meniscus and the cartilage, 2–3mm in total, allows load transmission on the central tibial plateau, and causes radial expansion and tension of the meniscus providing restraint to femoral displacements. This leads to our hypotheses that the highest loading on the medial meniscus would be at the extremes of motion, rather than in the mid-range, and that the meniscus would provide the majority of the restraint to anterior-posterior femoral displacements throughout flexion when compressive loads were acting.

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.

Introduction

The role of soft tissue balancing in optimizing functional outcome and patient satisfaction after total knee arthroplasty surgery is gaining interest. This is due in part to the inability of pure alignment to demonstrate excellent functional outcomes 6. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery 4. In 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 surgical changes in laxity of the 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 scrutinized. The benefits of varus-valgus balancing within 2o include increased range of motion 7, whereas pressure imbalance between the medial and lateral joint compartments has been linked to condylar liftoff and abnormal kinematics post-TKA 8.

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 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.

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.