Hinge prostheses in the revision of unicompartmental knee replacement: a descriptive analysis of data from the national joint registry for England, Wales and Northern Ireland.

INTRODUCTION: Unicompartmental knee replacement (UKR) is an effective surgical strategy in patients with isolated medial or lateral compartment osteoarthritis. Study aims were to (1) describe the epidemiology of patients undergoing revision of UKR to a hinge knee replacement (HKR); (2) identify factors influencing time to revision; (3) evaluate HKR survival. MATERIALS AND METHODS: An analysis of National Joint Registry data was undertaken, exploring revision of UKR to HKR between 2007 and April 2021. Descriptive analysis of eligible patients and Cox Regression to identify key determinants of time to revision were performed. Failure of HKR post-revision was assessed using survival analysis. RESULTS: 111 patients underwent revision of UKR to HKR. Median age at revision was 70 years and most common indications were instability (n = 42) and infection (n = 22). The most common implant was a rotating HKR. Significant independent factors associated with earlier revision were periprosthetic fracture (p = 0.03) and malalignment (p = 0.03). Progressive osteoarthritis (p = 0.01) and higher ASA grades (3: p = 0.01, 4: p < 0.01) delayed time to revision; patient sex and age were not significant factors. Ten patients required subsequent re-revision; median age at re-revision was 61 years. HKR revised from UKR had an 89.3% revision-free risk at 5 years. Male sex (p < 0.01) and younger age (p < 0.01) were associated with re-revision. CONCLUSIONS: Factors associated with time to revision may be used to counsel patients prior to UKR. The survivorship of the HKR of 89.3% at 5 years is concerning and careful consideration should be given when using this level of constraint when revising UKR in younger or male patients.

Adjusting expected deaths for mortality displacement during the COVID-19 pandemic: a model based counterfactual approach at the level of individuals.

BACKGROUND: Near-real time surveillance of excess mortality has been an essential tool during the COVID-19 pandemic. It remains critical for monitoring mortality as the pandemic wanes, to detect fluctuations in the death rate associated both with the longer-term impact of the pandemic (e.g. infection, containment measures and reduced service provision by the health and other systems) and the responses that followed (e.g. curtailment of containment measures, vaccination and the response of health and other systems to backlogs). Following the relaxing of social distancing regimes and reduction in the availability of testing, across many countries, it becomes critical to measure the impact of COVID-19 infection. However, prolonged periods of mortality in excess of the expected across entire populations has raised doubts over the validity of using unadjusted historic estimates of mortality to calculate the expected numbers of deaths that form the baseline for computing numbers of excess deaths because many individuals died earlier than they would otherwise have done: i.e. their mortality was displaced earlier in time to occur during the pandemic rather than when historic rates predicted. This is also often termed "harvesting" in the literature. METHODS: We present a novel Cox-regression-based methodology using time-dependent covariates to estimate the profile of the increased risk of death across time in individuals who contracted COVID-19 among a population of hip fracture patients in England (N = 98,365). We use these hazards to simulate a distribution of survival times, in the presence of a COVID-19 positive test, and then calculate survival times based on hazard rates without a positive test and use the difference between the medians of these distributions to estimate the number of days a death has been displaced. This methodology is applied at the individual level, rather than the population level to provide a better understanding of the impact of a positive COVID-19 test on the mortality of groups with different vulnerabilities conferred by sociodemographic and health characteristics. Finally, we apply the mortality displacement estimates to adjust estimates of excess mortality using a "ball and urn" model. RESULTS: Among the exemplar population we present an end-to-end application of our methodology to estimate the extent of mortality displacement. A greater proportion of older, male and frailer individuals were subject to significant displacement while the magnitude of displacement was higher in younger females and in individuals with lower frailty: groups who, in the absence of COVID-19, should have had a substantial life expectancy. CONCLUSION: Our results indicate that calculating the expected number of deaths following the first wave of the pandemic in England based solely on historical trends results in an overestimate, and excess mortality will therefore be underestimated. Our findings, using this exemplar dataset are conditional on having experienced a hip fracture, which is not generalisable to the general population. Fractures that impede mobility in the weeks that follow the accident/surgery considerably shorten life expectancy and are in themselves markers of significant frailty. It is therefore important to apply these novel methods to the general population, among whom we anticipate strong patterns in mortality displacement - both in its length and prevalence - by age, sex, frailty and types of comorbidities. This counterfactual method may also be used to investigate a wider range of disruptive population health events. This has important implications for public health monitoring and the interpretation of public health data in England and globally.

Reliability of patient-reported comorbidities: a systematic review and meta-analysis.

Self-reported questionnaires have become a widely adopted method of reviewing patients in clinical practice. This systematic review aimed to determine the reliability of patient-reported comorbidities and to identify which patient factors influence the reliability. Included studies assessed the reliability of at least one patient-reported comorbidity against their medical record or clinical assessment as gold standard. Twenty-four eligible studies were included in the meta-analysis. Only endocrine diseases (Cohen's Kappa Coefficient (CKC) 0.81 (95% CI 0.76 to 0.85)), consisting of diabetes mellitus (CKC 0.83 (95% CI 0.80 to 0.86)) and thyroid disease (CKC 0.68 (95% CI 0.50 to 0.86)), showed good-to-excellent reliability. Factors most frequently reported to influence concordance included age, sex and educational level. This systematic review demonstrated poor-to-moderate reliability for most systems, except for endocrine which showed good-to-excellent reliability. Although patient self-reporting can be a useful guide to clinical management, several patient factors were demonstrated to affect reliability therefore it should be avoided as a standalone measure.

Coupled CFD-DEM modeling to predict how EPS affects bacterial biofilm deformation, recovery and detachment under flow conditions.

The deformation and detachment of bacterial biofilm are related to the structural and mechanical properties of the biofilm itself. Extracellular polymeric substances (EPS) play an important role on keeping the mechanical stability of biofilms. The understanding of biofilm mechanics and detachment can help to reveal biofilm survival mechanisms under fluid shear and provide insight about what flows might be needed to remove biofilm in a cleaning cycle or for a ship to remove biofilms. However, how the EPS may affect biofilm mechanics and its deformation in flow conditions remains elusive. To address this, a coupled computational fluid dynamic- discrete element method (CFD-DEM) model was developed. The mechanisms of biofilm detachment, such as erosion and sloughing have been revealed by imposing hydrodynamic fluid flow at different velocities and loading rates. The model, which also allows adjustment of the proportion of different functional groups of microorganisms in the biofilm, enables the study of the contribution of EPS toward biofilm resistance to fluid shear stress. Furthermore, the stress-strain curves during biofilm deformation have been captured by loading and unloading fluid shear stress to study the viscoelastic properties of the biofilm. Our predicted emergent viscoelastic properties of biofilms were consistent with relevant experimental measurements.

Reliability of patient-reported comorbidities: a systematic review and meta-analysis.

Self-reported questionnaires have become a widely adopted method of reviewing patients in clinical practice. This systematic review aimed to determine the reliability of patient-reported comorbidities and to identify which patient factors influence the reliability. Included studies assessed the reliability of at least one patient-reported comorbidity against their medical record or clinical assessment as gold standard. Twenty-four eligible studies were included in the meta-analysis. Only endocrine diseases (Cohen's Kappa Coefficient (CKC) 0.81 (95% CI 0.76 to 0.85)), consisting of diabetes mellitus (CKC 0.83 (95% CI 0.80 to 0.86)) and thyroid disease (CKC 0.68 (95% CI 0.50 to 0.86)), showed good-to-excellent reliability. Factors most frequently reported to influence concordance included age, sex and educational level. This systematic review demonstrated poor-to-moderate reliability for most systems, except for endocrine which showed good-to-excellent reliability. Although patient self-reporting can be a useful guide to clinical management, several patient factors were demonstrated to affect reliability therefore it should be avoided as a standalone measure.

A constrained-condylar fixed-bearing total knee arthroplasty is stabilised by the medial soft tissues.

PURPOSE: Revision constrained-condylar total knee arthroplasty (CCK-TKA) is often used to provide additional mechanical constraint after failure of a primary TKA. However, it is unknown how much this translates to a reliance on soft-tissue support. The aim of this study was therefore to compare the laxity of a native knee to the CCK-TKA implanted state and quantify how medial soft-tissues stabilise the knee following CCK-TKA. METHODS: Ten intact cadaveric knees were tested in a robotic system at 0°, 30°, 60° and 90° flexion with ± 90  N anterior-posterior force, ± 8 Nm varus-valgus and ± 5 Nm internal-external torques. A fixed-bearing CCK-TKA was implanted and the laxity tests were repeated with the soft tissues intact and after sequential cutting. The deep and superficial medial collateral ligaments (dMCL, sMCL) and posteromedial capsule (PMC) were sequentially transected and the percentage contributions of each structure to restraining the applied loads were calculated. RESULTS: Implanting a CCK-TKA did not alter anterior-posterior laxity from that of the original native knee, but it significantly decreased internal-external and varus-valgus rotational laxity (p < 0.05). Post CCK-TKA, the sMCL restrained 34% of the tibial displacing load in anterior drawer, 16% in internal rotation, 17% in external rotation and 53% in valgus, across the flexion angles tested. The dMCL restrained 11% of the valgus rotation moment. CONCLUSIONS: With a fully-competent sMCL in-vitro, a fixed-bearing CCK-TKA knee provided more rotational constraint than the native knee. The robotic test data showed that both the soft-tissues and the semi-constrained implant restrained rotational knee laxity. Therefore, in clinical practice, a fixed-bearing CCK-TKA knee could be indicated for use in a knee with lax, less-competent medial soft tissues. LEVEL OF EVIDENCE: Controlled laboratory study.

Diagnostic value of routine pre-operative investigations used in combination in the diagnosis of periprosthetic joint infection.

The primary aim of this study was to assess the diagnostic accuracy of joint aspiration culture, serum C-reactive protein (CRP) and serum erythrocyte sedimentation rate (ESR), individually, and in combination for the diagnosis of periprosthetic joint infection (PJI). A consecutive patient series with pre-operative inflammatory marker levels, an aspiration culture of either hip or knee arthroplasty and intra-operative culture samples from subsequent revision surgery was compiled. This retrospective patient cohort analysis included 128 aspiration. The data were analysed to compare pre-operative aspiration cultures, serum ESR and CRP levels to the chosen gold standard for PJI diagnosis of intra-operative culture samples. A diagnostic algorithm was created using the above tests combined with clinical suspicion index. The values that had the highest sensitivity and specificity of predicting PJI were >5 for CRP and >16 for ESR. CRP used individually had the highest sensitivity and negative predictive value (NPV) of any test (75.0% and 75.9%, respectively). ESR + aspirate had the highest specificity and positive predictive value (PPV), of 100% for both. Using all three tests together the specificity and PPV were higher than the test individual values (95.3% and 85.0% respectively). Based on subgroup analyses the combination of ESR or CRP plus joint aspiration has superior PPV compared to individual tests. ESR and CRP had the highest NPV when used in isolation. An algorithm has been developed to guide clinical diagnosis.

The alpha defensin lateral flow test is effective in predicting eradication of periprosthetic joint infection after surgical debridement.

The primary aim of this study was to assess the utility of the alpha defensin lateral flow (ADLF) test for predicting the eradication of PJI after surgical debridement. The secondary aim was to describe the reliability of ADLF test in diagnosis of PJI intra- operatively. A prospective observational study was conducted in three independent orthopaedic centres. Twenty-two patients undergoing revision surgery (debridement, antibiotics and implant retention (DAIR), single or two-stage revision) for PJI were recruited, 13 female and 9 male with an average age of 64 years. Samples were collected intra-operatively at the start of the first surgical procedure and then at the completion of debridement or prior to reimplantation depending on the operation performed. These samples were tested using ADLF and then sent for microbiological analysis. The ADLF result was then compared to the corresponding culture result in order to determine the diagnostic predictive accuracy. The reliability of ADLF test to predict eradication of infection after debridement of PJI was excellent for specificity and positive predictive value (PPV) of which both where 100%, but had a poor sensitivity (14.3%) and negative predictive value (NPV) (62.5%). The reliability of ADLF test to predict PJI was poor with only a 50% sensitivity and specificity. The ADLF test has a high specificity and PPV for diagnosing eradication of infection after debridement. In contrast the ADLF testing appears to have poor diagnostic accuracy for PJI when used on intra-operative samples, prior to surgical intervention.

Identification of a novel, methylation-dependent, RUNX2 regulatory region associated with osteoarthritis risk.

Osteoarthritis (OA) is a common, multifactorial and polygenic skeletal disease that, in its severest form, requires joint replacement surgery to restore mobility and to relieve chronic pain. Using tissues from the articulating joints of 260 patients with OA and a range of in vitro experiments, including CRISPR-Cas9, we have characterized an intergenic regulatory element. Here, genotype at an OA risk locus correlates with differential DNA methylation, with altered gene expression of both a transcriptional regulator (RUNX2), and a chromatin remodelling protein (SUPT3H). RUNX2 is a strong candidate for OA susceptibility, with its encoded protein being essential for skeletogenesis and healthy joint function. The OA risk locus includes single nucleotide polymorphisms (SNPs) located within and flanking the differentially methylated region (DMR). The OA association SNP, rs10948172, demonstrates particularly strong correlation with methylation, and two intergenic SNPs falling within the DMR (rs62435998 and rs62435999) demonstrate genetic and epigenetic effects on the regulatory activity of this region. We therefore posit that the OA signal mediates its effect by modulating the methylation of the regulatory element, which then impacts on gene expression, with RUNX2 being the principal target. Our study highlights the interplay between DNA methylation, OA genetic risk and the downstream regulation of genes critical to normal joint function.

Improved mediolateral load distribution without adverse laxity pattern in robot-assisted knee arthroplasty compared to a standard manual measured resection technique.

PURPOSE: Robot-assisted total knee arthroplasty (rTKA) remains in its infancy, is expensive but offers the promise of improved kinematic performance through precise bone cuts, with minimal soft tissue disruption, based on pre-resection soft tissue behaviour. This cadaveric study examined load transfer, soft tissue performance and radiographic indices for conventional (sTKA) versus rTKA. The null hypothesis was there would be no difference between the two modes of implantation. METHODS: Whole (ten) cadaveric limbs were randomised to receive either robotic (rTKA, N = 5) or conventional measured resection (sTKA, N = 5) knee arthroplasty. Laxity patterns were established using validated fixed sensors (Verasense) with manual maximum displacement for six degrees of freedom. Tibiofemoral load and contact points were determined dynamically using remote sensor technology for medial and lateral compartments through a functional arc of motion (0-110 degrees of motion). Final component position was assessed using pre- and post-implantation CT. RESULTS: No significant intergroup differences for laxity were found (n.s.). The rTKA group exhibited consistently balanced mediolateral load throughout the full arc with significantly reduced overall total load across the joint (for distinct points of measurement, p < 0.05). Despite using flexion-extension and mediolateral gap balancing with measured resection, the sTKA group failed to achieve balance in at least three points of the flexion arc. Post-operative CT confirmed satisfactory component alignment with no significant differences for positioning between the two groups. CONCLUSION: This work found improved load sharing for rTKA when compared to conventional surgery for same donor knees. Laxity and CT determined final component positioning was not significantly different. The work supports the contention that robot-assisted TKA delivers improved tibiofemoral load sharing in time zero studies under defined conditions but such offers the promise of improved clinical performance and reduced implant wear.

Fibroblasts Promote Inflammation and Pain via IL-1α Induction of the Monocyte Chemoattractant Chemokine (C-C Motif) Ligand 2.

Fibroblasts persist within fibrotic scar tissue and exhibit considerable phenotypic and functional plasticity. Herein, we hypothesized that scar-associated fibroblasts may be a source of stress-induced inflammatory exacerbations and pain. To test this idea, we used a human model of surgery-induced fibrosis, total knee arthroplasty (TKA). Using a combination of tissue protein expression profiling and bioinformatics, we discovered that many months after TKA, the fibrotic joint exists in a state of unresolved chronic inflammation. Moreover, the infrapatellar fat pad, a soft tissue that becomes highly fibrotic in the post-TKA joint, expresses multiple inflammatory mediators, including the monocyte chemoattractant, chemokine (C-C motif) ligand (CCL) 2, and the innate immune trigger, IL-1α. Fibroblasts isolated from the post-TKA fibrotic infrapatellar fat pad express the IL-1 receptor and on exposure to IL-1α polarize to a highly inflammatory state that enables them to stimulate the recruitment of monocytes. Blockade of fibroblast CCL2 or its transcriptional regulator NF-κB prevented IL-1α-induced monocyte recruitment. Clinical investigations discovered that levels of patient-reported pain in the post-TKA joint correlated with concentrations of CCL2 in the joint tissue, such that the chemokine is effectively a pain biomarker in the TKA patient. We propose that an IL-1α-NF-κB-CCL2 signaling pathway, operating within scar-associated fibroblasts, may be therapeutically manipulated for alleviating inflammation and pain in fibrotic joints and other tissues.

Subcellular origin of mitochondrial DNA deletions in human skeletal muscle.

OBJECTIVE: In patients with mitochondrial DNA (mtDNA) maintenance disorders and with aging, mtDNA deletions sporadically form and clonally expand within individual muscle fibers, causing respiratory chain deficiency. This study aimed to identify the sub-cellular origin and potential mechanisms underlying this process. METHODS: Serial skeletal muscle cryosections from patients with multiple mtDNA deletions were subjected to subcellular immunofluorescent, histochemical, and genetic analysis. RESULTS: We report respiratory chain-deficient perinuclear foci containing mtDNA deletions, which show local elevations of both mitochondrial mass and mtDNA copy number. These subcellular foci of respiratory chain deficiency are associated with a local increase in mitochondrial biogenesis and unfolded protein response signaling pathways. We also find that the commonly reported segmental pattern of mitochondrial deficiency is consistent with the three-dimensional organization of the human skeletal muscle mitochondrial network. INTERPRETATION: We propose that mtDNA deletions first exceed the biochemical threshold causing biochemical deficiency in focal regions adjacent to the myonuclei, and induce mitochondrial biogenesis before spreading across the muscle fiber. These subcellular resolution data provide new insights into the possible origin of mitochondrial respiratory chain deficiency in mitochondrial myopathy. Ann Neurol 2018;84:289-301.

A load-measuring device can achieve fine-tuning of mediolateral load at knee arthroplasty but may lead to a more lax knee state.

PURPOSE: A balanced knee arthroplasty should optimise survivorship and performance. Equilibration of medial and lateral femorotibial load requires guided judicious pericapsular ligament release. The null hypothesis was that there would be no difference between use of a tensiometer device and a remote load sensor final load transfer across the joint through functional arc of motion. METHODS: A cadaveric study, using eight knees, was performed to define the impact of an established gap distraction device against load sensor-aimed soft tissue release in a TKA setting. Using validated measures of laxity in six degrees of freedom and true real-time load sensing four states were examined: native knee, TKA using spacer blocks (TKA), TKA with soft tissue release aided by a monogram tensiometer (TKA-T) and finally where load across the tibiofemoral articulation remains unbalanced final soft tissue release using a sensor device (TKA-OS). RESULTS: The laxity pattern was equivalent for TKA-T and TKA-OS. However, in only four of these seven knees despite the tensiometer confirming equivalence of rectangular flexion-extension gap dimensions and centralisation of collateral ligament distraction, there remained a > 15lb medial to lateral load difference for at least one point of the flexion arc. This was corrected by further final soft tissue release guided by the OS sensor device in the final three knees. CONCLUSION: Tensiometer-guided soft tissue release at two points of flexion failed to achieve balance for three out of seven knee arthroplasty procedures. Sensor technology guided final soft tissue balancing to equilibrate load across the joint through full arc of motion. This work argues for the role of continuous sensor readings to guide the soft tissue balancing during total knee arthroplasty.

Correction to: The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty.

Unfortunately, Fig. 1 in the original article contained incorrect information. Hereby, the correct figure is published and we apologise for the inconvenience.

An Overview and Predictors of Achieving the Postoperative Ceiling Effect of the WOMAC Score Following Total Knee Arthroplasty.

BACKGROUND: To describe the ceiling effect for the components of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and identify preoperative independent predictors for patients who achieve maximal scores (ceiling effect) after total knee arthroplasty (TKA). METHODS: A retrospective cohort of 2589 patients undergoing a primary TKA were identified from an established arthroplasty database. Patient demographics, WOMAC and Short Form 12 (SF-12) scores were collected preoperatively and 1 year postoperatively. Logistic regression analysis was used to identify independent preoperative predictors of patients achieving ceiling scores. RESULTS: The ceiling effect was 26.8% (n = 695) for the pain score, 6.4% (n = 165) for the function score, and 21.2% (n = 548) for the stiffness score. Lower body mass index (P = .001), absence of gastric ulceration (P = .04), absence of anemia (P = .02), absence of depression (P = .004), and absence of back pain (P < .001) and better preoperative WOMAC pain and SF-12 physical (P = .01) and mental (P < .001) scores were associated with a ceiling WOMAC pain score. Male gender (P = .03), lower body mass index (P = .040), absence of gastric ulceration (P = .004), and absence of back pain (P < .001) and better preoperative SF-12 physical (P = .02) scores were associated with a ceiling WOMAC function score. Male gender (P = .001), absence of back pain (P < .001), and better preoperative WOMAC stiffness score (P = .005) and SF-12 mental (P = .001) scores were associated with a ceiling WOMAC stiffness score. CONCLUSION: The WOMAC pain and stiffness components demonstrated a high ceiling effect but in contrast the functional score had a low ceiling effect. The absence of back pain was a common predictive factor for all 3 components and had the greatest impact upon the likelihood of achieving a ceiling score.

Asynchronous Bilateral Total Knee Arthroplasty: Predictors of the Functional Outcome and Patient Satisfaction for the Second Knee Replacement.

BACKGROUND: The primary aim of this study is to identify independent preoperative predictors of outcome and patient satisfaction for the second total knee arthroplasty (TKA). METHODS: A retrospective cohort of 454 patients undergoing an asynchronous (6 weeks or more apart) bilateral primary TKA were identified from an arthroplasty database. Patient demographics, comorbidities, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Short Form-12 scores were collected preoperatively and 1 year postoperatively. Overall patient satisfaction was assessed at 1 year. RESULTS: The 1 year WOMAC pain score (P = .01), and improvement in WOMAC pain (P < .001) and functional (P = .002) scores were significantly lower for the second TKA. Worse preoperative WOMAC pain, function, and stiffness scores were demonstrated to be independent predictors of improvement in the WOMAC pain, function, and stiffness scores, respectively, for both the first and second TKA. The overall rate of satisfaction with the first TKA was 94.0% and 94.7% for the second TKA (P = .67). The rate of satisfaction for the second TKA was 77.8% for patients that were dissatisfied with their first TKA, which was an independent predictor of dissatisfaction (P = .02). CONCLUSION: Improvement in pain and function is less with the second TKA, but the satisfaction rate remains similar. There are common independent predictors for change in the WOMAC score for the first and second TKA; however, the predictors of satisfaction were different with no common factors. Patients that were dissatisfied with their first TKA were more likely to be dissatisfied with their second TKA. LEVEL OF EVIDENCE II: Prognostic retrospective cohort study.

Staphylococcal resistance profiles in deep infection following primary hip and knee arthroplasty: a study using the NJR dataset.

INTRODUCTION: This study aimed to (1) report the rates of resistance against a variety of antibiotics for pure Staphylococcal infections, and (2) examine the impact of ALBC use at primary surgery has on resistance patterns for patients undergoing first-time revision of primary hip and knee arthroplasty for indication of infection. MATERIALS AND METHODS: Data from the National Joint Registry database for England and Wales were linked to microbiology data held by Public Health England to identify a consecutive series of 258 primary hip and knee arthroplasties performed between April 2003 and January 2014 that went on to have a revision for Staphylococcal deep periprosthetic infection. Multivariate binary logistic regression was used to study predictors of microorganism resistance to a range of antimicrobials. RESULTS: After adjusting for patient and surgical factors, multivariate analysis showed the use of gentamicin-loaded bone cement at the primary surgery was associated with a significant increase in the risk of Staphylococcal gentamicin resistance (odds ratio 8.341, 95% CI 2.297-30.292, p = 0.001) and methicillin resistance (odds ratio 3.870, 95% CI 1.319-11.359, p = 0.014) at revision for infection. CONCLUSIONS: Clinicians must anticipate the possibility of antibiotic resistance to ALBC utilised at primary surgery.

What is the Minimum Clinically Important Difference for the WOMAC Index After TKA?

BACKGROUND: The WOMAC score is a validated outcome measure for use in patients undergoing TKA. Defining meaningful changes in the WOMAC score is important for sample-size calculations in clinical research and for interpreting published studies. However, inconsistencies among published studies regarding key definitions for changes in the WOMAC score after TKA potentially could result in incorrectly powered studies and the misinterpretation of clinical research results. QUESTIONS/PURPOSES: (1) To identify the minimum clinically important difference (MCID) for the total WOMAC score and its components 1 year after TKA using an anchor-based methodology. (2) To define the minimum important change (MIC) and the minimum detectable change with 95% confidence (MDC95) for the total WOMAC score and its components 1 year after TKA. METHODS: Between 2003 and 2013, 3641 patients underwent primary TKA at one center. Of those, 460 patients (13%) were excluded from this retrospective study for prespecified reasons (mainly secondary OA and bilateral surgery), and 592 patients (16%) were either lost to followup or could not be included because of incomplete questionnaires. WOMAC scores were recorded preoperatively and at 1 year postoperatively. Patient demographics and preoperative Short Form-12 and WOMAC scores were no different for the 16% of patients who were lost to followup or failed to complete 1-year questionnaires and the study cohort (n = 2589). At 1 year, patients were asked "How much did the knee replacement surgery improve the quality of your life?" Their responses were recorded as: a great improvement, moderate improvement, little improvement, no improvement at all, or the quality of my life is worse. The MCID was defined as the difference in the mean change in the WOMAC score between patients with no improvement compared with those with little improvement according to the anchor question. The MIC was defined as the change in the WOMAC score relative to the baseline score for patients who reported a little improvement in their quality of life. The MDC is the smallest change for an individual who is likely to be beyond the measurement error of the scoring tool and represents true change rather than variability in the scoring measure; we report it with 95% confidence bounds defining real change rather than variability in the scoring measure (MDC95). We calculated this with distribution-based methods for the whole cohort. Patients recording a little improvement (n = 211) and no improvement (n = 115) were used as anchor responses to calculate the MCID (using regression analysis to adjust for potential confounding variables such as age, gender, BMI and preoperative Short Form-12 or WOMAC scores) and the MIC (using receiver operative characteristics curves). RESULTS: After adjusting for confounding variables such as age, gender, BMI as well as preoperative Short Form-12 and WOMAC scores, the MCID was 11 for pain, 9 for function, 8 for stiffness and 10 for the total WOMAC score. The MIC was 21 for pain, 16 for function, 13 for stiffness and 17 for the total WOMAC score. The MDC95 was 23 for pain, 11 for function, 27 for stiffness and 12 for the total WOMAC score. CONCLUSIONS: The MCID and MIC for the WOMAC score represent the smallest meaningful effect sizes when comparing the outcome of two groups (difference in mean change between the groups) or when assessing a cohort (a change in score for the group) after TKA, respectively, helping the reader to distinguish between a clinically important effect size and a mere statistical difference. We determined that the error in measurement (based on the MDC95) for the function component and total WOMAC scores were less than the MIC, which suggests changes beyond the MIC are clinically real and not due to uncertainty in the score. These parameters are essential to interpret TKA outcomes research and to ensure clinical research studies are amply powered to detect meaningful differences. Future studies using the WOMAC score to assess TKA outcomes should report not only the statistical significance (a p value) but also the clinical importance using the reported MCID and MIC values. LEVEL OF EVIDENCE: Level III, diagnostic study.

Internal femoral component rotation adversely influences load transfer in total knee arthroplasty: a cadaveric navigated study using the Verasense device.

PURPOSE AND HYPOTHESIS: Correct femoral component rotation at knee arthroplasty influences patellar tracking and may determine function at extremes of movement. Additionally, such malrotation may deleteriously influence flexion/extension gap geometry and soft tissue balancing kinematics. Little is known about the effect of subtle rotational change upon load transfer across the tibiofemoral articulation. Our null hypothesis was that femoral component rotation would not influence load across this joint in predictable manner. METHODS: A cadaveric study was performed to examine load transfer using the orthosensor device, respecting laxity patterns in 6° of motion, to examine load across the medial and lateral compartments across a full arc of motion. Mixed-effect modelling allowed for quantification of the effect upon load with internal and external femoral component rotation in relation to a datum in a modern single-radius cruciate-retaining primary knee design. RESULTS: No significant change in maximal laxity was found between different femoral rotational states. Internal rotation of the femoral component resulted in significant increase in medial compartment load transfer for knee flexion including and beyond 60°. External rotation of the femoral component within the limits studied did not influence tibiofemoral load transfer. CONCLUSIONS: Internal rotation of the femoral component will adversely influence medial compartment load transfer and could lead to premature polyethylene wear on the medial side.

The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty.

PURPOSE: The primary aim of this study was to define a classification in the WOMAC score after total knee arthroplasty (TKA) according to patient satisfaction. The secondary aims were to describe patient demographics for each level of satisfaction. METHODS: A retrospective cohort consisting of 2589 patients undergoing a primary TKA were identified from an established arthroplasty database. Patient demographics, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and short form (SF) 12 scores were collected pre-operatively and 1 year post-operatively. In addition, patient satisfaction was assessed at 1 year with four responses: very satisfied, satisfied, dissatisfied or very dissatisfied. Receiver operating characteristic (ROC) curves were used to identify values in the components and total WOMAC scores that were predictive of each level of satisfaction, which were used to define the categories of excellent, good, fair and poor. RESULTS: At 1 year, there were 1740 (67.5%) very satisfied, 572 (22.2%) satisfied, 190 (7.4%) dissatisfied and 76 (2.9%) very dissatisfied patients. ROC curve analysis identified excellent, good, fair and poor categories for the pain (> 78, 59-78, 44-58, < 44), function (> 72, 54-72, 41-53, < 41), stiffness (> 69, 56-69, 43-55, < 43) and total (> 75, 56-75, 43-55, < 43) WOMAC scores, respectively. Patients with lung disease, diabetes, gastric ulcer, kidney disease, liver disease, depression, back pain, with worse pre-operative functional scores (WOMAC and SF-12) and those with less of an improvement in the scores, had a significantly lower level of satisfaction. CONCLUSION: This study has defined a post-operative classification of excellent, good, fair and poor for the components and total WOMAC scores after TKA. The predictors of level of satisfaction should be recognised in clinical practice and patients at risk of a lower level of satisfaction should be made aware in the pre-operative consent process. LEVEL OF EVIDENCE: III.