Introduction

Robot systems have been successfully introduced to improve the accuracy and reduce severe iatrogenic soft tissue damage in knee arthroplasty. Unfortunately to perform complete a complete bone cut, the cutting tool has to slightly pass the edge of the bone. In the posterior zones were retractor protection is impossible this will lead to contact between the cutting tool and the soft tissue envelope. Therefore, complete soft tissue preservation cannot be guaranteed with the current commercial systems.

Background

Under- or oversizing of either component of a total knee implant can lead to early component loosening, instability, soft tissue irritation or overstuffing of joint gaps. All of these complications may cause postoperative persistent pain or stiffness. While survival of primary TKA's is excellent, recent studies show that patient satisfaction is worse. Up to 20% of the patients are not satisfied with the outcome as and residual pain is still a frequent occurrence.

The goal of this study was therefore to evaluate if the sizing of the femoral component, as measured on a 3D-reconstructed projection, is related to patient reported outcome measures.

From our prospectively collected TKA outcome database, all patients with a preoperative CT and a postoperative X-ray of their operated knee were included in this study. Of these 43 patients, 26 (60,5%) were women and 17 (39,5%) were men. The mean age (+/−SD) was 74,6 +/− 9 years.

Background

Kinematic patterns in total knee arthroplasty (TKA) can vary considerably from the native knee. No study has shown a relation between a given kinematic pattern and patient satisfaction yet.

INTRODUCTION

Thorough understanding and feedback of the post-operative implant position relative to the pre-operative anatomy is missing in today's clinical practice. However, three dimensional insights in the local under or oversizing of the implant can provide important feedback to the surgeon. For the knee for instance, to identify a shift in the sagittal joint line that potentially links to mid-flexion instability or to identify zones at risk for soft tissue impingement.

Despite a proven inferior outcome, clinical post-operative implant evaluation remains primarily based on bi-planar, static 2D x-rays rather than 3D imaging. Along with the cost, a possible reason is the increased radiation dose and/or metal artifact scatter in computed tomography (CT) and/or magnetic resonance imaging (MRI). These detrimental effects are now avoided by using recently released x-ray processing software. This technique uses standard-of-care post-operative x-rays in combination with a pre-operative CT and 3D file of the implant to determine the implant position relative to the pre-operative situation. The accuracy of this new technique is evaluated in this paper using patient cases. Therefore, the obtained implant position is benchmarked against post-operative CT scans.

INTRODUCTION

To assess and compare the effect of new orthopedic surgical procedures, in vitro evaluation remains critical during the pre-clinical validation. Focusing on reconstruction surgery, the ability to restore normal kinematics and stability is thereby of primary importance. Therefore, several simulators have been developed to study the kinematics and create controlled boundary conditions.

To simultaneously capture the kinematics in six degrees of freedom as outlined by Grood & Suntay, markers are often rigidly connected to the moving bone segments. The position of these markers can subsequently be tracked while their position relative to the bones is determined using computed tomography (CT) of the test specimen with the markers attached. Although this method serves as golden standard, it clearly lacks real-time feedback. Therefore, this paper presents the validation of a newly developed real-time framework to assess knee kinematics at the time of testing.

INTRODUCTION

During TKA surgery, the usual goal is to achieve equal balancing between the lateral and medial side, which can be achieved by ligament releases or “pie crusting”. However little is known regarding a relationship between the balancing forces on the medial and lateral plateaus during TKA surgery, and the varus and valgus and rotational laxities when the TKA components are inserted. It seems preferable that the laxity after TKA is the same as for the normal intact knee. Hence the first aim of this study was to compare the laxity envelope of a native knee, with the same knee after TKA surgery. The second aim was to examine the relationship between the Varus-Valgus (VV) laxity and the contact forces on the tibial plateau.

Background

Total knee arthroplasty (TKA) is a proven and cost-effective treatment for osteoarthritis. Despite the good to excellent long-term results, some patients remain dissatisfied. Our study aimed at establishing a predictive model to aid patient selection and decision-making in TKA.

Introduction

A correct balancing of the knee following TKA surgery is believed to minimize instability and improve patient satisfaction. In that respect, trial components containing force sensors can be used. These force sensors provide insight in the medial/lateral force ratio as well as absolute contact forces. Although this method finds clinical application already, the target values for both the force magnitude and ratio under surgical conditions remain uncertain.

Purpose

Analysis of the morphology of the distal femur, and by extension of the femoral components in total knee arthroplasty (TKA), has been related to the aspect ratio, which represents the width of the femur. Little is known about variations in trapezoidicity (i.e whether the femur is more rectangular or more trapezoidal). This study aimed to quantify additional morphological characteristics of the distal femur and identify anatomical features associated with higher risks of over- or under-sizing of components in TKA.

Introduction

Better functional outcomes, lower pain and better stability have been reported with knee designs which restore physiological knee kinematics. Also the ability of the TKA design to properly restore the physiological femoral rollback during knee flexion, has shown to be correlated with better restoration of the flexor/extensor mechanism (appropriate flexor/extensor muscle lever arm, sufficient quadriceps force to extend the knee under load and limited patello-femoral force), which is fundamental to the function of the human knee. The purpose of the study is to compare the kinematics of three different TKA designs, by evaluating knee motion during Activities of Daily Living. The second goal is to see if there is a correlation between the TKA kinematics and the patient reported outcomes.

Total knee arthroplasty can largely impact the functioning of a knee. To minimize the impact of surgery and increase patient satisfaction, it is believed that restoring knee stability and control of the laxity has the potential to improve surgical outcome. In that respect, it is hypothesized that a well-balanced knee restores the native knee's laxity and stability, whereas unbalanced conditions result in an increased laxity and instability. This study intends to precisely evaluate knee laxity and stability in a cadaveric model in order to improve the clinical evaluation of the knee laxity under surgical conditions. This paper provides insight in the design considerations and methodology of a novel knee simulator and the preliminary results

In a first phase, a new knee simulator has therefore been developed. This simulator allows quantifying the knee kinematics and surgical feel at the time of surgery in a laboratory environment. More specifically, full lower limb specimens can be mounted in the simulator. This overcomes the need for disarticulation at the hip and ankle, often reported in cadaveric testing. The latter is believed to potentially release the tension in the knee and should therefore be avoided. Note that in respect to surgical conditions no muscle activation is considered for this simulator.

To facilitate a repeatable and unbiased evaluation of the knee kinematics, it is important that the knee simulator provides full kinematic freedom to the tested knee specimen. To obtain six degrees of freedom, a dedicated hip and ankle setup has been created (figure 1). The hip setup constrains the hip joint to a single axis hinge joint around the femoral head center. The remaining five degrees of freedom are built into the ankle setup. More specifically, the ankle setup has two translational degrees of freedom and full rotational freedom. The translational freedom is provided along the specimen's proximal-distal axis and medio-lateral axis. The rotational freedom is provided at a single point, using a ball in socket joint located along the mechanical axis of the tibia. The translation along the proximal-distal axis is thereby actively controlled by the operator, simulating heel push conditions. In addition to studying the neutral path kinematics, the presented simulator allows evaluating the laxity boundaries throughout the range of motion. Therefore, a constant internal/external torque can be applied to the tibia. Alternatively, a constant varus/valgus moment can be simulated.

Second, following the design and construction of this simulator, a set of ten cadaveric knees has been tested on this simulator, both before and after TKA surgery. For the native knees, the results of these tests confirm the kinematic freedom provided to the tested knee. In addition, the laxity envelope around the neutral path can be realistically evaluated and quantified.

Introduction

For the evaluation of new orthopaedic implants, cadaveric testing remains an attractive solution. However, prior to cadaveric testing, the performance of an implant can be evaluated using numerical simulations. These simulations can provide insight in the kinematics and contact forces associated with a specific implant design and/or positioning.

For evaluating the impact of knee surgery, cadaveric knee simulators are commonly applied. However, most of the knee simulators are based on the Oxford type as originally described by Zavatsky (Zavatsky, J. of Biomechanics, 1997). These simulators mainly focus on the squatting motion. Although a wide range of flexion angles can be examined while performing this motion, the significance for activities of daily living is limited.

To that extent a new knee simulator has recently been developed at Ghent University. In this simulator, the ankle motion is dynamically controlled in the sagittal plane; both in the proximal/distal direction and the anterior/posterior direction. As a result, this simulator allows simulating random motion patterns, e.g. cycling, stair ascent and descent, … The ankle translation is unrestrained in the medial/lateral direction. In addition, all rotational degrees of freedom are unrestrained at the ankle, resulting in four degrees of freedom at the ankle. The hip adds one rotational degree of freedom being the rotation in the sagittal plane. This leaves 5 degrees of freedom (DOF) to the knee; the sixth being flexion/extension that is controlled by the actuators at the ankle. During the simulation of different motion patterns, the quadriceps and hamstring force are actively controlled to mimic realistic conditions obtained through musculoskeletal simulations.

In this study, five cadaveric experiments have been performed on the simulator. While mounting the cadaveric specimens in the test rig, the initial alignment remains crucial. Whilst the rig leaves 5 DOF to the knee, it is important to restore the anatomical position of the hip and ankle. To minimize the impact of the mounting procedure, cadaver specific 3D printed guides are used to assure the alignment of the cadaver in the test rig. As a result, the kinematics are more likely to represent physiological conditions. These kinematics have been evaluated in accordance to the methodology described by Grood&Suntay (Grood & Suntay, Transactions of the ASME, 1983). Therefore, a CT scan of the examined knee is combined with motion tracking data from rigidly attached markers on both the femur and the tibia. The cadaveric knees have been subjected to a variety of motion patterns, i.e. squatting and cycling. The squatting experiments provide evidence that the knee simulator creates adequate boundary conditions as the kinematic patterns coincide with literature reportings. The cycling experiments however significantly differ from the squatting patterns. Most noteworthy is the difference in terms of internal/external rotation for these native knees (Figure 1). This internal/external rotations is highly fluctuating from flexion to extension. This is understood as the quadriceps force is not constant during the extension phase, representing physiological conditions.

Total knee arthroplasty aims at restoring the function of the native knee. An important aspect at this point are the knee kinematics, as it can be assumed that following TKA surgery these should resemble the native conditions. The use of cadaveric testing is since long an important step in the development and validation of implant designs and surgical techniques. However, this cadaveric testing has primarily focused on squatting under load bearing conditions. The main research question of this paper is therefore to evaluate the impact of TKA surgery on the knee kinematics under a range of boundary conditions.

A set of five cadaveric knees have been tested in a newly developed and validated knee simulator at Ghent University. In contrast to other simulators, this simulator allows simulating a wide range of conditions as it facilitates a controlled movement of the ankle in the sagittal plane under continuously variable hamstring and quadriceps loading. In the framework of this study, two different motion patterns have been studied. First, the knees were subjected to a traditional squatting motion maintaining constant quadriceps loading. Second, the knees were tested while performing a cycling movement with a highly variable quadriceps load during the extension phase. For both cases, the studied motion patterns have been repeated five times. Following the evaluation of the native knee kinematics, TKA surgery was performed using a single radius implant. During surgery, the implant alignment has been controlled using computer navigation. Subsequently, the same boundary conditions have been applied and the kinematics again recorded.

Focusing on the native knee, the measured kinematic patterns for the squatting motion significantly differ from the ones observed for the cycling movement for similar flexion angles. This is attributed to a difference in quadriceps loading. However, following TKA surgery, the kinematic patterns are remarkably comparable between the squatting and cycling experiments. These observations suggest that the TKA design considered in this study displays a highly constrained behavior. More specifically, the design appears to favor the squatting behavior. Further study is however required to thoroughly evaluate this observation for other implant designs and a wider range of motion patterns.

Goals of the study

(1) to investigate the relationships between the bony contours of the knee and the Popliteus Tendon (PT) in the healthy knee and after implantation of a TKA and (2) to analyze the influence of implant sizing.

An accurate evaluation of the mechanical properties of human tissue is key to understanding and successfully simulating (parts of) human joints. Due to the rapid post-mortem decay, however, the cadavers are usually frozen or embalmed. The main aim of this paper is to quantitatively compare the impact of both techniques on the biomechanical properties. To that extent, the Achilles tendons of seven cadavers have been tested. For each cadaver, one of the Achilles tendons was tested after being frozen for at maximum two weeks, whilst the other tendon was tested following a Thiel embalming process.

All specimens were gripped in custom made clamps and subjected to uniaxial tensile loading. The specimens were scanned using a micro-CT to determine their cross-sectional area, which allowed transferring the applied forces to stresses. During the tensile tests, the specimens’ elongation was measured both using the digital image correlation (DIC) technique and using linear variable displacement transducers (LVDT's) mounted across the grips. The former allowed to assess the severity of slip in the grips. As is well described in literature, the obtained stress-strain relationship is not linear (Figure 1). Accordingly, the following bilinear relationship was fitted through the data points using a least squares fit:

s = E₀ e     e <= ê

As a result, the stress-strain response is sub-divided in two regions: a toe-region (e <= ê) with a low slope and stiffness (E₀) and a linear elastic region (e > ê) with a higher stiffness (E). Both stiffness values were subsequently compared between the fresh frozen and Thiel embalmed group. Given the non-normal distribution of the test data, the non-parametric Wilcoxon signed rank test was used to assess the statistical significance of the obtained results.

No statistically significant difference was observed between the stiffness of the toe-region (e <= ê) obtained from Thiel embalmed and fresh frozen specimens (p-value = 0.249). In the contrary, the stiffness of linear elastic region (e > ê) was significantly different between both groups (p-value = 0.046 – see Figure 2). An average, the Thiel embalmed specimens displayed a 36% higher stiffness compared to the fresh frozen specimens. The latter contrasts the findings of other studies reported in literature, which report a decrease of the stiffness following Thiel embalming. To the authors’ opinion, this discrepancy could either be attributed to a difference in testing protocol (embalming time, donor factors, …) or tissue perfusion kinetics (Achilles tendon is relatively massive).

In conclusion, this study has demonstrated that Thiel embalming significantly alters the biomechanical properties of tendons. Specimens that underwent Thiel embalming should therefore not be considered for determining input parameters for advanced numerical models.

To evaluate the impact of a knee prosthesis on the soft-tissue envelope or knee kinematics, cadaveric lower extremities are often mounted in a custom test rig, e.g. Oxford knee rig. Using such test rig, the knee is tested while performing a squatting motion. However, such motion is of limited daily-life relevance and clinical practices has shown that squatting commonly causes problems for knee patients. As a result, a new test rig was developed that allows a random, controlled movement of the ankle relative to the hip in the sagittal plane.

Mounting the specimen in the test rig, restricts five degrees of freedom (DOF) at the hip; only the rotation in the sagittal plane is not restrained (Figure 1). On the other hand, at the ankle, only two degrees of freedom are restrained, namely the movement in the sagittal plane. The ankle has thus three rotational degrees of freedom, all rotation axis intersect in a single point: the center of the ankle. In addition, the out-of-plane translational movement of the ankle remains free. This is achieved by means of a linear bearing. The other translational degrees of freedom, in the sagittal plane, are controlled by two actuators. As a result, the knee has five degrees of freedom left; flexion-extension is controlled. This represents typical closed chain applications, such as cycling.

In a first step, the knee kinematics have been evaluated under un-loaded conditions (no quadriceps or hamstring forces applied). To evaluate the knee kinematics, an infrared camera system (OptiTrack, NaturalPoint Inc, USA) is used. Therefore, three infrared markers are placed on the femur and tibia respectively. In addition, markers are placed on the test rig itself, to evaluate the accuracy of the applied motion. All markers are tracked using eight infrared cameras. At the ankle, a 2D circular motion with a radius of 100 mm was applied. Based on the 3D motion analysis, it was demonstrated that the control system has an accuracy of ± 0.5 mm.

The evaluation of the knee kinematics in accordance to Grood and Suntay (J. of Biomechanical Engineering, 1983), additionally requires the evaluation of the knee anatomy. To that extent, the cadaveric specimen has been visualized using a CT scan, with the infrared markers in place. From these CT images, a 3D reconstruction has been created (Mimics, Materialise, Belgium). Subsequently, custom software has been developed that combines the CT data with the motion analysis data (Matlab, The MathWorks Inc., USA). As a result, knee motion is visualized in 3D (Figure 2.a) and clinical relevant kinematic parameters can be derived (Figure 2.b).

In conclusion, the presented test rig and analysis framework is ready to evaluate more complex knee kinematics with reasonable accuracy and stability of the control loops. Future research will however primarily focus on the evaluation and validation of the impact of forces applied onto the specimen.

It is nowadays widely recognized that patient satisfaction following knee arthroplasty strongly depends on ligament balancing. To obtain this balancing, the occurring ligament strain is assumed to play a crucial role. To measure this strain, a method is described in this paper that allows full field 3D evaluation of the strains. The latter is preferred over traditional measurement techniques, e.g. displacement transducers or strain gauges, as human soft tissue is not expected to deform uniformly due to its highly inhomogeneous and anisotropic properties.

To facilitate full field strain measurements, the 3D digital image correlation (DIC) technique was adopted. This technique was previously validated by our research group on human tissue. First, a high contrast speckle pattern was applied on the sMCL. Therefore, the specimens are first coated with a small layer of methylene blue. Following, a random white speckle pattern is applied. During knee flexion, two cameras simultaneously take pictures of the deforming region at predefined flexion angles. Using dedicated software, the captured images are eventually combined and result in 3D full field strains and displacements.

Using this method, the strain distribution was studied in six cadaveric knees during flexion extension movement. Therefore, the femur was rigidly fixed in a custom test rig. The tibia was left unconstrained, allowing the six degrees of freedom in the knee. A load was applied to all major muscles in physiological directions of each muscle by attaching a series of calibrated weights (Farahmand et al., J Orthop Res., 1998;16(1)). The direction of the pulling cables was controlled using a digital inclinometer for each specimen. As a result, a statically balanced muscle loading of the knee was obtained.

From these cadaveric experiments, it is observed that on average the sMCL behaves isometrically between 0° and 90° of flexion. However, high regional differences in strain distribution are observed from the full field measurements. The proximal region of the sMCL experiences relatively high strains upon flexion. These strains are positive (tension) in the anterior part and negative (compression) in the posterior region. In contrast, the distal region remains approximately isometric upon knee flexion (see Figure 1).

It is accordingly concluded that the sMCL behaves isometric, though large regional differences are observed. The proximal region experiences higher strains. Furthermore, the DIC technique provided valuable insights in the deformation of the sMCL. This technique will therefore be applied to study the impact of knee arthroplasty in the near future.

Caption with figure 1: Full field strain distribution in the sMCL's longitudinal direction for specimen in 45° (a) and 90° (b) of knee flexion

Background

The use of Computed Tomography (CT) as a medical imaging tool has widespread applications in the field of knee surgery. Surgeons use a CT scan in a conventional way during the pre-operative stage, to plan the position of the femoral component in the horizontal plane. In the post-operative stage, the use of a CT scan is a routine tool in the evaluation of failed TKA as rotational malalignment of the femoral component has been determined as a cause of poor clinical outcome after TKA.

Introduction

Total Knee Arthroplasty (TKA) is a proven successful and cost-effective method to relieve pain and improve joint function and quality of life in patients with advanced knee arthritis. However, after a TKA, only 75 to 89% of patients are satisfied. Since patient satisfaction is one of the main objectives of elective orthopaedic surgery, it is important to investigate the reasons for dissatisfaction and develop remedial strategies.