A multiaxial force-sensing implantable tibial prosthesis

Accurate in vivo measurement of tibiofemoral forces is important in total knee arthroplasty. These forces determine polyethylene stresses and cold-flow, stress distribution in the implant, and stress transfer to the underlying implant bone interface. Theoretic estimates of tibiofemoral forces have varied widely depending on the mathematical models used. The six degrees of freedom of motion, complex articular surface topography, changing joint-contact position, intra- and extra-articular ligaments, number of muscles crossing the knee joint, and the presence of the patellofemoral joint contribute to the difficulty in developing reliable models of the knee. A prototype instrumented total knee replacement tibial prosthesis was designed, manufactured, and tested. This prosthesis accurately measured all six components of tibial forces (R2>0.997). The prosthesis was also instrumented with an internal microtransmitter for wireless data transmission. Remote powering of the sealed implanted electronics was achieved using magnetic coil induction. This device can be used to validate existing models of the knee that estimate these forces or to develop more accurate models. In conjunction with kinematic data, accurate tibiofemoral force data may be used to design more effective knee-testing rigs and wear simulators. Additional uses are intraoperative measurement of forces to determine soft-tissue balancing and to evaluate the effects of rehabilitation, external bracing, and athletic activities, and activities of daily living.     

Design, calibration and pre-clinical testing of an instrumented tibial tray

An instrumented tibial tray was developed that enables the measurement of six load components in a total knee arthroplasty (TKA). The design is fully compatible with a commonly available knee arthroplasty product since it uses the original tibial insert and femoral component. Two plates with hollow stems made from titanium alloy are separated by a small gap. Six semiconductor strain gages are used for measuring the load-dependent deformation of the inner hollow stem. A 9-channel telemetry unit with a radio-frequency transmitter is encapsulated hermetically in the cavity of the prosthesis. The telemetry is powered inductively and strain gage signals are transmitted via a small antenna at the tip of the implant. The mean sampling rate is 125Hz. The calibration of the prosthesis resulted in an accuracy better than 2% mean measuring error. Fatigue testing of the implant was performed up to 10 million loading cycles and showed no failure. The pending in vivo application will give further insight into the kinetics of TKA. The measured values will enhance the quality of future pre-clinical testing, numerical modeling in knee biomechanics and the patients' physiotherapy and rehabilitation.     

The influence of tibial component fixation techniques on resorption of supporting bone stock after total knee replacement

Periprosthetic bone resorption after tibial prosthesis implantation remains a concern for long-term fixation performance. The fixation techniques may inherently aggravate the "stress-shielding" effect of the implant, leading to weakened bone foundation. In this study, two cemented tibial fixation cases (fully cemented and hybrid cementing with cement applied under the tibial tray leaving the stem uncemented) and three cementless cases relying on bony ingrowth (no, partial and fully ingrown) were modelled using the finite element method with a strain-adaptive remodelling theory incorporated to predict the change in the bone apparent density after prosthesis implantation. When the models were loaded with physiological knee joint loads, the predicted patterns of bone resorption correlated well with reported densitometry results. The modelling results showed that the firm anchorage fixation formed between the prosthesis and the bone for the fully cemented and fully ingrown cases greatly increased the amount of proximal bone resorption. Bone resorption in tibial fixations with a less secure anchorage (hybrid cementing, partial and no ingrowth) occurred at almost half the rate of the changes around the fixations with a firm anchorage. The results suggested that the hybrid cementing fixation or the cementless fixation with partial bony ingrowth (into the porous-coated prosthesis surface) is preferred for preserving proximal tibial bone stock, which should help to maintain post-operative fixation stability. Specifically, the hybrid cementing fixation induced the least amount of bone resorption.     

Analysis of bone–prosthesis interface micromotion for cementless tibial prosthesis fixation and the influence of loading conditions

A lack of initial stability of the fixation is associated with aseptic loosening of the tibial components of cementless knee prostheses. With sufficient stability after surgery, minimal relative motion between the prosthesis and bone interfaces allows osseointegation to occur thereby providing a strong prosthesis-to-bone biological attachment. Finite element modelling was used to investigate the bone–prosthesis interface micromotion and the relative risk of aseptic loosening. It was anticipated that by prescribing different joint loads representing gait and other activities, and the consideration of varying tibial–femoral contact points during knee flexion, it would influence the computational prediction of the interface micromotion. In this study, three-dimensional finite element models were set up with applied loads representing walking and stair climbing, and the relative micromotions were predicted. These results were correlated to in-vitro measurements and to the results of prior retrieval studies. Two load conditions, (i) a generic vertical joint load of 3×body weight with 70%/30% M/L load share and antero-posterior/medial-lateral shear forces, acted at the centres of the medial and lateral compartments of the tibial tray, and (ii) a peak vertical joint load at 25% of the stair climbing cycle with corresponding antero-posterior shear force applied at the tibial–femoral contact points of the specific knee flexion angle, were found to generate interface micromotion responses which corresponded to in-vivo observations. The study also found that different loads altered the interface micromotion predicted, so caution is needed when comparing the fixation performance of various reported cementless tibial prosthetic designs if each design was evaluated with a different loading condition.     

In vivo contact kinematics and contact forces of the knee after total knee arthroplasty during dynamic weight-bearing activities

Analysis of polyethylene component wear and implant loosening in total knee arthroplasty (TKA) requires precise knowledge of in vivo articular motion and loading conditions. This study presents a simultaneous in vivo measurement of tibiofemoral articular contact forces and contact kinematics in three TKA patients. These measurements were accomplished via a dual fluoroscopic imaging system and instrumented tibial implants, during dynamic single leg lunge and chair rising-sitting. The measured forces and contact locations were also used to determine mediolateral distribution of axial contact forces. Contact kinematics data showed a medial pivot during flexion of the knee, for all patients in the study. Average axial forces were higher for lunge compared to chair rising-sitting (224% vs. 187% body weight). In this study, we measured peak anteroposterior and mediolateral forces averaging 13.3% BW during lunge and 18.5% BW during chair rising-sitting. Mediolateral distributions of axial contact force were both patient and activity specific. All patients showed equitable medial-lateral loading during lunge but greater loads at the lateral compartment during chair rising-sitting. The results of this study may enable more accurate reproduction of in vivo loads and articular motion patterns in wear simulators and finite element models. This in turn may help advance our understanding of factors limiting longevity of TKA implants, such as aseptic loosening and polyethylene component wear, and enable improved TKA designs.     

Strength requirements for internal and external prostheses

Throughout the history of development of joint replacement implants and external prostheses there have been mechanical failures due to a discrepancy between material strength, cross-sectional characteristics and the loads developed in normal or abnormal function by the patient utilising the device. Particularly for internal prostheses attention is being paid at the present time to wear characteristics and the requirements for the articulating surfaces and the volume of wear particles produced during tests simulating the use of the device within the patient. The particular importance of the wear particles is that they seem to be associated with accelerated resorption of bone at areas essential for successful fixation of the implant within it. This article will consider joint replacements at the knee and hip and external prostheses for the leg. If failure due to external trauma is ignored the loads to be considered in testing standards correspond in implants to the muscular and ligamentous forces related to the forces developed between ground and foot and to the bending moments in the structure of leg prostheses. Generally it can be assumed that the treatment of the patient following trauma is more easily accomplished and more likely to be successful if the prosthesis has failed and not the bony structure of the patient. However, the author is unaware that these devices have ever been designed to have lower intrinsic strength than the anatomical structures to which they are connected; indeed in many cases particularly for implants they are much stronger than the bone to which they are connected. The major difficulty in rational design of prosthetic devices has been uncertainty about the importance of occasionally applied loads of a high value relative to those on a frequent basis and also to the frequency of application of these overloads. In this paper consideration is given to methods of determination of load systems relevant to the mechanical performance of implanted joint replacements at the hip and the knee and external prostheses for leg amputees. New data are presented relating to walking, other daily activities and the corresponding frequency of occurrence of these. Loading data on implants obtained by various biomechanical models is compared and related to the loads actually measured by implanted transducers. The philosophy of the standardised test load systems and the performance requirements is reviewed.     

In vivo knee moments and shear after total knee arthroplasty

Tibiofemoral loading is very important in cartilage degeneration as well as in component survivorship after total knee arthroplasty. We have previously reported the axial knee forces in vivo. In this study, a second-generation force-sensing device that measured all six components of tibial forces was implanted in a 74-kg, 83-year-old male. Video motion analysis, ground reaction forces, and knee forces were measured during walking, stair climbing, chair-rise, and squat activities. Peak total force was 2.3 times body weight (BW) during walking, 2.5 x BW during chair rise, 3.0 x BW during stair climbing, and 2.1 x BW during squatting. Peak anterior shear force at the tibial tray was 0.30 x BW during walking, 0.17 x BW during chair rise, 0.26 x BW during stair climbing, and 0.15 x BW during squatting. Peak flexion moment at the tray was 1.9% BW x Ht (percentage of body weight multiplied by height) for chair-rise activity and 1.7% BW x Ht for squat activity. Peak adduction moment at the tray was -1.1% BW x Ht during chair-rise, -1.3% BW x Ht during squatting. External knee flexion and adduction moments were substantially greater than flexion and adduction moments at the tray. The axial component of forces predominated especially during the stance phase of walking. Shear forces and moments at the tray were very modest compared to total knee forces. These findings indicate that the soft tissues around the knee absorbed most of the external shear forces. Our results highlight the importance of direct measurements of knee forces.     

Tibiofemoral joint contact force in deep knee flexion and its consideration in knee osteoarthritis and joint replacement

The aim of the study was to estimate the tibiofemoral joint force in deep flexion to consider how the mechanical load affects the knee. We hypothesize that the joint force should not become sufficiently large to damage the joint under normal contact area, but should become deleterious to the joint under the limited contact area. Sixteen healthy knees were analyzed using a motion capture system, a force plate, a surface electromyography, and a knee model, and then tibiofemoral joint contact forces were calculated. Also, a contact stress simulation using the contact areas from the literature was performed. The peak joint contact forces (M +/- SD) were 4566 +/- 1932 N at 140 degrees in rising from full squat and 4479 +/- 1478 N at 90 degrees in rising from kneeling. Under normal contact area, the tibiofemoral contact stresses in deep flexion were less than 5 MPa and did not exceed the stress to damage the cartilage. The contact stress simulation suggests that knee prosthesis having the contact area smaller than 200 mm2 may be problematic since the contact stress in deep flexion would become larger than 21 MPa, and it would lead damage or wear of the polyethylene.     

Thigh–calf contact: Does it affect the loading of the knee in the high-flexion range?

Recently, high-flexion knee implants have been developed to provide for a large range of motion (ROM>120°) after total knee arthroplasty (TKA). Since knee forces typically increase with larger flexion angles, it is commonly assumed that high-flexion knee implants are subjected to larger loads than conventional knee implants. However, most high-flexion studies do not consider thigh–calf contact which occurs during high-flexion activities such as squatting and kneeling. In this study, we hypothesized that thigh–calf contact reduces the knee forces during deep knee flexion as the tibio-femoral load shifts from occurring inside the knee towards the thigh–calf contact interface. Hence, the effect of thigh–calf contact on the knee loading was evaluated using a free body diagram and a finite element model and both the knee forces and polyethylene stresses were analyzed. Thigh–calf contact force characteristics from an earlier study were included and a squatting movement was simulated. In general, we found thigh–calf contact considerably reduced both the knee forces and polyethylene stresses during deep knee flexion. At maximal flexion (155°), the compressive knee force decreased from 4.89 to 2.90 times the bodyweight (BW) in case thigh–calf contact was included and the polyethylene contact stress at the tibial post decreased from 49.3 to 28.1 MPa. Additionally, there was a clear correlation between a subject's thigh and calf circumference and the force reduction at maximal flexion due to thigh–calf contact (R=0.89). The findings presented in this study can be used to optimize the mechanical behavior of high-flexion total knee arthroplasty designs.     

Ligament balancing in TKA: evaluation of a force-sensing device and the influence of patellar eversion and ligament release

Ligament balancing in total knee arthroplasty may have an important influence on joint stability and prosthesis lifetime. In order to provide quantitative information and assistance during ligament balancing, a device that intraoperatively measures knee joint forces and moments was developed. Its performance and surgical advantages were evaluated on six cadaver specimens mounted on a knee joint loading apparatus allowing unconstrained knee motion as well as compression and varus-valgus loading. Four different experiments were performed on each specimen. (1) Knee joints were axially loaded. Comparison between applied and measured compressive forces demonstrated the accuracy and reliability of in situ measurements (1.8N). (2) Assessment of knee stability based on condyle contact forces or varus-valgus moments were compared to the current surgical method (difference of varus-valgus loads causing condyle lift-off). The force-based approach was equivalent to the surgical method while the moment-based, which is considered optimal, showed a tendency of lateral imbalance. (3) To estimate the importance of keeping the patella in its anatomical position during imbalance assessment, the effect of patellar eversion on the mediolateral distribution of tibiofemoral contact forces was measured. One fourth of the contact force induced by the patellar load was shifted to the lateral compartment. (4) The effect of minor and major medial collateral ligament releases was biomechanically quantified. On average, the medial contact force was reduced by 20% and 46%, respectively. Large variation among specimens reflected the difficulty of ligament release and the need for intraoperative force monitoring. This series of experiments thus demonstrated the device's potential to improve ligament balancing and survivorship of total knee arthroplasty.     

Muscle and external load contribution to knee joint contact loads during normal gait

Large knee adduction moments during gait have been implicated as a mechanical factor related to the progression and severity of tibiofemoral osteoarthritis and it has been proposed that these moments increase the load on the medial compartment of the knee joint. However, this mechanism cannot be validated without taking into account the internal forces and moments generated by the muscles and ligaments, which cannot be easily measured. Previous musculoskeletal models suggest that the medial compartment of the tibiofemoral joint bears the majority of the tibiofemoral load, with the lateral compartment unloaded at times during stance. Yet these models did not utilise explicitly measured muscle activation patterns and measurements from an instrumented prosthesis which do not portray lateral compartment unloading. This paper utilised an EMG-driven model to estimate muscle forces and knee joint contact forces during healthy gait. Results indicate that while the medial compartment does bear the majority of the load during stance, muscles provide sufficient stability to counter the tendency of the external adduction moment to unload the lateral compartment. This stability was predominantly provided by the quadriceps, hamstrings, and gastrocnemii muscles, although the contribution from the tensor fascia latae was also significant. Lateral compartment unloading was not predicted by the EMG-driven model, suggesting that muscle activity patterns provide useful input to estimate muscle and joint contact forces.     

Forces in anterior cruciate ligament during simulated weight-bearing flexion with anterior and internal rotational tibial load

This study determined in-vitro anterior cruciate ligament (ACL) force patterns and investigated the effect of external tibial loads on the ACL force patterns during simulated weight-bearing knee flexions. Nine human cadaveric knee specimens were mounted on a dynamic knee simulator, and weight-bearing knee flexions with a 100N of ground reaction force were simulated; while a robotic/universal force sensor (UFS) system was used to provide external tibial loads during the movement. Three external tibial loading conditions were simulated, including no external tibial load (termed BW only), a 50N anterior tibial force (ATF), and a 5Nm internal rotation tibial torque (ITT). The tibial and femoral kinematics was measured with an ultrasonic motion capture system. These movement paths were then accurately reproduced on a robotic testing system, and the in-situ force in the ACL was determined via the principle of superposition. The results showed that the ATF significantly increased the in-situ ACL force by up to 60% during 0-55 degrees of flexion, while the ITT did not. The magnitude of ACL forces decreased with increasing flexion angle for all loading conditions. The tibial anterior translation was not affected by the application of ATF, whereas the tibial internal rotation was significantly increased by the application of ITT. These data indicate that, in a weight-bearing knee flexion, ACL provides substantial resistance to the externally applied ATF but not to the ITT.     

Contact forces in several TKA designs during squatting: A numerical sensitivity analysis

Total knee arthroplasty (TKA) is a very successful procedure, but pain or difficulties during activities still persist in patients. Patient outcomes in TKA surgery can be affected by implant design, alignment or patient-related anatomical factors. This paper presents a numerical sensitivity analysis of several TKA types: a fixed bearing, posterior stabilized prosthesis, a high flexion fixed bearing guided motion prosthesis, a mobile bearing prosthesis and a hinge prosthesis. Each prosthesis was virtually implanted on the same cadaver leg model and it underwent a loaded squat, in 10s, between 0° and 120°, similar to several previous experimental tests performed on knee kinematics simulators. The aim of this examination was to investigate the sensitivity of the patello-femoral (PF) and tibio-femoral (TF) contact forces to patient-related anatomical factors, and component position in the different implant types. The following parameters were used for the sensitivity study: the proximo-distal patellar position, the patellar component tilting, the tibial component position and orientation, the locations of the medial and lateral collateral ligaments with respect to femur and tibia and the patellar tendon length. The sensitivity analysis showed that PF contact forces are mostly affected by patella height (increases up to 67% for one TKA type in patella-alta configuration), by an anterior tibial component translation (increases up to 30%), and by patellar component tilting (increases up to 29%); TF contact forces are mostly affected by the anterior displacement of the insertion points of the medial collateral ligament with respect to the reference position (increases up to 48%).     

Estimating total knee replacement joint load ratios from kinematics

Accurate prediction of loads acting at the joint in total knee replacement (TKR) patients is key to developing experimental or computational simulations which evaluate implant designs under physiological loading conditions. In vivo joint loads have been measured for a small number of telemetric TKR patients, but in order to assess device performance across the entire patient population, a larger patient cohort is necessary. This study investigates the accuracy of predicting joint loads from joint kinematics. Specifically, the objective of the study was to assess the accuracy of internal–external (I–E) and anterior–posterior (A–P) joint load predictions from I–E and A–P motions under a given compressive load, and to evaluate the repeatability of joint load ratios (I–E torque to compressive force (I–E:C), and A–P force to compressive force (A–P:C)) for a range of compressive loading profiles. A tibiofemoral finite element model was developed and used to simulate deep knee bend, chair-rise and step-up activities for five patients. Root-mean-square (RMS) differences in I–E:C and A–P:C load ratios between telemetric measurements and model predictions were less than 1.10e–3 Nm/N and 0.035 N/N for all activities. I–E:C and A–P:C load ratios were consistently reproduced regardless of the compressive force profile applied (RMS differences less than 0.53e–3 Nm/N and 0.010 N/N, respectively). When error in kinematic measurement was introduced to the model, joint load predictions were forgiving to kinematic measurement error when conformity between femoral and tibial components was low. The prevalence of kinematic data, in conjunction with the analysis presented here, facilitates determining the scope of A–P and I–E joint loading ratios experienced by the TKR population.     

Contact stresses and fatigue life in a knee prosthesis: comparison between in vitro measurements and computational simulations

The evaluation of contact areas and pressures in total knee prosthesis is a key issue to prevent early failure. The first part of this study is based on the hypothesis that the patterns of contact stresses on the tibial insert of a knee prosthesis at different stages of the gait cycle could be an indicator of the wear performances of a knee prosthesis. Contact stresses were calculated for a mobile bearing knee prosthesis by means of finite element method (FEM). Contact areas and stresses were also measured through in vitro tests using Fuji Prescale film in order to support the FEM findings.The second part of this study addresses the long-term structural integrity of metal tibial components in terms of fatigue life by means of experimental tests and FEM simulations. Fatigue experimental evaluations were performed on Cr-Co alloy tibial tray, based on ISO standards. FEM models were used to calculate the stress patterns. The failure risk was estimated with a standard fatigue criterion on the basis of the results obtained from the FEM calculations. Experimental and computational results showed a positive matching.     

Mechanisms of anterior-posterior stability of the knee joint under load-bearing

The anterior-posterior (AP) stability of the knee is an important aspect of functional performance. Studies have shown that the stability increases when compressive loads are applied, as indicated by reduced laxity, but the mechanism has not been fully explained. A test rig was designed which applied combinations of AP shear and compressive forces, and measured the AP displacements relative to the neutral position. Five knees were evaluated at compressive loads of 0, 250, 500, and 750 N, with the knee at 15° flexion. At each load, three cycles of shear force at ±100 N were applied. For the intact knee under load, the posterior tibial displacement was close to zero, due to the upward slope of the anterior medial tibial surface. The soft tissues were then resected in sequence to determine their role in AP laxity. After anterior cruciate ligament (ACL) resection, the anterior tibial displacement increased significantly even under load, highlighting its importance in stability. Meniscal resection further increased displacement but also the vertical displacement increased, implying the meniscus was providing a buffering effect. The PCL had no effect on any of the displacements under load. Plowing cartilage deformation and surface friction were negligible. This work highlighted the particular importance of the upward slope of the anterior medial tibial surface and the ACL to AP knee stability under load. The results are relevant to the design of total knees which reproduce anatomic knee stability behavior.     

A finite element model for evaluation of tibial prosthesis-bone interface in total knee replacement

A numerical model based on the finite element method was developed for the load transfer analysis at the tibial bone-implant interfaces in total knee replacement. A transverse isotropic material model, based on a quadratic elastic potential and on Hill's quadratic yield criterion, was next developed for bone constitutive laws. The bone-cement and bone-prosthesis interfaces were both assumed to be discontinuous. A dry friction model based on Coulomb's criterion was adopted for the interfaces friction. The model was shown to be able to give compressive and shear stresses distributions and distractive and relative shear micromotions at these interfaces. A preliminary application was conducted for cemented metal tray total condylar (MTTC) and for cemented and uncemented porous coated anatomic (PCA) tibial plateaus. The PCA plateaus were found to be more deformable and had greater global displacements than the MTTC one. Debonding of the bone-peg interface was observed for the uncemented PCA. Correspondingly, the stress peaks at the interface beneath the tray were lower for the PCA than for the MTTC. Shear micromotions appeared under the tray for both the two prostheses. We observed that bone anisotropy and interface discontinuity affected the results sensibly.     

A three-dimensional non-linear finite element study of the effect of cement-prosthesis debonding in cemented femoral total hip components.

A three-dimensional non-linear finite element analysis of a cemented femoral component in which the component was partially debonded from the cement mantle was used to assess the effects of debonding on stresses in the cement. Three cases of partial cement-metal debonding were modelled with debonding of the proximal portion of the implant down to a horizontal plane which was 35, 62.5, or 82.5 mm below the prosthesis collar. Each situation was studied under loads simulating both gait and stairclimbing. Also, complete debonding between the implant and the surrounding cement mantle was modeled for loads simulating gait. Under stair climbing loads with partial cement-mental debonding, hoop stresses of 13-18 MPa were observed in the cement at the cement-metal interface at the proximal postero-medial corner of the implant. Similarly, in stair climbing, the maximum principal stresses in the cement were also adjacent to the proximal postero-medial region of the implant. These stresses were compressive and increased from 15 MPa with fully bonded interfaces to 48 MPa with debonding down to 82.5 mm below the prosthesis collar. Under gait loads, complete debonding caused high compressive stresses up to 34.9 MPa in the cement distal to the prosthesis tip. Thus, cement failure subsequent to prosthesis debonding is likely in the proximal region in a partially debonded implant due to stair climbing loads and is likely below the prosthesis tip in a fully debonded implant due to gait loading.     

In vitro forces in the normal and cruciate-deficient knee during simulated squatting motion

Three orthogonal components of the tibiofemoral and patellofemoral forces were measured simultaneously for knees with intact cruciate ligaments (nine knees), following anterior cruciate ligament resection (six knees), and subsequent posterior cruciate ligament resection (six knees). The knees were loaded using an experimental protocol that modeled static double-leg squat. The mean compressive tibial force increased with flexion angle. The mean anteroposterior tibial shear force acted posteriorly on the tibia below 50 deg flexion and anteriorly above 55 deg. Mediolateral shear forces were low compared to the other force components and tended to be directed medially on both the patella and tibia. The mean value of the ratio of the resultant tibial force divided by the quadriceps force decreased with increasing flexion angle and was between 0.6 and 0.7 above 70 deg flexion. The mean value of the ratio of the resultant tibiofemoral contact force divided by the resultant patellofemoral contact force decreased with increasing flexion and was between 0.8 and 1.0 above 55 deg flexion. Cruciate ligament resection resulted in no significant changes in the patellar contact forces. Following resection of the anterior cruciate ligament, the tibial anteroposterior shear force was directed anteriorly over all flexion angles tested. Subsequent resection of the posterior cruciate ligament resulted in an approximately 10 percent increase in the quadriceps tendon and tibial compressive force.