Persistent medial laxity increases the risk of failure for ACL reconstruction. To address this, multiple reconstruction techniques have been created. To date, no single strand reconstruction constructs have been able to restore both valgus and rotational stability. In response to this, a novel single strand Short Isometric Construct (SIC) MCL reconstruction was developed. Eight fresh-frozen cadaveric specimens were tested in three states: 1) intact 2) after sMCL and dMCL transection, and 3) after SIC MCL reconstruction. In each state, four loading conditions were applied at varying flexion angles: 90N anterior drawer, 5Nm tibial external rotation torque, 8Nm valgus torque, and combined 90N anterior drawer plus 5Nm tibial external rotation torque.Abstract
Introduction
Methods
Historic MCL reconstruction techniques focused on the superficial MCL to restore valgus stability while overlooking tibial external rotation and the deep MCL. This study assessed the ability of a contemporary medial collateral ligament (MCL) reconstruction and a deep MCL (dMCL) reconstruction to restore rotational and valgus knee stability. Six pairs fresh-frozen cadaveric knee specimens with intact soft tissue were tested in four states: 1) intact 2) after sMCL and dMCL sectioning, 3) contemporary MCL reconstruction (LaPrade et al), and 4) dMCL reconstruction. In each state, four loading conditions were applied at varying flexion angles: 8Nm valgus torque, 5Nm tibial external rotation torque, 90N anterior drawer, and combined 90N anterior drawer plus 5Nm tibial external rotation torque.Abstract
Introduction
Methods
The increasing incidence of periprosthetic femoral fractures (PFF) after total hip arthroplasty presents growing concerns due to challenges in treatment and increased mortality. PFF are often observed when the prosthesis is implanted in varus, especially with blade-type stems. To help elucidate its impact on the PFF risk, the specific research question is: What is the effect of misalignment of a blade-type stem (resulting in down-sized prosthesis) on 1)the distribution and magnitude of cortical stresses and 2)implant-bone micromotion. We developed two finite element models consisting of an average female femur implanted within a generic blade-type stem prosthesis, (i)in neutral alignment, and (ii)oriented in 5° of varus, coupled with corresponding down-sizing of the prosthesis. Each model consisted of 1.1million elements, while the average mesh length at the implant-bone interface was 0.4mm. Elastic moduli of 15GPa(cortex), 150MPa(trabecular bone), and 121GPa(implant), and Poisson's ratio of 0.3 were assumed. The distal end was fixed and the interface was defined as a surface-to-surface contact with friction coefficients (dynamic 0.3; static 0.4). Walking and stair-climbing were simulated by loading the joint contact and muscle forces after scaling to the subjects’ body weight. The peak von Mises stress and the average stress within the surface having 1cm diameter and the center at where the peak stress occurred at each contacting area, the interfacial micromotion along medial, lateral side were analyzed. For statistical analysis, two-tailed t-test was performed between the neutral and varus cases over four loading cycles with significance level of p<0.05.INTRODUCTION
METHOD
Corrosion products from modular taper junctions are a potent source of adverse tissue reactions after THR. In an attempt to increase the area of contact and resistance to interface motion in the face of taper mismatches, neck trunnions are often fabricated with threaded surfaces designed to deform upon assembly. However, this may lead to incomplete contact and misalignment of the head on the trunnion, depending upon the geometry and composition of the mating components. In this study we characterized the effect of different femoral head materials on the strength and area of contact of modular taper constructs formed with TiAlV trunnions. Three groups of 36mm femoral heads (CoCr, Biolox ceramic; Oxinium) and matching Ti-6Al-4V rods with 12/14 trunnions were selected for use in this study. The surface of each trunnion was coated with a 20nm layer of gold applied by sputter-coating in vacuo. Each head/trunnion pair was placed in an alignment jig and assembled with a peak axial impaction force of 2000N using a drop tower apparatus. After assembly, each taper was disassembled in a custom apparatus mounted in a mechanical testing machine (Bionix. MTS. After separation of the components, the surface of each trunnion was examined with backscattered electron microscopy to reveal the area of disruption of the original gold-coated surface. Images encompassing the entire surface of the trunnion were collected and quantified by image processing.Introduction
Materials and Methods
In theory, Finite Element Analysis (FEA) is an attractive method for elucidating the mechanics of modular implant junctions, including variations in materials, designs, and modes of loading. However, the credence of any computational model can only be established through validation using experimental data. In this study we examine the validity of such a simulation validated by comparing values of interface motion predicted using FEA with values measured during experimental simulation of stair-climbing. Two finite element models (FEM) of a modular implant assembly were created for use in this study, consisting of a 36mm CoCr femoral head attached to a TiAlV rod with a 14/12 trunnion. Two head materials were modelled: CoCr alloy (118,706 10-noded tetrahedral elements), and alumina ceramic (124,710 10-noded tetrahedral elements). The quasi-static coefficients of friction (µs) of the CoCr-TiAlV and Ceramic-TiAlV interfaces were calculated from uniaxial assembly (2000N) and dis-assembly experiments performed in a mechanical testing machine (Bionix, MTS). Interface displacements during taper assembly and disassembly were measured using digital image correlation (DIC; Dantec Dynamics). The assembly process was also simulated using the computational model with the friction coefficient set to µs and solved using the Siemens Nastran NX 11.0 Solver. The frictional conditions were then varied iteratively to find the value of µ providing the closest estimate to the experimental value of head displacement during assembly. To validate the FEA model, the relative motion between the head and the trunnion was measured during dynamic loading simulating stair-climbing. Each modular junction was assembled in a drop tower apparatus and then cyclically loaded from 230–4300N at 1 Hz for a total of 2,000 cycles. The applied load was oriented at 25° to the trunnion axis in the frontal plane and 10° in the sagittal plane. The displacement of the head relative to the trunnion during cyclic loading was measured by a three-camera digital image correlation (DIC) system. The same loading conditions were simulated using the FEA model using the optimal value of µ derived from the initial head assembly trials.INTRODUCTION
MATERIALS and METHODS
Most patients presenting with loss of hip motion secondary to FAI have a combination of cam and pincer morphology. In this study, we present a composite index for predicting joint ROM based on anatomic parameters derived from both the femur and acetabulaum using a single reformatted CT slice. Computer models of the hip joint were reconstructed from CT scans of 31 patients with mixed-type FAI (Average alpha angle: 73.6±11.1°, average LCE: 38.9±7.2°). The internal rotation of the hip at impingement was measured at 90° flexion using custom software. With the joint in neutral, a single slice perpendicular to the acetabular rim was taken at the 2 o'clock position. A set of 11 femoral and acetabular parameters measured from this slice were correlated with hip ROM using stepwise logistic regression. Three anatomic parameters provided significant discrimination of cases impinging at <15 and >15 degrees IR: femoral anteversion (28%, p=0.026), the arc of anterior femoral head sphericity (10%, p=0.040), and the LCE in the 2 o'clock plane (10%, p=0.048). This led to the following definition of the Impingement Index: 0.16*(fem version) +0.11*(ant arc)−0.17*(LCE) which correctly classified 82% of cases investigated. None of the traditional parameters (e.g. alpha angle) were significantly correlated with ROM. Our study has identified alternative morphologic parameters that could act as strong predictors of FAI in preoperative assessments. Using this information, each patient's individual risk of impingement may be estimated, regardless of the relative contributions of deformities of the femur and the acetabulum.
Stable fixation of cementless tibial trays remains a challenge due bone density variability within the proximal tibia and the spectrum of loads imposed by different activities. This study presents a novel approach to measuring the interface motion of cementless tibial components during functional loading and tests whether interface motion of cementless tibial trays varies around the implant periphery. We developed a method to measure relative displacement of a tibial tray relative to the underlying bone using 3D digital image correlation (DIC) and multi-camera stereo photogrammetry. A clinically successful design of cementless total knee prosthesis (Zimmer Inc, Warsaw, IN) was implanted in 6 fresh cadaveric knees. A black-on-white stochastic pattern was applied to the outer surface of the tibia and the cementless prosthesis. High resolution digital images were prepared of the interface region and divided into 25 × 25 pixel regions of interest (ROI). Stereo images of the same ROI were generated using two cameras angled at 60 degrees using image correlation techniques. All specimens were mounted in a custom-built functional activity simulator and loaded with the forces and moments recorded during three common functional activities (standing from a seated position, walking, and stair descent), as reported in the Orthoload database, scaled by 50% for application to cadaveric bone. Prior to functional testing, each implant-tibia construct was preconditioned with 500 cycles of flexion from 5–100 degrees under a vertical tibial load of 1050 N at a frequency of 0.2 Hz. During loading, image data was acquired simultaneously (±20 μs) from the entire circumference of the tibial interface forming 4 stereo images using 8 cameras spaced at 90 degree intervals (Allied Vision Technologies, Exton, PA) using custom image acquisition software (Mathworks, Natick, MA) (Figure 1). The multiple stereo images were registered using the surface topography of each specimen as measured by laser scanning (FARO Inc., Montreal) (Figure 2). During post-processing, the circumferential tray/tibia interface was divided into 10 zones for subsequent analysis (Figure 3). Interface displacements were measured on a point-to-point basis at approximately 700 sites on each specimen using commercial DIC software (Dantec Dynamics, Skovlunde, Denmark) (Figure 4).INTRODUCTION
METHODS
Cementless tibial trays commonly fail through failure of fixation due to excessive interface motion. However, the specific combination of axial and shear forces precipitating implant failure is unknown. This has led to generic loading profiles approximating walking to perform pre-clinical assessment of new designs, even though telemetric data demonstrates that much larger forces and moments are generated during other functional activities. This study was undertaken to test the hypotheses: (i) interface motion of cementless tibial trays varies as a function of specific activities, and (ii) the response of the cementless tibial interface to walking loading is not representative of other functional activities. Six fresh-frozen cadaveric tibias were tested using a custom designed functional activity simulator after implantation of a posterior stabilized total knee replacement (NexGen LPS, Zimmer, Warsaw IN). Activity scenarios were selected using force (Fx, Fy, Fz) and moment (Mx, My, Mz) data from patients with instrumented tibial trays (E-tibia) published by Bergmann et al. A pattern of black and white spray paint was applied to the surface of the specimen including the tibial tray and bone. Each specimen was preconditioned through application of a vertical load of 1050N for 500 cycles of flexion-extension from 5–100°. Following preconditioning, each tibia was loaded using e-tibia values of forces and moments for walking, stair-descent, and sit-to-stand activities. The differential motion of the tibial tray and the adjacent bony surface was monitored using digital image correlation (DIC) (resolution: 1–2 microns in plane; 3–4 microns out-of-plane). Four pairs of stereo-images of the tray and tibial bone were prepared at sites around the circumference of the construct in both the loaded and unloaded conditions: (i) before and after pre-conditioning and (ii) before and after the 6 functional loading profiles. The images were processed to provide circumferential measurements of interface motion during loading. Differences in micromotion and migration were evaluated statistically using step-wise multivariate regression.INTRODUCTION
MATERIALS and METHODS
Numerous factors have been hypothesized as contributing to mechanically-assisted corrosion at the head-neck junction of total hip prostheses. While variables attributable to the implant and the patient are amenable to investigation, parameters describing assembly of the component parts can be difficult to determine. Nonetheless, increasing evidence suggests that the manner of intraoperative assembly of modular components plays a critical role in the fretting and corrosion of modular implants. This study was undertaken to measure the magnitude and direction of the impaction forces applied by surgeons in assembling modular head-neck junctions under operative conditions where both the access and visibility of the prosthesis may potentially compromise component fixation. A surrogate consisting of the lower limb with overlying soft tissue was developed to simulate THR performed via a 10cm incision using the posterior approach. The surrogate was modified to match the resistance of the body to retraction of the incision, mobilization of the femur and hammering of the implanted femoral component. An instrumented femoral stem (SL PLUS) was surgically implanted into the bone after attachment of 3 miniature accelerometers (Dytran Inc) in an orthogonal array to the proximal surface of the prosthesis. A 32mm cobalt chrome femoral head was mounted on the trunnion (12/14 taper, machined) of the femoral stem. 15 Board-certified and trainee surgeons replicated their surgical technique in exposing the femur and impacting the modular head on the tapered trunnion. Impaction was performed using an instrumented hammer (5000 Lbf Dytran impact hammer) that provided measurements of the magnitude and temporal variation of the impact force. The components of force acting along the axis aof the neck and in the AP and ML directions were continuously samples using the accelerometers.Introduction
Methods
Recent advances in materials and manufacturing processes for arthroplasty have allowed fabrication of intricate implant surfaces to facilitate bony attachment. However, refinement and evaluation of these new design strategies is hindered by the cost and complications of animal studies, particularly during early iterations in development process. To address this problem, we have constructed and validated an Cancellous cylindrical bone cores were harvested from bovine metatarsals and divided into five groups under different conditions. After incubation for 4 & 7 weeks, the viability of each bone sample was evaluated using Live-Dead assay and microscopic anatomy of cells were determined using histology stain H&E. Matrix deposits on the scaffolds were examined with scanning electron microscopy (SEM) while its chemical composition was measured using energy-dispersive x–ray spectroscopy (EDX).Background
Methods
As the population continues to grow and age, the incidence of revision total knee replacement (RTKR) is expected to rise significantly. Modularity within revision total knee systems is common, and recognition of modular junctions as an important source adverse local tissue reaction (ALTR) has not yet been fully described in the literature. In both hips and knees, ALTR may be caused by wear debris from articulating surfaces, stress shielding, and other classic areas of focus, but now attention is shifting towards the role of corrosion products from modular junctions. In severe cases, junctions can become welded together creating significant hurdles in revisions and potentially altered biomechanics in vivo. In view of these issues, the present study was undertaken: (i) to examine the level of damage observed in modular junctions of total knee prostheses obtained at revision, (ii) to correlate the severity of surface damage to the design and composition of the mating components, and (iii) to associate patient demographics and comorbidities with the spectrum of corrosion and fretting seen in retrieved implants. 117 TKR components from 76 patients were examined after retrieval from revision procedures performed at a single institution. Patient demographics and clinical data were compiled. The retrievals consisted of 57 femoral components and 60 tibial components from a diverse range of manufacturers. The implants were disassembled manually, or in a mechanical testing machine if cold welded, and separated into groups based on mating material type. Modular junctions were then examined using stereomicroscopy (Wild) at magnifications of X6 to X31. Upon inspection, damage on the male component was graded using modified Goldberg scales for corrosion and fretting (Table 1). Factors associated with trunnions having damage scores of 3 or higher were evaluated using standard statistical procedures to determine the susceptibility for corrosion of each junction type and location.Introduction
Methods
Corrosion products from modular taper junctions of hip prostheses have been implicated in adverse local tissue reactions after THR. Numerous factors have been proposed as the root causes of this phenomenon, including implant design and materials, manufacturing variables, intraoperative assembly, and patient lifestyle. As significant taper damage only occurs in a few percent of cases of THR, we have addressed this complication using a “forensic” examination of retrieval specimens to gain insight into the factors initiating the cascade leading to irreversible damage of the modular interface. In this study we report the categorization of over 380 retrievals into groups having shared damage patterns, metallic composition, and interface surface geometries to isolate the genesis of mechanically-assisted corrosion and its relation to intraoperative assembly, manufacturing, and postoperative loading. A total of 384 femoral components were examined after retrieval at revision THR. The implants were produced by a diverse range of manufacturers, 271 in CoCr, and 113 in TiAlV, with both smooth (253) and machined (131) tapers. Initially, the implants were sorted into groups based on composition and taper roughness. Each trunnion was then cleaned to remove organic deposits and examined by stereomicroscopy at X6-X31. After an initial pilot study, we developed a classification system consisting of 8 basic patterns of damage (Table 1). We then classified all 384 trunnions according to this 8-group system. The prevalence of each pattern was calculated on the basis of both composition and surface texture of the trunnion.Introduction
Methods
Restoration of knee function after total knee arthroplasty (TKA) often entails a balance between normal kinematics and normal knee stability, especially in performing demanding physical activities. The ultra-congruent (UC) knee design prioritizes stability over kinematics through close conformity between the femoral component and the tibial insert in extension. This configuration is intended to provide AP stability in the absence of the posterior cruciate ligament during activities that would otherwise cause anterior femoral subluxation. In this study we examine the kinematics of an ultra-congruent knee design in comparison with the intact knee and with conventional articulations used in PCL-retaining (CR) and PCL-substituting (PS) TKR designs. The 3D tibio-femoral kinematics of 6 fresh frozen cadaveric human knees were tested during loaded simulation of squatting in a computer-controlled knee testing rig. Muscle forces were simulated by loading rectus femoris and vastus intermedius (150N), vastus lateralis (100N), vastus medialis (75N), and the hamstring muscles (60N) (total: 385N). Testing was performed on the intact knee, and after implanting a standard design of total knee prosthesis with the posterior cruciate ligament intact (CR-TKA), resected (PCL-substituting insert; PS-TKA), and a UC insert (UC-TKA group). The 3D positions of the tibia and femur were tracked with a high resolution 12 camera motion analysis system (Motion Analysis Inc.) and used to position 3D CT reconstructions of each bone. The translation and rotation of the femur with respect to the tibia were calculated by projecting the femoral transcondylar axis onto a plane normal to the longitudinal anatomical axis of the tibia coincident with the transverse axis of the tibial plateau.Introduction
Materials and Methods
The success of knee replacement surgery depends, in part, on restoration of the correct alignment of the leg with respect to the load-bearing vector passing from the hip to the ankle (the mechanical axis). Conventional thinking is that the correct angle of resection of the distal femur (Valgus Cut Angle, VCA) depends on femoral length or femoral offset, though femoral bowing, in addition to length and medial offset, may also have a significant influence on the VCA. We hypothesized that femoral bowing has a strong effect on the VCA necessary to restore physiologic alignment after arthroplasty or osteotomy. A total of 102 long-leg radiographs were obtained from patients scheduled for primary total knee arthroplasty. The patients on average were 41% male 59% female, 67.9 ± 11.1 years, 67.0 ± 4.7 in, 192 ± 43 lbs, and had a BMI of 29.7 ± 4.8. All radiographs were prepared with the feet placed in identical rotation and the patellae pointing forward, and were excluded if there was evidence of malrotation, as defined by (i) a difference in the medial head offsets of the right and left femur of >3mm, (ii) a difference in the width of the tibiofibular syndesmoses, or (iii) a difference in the rotation of one foot compared to the other. The following anatomic variables were measured on each radiograph: (i) the neck shaft angle (NSA) of the femur, (ii) the length of the femur, (iii) the length of the femoral shaft, (iv) the medial head offset, (v) the medial-lateral bow of the distal femur, (vi) the hip- knee axis angle, (vii) the mechanical axis deviation of the extremity at the knee, (viii) the medio-lateral bow of the tibia, and (ix) the valgus cut angle required to restore the mechanical axis to the center of the knee during surgery (VCA). Bivariate plots were constructed using the measurements thought to influence the VCA: femoral bowing, femoral offset, and length of femur. Multivariate regression was then used to find the variable that had the strongest effect on the VCA.Introduction
Methods
Angular mismatch between the head and trunnion is recognized as a contributing factor to mechanically-assisted corrosion of modular hip prostheses. Although manufacturing standards have been adopted to define acceptable tolerances for taper angles of mating components, the relationship between the head and trunnion taper angles (positive or negative) differs between manufacturers. In this study, we investigated the effect of positive and negative angular mismatch on the interface mechanics of a standard design of taper junction using finite element analysis (FEA). Computer simulations were executed using an FE model which had been previously verified through direct comparison with experimental studies. The neck and trunnion of a Ti6Al4V femoral component (taper size: 12/14mm) were modelled using a stable hexahedral mesh (33,648 elements), while the femoral head (CoCrMo, size: 32mm) was modelled using a tetrahedral mesh (51,182 elements). Assembly of the head on the trunnion was simulated through the application of a load of 4000N along the trunnion axis. This was followed by the application of a gait load of 1638N (2.34×700N BW) at an angle of 30o to the trunnion axis. A friction-based sliding interface (mu=0.12) was simulated at the trunnion-head junction. A linear static solution was set up using Siemens NX Nastran. In addition to a perfect match, 7 positive and negative mismatch angles were simulated ranging from −0.100 to 0.100 degrees. Head taper interface motion, contact pressure and internal stresses (von Mises) were calculated for each mating condition.Introduction
Methods
Relative motion at the modular head-neck junction of hip prostheses can lead to severe surface damage through mechanically-assisted corrosion. One factor affecting the mechanical performance of modular junctions is the frictional resistance of the mating surfaces to relative motion. Low friction increasing forces normal to the head-neck interface, leading to a lower threshold for slipping during weight-bearing. Conversely, a high friction coefficient is expected to limit interface stresses but may also allow uncoupling of the interface in service. This study was performed to examine this trade-off using finite element models of the modular head-neck junction A finite element model (FEM) of the trunnion/ head assembly of a total hip prosthesis was initially created and experimentally validated. CAD models of a stem trunnion (taper size: 12/14mm) and a prosthetic femoral head (diameter: 28mm) were discretized into elements for finite element analysis (FEA). The trunnion (Ti6Al4V) was modelled with a hexahedral mesh (33,648 elements) and the femoral head (CoCrMo) with a tetrahedral mesh (51,182 elements). A friction-based sliding contact interface was defined between the mating surfaces. The model was loaded in 2 stages: (i) an assembly load of 4000N applied along the trunnion axis, and (ii) 500N applied along the trunnion axis in combination with a torque of 10Nm. A linear static solution was set up using Siemens NX-Nastran solver. Multiple simulations were executed by modulating the frictional coefficient at the taper-bore interface from 0.05 to 0.15 in increments of 0.01, the coefficient of 0.1 serving as the control case (Swaminathan and Gilbert, 2012).Introduction
Methods
Patients who undergo hip resurfacing, total hip arthroplasty (THA), and total knee arthroplasty (TKA) are frequently assessed post-operatively using objective scoring indices. A small yet significant percentage of these patients report specific unfulfilled functions following surgery, indicating unmet expectations. The purpose of this study was to examine the types of functional deficits reported for each class of surgery, how frequently these limitations occur, and the demographic of patients who experience/report these limitations. Four groups of subjects were enrolled in this study: (i) 111 hip resurfacing patients at an average of 14 months after resurfacing, (ii) 170 patients at an average of 16 months post-primary THA, (iii) 61 patients at an average of 12 months post-primary TKA, and (iv) 64 control subjects with no history of hip or knee surgery or pathology. Each participant completed a self-administered Hip Function Questionnaire, Knee Function Questionnaire, or Hip Resurfacing Questionnaire which assessed each subject's overall satisfaction and expectations following surgery. The questionnaires included numerical scores of post-operative function as well as an open-ended question which inquired “Is there anything your knee/hip keeps you from doing?”Introduction
Methods
Patients who undergo hip resurfacing, total hip arthroplasty (THA), and total knee arthroplasty (TKA) are frequently assessed post-operatively using objective scoring indices. A small yet significant percentage of these patients report pain and discomfort related to specific physical activities following surgery. The purpose of this study was to examine the types of activities which prove difficult for patients for each class of surgery, how important these activities are to the individual patients, and the demographic of patients who experience/report these limitations. Four groups of subjects were enrolled in this study: (i) 111 hip resurfacing patients at an average of 14 months after resurfacing, (ii) 170 patients at an average of 16 months post-primary THA, (iii) 61 patients at an average of 12 months post-primary TKA, and (iv) 64 control subjects with no history of hip or knee surgery or pathology. Each participant completed a self-administered Hip Function Questionnaire, Knee Function Questionnaire, or Hip Resurfacing Questionnaire which assessed each subject's overall satisfaction and expectations following surgery. The questionnaires included a section with 58 physical activities and asked the patients to rate the activities based on frequency of participation, importance of the activity, and how much their knee or hip bothered them when performing the activity.Introduction
Methods
There is tremendous variability amongst surgeons' ability to reference anatomic landmarks. This may suggest the necessity of other objective methods in determining femoral alignment and rotation. Despite the durability of total knee arthroplasty, there is much room for improvement with regards to functional outcome and patient satisfaction. One important factor contributing to poor outcomes after TKA is malrotation of the femoral component. It has been postulated that this is due to failure of surgeons to correctly reference bony landmarks, principally the femoral epicondyles, however, this is unproven. The purpose of this study was to evaluate the accuracy of joint surgeons and trainees in identifying anatomic landmarks for positioning the femoral component and to determine the effect of prior training and experience.Summary
Introduction
The timely identification of outliers (implants, surgeons or patients) using prospectively collected registry data is confounded by many factors, including the assumption that the sampled population is representative of the entire cohort of patients. In this study we utilized a computer simulation of a joint registry to address the question: How does incomplete enrollment of patients in registries affect the reliability of identification of outliers, and what percent capture of the target population is sufficient? A synthetic registry was created consisting of 10,000 patients (100 surgeons), of whom, 1000 underwent joint replacement using a new implant. A predictive model for the risk of revision was created from data published by the Swedish TKR Registry and the AOANJRR. The pairing of patients, surgeons and implants was randomized and for each assignment, the probability of revision was computed. We then chose random samples of all patients in 10% increments from 10% to 100%, simulating incomplete capture of all potential cases by the registry. For each sample we calculated the number of cases of the new implant predicted to end in revision. The assignments were repeated 2000 times using implants with revision rates of 1.5%, 2.0% and 3.0% per annum vs. 1.0% for all other implants of the same class.INTRODUCTION
MATERIALS AND METHODS
