Risk and Epidemiology of Periprosthetic Knee Fractures After Primary Total Knee Arthroplasty: A Nationwide Cohort Study.

BACKGROUND: Periprosthetic knee fractures (PPKF) following total knee arthroplasty (TKA) are uncommon, but potentially serious injuries. We analyze the risk and risk factors for a PPKF in standard primary TKA patients who have osteoarthritis (OA) and a minimally (cruciate-retaining TKAs without a femoral box cut) or posterior-stabilized TKA. In addition, we report the risk for patients who have other underlying knee disorders and/or a higher level of TKA constraint. METHODS: All primary TKAs were identified from the Danish National Patient Register and the Danish Knee Arthroplasty Register using data between 1997 and 2022. Subsequent fractures were identified through the International Classifications of Disease (ICD) diagnosis code, Nordic Medico-Statistical Committee (NOMESCO) procedure code, or indication for revision TKA. RESULTS: We included 120,642 standard primary TKA patients who had 1,434 PPKFs. The cumulated proportions were 0.3% (95% confidence interval (CI) 0.3 to 0.3) at 2 years 0.7% (0.6 to 0.7) at 5 years. At 10 years, the cumulated proportion was 1.5% (1.4 to 1.6), with 1.2% in the femur, 0.2% in the patella, and 0.1% in the tibia. Significant risk factors were (hazard ratio (HR) (95% CI)); ipsilateral hip arthroplasty (2.5 (2.1 to 2.8)); women (2.0 (1.8 to 2.3)), osteoporosis (1.4 (1.1 to 1.7)); age 80+ (1.4 (1.2 to 1.6)), and Charlson Comorbidity Index (CCI) score 3+ (1.4 (1.0 to 1.8)). An additional 22,624 primary TKA patients who had other underlying knee disorders and/or a higher level of implant constraint were included with 485 PPKFs. The 10-year cumulated proportions were 5.5% (95% CI 4.4 to 6.9) when the underlying disorder was a previous fracture, 2.3% (1.7 to 2.9) for rheumatic disorders, and 3.5% (1.4 to 8.8) for osteonecrosis. In patients who had condylar constrained knees, it was 4.3% (2.9 to 6.3), and 7.3% (4.1 to 13.1) for hinges. CONCLUSION: In standard primary TKA patients, the 10-year cumulated proportion of PPKFs was 1.5%, and ipsilateral hip arthroplasty, women, osteoporosis, advanced age, and higher CCI increased the risk. Higher risks were observed in non-OA patients and/or patients who had a higher level of TKA constraint.

A literature review and expert consensus statement on diagnostics in suspected metal implant allergy.

BACKGROUND: Although rare, allergic reactions to metal implants represent a diagnostic challenge in view of missing guidelines. OBJECTIVES: To develop an European expert consensus on characteristics of metal allergy reactions and the utility of various diagnostic tools in suspected metal implant allergy. METHODS: A nominal group technique (NGT) was applied to develop consensus statements. Initially an online literature database was created on a secure server to enable a comprehensive information. Twenty-three statements were formulated on potential aspects of metal implant allergy with a focus on diagnostics and grouped into five domains. For the consensus development, the panel of 12 experts initially did refine and reformulate those statements that were ambiguous or had unclear wording. By face-to-face (9/12) or virtual participation (3/12), an anonymous online voting was performed. RESULTS: Consensus (≥80% of agreement) was reached in 20/23 statements. The panel agreed that implant allergy despite being rare should be considered in case of persistent unexplained symptoms. It was, however, recommended to allow adequate time for resolution of symptoms associated with healing and integration of an implant. Obtaining questionnaire-aided standardized medical history and standardized scoring of patient outcomes was also considered an important step by all experts There was broad consensus regarding the utility/performance of patch testing with additional late reading. It was recognized that the lymphocyte transformation test (LTT) has to many limitations to be generally recommended. Prior to orthopaedic implant, allergy screening of patients without a history of potential allergy to implant components was not recommended. CONCLUSIONS: Using an expert consensus process, statements concerning allergy diagnostics in suspected metal implant allergy were created. Areas of nonconsensus were identified, stressing uncertainty among the experts around topics such as preoperative testing in assumed allergy, histological correlate of periimplant allergy and in vitro testing, which underscores the need for further research.

Mismatch 'never events' in hip and knee arthroplasty: a cohort and intervention study.

AIMS: The aim of this study was to give estimates of the incidence of component incompatibility in hip and knee arthroplasty and to test the effect of an online, real-time compatibility check. MATERIALS AND METHODS: Intraoperative barcode registration of arthroplasty implants was introduced in Denmark in 2013. We developed a compatibility database and, from May 2017, real-time compatibility checking was implemented and became part of the registration. We defined four classes of component incompatibility: A-I, A-II, B-I, and B-II, depending on an assessment of the level of risk to the patient (A/B), and on whether incompatibility was knowingly accepted (I/II). RESULTS: A total of 26 524 arthroplasties were analyzed. From 12 307 procedures that were undertaken before implementation of the compatibility check, 21 class A incompatibilities were identified (real- or high-risk combinations; 0.17%; 95% confidence interval (CI) 0.11 to 0.26). From 5692 hip and 6615 knee procedures prior to implementation of the compatibility check, we found rates of class A-I incompatibility (real- or high-risk combinations unknowingly inserted) of 0.14% (95% CI 0.06 to 0.28) and 0.17% (95% CI 0.08 to 0.30), respectively. From 14 217 procedures after the introduction of compatibility checking (7187 hips and 7030 knees), eight class A incompatibilities (0.06%; 95% CI 0.02 to 0.11) were identified. This difference was statistically significant (p = 0.008). CONCLUSION: Our data presents validated estimates of the baseline incidence of incompatibility events for hip and knee arthroplasty procedures and shows that a significant reduction in class A incompatibility events is possible using a web-based recording system. Cite this article: Bone Joint J 2019;101-B:960-969.

Re-admissions, re-operations and length of stay in hospital after aseptic revision knee replacement in Denmark: a two-year nationwide study.

We present detailed information about early morbidity after aseptic revision knee replacement from a nationwide study. All aseptic revision knee replacements undertaken between 1st October 2009 and 30th September 2011 were analysed using the Danish National Patient Registry with additional information from the Danish Knee Arthroplasty Registry. The 1218 revisions involving 1165 patients were subdivided into total revisions, large partial revisions, partial revisions and revisions of unicondylar replacements (UKR revisions). The mean age was 65.0 years (27 to 94) and the median length of hospital stay was four days (interquartile range: 3 to 5), with a 90 days re-admission rate of 9.9%, re-operation rate of 3.5% and mortality rate of 0.2%. The age ranges of 51 to 55 years (p = 0.018), 76 to 80 years (p < 0.001) and ≥ 81 years (p < 0.001) were related to an increased risk of re-admission. The age ranges of 76 to 80 years (p = 0.018) and the large partial revision subgroup (p = 0.073) were related to an increased risk of re-operation. The ages from 76 to 80 years (p < 0.001), age ≥ 81 years (p < 0.001) and surgical time > 120 min (p < 0.001) were related to increased length of hospital stay, whereas the use of a tourniquet (p = 0.008) and surgery in a low volume centre (p = 0.013) were related to shorter length of stay. In conclusion, we found a similar incidence of early post-operative morbidity after aseptic knee revisions as has been reported after primary procedures. This suggests that a length of hospital stay ≤ four days and discharge home at that time is safe following aseptic knee revision surgery in Denmark.

Local infiltration analgesia for total knee arthroplasty: should ketorolac be added?

BACKGROUND: Adequate postoperative analgesia with minimal side-effects is essential for early mobilization and recovery in patients undergoing total knee arthroplasty (TKA). High-volume local infiltration analgesia (LIA) with ropivacaine has been introduced, but effects of adjuvants are still debated. We tested the hypothesis that the addition of ketorolac to LIA significantly improves analgesia after TKA. METHODS: Sixty patients undergoing TKA were randomized to receive intraoperative LIA (ropivacaine 300 mg and epinephrine 0.5 mg) combined with either ketorolac 30 mg (ketorolac group) or saline (control group). After surgery, eight bolus doses of ropivacaine 100 mg combined with either ketorolac 15 mg (ketorolac group) or saline (control group) were administered every 6 h via an intra-articular catheter. The primary outcome was postoperative consumption of i.v. morphine patient-controlled analgesia (PCA). Secondary outcomes were time to first request of i.v. morphine PCA, pain intensity, side-effects, and readiness for hospital discharge. RESULTS: Consumption of i.v. morphine PCA was lower in the ketorolac group vs control group {0-6 h: 0 (0-0) vs 5 (0-10) mg, P<0.0001; 0-48 h: 10 (0-22.5) vs 48.75 (30-82.5) mg, P<0.0001 [median (inter-quartile range, IQR)]}. Time to first request of i.v. morphine PCA was longer in the ketorolac group vs the control group [490 (248-617) vs 223 (115-319) min, P=0.02, median (IQR)]. Early postoperative pain (<48 h) and readiness for hospital discharge were also significantly reduced in the ketorolac group. CONCLUSIONS: LIA with ketorolac results in reduced morphine consumption, reduced pain intensity, and earlier readiness for hospital discharge.

Translation, cross-cultural adaptation and validation of the Danish version of the Oxford hip score: Assessed against generic and disease-specific questionnaires.

OBJECTIVES: The Oxford hip score (OHS) is a 12-item questionnaire designed and developed to assess function and pain from the perspective of patients who are undergoing total hip replacement (THR). The OHS has been shown to be consistent, reliable, valid and sensitive to clinical change following THR. It has been translated into different languages, but no adequately translated, adapted and validated Danish language version exists. METHODS: The OHS was translated and cross-culturally adapted into Danish from the original English version, using methods based on best-practice guidelines. The translation was tested for psychometric quality in patients drawn from a cohort from the Danish Hip Arthroplasty Register (DHR). RESULTS: The Danish OHS had a response rate of 87.4%, no floor effect and a 19.9% ceiling effect (as expected in post-operative patients). Only 1.2% of patients had too many items missing to calculate a sum score. Construct validity was adequate and 80% of our predefined hypotheses regarding the correlation between scores on the Danish OHS and the other questionnaires were confirmed. The intraclass correlation (ICC) of the different items ranged from 0.80 to 0.95 and the average limits of agreement (LOA) ranged from -0.05 to 0.06. The Danish OHS had a high internal consistency with a Cronbach's alpha of 0.99 and an average inter-item correlation of 0.88. CONCLUSIONS: This Danish version of the OHS is a valid and reliable patient-reported outcome measurement instrument (PROM) with similar qualities to the original English language version.

A comparison of structural and mechanical properties in cancellous bone from the femoral head and acetabulum.

Mechanical interlock obtained by penetration of bone cement into cancellous bone is critical to the success of cemented total hip replacement (THR). Although acetabular component loosening is an important mode of THR failure, the properties of acetabular cancellous bone relevant to cement penetration are not well characterized. Bone biopsies (9 mm diameter, 10 mm long) were taken from the articular surfaces of the acetabulum and femoral head during total hip replacement. After mechanical and chemical defatting the two groups of bone specimens were characterized using flow measurement, mechanical testing and finally serial sectioning and three-dimensional computer reconstruction. The mean permeabilities of the acetabular group (1.064 x 10(-10) m2) and femoral group (1.155 x 10(-10) m2) were calculated from the flow measurements, which used saline solution and a static pressure of 9.8 kPa. The mean Young's modulus, measured non-destructively, was 47.4 MPa for the femoral group and 116.4 MPa for the acetabular group. Three-dimensional computer reconstruction of the specimens showed no significant differences in connectivity and porosity between the groups. Results obtained using femoral head cancellous bone to investigate bone cement penetration and fixation are directly relevant to fixation in the acetabulum.

Changes in the three-dimensional microstructure of human tibial cancellous bone in early osteoarthritis.

We obtained medial and lateral subchondral cancellous bone specimens from ten human post-mortem proximal tibiae with early osteoarthritis (OA) and ten normal age- and gender-matched proximal tibiae. The specimens were scanned by micro-CT and the three-dimensional microstructural properties were quantified. Medial OA cancellous bone was significantly thicker and markedly plate-like, but lower in mechanical properties than normal bone. Similar microstructural changes were also observed for the lateral specimens from OA bone, although there had been no sign of cartilage damage. The increased trabecular thickness and density, but relatively decreased connectivity suggest a mechanism of bone remodelling in early OA as a process of filling trabecular cavities. This process leads to a progressive change of trabeculae from rod-like to plate-like, the opposite to that of normal ageing. The decreased mechanical properties of subchondral cancellous bone in OA, which are due to deterioration in architecture and density, indicate poor bone quality.

Parallel plate model for trabecular bone exhibits volume fraction-dependent bias.

Unbiased stereological methods were used in conjunction with microcomputed tomographic (micro-CT) scans of human and animal bone to investigate errors created when the parallel plate model was used to calculate morphometric parameters. Bone samples were obtained from the human proximal tibia, canine distal femur, rat tail, and pig spine and scanned in a micro-CT scanner. Trabecular thickness, trabecular spacing, and trabecular number were calculated using the parallel plate model. Direct thickness, and spacing and connectivity density were calculated using unbiased three-dimensional methods. Both thickness and spacing calculated using the plate model were well correlated to the direct three-dimensional measures (r(2) = 0. 77-0.92). The correlation between trabecular number and connectivity density varied greatly (r(2) = 0.41-0.94). Whereas trabecular thickness was consistently underestimated using the plate model, trabecular spacing was underestimated at low volume fractions and overestimated at high volume fractions. Use of the plate model resulted in a volume-dependent bias in measures of thickness and spacing (p < 0.001). This was a result of the fact that samples of low volume fraction were much more "rod-like" than those of the higher volume fraction. Our findings indicate that the plate model provides biased results, especially when populations with different volume fractions are compared. Therefore, we recommend direct thickness measures when three-dimensional data sets are available.

Properties of growing trabecular ovine bone. Part II: architectural and mechanical properties.

We aimed to highlight the relationship between age and the architectural properties of trabecular bone, to outline the patterns in which the variations in these properties take place, and to investigate the influence of the architecture on the mechanical properties of trabecular bone in growing animals. We studied 30 lambs in three age groups and 20 sheep in two age groups. Cubes of subchondral bone were cut from the proximal tibia according to a standardised protocol. They were serially sectioned and their architectural properties were determined. Similar cubes were obtained from the identical anatomical position of the contralateral tibia and their compressive mechanical properties measured. The values obtained from the skeletally immature and mature individuals were compared. Multiple regression analyses were performed between the architectural and the mechanical properties. The bone volume fraction, the mean trabecular volume, the architectural and the mechanical anisotropy, the elastic modulus, the bone strength, the energy absorption to failure, and the elastic energy correlated positively with increasing age whereas the connectivity density, the bone surface density, the ultimate strain, the absorption of viscoelastic energy and the relative loss of energy correlated inversely. The values of all variables were significantly different in the skeletally mature and immature groups. We determined the patterns in which the variations took place. The bone volume fraction of the trabecular bone tissue was found to be the major predictor of its compressive mechanical properties. Together with the mean trabecular volume and the bone surface density, it explained 81% of the variations in the compressive elastic modulus of specimens obtained from the contralateral tibiae.

Constitutive relationships of fabric, density, and elastic properties in cancellous bone architecture.

The hypothesis that trabecular morphology can predict the elastic properties of cancellous bone has only partly been verified and no predictive analytical model is currently available. Such models are becoming increasingly relevant as the resolution levels of three-dimensional scanning techniques approach the size of trabeculae. This study took advantage of micro-finite-element methods and tested the aforementioned hypothesis in normal cancellous bone material collected at six anatomical locations from 56 individuals. Numerical analysis was based on high-resolution three-dimensional computer reconstructions of cancellous bone specimens from which the complete elastic characteristics and trabecular morphology, represented by three different fabric measures (the mean intercept length and two volume-based ones), were calculated. Each fabric measure was analyzed individually using the tensorial relationships derived by Cowin (Mech Mater 4:137-147; 1985). Models for both stiffness and compliance entries were developed. The models based on stiffness entries could explain 93.4%-95.6% of the variance, whereas those based on compliance entries could explain 89.2%-89.4%. When using the former model, the MIL (mean intercept length measure) performed slightly better than the two volume-based measures, VO (volume orientation) and SVD (star volume distribution), with 23% less remaining variance. The high correlations found strongly support the hypothesis and increase the hope that, on the basis of information on trabecular morphology, it will be possible to obtain considerably better estimates of bone quality in vivo compared with the rough two-dimensional density measurements used today.

The role of an effective isotropic tissue modulus in the elastic properties of cancellous bone.

Conceptually, the elastic characteristics of cancellous bone could be predicted directly from the trabecular morphology--or architecture--and by the elastic properties of the tissue itself. Although hardly any experimental evidence exists, it is often implicitly assumed that tissue anisotropy has a negligible effect on the apparent elastic properties of cancellous bone. The question addressed in this paper is whether this is actually true. If it is, then micromechanical finite element analysis (micro-FEA) models, representing trabecular architecture, using an 'effective isotropic tissue modulus' should be able to predict apparent elastic properties of cancellous bone. To test this, accurate multi-axial compressive mechanical tests of 29 whale bone specimens were simulated with specimen-specific micro-FEA computer models built from true three-dimensional reconstructions. By scaling the micro-FEA predictions by a constant tissue modulus, 92% of the variation of Young's moduli determined experimentally could be explained. The correlation even increased to 95% when the micro-FEA moduli were scaled to the isotropic tissue moduli of individual specimens. Excellent agreement was also found in the elastic symmetry axes and anisotropy ratios. The prediction of Poisson's ratios was somewhat less precise at 85% correlation. The results support the hypothesis; for practical purposes, the concept of an 'effective isotropic tissue modulus' concept is a viable one. They also suggest that the value of such a modulus for individual cases might be inferred from the average tissue density, hence the degree of mineralization. Future studies must clarify how specific the tissue modulus should be for different types of bone if adequate predictions of elastic behavior are to be made in this way.

Accuracy of cancellous bone volume fraction measured by micro-CT scanning.

Volume fraction, the single most important parameter in describing trabecular microstructure, can easily be calculated from three-dimensional reconstructions of micro-CT images. This study sought to quantify the accuracy of this measurement. One hundred and sixty human cancellous bone specimens which covered a large range of volume fraction (9.8-39.8%) were produced. The specimens were micro-CT scanned, and the volume fraction based on Archimedes' principle was determined as a reference. After scanning, all micro-CT data were segmented using individual thresholds determined by the scanner supplied algorithm (method I). A significant deviation of volume fraction from method I was found: both the y-intercept and the slope of the regression line were significantly different from those of the Archimedes-based volume fraction (p < 0.001). New individual thresholds were determined based on a calibration of volume fraction to the Archimedes-based volume fractions (method II). The mean thresholds of the two methods were applied to segment 20 randomly selected specimens. The results showed that volume fraction using the mean threshold of method I was underestimated by 4% (p = 0.001), whereas the mean threshold of method II yielded accurate values. The precision of the measurement was excellent. Our data show that care must be taken when applying thresholds in generating 3-D data, and that a fixed threshold may be used to obtain reliable volume fraction data. This fixed threshold may be determined from the Archimedes-based volume fraction of a subgroup of specimens. The threshold may vary between different materials, and so it should be determined whenever a study series is performed.

Connectivity and the elastic properties of cancellous bone.

This study addresses the possible significance of trabecular connectivity for the mechanical quality of cancellous bone. A total of 141 cubic trabecular bone specimens collected from autopsy material from 56 individuals without any known bone or metastatic diseases were used. Age variation was in the range of 14-91 years and a wide range of trabecular architecture was found. Each specimen was three-dimensionally reconstructed with a voxel size of either 20 or 25 microm. Using the detailed three-dimensional reconstructions as input for microstructural finite-element models, the complete elastic properties of the trabecular architecture were obtained and maximum and mean stiffness could be calculated. Volume fraction and true three-dimensional architectural measurements of connectivity density and surface density were determined. Connectivity density was determined in an unbiased manner by the Euler number, which is a topological property. Using multiple regression analysis it was found that volume fraction explained by far the greatest part (84%-94%) of the variation in both mean and maximum stiffness. When connectivity density and surface density were included, the correlations increased marginally to 89%-95%. Noticeably negative regression coefficients were found for connectivity density. The results suggest that, in normal cancellous bone, the connectivity density has very limited value for assessment of elastic properties by morphological variables, but if a relation exists then stiffness decreases with increasing connectivity.

Star length distribution: a volume-based concept for the characterization of structural anisotropy.

Determination and quantification of anisotropy is of great interest in research fields dealing with physical structures or surface textures. In this paper, a volume-based method is presented, which essentially determines the mean object length in a certain direction for a typical point within a structure or texture. The mean object lengths for all orientations together form the so-called star length distribution (SLD). The validity and the accuracy of the SLD method are investigated, and illustrated by applying it to trabecular bone. By using a line sampling algorithm, the relation with other anisotropy measures could be studied analytically. Preliminary tests suggest that with SLD a more exact description of the mechanical properties of porous structures may be obtained than with other anisotropy measures. However, due to possible secondary orientations that become apparent with SLD, a fabric tensor must be of rank higher than two in order to properly describe an orthogonal structure mathematically.

Star length distribution: a volume-based concept for the characterization of structural anisotropy.

Determination and quantification of anisotropy is of great interest in research fields dealing with physical structures or surface textures. In this paper, a volume-based method is presented, which essentially determines the mean object length in a certain direction for a typical point within a structure or texture. The mean object lengths for all orientations together form the so-called star length distribution (SLD). The validity and the accuracy of the SLD method are investigated, and illustrated by applying it to trabecular bone. By using a line sampling algorithm, the relation with other anisotropy measures could be studied analytically. Preliminary tests suggest that with SLD a more exact description of the mechanical properties of porous structures may be obtained than with other anisotropy measures. However, due to possible secondary orientations that become apparent with SLD, a fabric tensor must be of rank higher than two in order to properly describe an orthogonal structure mathematically.

Glenoid bone architecture.

This article describes regional variations in trabecular bone architecture in terms of density and orientation within six glenoid specimens. The mean donor age was 56 years and ranged from 31 to 72 years. An automated imaging technique based on 3-dimensional serial sectioning was used for the direct examination of the glenoid cancellous bone structures. Subchondral plate thickness was on average 1.9 mm and ranged from 1.2 mm to 2.9 mm. The volume fraction of trabecular bone varied from 11% to 45% with peak values at the posterior glenoid vault. On graphic 3-dimensional reconstructions, the glenoid appeared as platelike trabeculae, radially oriented perpendicular to the subchondral plate and interconnected by thin rods. These views also displayed regional variations throughout the glenoid, reflecting differences in the macroscopic appearance. Quantitative structural analysis revealed different degrees of anisotropy at the glenoid cancellous region, predominantly transverse isotropy. Resemblance to direct weight-bearing cancellous bone such as the proximal tibia was evident.

Relationships between bone morphology and bone elastic properties can be accurately quantified using high-resolution computer reconstructions.

It would be advantageous if the mechanical properties of trabecular bone could be directly inferred from stereomorphometric parameters. For that purpose, apparent density and mean intercept length, as measures of bone mass and directionality (fabric), are commonly correlated with the elastic characteristics of bone samples, as determined in compression tests. However, complete and accurate relationships have not yet been established in this way. This may be due not only to the occurrence of artifacts in both the stereomorphometric and the mechanical assessments but also to an inherent inadequacy of mean intercept length in characterizing the full mechanical significance of bone architecture or nonhomogeneities in trabecular tissue properties not accounted for in stereomorphometry. In this study, we introduce a computer modeling approach allowing these biases to be eliminated. With use of high-resolution three-dimensional computer reconstructions of trabecular bone specimens for stereomorphometry and for microstructural finite element models to simulate mechanical tests, unbiased comparisons become feasible. The purpose was to investigate if accurate and complete relationships can be established in this way. Four different fabric measures were considered: mean intercept length and three volume-based ones. Compliance matrices were calculated from fabric tensors, with use of the mathematical relationship proposed by Cowin for 29 vertebral whale-bone specimens. These were correlated with the compliance constants determined directly from the microstructural finite element model simulation. The nine orthotropic elastic constants of all 29 specimens were well predicted from their stereomorphometric fabric and volume fraction values, with correlation coefficients ranging from R2adj = 0.9934 to 0.9963. When individual compliance components were considered (1/Ei, 1/Gij, or -v[ij]/Ei), correlation coefficients ranged from R2adj = 0.924 to 0.982. All four fabric measures performed equally well. It is concluded that volume fraction and fabric measures correlate highly with the apparent elastic properties of bone samples, provided that anisotropy and nonhomogeneity in the elastic properties of the trabecular tissue itself have negligible effects on the apparent properties. Whether this is true for bone in general remains to be seen, as only a subset was analyzed here. These methods, however, can be valuable in similar assessments of other subsets.