Despite all the attention to new technologies and sophisticated implant designs, imperfect surgical technique remains a obstacle to improving the results of total knee replacement (TKR). On the tibial side, common errors which are known to contribute to post-operative instability and reduced function include internal rotation of the tibial tray, inadequate posterior slope, and excessive component varus or valgus. However, the prevalence of each error in surgeries performed by surgeons and trainees is unknown. The following study was undertaken to determine which of these errors occurs most frequently in trainees acquiring the surgical skills to perform TKR. A total of 43 knee replacement procedures were performed by 11 surgical trainees (surgical students, residents and fellows) in a computerized training center. After initial instruction, each trainee performed a series of four TKR procedures in cadavers (n = 2) and bone replicas (n = 2) using a contemporary TKR instrument set and the assistance of an experienced surgical instructor. Prior to each procedure, computer models of each cadaver and/or bone replica tibia were prepared by reconstructing CT scans of each specimen. All training procedures were performed in a navigated operating room using a 12 camera motion analysis system (Motion Analysis Inc.) with a spatial resolution in all three orthogonal directions of ± 0.15 mm. The natural slope, varus/valgus alignment, and axial rotation of the proximal tibial surface were recorded prior to surgery and after placement of the tibial component. For evaluation of all data, acceptable limits for implantation were defined as: posterior slope: 0–10°; varus/valgus inclination of tibial resection: ± 3°; and external rotation: 0–10°.Introduction:
Materials and Methods:
The sealing function of the acetabular labrum is central to the stability of the hip and the health of the joint. Disruption of the labrum has been shown to reduce intra-articular pressure and increase the rate of cartilage consolidation during static loading. Functional activities require movement of the hip through wide ranges of joint motion which disrupt joint congruency, and thus may alter the seal. This study was performed to test the hypothesis that the sealing function of the labrum varies with the position of the hip during functional activities. Six fresh cadaveric hip joint specimens were obtained from donors of average age 45.5 ± 16.1 years (range 25–63 years). Each specimen was dissected free of soft tissue, leaving the capsule and labrum intact, potted in mounting fixtures, and placed in a loading apparatus. Catheters were inserted into the central and peripheral compartments of each hip to allow infusion of fluid and monitoring of compartment pressures via miniature transducers (OMEGA Engineering, Inc). After application of a joint load of 0.50 BW, fluid was introduced into the central compartment at a constant rate until transport was indicated by a rise in pressure within the peripheral compartment. These measurements were performed with each hip placed in 10 functional positions ranging from −5 to 105 degrees of flexion, −5 to 13 degrees of abduction, and −25 to 35 degrees of external rotation simulating the sequential stages of gait, stooping, and pivoting. Motion analysis was performed via reflective marker arrays attached to the femur and pelvis to allow computer visualization of the position of the pelvis and femur using CT reconstructions. In each hip position, we measured the peak pressure (kPA) developed within the central compartment prior to fluid transfer to the peripheral compartment.Introduction:
Methods:
The use of registry data to detect and eliminate inferior devices is based on the assumption that the results of the first cases performed with a new device are indicative of how the same implant would perform with widespread usage. However, existing registry data clearly proves that the performance of individual implants is very surgeon dependent. In this study we utilized a computer simulation of a large implant registry to address the question: How does the pairing of different surgeons with different implants affect the ability of registries to correctly identify inferior devices? A synthetic implant registry was created consisting of 10,000 patients who underwent joint replacement performed by 100 different surgeons using 5 different implants. Hazard functions representing the relative risks for revision associated with individual patients and surgeons were derived from the annual reports of implant registries. The cumulative revision rates (CRR values) of the 5 hypothetical implants were fixed at nominal values of 10%, 15%, 20%, 25%, and 30% at 15 years post operation vs. 10% for average implants. The surgeons were ordered according to their individual probabilities of a revision at less than 15 years post-op. Each surgeon was placed in one of 8 subsets comprised of 12.5% of the total surgeon pool, ranging from the lowest to the highest risk of revision. Patients, surgeons, and implants were randomly matched in an iterative fashion to simulate 500 separate RCTs, starting with the group of surgeons of with the lowest risk, and then repeating the simulation using surgeons with the lowest and second lowest risk of revision. This process was repeated iteratively until all surgeons were enrolled.Background:
Materials and Methods:
Increasing attention to the functional outcome of total knee arthroplasty (TKA) has demonstrated that many patients experience limitations when attempting to perform demanding activities that are normal for age-matched peers, primarily because of knee symptoms. Episodes of instability following TKA are most commonly reported during activities in which significant transverse or torsional forces are supported by the joint with relatively low joint compression forces, including stair-descent and walking on sloped or uneven surfaces. This study was performed to examine the influence of conformity between the femoral and tibial components on the Antero-Posterior (AP) stability of knee during stair descent. Six cadaveric knees were loaded in a six degree-of-freedom joint simulator, with the application of external forces simulating the action of the quadriceps and hamstring muscles and the external loads and moments occurring during stair descent, including the stages of terminal swing phase, weight-acceptance phase (prior to and after quadriceps contraction) and mid-stance. During these manoeuvres, the displacement and rotation of the femur and the tibia were measured with a multi-camera high resolution motion analysis system (Fig. 1). Each knee was tested in the intact and ACL deficient condition – and after implantation of total knee prosthesis with Cruciate-Retaining (CR), Cruciate-Sacrificing with an intact PCL (CS + PCL), Cruciate-Sacrificing with an absent PCL (CS-PCL) and Posterior-Stabilizing (PS) tibial inserts (Figs 2 and 3).Introduction
Methods
Experimental disruption of the labrum has been shown to compromise its sealing function and alter cartilage lubrication. However, it is not known whether pathological changes to the labrum secondary to femoro-acetabular impingement (FAI) have a similar impact on labral function. This study was performed to determine the effect of natural labral damage secondary to abnormal femoral morphology on the labral seal. Ten intact hip specimens were obtained from male donors (47.8 ± 1.5 yrs) for use in this study. CT reconstructions demonstrated that 6 specimens were of normal morphology, while 4 displayed morphology typical of cam-FAI. Specimens were dissected free of the overlying soft tissue, leaving the capsule and labrum intact. Each specimen was potted and placed in a loading apparatus (0.5 BW). Pressures developed within the central and peripheral compartments were monitored with miniature pressure transducers. The sealing capacity of the labrum was measured by introducing fluid into the central compartment at a constant rate until transport was detected from the central to the peripheral compartment. These measurements were performed in 10 functional positions simulating sequential stages of gait, stooping, and pivoting. During testing, the 3D motion of the femoral head in the acetabulum was measured with motion analysis combined with computer visualization. Peak pressures were compared between specimens with and without labral damage for each of the three activities (p < 0.05).Objectives:
Methods:
A disturbing prevalence of short-term failures of metal-on-metal (MoM) hip resurfacings has been reported by joint registries. These cases have been primarily due to painful inflammatory reactions and, in extreme cases, formation of pseudotumors within periarticular soft-tissues. The likely cause is localized loading of the acetabular shell leading to “edge wear” which is often seen after precise measurement of the bearing surfaces of retrieved components. Factors contributing to edge wear of metal-on-metal arthroplasties are thought to include adverse cup orientation, patient posture, and the direction of hip loading. The purpose of this study was to investigate the role of different functional activities in edge loading of hip resurfacing prostheses as a function of cup inclination and version. We developed a computer model of the hip joint through reconstruction of CT scans of a proto-typical pelvis and femur and virtually implanting a hip resurfacing prosthesis in an ideal position. Using this model, we examined the relationship between the resultant hip force vector and the edge of the acetabular shell during walking, stair ascent and descent, and getting in and out of a chair. Load data was derived from 5 THR patients implanted with instrumented hip prostheses (Bergmann et al). We calculated the distance from the edge of the shell to the point of intersection of the load vector and the bearing surface for cup orientations ranging from 40 to 70 degrees of inclination, and 0 to 40 degrees of anteversion.Introduction
Methods
There is increasing interest in the most responsible method for the introduction of new technologies in joint replacement, given the catastrophic consequences of widespread usage of poorly-performing devices. Two factors that make evaluation of new devices particularly difficult is the presence of the learning curve, and the desire of manufacturers to gain early market share for new technologies to recoup initial investment. Both of these factors are expected to lead to inferior early results, however, documentation is lacking. This study examines the effect of different methods of commercial introduction of new devices on early survivorship. We modeled a database of 6000 operations performed using a new implant over a 5 year period. We assumed an average revision rate of 3.4% based on survivorship for hip resurfacing. Four different scenarios were modeled corresponding to the manner of introduction of this device to surgical practice. The “Standard” scenario assumed that 165 surgeons gradually adopted the device over a 5 year period based on the initial favorable experience of a small pilot group. Alternative scenarios were modeled, including limited release of the device (65 surgeons/64 cases each), increased distribution (310 surgeons 20 cases), and rapid early promotion (250 surgeons 24cases). Computer routines were utilized to predict the expected failure rate of each procedure using a standard survivorship curve based on surgeon experience. The sensitivity of the simulation to capture of all cases was also examined by repeating the Standard Scenario will censorship of the first 3 cases, and then the first 5 cases performed by each surgeon.Background
Materials and Methods
With the growing emphasis on the cost of medical care, there is renewed interest in the productivity and efficiency of surgical procedures. We have developed a method to systematically examine the efficiency of the surgical team during primary total knee replacement (TKR). In this report, we present data derived from a series of procedures performed by different joint surgeons. This data demonstrates a variation between the duration and efficiency of each step in this procedure and its relationship to the experience and coordination of the surgeon working with the scrub team. After consent was achieved, videotaped recordings were prepared of ten primary TKR procedures performed by five highly experienced joint surgeons. For quantitative analysis, each procedure was divided into 7 principal tasks from initial incision to wound closure. In order to quantify efficiency, we recorded the occurrence of events leading to delays in each step of the procedure. Starting with a total score of 100 points, deductions were made, based on the number of delaying events and its impact on the efficiency of the procedure. A final score for the surgery was then determined using the individual scores from each principal task. The experience of each member of the surgical team in participating in TKR, and in working with the surgeon, were recorded and correlated with the total efficiency score for the entire procedure.Introduction
Methods
There are several component position and design variables that increase the risk of edge loading and high wear in metal-on-metal hip resurfacing (MOM-HR). In this study we combined all of these variables to calculate the ‘contact patch to rim distance’ (CPRD) in patients undergoing revision of their MOM-HR. We then determined whether CPRD was more strongly correlated with component wear and blood metal ion levels, when compared to any other commonly reported clinical variable. This was a retrospective study of 168 consecutively collected MOM-HR retrieval cases. All relevant clinical data was documented, including pre-revision whole blood cobalt and chromium ion levels. Wear of the bearing surfaces was then measured using a roundness-measuring machine. We found four variables to be significantly (p < 0.05) correlated with component wear and blood metal ion levels: (1) cup inclination angle, (2) cup version angle, (3) arc of cover, and (4) CPRD. The correlations between CPRD and both wear and ion levels were significantly stronger than those seen with any other variable (all p < 0.0001). Our study has shown that CPRD is the best predictor of component wear and blood metal ion levels, and may therefore be a useful parameter to help determine those patients who are at risk of high wear and require more frequent clinical surveillance.
The use of registry data to detect and eliminate inferior devices is based on the assumption that the results of the first cases performed with a new device are indicative of how the same implant would perform with widespread usage. However, existing registry data clearly proves that the performance of individual implants is very surgeon dependent. In this study we utilized a computer simulation of a large implant registry to address the question: How does the pairing of different surgeons with different implants affect the ability of registries to correctly identify inferior devices? A synthetic implant registry was created consisting of 10,000 patients who underwent joint replacement performed by 100 different surgeons using 5 different implants. Hazard functions representing the relative risks for revision associated with individual patients and surgeons were derived from the annual reports of implant registries. The cumulative revision rates (CRR values) of the 5 hypothetical implants were fixed at nominal values of 10%, 15%, 20%, 25%, and 30% at 15 years post operation vs. 10% for average implants. The surgeons were ordered according to their individual probabilities of a revision at less than 15 years post-op. Each surgeon was placed in one of 8 subsets comprised of 12.5% of the total surgeon pool, ranging from the lowest to the highest risk of revision. Patients, surgeons, and implants were randomly matched in an iterative fashion to simulate 500 separate RCTs, starting with the group of surgeons of with the lowest risk, and then repeating the simulation using surgeons with the lowest and second lowest risk of revision. This process was repeated iteratively until all surgeons were enrolled.BACKGROUND
MATERIALS AND METHODS
Edge loading is a common wear mechanism in Metal-on-Metal (MOM) hip resurfacing and is associated with higher wear rates and the incidence of pseudotumour. The purpose of this study was to develop a method to investigate the contributions of patient, surgical and implant design variables on the risk of edge loading. We created a mathematical model to calculate the distance from the head-cup contact patch to the rim of the cup and used this to investigate the effect of component position, specific design features and patient activity on the risk of edge loading. We then used this method to calculate the contact patch to rim distance (CPRD) for 160 patients having undergone revision of their MOM hip resurfacing in order to identify any possible associations.Introduction
Method
It has been speculated that impact deformation of thin 1-piece cups used for modern metal-on-metal hip replacement may contribute to early failure. The purpose of this study was to reproduce typical impact deformation and quantify the effect of this on the frictional torque generated at the hip. We tested nine hip couples of three designs (the ASR, BHR and Durom) and three sizes (42mm, 46mm and 50mm). A custom compression device was designed to replicate the in vivo forces and impact deformation of 1-piece metal cups reported in the literature. Each cup was mounted in the device, which itself was mounted on a mechanical testing machine. The cups were compressed with incremental loads up to a maximum of 2000N. At each increment we measured cup deformation, and then the head component was seated into the cup. The hip was lubricated and the head component rotated 60 degrees axially within the cup and the axial torque was measured.Introduction
Methods
The new Knee Society Score has been developed and validated, in part, to characterize better the expectations, components of satisfaction, and the physical activities of the younger, more diverse modern population of TKA patients. This study aims to reveal patients' activity levels' post-TKA and to determine how it contributes to their subjective evaluation of the surgery. As part of a multi-centered and regionally diverse study sponsored by the Knee Society, the new Knee Society Score (KSS) was administered 243 patients (44% male; avg 66.4years; 56% female, avg 67.7years) following primary TKA (follow up > 1year, avg. 25mos). The new, validated KSS questionnaire consists of a traditional objective component, as well as subjective components inquiring into patient symptoms, satisfaction, expectations and activity levels as well as a survey of three physical activities that are viewed as important to the patients. Responses were analyzed as a whole group and as subgroups of male and female and as younger (<65) and older (>65).Introduction
Methods
Knee prostheses retrieved at revision often show patterns and severity of damage neither seen nor predicted from standard wear simulator testing. We hypothesized that this is because these implants are exposed to combinations of loads and motions that are more damaging than the simple loading profiles utilized in laboratory testing. We examined the magnitude, direction, and combination of forces and moments acting on the knee during various activities in order to guide the future development and testing of high-performance knee replacements. In vivo data from five patients with instrumented tibial implants were obtained from an open database (www.orthoload.com). We determined the direction and magnitude of forces and moments that the knee experiences during the following common physiologic activities: stair descent, stair ascent, deep knee bend, one leg stance, and walking. In order to capture the loading pattern, we investigated the three component forces and moments acting on the knee at several high demand points for each of these activities. The e-tibia data were compared to the loading profiles used in conventional laboratory testing (ISO 14243-1).Introduction
Methods
Although the “learning curve” in surgical procedures is well recognized, little data exists documenting the accuracy of surgeons in performing individual steps of orthopedic procedures. In this study we have used a validated computer-based training system to measure variations instrument placement and alignment in TKA, specifically those relating to tibial preparation. Eleven trainees (surgical students, residents and fellows) were recruited to perform a series of 43 knee replacement procedures in a computerized training center. After initial instruction, each trainee performed a series of four TKA procedures in cadavers (n=2) and bone replicas (n=2) using a contemporary TKA instrument set and the assistance of an experienced surgical instructor. The Computerized Bioskills system was utilized to monitor the placement and orientation of the proximal tibial osteotomy and the tibial tray.Introduction
Methods
Femoro-acetabular impingement (FAI) is a common source of impaired motion of the hip, often attributed to the presence of an aspherical femoral head. However, other types of femoral deformity, including posterior slip, retroversion, and neck enlargement, can also limit hip motion. This study was performed to establish whether the “cam” impinging femur has a single deformity of the head/neck junction or multiple abnormalities. Computer models of 71 femora (28 normal and 43 “cam” impinging) were prepared from CT scans. Morphologic parameters describing the dimensions of the head, neck, and medullary canal were calculated for each specimen. The anteversion angle, alpha angle of Notzli, beta angle of Beaulé, and normalized anterior heads offset were also calculated. Average dimensions were compared between the normal and impinging femora.Introduction
Materials and Methods
Proper rotational alignment of the tibial component is a critical factor affecting the outcome of TKA. Traditionally, the tibial component is oriented with respect to fixed landmarks on the tibia without reference to the plane of knee motion. In this study, we examined differences between rotational axes based on anatomic landmarks and the true axis of knee motion during a functional activity. 24 fresh-frozen lower limb specimens were mounted in a joint simulator which enable replication of lunging and squatting through application of muscle and body-weight forces. Kinematic data was collected using a 3D motion analysis system. Computer models of the femur and tibia were generated by CT reconstruction. The motion axis of each knee (TFA) was defined by the 3D path of the femur with respect to the tibia as the knee was flexed from 30 to 90 degrees. The orientation the TFA was compared to 5 different anatomic axes commonly proposed for alignment of the tibial component.Introduction
Materials and Methods
Joint Registries are a valuable resource for defining the survivorship of prostheses and procedures undertaken for the treatment of joint disease. However, the use of this data as a basis for advocating specific implant designs is controversial because of the confounding effects of variations in patient selection, the training, skill and experience of surgeons, and the priorities of individual patients. Despite these challenges, the Australian Joint Registry has utilized its early survivorship data to identify specific designs that are expected to exhibit lower than average durability in the long term. The aim of this study was to assess the accuracy of this practice in identifying implants providing inferior long-term performance. Over the period 2004–8, the Australian Registry identified 48 prosthetic components used in primary THA, HRA, TKA or UKA which exhibited a statistically significant increase in the early revision rate. For each of these components, we compared the rate of revisions per 100 “component-years” when it was first identified by the Registry, to its ultimate fiveyear cumulative survival in 2008. These survival parameters were also compared to average values based on procedure (eg.THR) and fixation method (i.e. cemented, cementless, hybrid). Regression analysis was performed to determine the accuracy of initial relative revisions per 100 OCY as a predictive measure of eventual component revision rate. Five year survival data was available on 30 of the 48 implants identified by the registry. There was a strong correlation (R2=0.9614) between initial revisions per 100 component-years and the 5-yr survival of the identified designs. 29 of 30 designs (97%) exhibited lower than average survivorship at 5 years. Six designs (20%) had failure rates within 2% of average values, and 7 (23%) had a 5–year failure rate less than 50% above average values. Although, when identified by the Registry, 80% of identified components exceeded the average rate of revision by 100%, only 60% displayed more than twice the cumulative revision rate at 5 years post-op. These results demonstrate that early data collected by Joint Registries can form the basis of accurate identification of designs which ultimately prove to be clinically unsuccessful. Predictions made by the Australian Registry concerning inferior designs have an accuracy of approximately 80%. Further work is recommended to enhance the valuable potential of Registry data in predicting the outcome of both implants and procedures.
Several studies have suggested that, in TKR, gender specific-prostheses are needed to accommodate anatomic differences between males and females. This study was performed to examine whether gender is a factor contributing to the variability of the size, shape and orientation of the patellofemoral sulcus. 3D computer models of the femur were reconstructed from CT scans of 20 male and 20 female femora. The patellofemoral groove was quantified by measuring landmarks at 10 degree increments around the epicondylar axis. The orientation of the groove was defined by the tracking path generated by a sphere moving from the top of the groove to the intercondylar notch. To assess the influence of gender on the shape of the distal femur, all morphologic parameters were normalized for differences in bone size. Overall, the distal femur was 15% larger in males compared to females. The male condyles were 4% wider than the female for constant AP depth (p=0.13). When normalized for bone size, there was no gender difference in most patello-femoral dimensions, including the length, width, angle or tilt of the sulcus. Female femora had a less prominent medial anterior ridge (p=0.07), and a larger normalized radius of curvature of the tracking path (p=0.03). In addition, the orientation of the sulcus differed by 1–2 degrees in both the coronal and axial planes. Overall, gender explained 4.7% of the anatomic variation of the parameters examined, varying from 0 to 15.9%. The size, shape and orientation of the patello-femoral groove are highly variable. While the patello-femoral morphology of male and female femora are very similar, some of the anatomic variability is related to gender, particularly the prominence of the medial ridge and the sulcus radius of curvature. The biomechanical and clinical significance of these differences after TKA have yet to be determined.
