Low serum albumin as a risk factor for delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage: eICU collaborative research database analysis.

BACKGROUND: Delayed cerebral ischemia (DCI) represents a devastating complication of aneurysmal subarachnoid hemorrhage (aSAH) and is a significant predictor of morbidity and mortality. Recent studies have implicated inflammatory processes in the pathogenesis of DCI. METHODS: aSAH patient data were retrospectively obtained from the eICU Collaborative Research Database (eICU CRD). Multivariable logistic regression models and receiver operating characteristic (ROC) curve analyses were employed to assess the association between low serum albumin (< 3.4 g/dL) and clinical endpoints: DCI and in-hospital mortality. RESULTS: Among 276 aSAH patients included in the analysis, 35.5% (n=98) presented with low serum albumin levels and demonstrated a higher incidence of DCI (18.4% vs. 8.4%, OR=2.45, 95% CI 1.17, 5.10; p=0.017) and in-hospital mortality (27.6% vs. 16.3%, OR=1.95, 95% CI 1.08, 3.54; p=0.027) compared to patients with normal admission albumin values. In a multivariable model controlling for age and World Federation of Neurosurgical Societies grade, low serum albumin remained significantly associated with DCI (OR=2.52, 95% CI 1.18, 5.36; p=0.017), but not with in-hospital mortality. A combined model for prediction of DCI, encompassing known risk factors in addition to low serum albumin, achieved an area under the curve of 0.65 (sensitivity=0.55, specificity=0.75). CONCLUSIONS: Serum albumin, a routine and inexpensive laboratory measurement, can may potentially aid in the identification of patients with aSAH at risk for the development of DCI.

Functional Outcomes of a Musculoskeletal Integrated Practice Providing Comprehensive Whole Person Care for Hip Osteoarthritis.

BACKGROUND: Outcomes of hip osteoarthritis (OA) management within integrated practice units (IPUs) are lacking. This study reports 6-month and 1-year patient-reported outcomes (PROs) of IPU care, the proportion of patients achieving minimal clinically important difference (MCID) and substantial clinical benefit (SCB) at 1 year, and baseline factors associated with the likelihood of achieving MCID and SCB. METHODS: We retrospectively evaluated 1009 new patients presenting to an IPU with hip OA between October 2017 and June 2020. Patients experienced multidisciplinary team-based management. Individuals with baseline and 6-month PROs or baseline and 1-year PROs (Hip Disability and Osteoarthritis Outcome Score Joint Replacement, HOOS JR) were included. We used anchor-based MCID and SCB thresholds and multivariable binary logistic regression models to identify baseline factors associated with achieving 1-year MCID and SCB. RESULTS: HOOS JR increased from baseline to 6 months (Δ = 19.1 ± 2.1, P = .065) and baseline to 1 year (Δ = 35.8 ± 2.9, P < .001). At 1 year, 72.7% (IPU only) and 88% (IPU-based total hip arthroplasty [THA]) achieved MCID (P < .001), and 62.3% (IPU only) and 88% (IPU-based THA) achieved SCB (P < .001). In multivariable regression, lower baseline HOOS JR scores (r = 0.96, P = .04), undergoing THA (r = 0.213, P < .001), and fewer symptoms of generalized anxiety (r = 0.932, P = .018) were independently associated with achieving MCID at 1 year. The same factors were independently associated with achieving SCB at 1 year. Lower baseline anxiety (Generalized Anxiety Disorder Questionnaire-7 item) and greater hip-related preoperative limitations result in greater likelihood of achieving MCID and SCB. CONCLUSION: Significant improvements in patient outcomes can be achieved by IPUs providing comprehensive care for hip OA including the management of psychological distress. Future prospective studies should compare the outcomes of IPUs with traditional care in managing diverse patient phenotypes.

Endovascular thrombectomy with and without preceding intravenous thrombolysis for treatment of large vessel anterior circulation stroke: A cross-sectional analysis of 50,000 patients.

INTRODUCTION: The safety and efficacy of intravenous thrombolysis (IVT) before endovascular thrombectomy (EVT) for large vessel occlusion stroke remains a highly contested and unanswered clinical question. We aim to characterize the clinical profile, complications, and discharge disposition of EVT patients treated with and without preceding IVT using a large, nationally-representative sample. METHODS: The National Inpatient Sample was queried from 2015 to 2018 to identify adult patients with anterior circulation stroke treated with EVT with and without preceding IVT. Multivariable logistic regression analysis and propensity-score matching were employed to assess adjusted associations with clinical endpoints and to address confounding by indication for IVT, respectively. RESULTS: Among 48,525 patients identified, 40.7% (n = 19,735) received IVT prior to EVT. On unadjusted analysis, patients treated with IVT bridging therapy experienced higher rates of intracranial hemorrhage (26% vs. 24%, p = 0.003) and routine discharge to home with or without services (33% vs. 27%, p < 0.001), a lower frequency of thromboembolic complications (3% vs. 5%, p < 0.001), and lower rates of extended hospital stays (eLOS) (20% vs. 24%, p < 0.001). Multivariable logistic regression analysis adjusting for demographic and baseline clinical characteristics demonstrated independent associations of IVT bridging therapy with intracranial hemorrhage (aOR 1.28, 95% CI 1.15, 1.43; p < 0.001), thromboembolic complications (aOR 0.66, 95% CI 0.53, 0.83; p < 0.001), routine discharge (aOR 1.27, 95% CI 1.15, 1.40; p < 0.001), and eLOS (aOR 0.76, 95% CI 0.68, 0.85; p < 0.001). Sensitivity testing confirmed these findings. CONCLUSION: Preceding IVT was associated with favorable functional outcomes following endovascular therapy. Prospective randomized clinical trials are warranted for further evaluation.

COVID-19 in spinal cord injury patients at a veterans administration hospital: A case series.

OBJECTIVE: To describe the clinical features and disease course of COVID-19 in veterans with spinal cord injury (SCI). DESIGN: Case series of consecutive veterans with SCI treated at a single center. SETTING: SCI Unit at an urban Veterans Administration hospital at the epicenter of the COVID-19 pandemic in the US. PARTICIPANTS: Seven SCI veterans with confirmed COVID-19 infection by PCR; all veterans were male, mean age was 60.6. Five had cervical level of injury, and five had complete injury (AIS A). Six veterans had a BMI > 22; three had chronic obstructive pulmonary disease; three had chronic kidney disease. INTERVENTIONS: None. OUTCOME MEASURES: Presence of co-morbidities, diagnostic values, and clinical findings. RESULTS: Each case presented differently; the most common presenting sign was fever. In the three individuals with critical and fatal infection, pre-existing comorbidities were more common and inflammatory markers were markedly elevated. CONCLUSION: Level and completeness of SCI did not appear to correlate with COVID-19 severity, as mild and asymptomatic illness was noted in persons with high grade SCI. As has been shown to be the case in the general population, pre-existing comorbidities are the most reliable predictors of severe SARS-CoV-2 infection currently available for persons with chronic SCI. Contrary to concerns that SCI may mask the cardinal signs of COVID-19, such as fever and cough, by way of compromised thermoregulation and thoracoabdominal musculature, such signs were common in our series. To facilitate early detection, prompt treatment, and minimized viral spread, the implementation of preventive strategies by SCI units is recommended.

Current evidence from a worldwide, multicentre, follow-up study of the recalled Articular Surface Replacement Hip System.

INTRODUCTION: Our first aim was to report the longitudinal clinical performance of patients treated with the ASR Hip System, a metal-on-metal (MoM) device, in their mid- to late-term follow-up. Secondly, we sought to report on the reasons and risk factors for mid- to late-term implant failure. METHODS: A total of 1721 ASR patients (1933 hips) from 16 centres in 6 countries were enrolled to a prospective, post-recall study. The average time to enrollment was 7.4 years from index surgery. Data from 3 follow-up visits over 2 years were analysed. Implant performance, based on ion levels and PROMs, was determined at each clinical visit. RESULTS: The proportion of those exhibiting good performance decreased over time for hip resurfacing (ASR HRA) and total hip arthroplasty (ASR XL) patients. ASR XL patients were likely to exhibit longitudinal blood metal ion increases regardless of symptom state. ASR HRA patients were more likely to present with and maintain good performance over time, especially males with high general health indicators. 6% of ASR HRA and 14% of ASR XL patients were revised throughout the study period. DISCUSSION: ASR XL THA patients are likely to exhibit blood metal ion increases without accompanying changes in symptom state, and therefore should be followed with annual blood tests at minimum. While appropriately selected ASR HRA patients were the most likely to exhibit low blood metal ion levels and report no symptoms, we recommend vigilant follow-up of all ASR patients to ensure that worsening clinical outcomes and asymptomatic soft tissue damage are not missed.

Progression of adverse local tissue reaction in ASR metal-on-metal hip arthroplasty: a longitudinal MARS-MRI study at mid- to long-term.

BACKGROUND: Despite the large number of studies assessing adverse local tissue reaction (ALTR) in metal-on-metal (MoM) hip implants, there is still a lack of knowledge about the natural progression of ALTR. The aims of this study were to describe the natural course of changes in ALTR at mid- to long-term follow-up for patients treated with metal-on-metal hip arthroplasty and to determine possible risk factors associated with change in ALTR. METHODS: A total of 158 patients (158 hips), 109 MoM hip resurfacing arthroplasties (HRAs) and 49 MoM total hip arthroplasties (THAs), with 2 clinical follow-ups including MARS-MRIs were included. The mean time from index operation to the first visit was 7.6 years (range 3.4-11.4 years), and the mean time between the 2 visits was 1.0 year (range 0.7-1.6 years). RESULTS: The proportion of patients with moderate or severe ALTR did not increase significantly between the first and second visit for the MoM HRA group (14.7-15.6%; p = 0.850) or the MoM THA group (32.7-36.7%; p = 0.671). 8 (7.3%) HRA patients and 9 (18.4%) THA patients progressed in ALTR grade. None of the collected clinical variables was sensitive or specific in identifying patients with ALTR progression. CONCLUSIONS: Although ALTR prevalence was high in our cohort, clinically significant ALTR progression was rare. We were unable to find any predictors associated with ALTR change. This indicates that MARS-MRI remains a valuable tool in the follow-up of patients treated with MoM hip devices in identifying patients who may need revision surgery.

External Validation of Achieving the Patient Acceptable Symptom State for the EuroQol-5 Dimension 1 Year After Total Hip Arthroplasty.

BACKGROUND: Patient acceptable symptom state (PASS) thresholds for the EuroQol-5 Dimension-3 Level (EQ-5D-3L) questionnaire have been established for patients being evaluated 1 year following total hip arthroplasty (THA) but with varying derivation cohorts and methods. The aim of this study was to (1) generate an EQ-5D PASS threshold 1 year following THA on the basis of an international patient cohort, (2) validate preexisting and newly generated PASS thresholds 1 year following THA using the institutional registry of an academic care center, and (3) assess whether THA PASS thresholds vary by patient age and sex. METHODS: The derivation cohort for the THA PASS threshold consisted of 774 patients (after exclusions) who were enrolled in an international, multicenter study from 2007 to 2012 and who completed the EQ-5D and a numerical rating scale (NRS) for satisfaction 1 year postoperatively. With the NRS dichotomized at 2.5 as the anchor, a PASS cutoff for the EQ-5D was generated using the 80% specificity method. The Youden method and 75th percentile approach served as sensitivity analyses. The external validation cohort comprised 1,472 patients who had undergone THA. PASS thresholds were used to dichotomize the external validation sample. The ability of the threshold to predict satisfaction was evaluated with receiver operating characteristic (ROC) curve analysis. Patient subcohorts were stratified by age (>65 and ≤65 years) and sex. RESULTS: Three THA PASS thresholds of 0.77 (our newly defined threshold), 0.82, and 0.92 were validated in this study. The EQ-5D PASS threshold of 0.77 (area under the curve [AUC] = 0.816) best predicted satisfaction 1 year after THA. Subcohort analyses yielded comparable 1-year PASS thresholds for THA between age cohorts and between sex cohorts. CONCLUSIONS: This study identifies PASS thresholds that best predict patient satisfaction 1 year following THA. Although the varied methodology and patient cohorts used to derive PASS values complicate the comparison of these thresholds, this analysis can help surgeons understand the level of health-related quality of life associated with patient satisfaction following THA. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Digital Phenotyping and Patient-Generated Health Data for Outcome Measurement in Surgical Care: A Scoping Review.

Digital phenotyping-the moment-by-moment quantification of human phenotypes in situ using data related to activity, behavior, and communications, from personal digital devices, such as smart phones and wearables-has been gaining interest. Personalized health information captured within free-living settings using such technologies may better enable the application of patient-generated health data (PGHD) to provide patient-centered care. The primary objective of this scoping review is to characterize the application of digital phenotyping and digitally captured active and passive PGHD for outcome measurement in surgical care. Secondarily, we synthesize the body of evidence to define specific areas for further work. We performed a systematic search of four bibliographic databases using terms related to "digital phenotyping and PGHD," "outcome measurement," and "surgical care" with no date limits. We registered the study (Open Science Framework), followed strict inclusion/exclusion criteria, performed screening, extraction, and synthesis of results in line with the PRISMA Extension for Scoping Reviews. A total of 224 studies were included. Published studies have accelerated in the last 5 years, originating in 29 countries (mostly from the USA, n = 74, 33%), featuring original prospective work (n = 149, 66%). Studies spanned 14 specialties, most commonly orthopedic surgery (n = 129, 58%), and had a postoperative focus (n = 210, 94%). Most of the work involved research-grade wearables (n = 130, 58%), prioritizing the capture of activity (n = 165, 74%) and biometric data (n = 100, 45%), with a view to providing a tracking/monitoring function (n = 115, 51%) for the management of surgical patients. Opportunities exist for further work across surgical specialties involving smartphones, communications data, comparison with patient-reported outcome measures (PROMs), applications focusing on prediction of outcomes, monitoring, risk profiling, shared decision making, and surgical optimization. The rapidly evolving state of the art in digital phenotyping and capture of PGHD offers exciting prospects for outcome measurement in surgical care pending further work and consideration related to clinical care, technology, and implementation.

Development and early findings of a semiautomated arthroplasty registry in a multi-institutional healthcare network.

AIMS: The primary aim of this paper was to outline the processes involved in building the Partners Arthroplasty Registry (PAR), established in April 2016 to capture baseline and outcome data for patients undergoing arthroplasty in a regional healthcare system. A secondary aim was to determine the quality of PAR's data. A tertiary aim was to report preliminary findings from the registry and contributions to quality improvement initiatives and research up to March 2019. METHODS: Structured Query Language was used to obtain data relating to patients who underwent total hip or knee arthroplasty (THA and TKA) from the hospital network's electronic medical record (EMR) system to be included in the PAR. Data were stored in a secure database and visualized in dashboards. Quality assurance of PAR data was performed by review of the medical records. Capture rate was determined by comparing two months of PAR data with operating room schedules. Linear and binary logistic regression models were constructed to determine if length of stay (LOS), discharge to a care home, and readmission rates improved between 2016 and 2019. RESULTS: The PAR captured 16,163 THAs and TKAs between April 2016 and March 2019, performed in seven hospitals by 110 surgeons. Manual comparison to operating schedules showed a 100% capture rate. Review of the records was performed for 2,603 random operations; 2,298 (88.3%) had complete and accurate data. The PAR provided the data for three abstracts presented at international conferences and has led to preoperative mental health treatment as a quality improvement initiative in the participating institutions. For primary THA and TKA surgeries, the LOS decreased significantly (p < 0.001) and the rate of home discharge increased significantly (p < 0.001) between 2016 and 2019. Readmission rates did not correlated with the date of surgery (p = 0.953). CONCLUSION: The PAR has high rates of coverage (the number of patients treated within the Partners healthcare network) and data completion and can be used for both research purposes and quality improvement. The same method of creating a registry that was used in the PAR can be applied to hospitals using similar EMR systems. Cite this article: Bone Joint J 2020;102-B(7 Supple B):90-98.

Patient-acceptable symptom state for the Oxford Hip Score and Forgotten Joint Score at 3 months, 1 year, and 2 years following total hip arthroplasty: a registry-based study of 597 cases.

Background and purpose - Patient-acceptable symptom states (PASS) represent the level on a patient-reported outcome measure (PROM) at which patients are satisfied with postoperative outcomes. We defined the PASS for the Oxford Hip Score (OHS) and Forgotten Joint Score (FJS-12) at 3-month, 1-year, and 2-year intervals after primary total hip arthroplasty (THA).Patients and methods - Between July 2018 and April 2019, primary THA patients in an academic medical center's registry completed the OHS, FJS-12, and a satisfaction anchor question at 3-month (n = 230), 1-year (n = 180), or 2-year (n = 187) postoperative intervals. PASS thresholds were derived with receiver operating characteristic analysis using the 80% specificity method. 95% confidence intervals (CI) were calculated using 1,000 non-parametric bootstrap replications.Results - 74%, 85%, and 86% of patients reported having a satisfactory symptom state at 3 months, 1, and 2 years after surgery, respectively. At 3-month, 1-year, and 2-year intervals, PASS thresholds were 34 (CI 31-36), 40 (CI 36-44), and 39 (CI 35-42) points for the OHS and 59 (CI 54-64), 68 (CI 61-75), and 69 (CI 62-75) points for the FJS-12.Interpretation - PASS thresholds varied with time for both the OHS and the FJS-12, with lower 3-month compared with 1-year and 2-year thresholds. These PASS thresholds represent OHS and FJS-12 levels at which the average patient is satisfied with THA outcomes, helping to interpret PROMs and serving as clinically significant benchmarks and patient-centered outcomes for research.

The AAHKS Clinical Research Award: No Evidence for Superior Patient-Reported Outcome Scores After Total Hip Arthroplasty With the Direct Anterior Approach at 1.5 Months Postoperatively, and Through a 5-Year Follow-Up.

BACKGROUND: The direct anterior approach to total hip arthroplasty (THA) may result in superior early postoperative patient-reported outcome measures (PROMs). This study compared PROMs between THA patients treated with the direct anterior or posterolateral approach between 1.5 months and 5 years, using literature-derived patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII) thresholds. METHODS: A propensity score match of 93 direct anterior patients to 93 posterolateral patients from a multicenter US collaboration (6 centers, 398 patients) was performed. The Harris Hip Score (HHS), the Short-Form 36, and a Numerical Rating Scale for Pain were collected preoperatively, postoperatively (mean days: 47), and at 1, 3, and 5 years. The proportion of patients reaching the HHS PASS, Pain MCII, and Function MCII in the direct anterior and posterolateral groups was compared using binary logistic regressions, controlling for age, gender, body mass index, and Charnley score. RESULTS: Direct anterior patients were less likely to reach the HHS PASS at the postoperative visit (P = .015; odds ratio = 0.454), but not at later visits (P > .082). Direct anterior patients had no difference from posterolateral patients in their tendency to reach the Pain MCII postoperatively or at 1 year (P > .090). The direct anterior patients were less likely to reach the Function MCII at the postoperative visit (P = .011; odds ratio = 0.422), but not at 1 year (P = .958). CONCLUSION: No evidence was found of superior early postoperative PROM scores in THA patients treated with the direct anterior approach. No PROM differences were found at or beyond 1 year, indicating that patients reach similar final symptom states, regardless of surgical approach.

Which Preoperative Factors are Associated with Not Attaining Acceptable Levels of Pain and Function After TKA? Findings from an International Multicenter Study.

BACKGROUND: Although TKA is a common and proven reliable procedure for treating end-stage knee osteoarthritis, a minority of patients still do not achieve satisfactory levels of pain relief and functional improvement. Even though several studies have attempted to identify patients at risk of having poor clinical outcomes, few have approached this issue by considering the outcome of the patient-acceptable symptom state (PASS), defined as the value on a patient-reported outcome measure scale above which the patient deems their current symptom state acceptable. QUESTIONS/PURPOSES: (1) What is the proportion of patients who do not attain the PASS in pain and function at 1 year after TKA? (2) Which preoperative patient factors are associated with not achieving the PASS in pain at 1 year after TKA? (3) Which preoperative patient factors are associated with not achieving the PASS in function at 1 year after TKA? METHODS: This retrospective study is a secondary analysis of the 1-year follow-up data from a prospective, international, multicenter study of a single TKA system. Inclusion criteria for that study were patients diagnosed with primary osteoarthritis or post-traumatic arthritis and who were able to return for follow-up for 10 years; exclusion criteria were infection, osteomyelitis, and failure of a previous joint replacement. Between 2011 and 2014, 449 patients underwent TKA at 10 centers in five countries. At 1 year, 13% (58 of 449) were lost to follow-up, 2% could not be analyzed (eight of 449; missing 1-year KOOS), leaving 85% (383 of 449) for analysis here. The primary outcomes were not surpassing evidence-derived PASS thresholds in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Activities in Daily Living (ADL) sub-scores. Multivariate binary logistic regressions considering preoperative demographic, radiographic, and patient-reported outcome measure data were constructed using a forward stepwise elimination algorithm to reach the simplest best-fit regression models. RESULTS: At 1 year after TKA, 38% of the patients (145 of 383) did not reach the PASS in KOOS Pain, 36% (139 of 383) did not reach the PASS in KOOS ADL, and 29% (110 of 383) did not achieve the PASS in either KOOS Pain or ADL. After controlling for potentially confounding variables such as gender, age, BMI, and comorbidity scores, we found that men (odds ratio 2.09; p = 0.01), and patients with less-than-advanced radiographic osteoarthritis (OR 2.09; p = 0.01) were strongly associated with not achieving the PASS in pain. After controlling for the same potentially confounding variables, we found that patients with less-than-advanced radiographic osteoarthritis (OR 2.09; p = 0.01) were also strongly associated with not achieving the PASS in function. CONCLUSIONS: We found that patients with less severe osteoarthritis were much less likely to attain the PASS in pain and function at 1 year after TKA, and that men were much less likely to achieve the PASS in pain at 1 year after TKA. Based on these findings, surgeons should strongly consider delaying surgery in patients who present with less-than-severe osteoarthritis, with increased caution in men. Surgeons should counsel their patients on their expectations and their chances of achieving meaningful levels of pain and functional improvement. Future regional and national registry studies should assess the true proportion of patients attaining PASS in pain and function after TKA and confirm if the preoperative factors identified in this study remain significant in larger, more diverse patient populations. LEVEL OF EVIDENCE: Level III, therapeutic study.

Radiostereometric Analysis of Stability and Inducible Micromotion After Locked Lateral Plating of Distal Femur Fractures.

OBJECTIVES: To evaluate interfragmentary motion over 1 year after distal femoral fracture fixation using radiostereometric analysis (RSA). The secondary aim was to assess whether RSA data are consistent with diagnoses of nonunion. DESIGN: Prospective cohort study. SETTING: Level I urban trauma center. PATIENTS: Sixteen patients between 22 and 89 years of age with distal femoral fracture (OTA/AO type 33). INTERVENTION: All fractures were treated with a lateral locking plate, and tantalum markers were inserted into the main proximal and distal fracture fragments. RSA was performed at 2, 6, 12, 18, and 52 weeks postoperatively. Both unloaded and loaded RSA measurements were performed. MAIN OUTCOME MEASUREMENTS: Unloaded fracture migration over time and inducible micromotion at the fracture site in the coronal plane were determined at each follow-up interval. RESULTS: RSA precision in the coronal plane of interfragmentary motion over time and inducible micromotion were 1.2 and 0.9 mm in the coronal plane, respectively. Two cases required revision surgery for nonunion 1 year postoperatively. For cases of union, unloaded fracture migration stopped being detectable between 12 and 18 weeks, and inducible micromotion was no longer detectable by the 12-week visit. For cases of nonunion, both unloaded migration and inducible micromotion were detected throughout the study period. CONCLUSIONS: RSA may be used to reliably assess distal femoral fracture healing. RSA revealed differences in cases of union and nonunion by 3 months and more consistently than traditional x-rays. LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Obesity is not associated with hip failure in patients with articular surface replacement of the hip.

BACKGROUND: Our main aim was to investigate whether obese patients were at increased risk of elevated metal ion levels and/or adverse local tissue reaction (ALTR) after being treated with articular surface replacement (ASR) hip arthroplasty. METHODS: This study included 360 patients who underwent metal-on-metal (MoM) hip resurfacing (HRA) or total hip arthroplasty (THA). 95 patients (26%) were underweight/normal weight (BMI < 25 kg/m2), 139 (39%) were overweight (BMI 25-30 kg/m2), and 126 (36%) were obese (BMI ⩾ 30 kg/m2). Blood metal ion levels and patient-reported outcome measures (PROMs) were obtained, and a sub-cohort of 85 patients had MARS MRI performed. Logistic regression analyses were used to assess the associations between obesity and metal ions, as well as ALTR. RESULTS: BMI was not associated with either elevated metal ion levels or ALTR. In HRA patients, female gender (OR 3.0; p = 0.019) and pain (OR 2.3; p = 0.046) were associated with elevated Co levels. Female patients had increased risk of elevated Cr levels (OR 3.0; p = 0.02). In THA patients, female gender (OR 2.2; p = 0.004) and VAS satisfaction (OR 2.1; p = 0.01) were associated with elevated Co levels. Female gender (OR 3.6; p = 0.001) and time from surgery (OR 1.4; p = 0.005) were associated with Cr levels. In the sub-cohort, ALTR was associated with Co levels (OR 16.1; p = 0.002) in HRA patients. CONCLUSION: Patients with BMI ⩾ 30 kg/m2 present no increased risk for elevated metal ion levels or development of ALTR.

The Patient Acceptable Symptom State for the Harris Hip Score Following Total Hip Arthroplasty: Validated Thresholds at 3-Month, 1-, 3-, 5-, and 7-Year Follow-Up.

BACKGROUND: The Patient Acceptable Symptom State (PASS) represents the value on a patient-reported outcome measure scale beyond which patients consider themselves well or in a satisfactory state. The aim of this study is to define and validate the PASS threshold for the HHS at 3 months, 1, 3, 5, and 7 years after THA. METHODS: A total of 976 patients from 14 centers in 7 countries were enrolled into a prospective study. Patients completed the HHS and a numerical rating scale for satisfaction at each follow-up. PASS thresholds for the HHS were calculated at each follow-up interval using the anchor-based, 80% specificity method. A bootstrapping method was used to internally validate the primary PASS thresholds. A patient sample sourced from an institutional registry was used for external validation. RESULTS: The HHS was an excellent predictor of satisfaction at each time point (area under the curve > 0.8; P < .001). PASS thresholds for the HHS were 76 points at 3 months, 89 points at 1 year, 93 points at 3 years, 94 points at 5 years, and 93 points at 7 years. When applied to the internal and external validation cohorts, all PASS thresholds showed acceptable or excellent ability to predict satisfaction (area under the curve = 0.73-80; P < .001). CONCLUSION: The present study is the first to present validated PASS thresholds for the HHS following THA. These findings will serve as a useful reference for future THA outcome studies and as benchmarks for surgeons in their assessment of their patients' clinical success.

Changes in Patient Satisfaction Following Total Joint Arthroplasty.

BACKGROUND: The primary aim is to identify the degree to which patient satisfaction with the outcome of total hip arthroplasty (THA) or total knee arthroplasty (TKA) changes between 1 and 3 years from the procedure. The secondary aim is to identify variables associated with satisfaction. METHODS: Data were sourced from 2 prospective international, multicenter studies (919 THA and 450 TKA patients). Satisfaction was assessed by a 10-point numerical rating scale, at 1- and 3-year follow-up. Linear mixed-effects models were used to assess factors associated with satisfaction. RESULTS: For the THA cohort, higher preoperative joint space width (odds ratio [OR] = 0.28; P = .004), pain from other joints (OR = 0.26; P = .033), and lower preoperative health state (OR = -0.02; P < .001) were associated with consistently lower levels of satisfaction. The model also showed that patients with preoperative anxiety/depression improved in satisfaction between 1 and 3 years (OR = -0.26; P = .031). For the TKA cohort, anterior (vs neutral or posterior) tibial component slope (OR = 0.90; P = .008), greater femoral component valgus angle (OR = 0.05; P = .012), less severe osteoarthritis (OR = -0.10; P < .001), and lower preoperative health state (OR = -0.02; P = .003) were associated with lower levels of satisfaction across the study period. In addition, patients with anterior tibial component slope improved in satisfaction level over time (OR = -0.33; P = .022). CONCLUSION: Changes in satisfaction following THA and TKA are rare between 1- and 3-year follow-up. The findings of this study can be used to guide patient counseling preoperatively and to determine intervals of routine follow-up postoperatively.

Regional differences between the US, Scandinavia, and South Korea in patient demographics and patient-reported outcomes for primary total knee arthroplasty.

INTRODUCTION: Differences in total knee arthroplasty (TKA) patient demographics and clinical outcomes may exist between international regions, yet research is limited. The aim of this study was, therefore, to compare TKA patient demographics and patient-reported outcome measure (PROM) scores between the US, Scandinavia, and South Korea. MATERIALS AND METHODS: A total of 398 TKA patients from three regions were assessed: 169 in Scandinavia (3 centers), 129 in the US (3 centers), and 100 patients in South Korea (2 centers). Regional variation in patient demographics was assessed using Kruskal-Wallis H tests. Regional variation in PROM scores from preoperative, 1-, 3- and 5-year visits was assessed using piecewise linear mixed effect models. The PROMs analyzed were a numerical rating scale for satisfaction and the Knee Osteoarthritis Outcome Score. RESULTS: South Korean patients were the oldest (p < 0.001) and had the highest Charnley class (p < 0.001); US patients had the highest BMI (p < 0.001); Scandinavian patients had the lowest preoperative KL grade (p < 0.001). Scandinavian patients were associated with better preoperative and worse postoperative PROM scores. Scandinavian patients were also associated with moderately lower levels of satisfaction. These differences were lessened but remained significant after controlling for relevant demographic and surgical factors. CONCLUSIONS: Regional differences were found in TKA patient demographics and PROMs between the US, Scandinavia, and South Korea. The regional differences in patient demographics support the need for more research and clear guidelines related to TKA appropriateness criteria. The better preoperative and worse postoperative Scandinavian PROM scores may have been related to their less severe KL grade but might also reflect cultural differences in how patients reflect on their health state when answering PROMs. Clinicians should be aware of these international differences in PROM scores when interpreting studies conducted in different international regions. Future studies should investigate TKA variation between more international regions and assess intraregional variation. LEVEL OF EVIDENCE: Level III.