Background Opioid use before TKA or THA is linked to a higher risk of revision surgery and less functional improvement. In Western countries, the frequency of preoperative opioid use has varied,... Show moreBackground Opioid use before TKA or THA is linked to a higher risk of revision surgery and less functional improvement. In Western countries, the frequency of preoperative opioid use has varied, and robust information on temporal changes in opioid prescriptions over time (in the months before surgery as well as annual changes) and among prescribers is necessary to pinpoint opportunities to improve on low-value care patterns, and when they are recognized, to target physician populations for intervention strategies.Questions/purposes (1) What proportion of patients undergoing arthroplasties receive an opioid prescription in the year before TKA or THA, and what were the preoperative opioid prescription rates over time between 2013 and 2018? (2) Does the preoperative prescription rate vary between 12 and 10 months and between 3 and 1 months in the year before TKA or THA, and did it change between 2013 and 2018? (3) Which medical professionals were the main prescribers of preoperative opioids 1 year before TKA or THA?Methods This was a large-database study drawn from longitudinally maintained national registry sources in the Netherlands. The Dutch Foundation for Pharmaceutical Statistics was linked to the Dutch Arthroplasty Register from 2013 to 2018. TKAs and THAs performed because of osteoarthritis in patients older than 18 years, which were also uniquely linked by age, gender, patient postcode, and low–molecular weight heparin use, were eligible. Between 2013 and 2018, 146,052 TKAs were performed: 96% (139,998) of the TKAs were performed for osteoarthritis in patients older than 18 years; of them, 56% (78,282) were excluded because of our linkage criteria. Some of the linked arthroplasties could not be linked to a community pharmacy, which was necessary to follow patients over time, leaving 28% (40,989) of the initial TKAs as our study population. Between 2013 and 2018, 174,116 THAs were performed: 86% (150,574) were performed for osteoarthritis in patients older than 18 years, one arthroplasty was excluded because of an outlier opioid dose, and a further 57% (85,724 of 150,574) were excluded because of our linkage criteria. Some of the linked arthroplasties could not be linked to a community pharmacy, leaving 28% (42,689 of 150,574) of THAs, which were performed between 2013 and 2018. For both TKA and THA, the mean age before surgery was 68 years, and roughly 60% of the population were women. We calculated the proportion of patients undergoing arthroplasties who had at least one opioid prescription in the year before arthroplasty and compared data from 2013 to 2018. Opioid prescription rates are given as defined daily dosages and morphine milligram equivalents (MMEs) per arthroplasty. Opioid prescriptions were assessed by preoperative quarter and by operation year. Possible changes over time in opioid exposure were investigated using linear regression, adjusted for age and gender, in which the month of operation since January 2013 was used as the determinant and MME as the outcome. This was done for all opioids combined and per opioid type. Possible changes in opioid prescription rates in the year before arthroplasty were assessed by comparing the time period of 1 to 3 months before surgery with the other quarters. Additionally, preoperative prescriptions per operation year were assessed per prescriber category: general practitioners, orthopaedic surgeons, rheumatologists, and others. All analyses were stratified by TKA or THA.Results The proportion of patients undergoing arthroplasties who had an opioid prescription before TKA increased from 25% (1079 of 4298) in 2013 to 28% (2097 of 7460) in 2018 (difference 3% [95% CI 1.35% to 4.65%]; p < 0.001), and before THA increased from 25% (1111 to 4451) to 30% (2323 to 7625) (difference 5% [95% CI 3.8% to 7.2%]; p < 0.001). The mean preoperative opioid prescription rate increased over time between 2013 and 2018 for both TKA and THA. For TKA, an adjusted monthly increase of 3.96 MME was observed (95% CI 1.8 to 6.1 MME; p < 0.001). For THA, the monthly increase was 3.8 MME (95% CI 1.5 to 6.0; p = 0.001. For both TKA and THA, there was a monthly increase in the preoperative oxycodone rate (3.8 MME [95% CI 2.5 to 5.1]; p < 0.001 and 3.6 [95% CI 2.6 to 4.7]; p < 0.001, respectively). For TKA, but not for THA, there was a monthly decrease in tramadol prescriptions (-0.6 MME [95% CI -1.0 to -0.2]; p = 0.006). Regarding the opioids prescribed in the year before surgery, there was a mean increase of 48 MME (95% CI 39.3 to 56.7 MME; p < 0.001) for TKA between 10 and 12 months and the last 3 months before surgery. For THA, this increase was 121 MME (95% CI 110 to 131 MME; p < 0.001). Regarding possible differences between 2013 and 2018, we only found differences in the period 10 to 12 months before TKA (mean difference 61 MME [95% CI 19.2 to 103.3]; p = 0.004) and the period 7 to 9 months before TKA (mean difference 66 MME [95% CI 22.0 to 110.9]; p = 0.003). For THA, there was an increase in the MMEs prescribed between 2013 and 2018 for all four quarters, with mean differences ranging from 43.9 to 55.4 MME (p < 0.05). The average proportion of preoperative opioid prescriptions prescribed by general practitioners ranged between 82% and 86% (41,037 of 49,855 for TKA and 49,137 of 57,289 for THA), between 4% and 6% (2924 of 49,855 for TKA and 2461 of 57,289 for THA), by orthopaedic surgeons, 1% by rheumatologists (409 of 49,855 for TKA and 370 of 57,289 for THA), and between 9% and 11% by other physicians (5485 of 49,855 for TKA and 5321 of 57,289 for THA). Prescriptions by orthopaedic surgeons increased over time, from 3% to 7% for THA (difference 4% [95% CI 3.6 to 4.9]) and 4% to 10% for TKA (difference 6% [95% CI 5% to 7%]; p < 0.001).Conclusion Between 2013 and 2018, preoperative opioid prescriptions increased in the Netherlands, mainly because of a shift to more oxycodone prescriptions. We also observed an increase in opioid prescriptions in the year before surgery. Although general practitioners were the main prescribers of preoperative oxycodone, prescriptions by orthopaedic surgeons also increased during the study period. Orthopaedic surgeons should address opioid use and its associated negative effects in preoperative consultations. More intradisciplinary collaboration seems important to limit the prescribing of preoperative opioids. Additionally, research is necessary to assess whether opioid cessation before surgery reduces the risk of adverse outcomes. Show less
Background: It is well documented that routinely collected patient sociodemographic characteristics (such as race and insurance type) and geography-based social determinants of health (SDoH)... Show moreBackground: It is well documented that routinely collected patient sociodemographic characteristics (such as race and insurance type) and geography-based social determinants of health (SDoH) measures (for example, the Area Deprivation Index) are associated with health disparities, including symptom severity at presentation. However, the association of patient-level SDoH factors (such as housing status) on musculoskeletal health disparities is not as well documented. Such insight might help with the development of more-targeted interventions to help address health disparities in orthopaedic surgery. Questions/purposes: (1) What percentage of patients presenting for new patient visits in an orthopaedic surgery clinic who were unemployed but seeking work reported transportation issues that could limit their ability to attend a medical appointment or acquire medications, reported trouble paying for medications, and/or had no current housing? (2) Accounting for traditional sociodemographic factors and patient-level SDoH measures, what factors are associated with poorer patient-reported outcome physical health scores at presentation? (3) Accounting for traditional sociodemographic factor patient-level SDoH measures, what factors are associated with poorer patient-reported outcome mental health scores at presentation? Methods: New patient encounters at one Level 1 trauma center clinic visit from March 2018 to December 2020 were identified. Included patients had to meet two criteria: they had completed the Patient-Reported Outcome Measure Information System (PROMIS) Global-10 at their new orthopaedic surgery clinic encounter as part of routine clinical care, and they had visited their primary care physician and completed a series of specific SDoH questions. The SDoH questionnaire was developed in our institution to improve data that drive interventions to address health disparities as part of our accountable care organization work. Over the study period, the SDoH questionnaire was only distributed at primary care provider visits. The SDoH questions focused on transportation, housing, employment, and ability to pay for medications. Because we do not have a way to determine how many patients had both primary care provider office visits and new orthopaedic surgery clinic visits over the study period, we were unable to determine how many patients could have been included; however, 9057 patients were evaluated in this cross-sectional study. The mean age was 61 +/- 15 years, and most patients self-reported being of White race (83% [7561 of 9057]). Approximately half the patient sample had commercial insurance (46% [4167 of 9057]). To get a better sense of how this study cohort compared with the overall patient population seen at the participating center during the time in question, we reviewed all new patient clinic encounters (n = 135,223). The demographic information between the full patient sample and our study subgroup appeared similar. Using our study cohort, two multivariable linear regression models were created to determine which traditional metrics (for example, self-reported race or insurance type) and patient-specific SDoH factors (for example, lack of reliable transportation) were associated with worse physical and mental health symptoms (that is, lower PROMIS scores) at new patient encounters. The variance inflation factor was used to assess for multicollinearity. For all analyses, p values < 0.05 designated statistical significance. The concept of minimum clinically important difference (MCID) was used to assess clinical importance.Regression coefficients represent the projected change in PROMIS physical or mental health symptom scores (that is, the dependent variable in our regression analyses) accounting for the other included variables. Thus, a regression coefficient for a given variable at or above a known MCID value suggests a clinical difference between those patients with and without the presence of that given characteristic. In this manuscript, regression coefficients at or above 4.2 (or at and below -4.2) for PROMIS Global Physical Health and at or above 5.1 (or at and below -5.1) for PROMIS Global Mental Health were considered clinically relevant. Results: Among the included patients, 8% (685 of 9057) were unemployed but seeking work, 4% (399 of 9057) reported transportation issues that could limit their ability to attend a medical appointment or acquire medications, 4% (328 of 9057) reported trouble paying for medications, and 2% (181 of 9057) had no current housing. Lack of reliable transportation to attend doctor visits or pick up medications (beta = -4.52 [95% CI -5.45 to -3.59]; p < 0.001), trouble paying for medications (beta = -4.55 [95% CI -5.55 to -3.54]; p < 0.001), Medicaid insurance (beta = -5.81 [95% CI -6.41 to -5.20]; p < 0.001), and workers compensation insurance (beta = -5.99 [95% CI -7.65 to -4.34]; p < 0.001) were associated with clinically worse function at presentation. Trouble paying for medications (beta = -6.01 [95% CI -7.10 to -4.92]; p < 0.001), Medicaid insurance (beta = -5.35 [95% CI -6.00 to -4.69]; p < 0.001), and workers compensation (beta = -6.07 [95% CI -7.86 to -4.28]; p < 0.001) were associated with clinically worse mental health at presentation. Conclusion: Although transportation issues and financial hardship were found to be associated with worse presenting physical function and mental health, Medicaid and workers compensation insurance remained associated with worse presenting physical function and mental health as well even after controlling for these more detailed, patient-level SDoH factors. Because of that, interventions to decrease health disparities should focus on not only sociodemographic variables (for example, insurance type) but also tangible patient-specific SDoH characteristics. For example, this may include giving patients taxi vouchers or ride-sharing credits to attend clinic visits for patients demonstrating such a need, initiating financial assistance programs for necessary medications, and/or identifying and connecting certain patient groups with social support services early on in the care cycle. Show less
Background: The double-blind, randomized, placebo-controlled phase 3 study of orally administered PLX3397 in patients with pigmented villonodular synovitis or giant cell tumor of the tendon sheath ... Show moreBackground: The double-blind, randomized, placebo-controlled phase 3 study of orally administered PLX3397 in patients with pigmented villonodular synovitis or giant cell tumor of the tendon sheath (ENLIVEN) showed that pexidartinib provides a robust objective tumor response in adults with tenosynovial giant cell tumors (TGCT) not amenable to improvement with surgery. Based on these results, in 2019, pexidartinib received accelerated approval in the United States in this population as a breakthrough therapy under an orphan drug designation. However, the ability of pexidartinib to relieve pain in ENLIVEN was not fully detailed, and the relationship between pain relief and objective tumor response was not described. Questions/purposes: (1) What level of pain relief was achieved by pexidartinib treatment in ENLIVEN? (2) How was pain relief related to objective tumor responses? (3) How durable was pain relief? Methods: The current study included planned primary and exploratory assessments of patient-assessed worst pain at the site of the tumor in the ENLIVEN trial. ENLIVEN was a phase 3 randomized, placebo-controlled clinical trial in which adults with TGCT not amenable to improvement with surgery received pexidartinib or placebo for 24 weeks, after which eligible patients could receive open-label pexidartinib. Of 174 patients assessed for eligibility, 121 were randomized (50% [60] to placebo, 50% [61] to pexidartinib), and 120 were given either placebo or pexidartinib (59 received placebo and 61 received pexidartinib) and were included in an intent-to-treat analysis. Fifty-nine percent (71 of 120) of the overall treated population was female, and 88% (106 of 120) were White. Mean age was 45 +/- 13 years. Tumors were mostly in the lower extremities (92% [110 of 120]), most commonly in the knee (61% [73 of 120]) and ankle (18% [21 of 120]). As a secondary outcome, patients scored worst pain at the site of the tumor in the past 24 hours on an 11-point numeric rating scale (NRS). The primary definition of a pain response was a decrease of at least 30% in the weekly mean worst-pain NRS score and increase of less than 30% in narcotic analgesic use between baseline and week 25. Planned exploratory assessments of pain included the frequency of a pain response using alternative thresholds, including a decrease in worst-pain NRS score of 50% or more and a decrease of at least 2 points (minimum clinically important difference [MCID]), the magnitude of pain reduction between baseline and week 25, correlation between worst-pain NRS score and tumor shrinkage by RECIST 1.1 criteria, and the durability of the pain response during the open-label extension. Pain responses during the randomized portion of the trial were compared according to intention-to-treat analysis, with a one-sided threshold of p < 0.025 to reduce the risk of false-positive results. Pain assessment was complete for 59% (35 of 59) of patients in the placebo group and 54% (33 of 61) of patients in the pexidartinib group. Demographic and disease characteristics did not differ between the two treatment groups. Results: ®A difference in the primary assessment of a pain response was not detected between pexidartinib and placebo (response percentage 31% [19 of 61] [95% CI 21% to 44%] versus 15% [9 of 59] [95% CI 8% to 27%]; one-sided p = 0.03). In the exploratory analyses, pexidartinib provided a modest improvement in pain (response percentage 26% [16 of 61] [95% CI 17% to 38%] versus 10% [6 of 59] [95% CI 5% to 20%]; one-sided p = 0.02 using the 50% threshold and 31% [19 of 61] [95% CI 21% to 44%] versus 14% [8 of 59] [95% CI 7% to 25%]; one-sided p = 0.02 using the MCID threshold). The least-squares mean change in the weekly mean worst-pain NRS score between baseline and week 25 was larger in patients treated with pexidartinib than placebo (-2.5 [95% CI -3.0 to -1.9] versus -0.3 [95% CI -0.9 to 0.3]; p < 0.001), although the mean difference between the two groups (-2.2 [95% CI -3.0 to -1.4]) was just over the MCID. Improvement in the weekly mean worst-pain NRS score correlated with the reduction in tumor size (r = 0.44; p < 0.001) and tumor volume score (r = 0.61; p < 0.001). For patients in the open-label extension, the change in the worst-pain NRS score from baseline was similar to the change at the end of the randomized portion and just above the MCID (mean -2.7 +/- 2.2 after 25 weeks and -3.3 +/- 1.7 after 50 weeks of receiving pexidartinib). Conclusion: Based on the current study, a modest reduction in pain, just larger than the MCID, may be an added benefit of pexidartinib in these patients, although the findings are insufficient to justify the routine use of pexidartinib for pain relief. Show less
Background Shoulder injections for conditions such as adhesive capsulitis are commonly performed and can be administered through image-based or landmark-based injection approaches. Ultrasound... Show moreBackground Shoulder injections for conditions such as adhesive capsulitis are commonly performed and can be administered through image-based or landmark-based injection approaches. Ultrasound-guided injections are widely used and accurate because ultrasound allows real-time visualization of the needle and injected contrast. Landmark-based injections would be advantageous, if they were accurate, because they would save the time and expense associated with ultrasound. However, few prospective studies have compared well-described landmark-based shoulder injection techniques without ultrasound. Question/purpose Using anatomic landmarks, and without using ultrasound, is the accuracy of glenohumeral injection for adhesive capsulitis greater via the posterior approach or via a new anterior approach? Methods Between 2018 and 2020, we treated 108 patients potentially eligible for adhesive capsulitis treatment. These patients had clinical symptoms of aggravating shoulder pain with a duration of less than 4 months and passively impaired, painful glenohumeral ROM. Due to the exclusion of patients with other shoulder conditions (full-thickness rotator cuff ruptures and posttraumatic stiffness), 95 patients received an injection in this sequential, prospective, comparative study. Between 2018 and 2019, 41 patients (17 males and 24 females; mean age 52 +/- 5 years; mean BMI 24 +/- 3 kg/m(2)) were injected through the posterior approach, with the acromion as the anatomical landmark, during the first part of the study period. After that, between 2019 and 2020, 54 patients (20 males and 34 females; mean age 54 +/- 4 years; mean BMI 23 +/- 3 kg/m(2)) received an injection through a new anterior approach, with the acromioclavicular joint as the anatomic landmark, during the second part of the study period. Injections via both approaches were administered by two experienced shoulder specialists (both with more than 10 years of experience). Both specialists had experience with the posterior approach before this study, and neither had previous training with the new anterior approach. Injections contained a corticosteroid, local anaesthetic, and contrast medium. Radiographs were taken within 20 minutes after the injection, and a radiologist blinded to the technique determined accuracy. Accurate injections were defined as having contrast fluid limited to the glenohumeral joint, while inaccurate injections displayed leakage of contrast fluid into the soft tissue or subacromial space. All of the enrolled patients were analyzed. Results In the group with the posterior approach, the accuracy was 78% (32 of 41) in contrast to 94% (51 of 54, odds ratio 0.21 [95% CI 0.05 to 0.83]; p = 0.03) in patients with the new anterior approach. Conclusion The new anterior approach without the use of ultrasound was more accurate than the posterior approach. In fact, it was nearly as accurate as previously published ultrasound-guided approaches. We recommend using the new anterior approach for intraarticular glenohumeral injections instead of ultrasound-guided injections because it will save time and costs associated with ultrasound. Still, the clinical effects (anxiety, pain, functional outcome, and adverse events) of the new anterior approach should be compared with ultrasound-guided injections in a randomized study. Show less
Background The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure... Show moreBackground The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure that incentivizes improved value for patients. There is concern that such a payment mechanism may lead to patient screening and denying or providing orthopaedic care to patients based on the number and severity of comorbid conditions present associated with complications after surgery. Currently, however, there is no clear consensus about whether such an association exists. Questions/purposes In this systematic review, we asked: (1) Is the implementation of a bundled payment model associated with a change in the sociodemographic characteristics of patients undergoing an orthopaedic procedure? (2) Is the implementation of a bundled payment model associated with a change in the comorbidities and/or case-complexity characteristics of patients undergoing an orthopaedic procedure? (3) Is the implementation of a bundled payment model associated with a change in the recent use of healthcare resources characteristics of patients undergoing an orthopaedic procedure? Methods This systematic review was registered in PROSPERO before data collection (CRD42020189416). Our systematic review included scientific manuscripts published in MEDLINE, Embase, Web of Science, Econlit, Policyfile, and Google Scholar through March 2020. Of the 30 studies undergoing full-text review, 20 were excluded because they did not evaluate the outcome of interest (patient selection) (n = 8); were editorial, commentary, or review articles (n = 5); did not evaluate the appropriate intervention (introduction of a bundled payment program) (n = 4); or assessed the wrong patient population (not orthopaedic surgery patients) (n = 3). This led to 10 studies included in this systematic review. For each study, patient factors analyzed in the included studies were grouped into the following three categories: sociodemographics, comorbidities and/or case complexity, or recent use of healthcare resources characteristics. Next, each patient factor falling into one of these three categories was examined to evaluate for changes from before to after implementation of a bundled payment initiative. In most cases, studies utilized a difference-in-difference (DID) statistical technique to assess for changes. Determination of whether the bundled payment initiative required mandatory participation or not was also noted. Scientific quality using the Adapted Newcastle-Ottawa Scale had a median (range) score of 8 (7 to 8; highest possible score: 9), and the quality of the total body of evidence for each patient characteristic group was found to be low using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. We could not assess the likelihood of publication using funnel plots because of the variation of patient factors analyzed in each study and the heterogeneity of data precluded a meta-analysis. Results Of the nine included studies that reported on the sociodemographic characteristics of patients selected for care, seven showed no change with the implementation of bundled payments, and two demonstrated a difference. Most notably, the studies identified a decrease in the percentage of patients undergoing an orthopaedic operative intervention who were dual-eligible (range DID estimate -0.4% [95% CI -0.75% to -0.1%]; p < 0.05 to DID estimate -1.0% [95% CI -1.7% to -0.2%]; p = 0.01), which means they qualified for both Medicare and Medicaid insurance coverage.Of the 10 included studies that reported on comorbidities and case-complexity characteristics, six reported no change in such characteristics with the implementation of bundled payments, and four studies noted differences. Most notably, one study showed a decrease in the number of treated patients with disabilities (DID estimate -0.6% [95% CI -0.97% to -0.18%]; p < 0.05) compared with before bundled payment implementation, while another demonstrated a lower number of Elixhauser comorbidities for those treated as part of a bundled payment program (before: score of 0-1 in 63.6%, 2-3 in 27.9%, > 3 in 8.5% versus after: score of 0-1 in 50.1%, 2-3 in 38.7%, > 3 in 11.2%; p = 0.033). Of the three included studies that reported on the recent use of healthcare resources of patients, one study found no difference in the use of healthcare resources with the implementation of bundled payments, and two studies did find differences. Both studies found a decrease in patients undergoing operative management who recently received care at a skilled nursing facility (range DID estimate -0.50% [95% CI -1.0% to 0.0%]; p = 0.04 to DID estimate: -0.53% [95% CI -0.96% to -0.10%]; p = 0.01), while one of the studies also found a decrease in patients undergoing operative management who recently received care at an acute care hospital (DID estimate -0.8% [95% CI -1.6% to -0.1%]; p = 0.03) or as part of home healthcare (DID estimate -1.3% [95% CI -2.0% to -0.6%]; p < 0.001). Conclusion In six of 10 studies in which differences in patient characteristics were detected among those undergoing operative orthopaedic intervention once a bundled payment program was initiated, the effect was found to be minimal (approximately 1% or less). However, our findings still suggest some level of adverse patient selection, potentially worsening health inequities when considered on a large scale. It is also possible that our findings reflect better care, whereby the financial incentives lead to fewer patients with a high risk of complications undergoing surgical intervention and vice versa for patients with a low risk of complications postoperatively. However, this is a fine line, and it may also be that patients with a high risk of complications postoperatively are not being offered surgery enough, while patients at low risk of complications postoperatively are being offered surgery too frequently. Evaluation of the longer-term effect of these preliminary bundled payment programs on patient selection is warranted to determine whether adverse patient selection changes over time as health systems and orthopaedic surgeons become accustomed to such reimbursement models. Show less
Bongers, M.E.R.; Karhade, A.V.; Setola, E.; Gambarotti, M.; Groot, O.Q.; Erdogan, K.E.; ... ; Palmerini, E. 2020
Background The Skeletal Oncology Research Group (SORG) machine learning algorithm for predicting survival in patients with chondrosarcoma was developed using data from the Surveillance,... Show moreBackground The Skeletal Oncology Research Group (SORG) machine learning algorithm for predicting survival in patients with chondrosarcoma was developed using data from the Surveillance, Epidemiology, and End Results (SEER) registry. This algorithm was externally validated on a dataset of patients from the United States in an earlier study, where it demonstrated generally good performance but overestimated 5-year survival. In addition, this algorithm has not yet been validated in patients outside the United States; doing so would be important because external validation is necessary as algorithm performance may be misleading when applied in different populations. Questions/purposes Does the SORG algorithm retain validity in patients who underwent surgery for primary chondrosarcoma outside the United States, specifically in Italy? Methods A total of 737 patients were treated for chondrosarcoma between January 2000 and October 2014 at the Italian tertiary care center which was used for international validation. We excluded patients whose first surgical procedure was performed elsewhere (n = 25), patients who underwent nonsurgical treatment (n = 27), patients with a chondrosarcoma of the soft tissue or skull (n = 60), and patients with peripheral, periosteal, or mesenchymal chondrosarcoma (n = 161). Thus, 464 patients were ultimately included in this external validation study, as the earlier performed SEER study was used as the training set. Therefore, this study-unlike most of this type-does not have a training and validation set. Although the earlier study overestimated 5-year survival, we did not modify the algorithm in this report, as this is the first international validation and the prior performance in the single-institution validation study from the United States may have been driven by a small sample or non-generalizable patterns related to its single-center setting. Variables needed for the SORG algorithm were manually collected from electronic medical records. These included sex, age, histologic subtype, tumor grade, tumor size, tumor extension, and tumor location. By inputting these variables into the algorithm, we calculated the predicted probabilities of survival for each patient. The performance of the SORG algorithm was assessed in this study through discrimination (the ability of a model to distinguish between a binary outcome), calibration (the agreement of observed and predicted outcomes), overall performance (the accuracy of predictions), and decision curve analysis (establishment on the ability of a model to make a decision better than without using the model). For discrimination, the c-statistic (commonly known as the area under the receiver operating characteristic curve for binary classification) was calculated; this ranged from 0.5 (no better than chance) to 1.0 (excellent discrimination). The agreement between predicted and observed outcomes was visualized with a calibration plot, and the calibration slope and intercept were calculated. Perfect calibration results in a slope of 1 and an intercept of 0. For overall performance, the Brier score and the null-model Brier score were calculated. The Brier score ranges from 0 (perfect prediction) to 1 (poorest prediction). Appropriate interpretation of the Brier score requires comparison with the null-model Brier score. The null-model Brier score is the score for an algorithm that predicts a probability equal to the population prevalence of the outcome for every patient.A decision curve analysis was performed to compare the potential net benefit of the algorithm versus other means of decision support, such as treating all or none of the patients. There were several differences between this study and the earlier SEER study, and such differences are important because they help us to determine the performance of the algorithm in a group different from the initial study population. In this study from Italy, 5-year survival was different from the earlier SEER study (71% [319 of 450 patients] versus 76% [1131 of 1487 patients]; p = 0.03). There were more patients with dedifferentiated chondrosarcoma than in the earlier SEER study (25% [118 of 464 patients] versus 8.5% [131 of 1544 patients]; p < 0.001). In addition, in this study patients were older, tumor size was larger, and there were higher proportions of high-grade tumors than the earlier SEER study (age: 56 years [interquartile range {IQR} 42 to 67] versus 52 years [IQR 40 to 64]; p = 0.007; tumor size: 80 mm [IQR 50 to 120] versus 70 mm [IQR 42 to 105]; p < 0.001; tumor grade: 22% [104 of 464 had Grade 1], 42% [196 of 464 had Grade 2], and 35% [164 of 464 had Grade 3] versus 41% [592 of 1456 had Grade 1], 40% [588 of 1456 had Grade 2], and 19% [276 of 1456 had Grade 3]; p <= 0.001). Results Validation of the SORG algorithm in a primarily Italian population achieved a c-statistic of 0.86 (95% confidence interval 0.82 to 0.89), suggesting good-to-excellent discrimination. The calibration plot showed good agreement between the predicted probability and observed survival in the probability thresholds of 0.8 to 1.0. With predicted survival probabilities lower than 0.8, however, the SORG algorithm underestimated the observed proportion of patients with 5-year survival, reflected in the overall calibration intercept of 0.82 (95% CI 0.67 to 0.98) and calibration slope of 0.68 (95% CI 0.42 to 0.95). The Brier score for 5-year survival was 0.15, compared with a null-model Brier of 0.21. The algorithm showed a favorable decision curve analysis in the validation cohort. Conclusions The SORG algorithm to predict 5-year survival for patients with chondrosarcoma held good discriminative ability and overall performance on international external validation; however, it underestimated 5-year survival for patients with predicted probabilities from 0 to 0.8 because the calibration plot was not perfectly aligned for the observed outcomes, which resulted in a maximum underestimation of 20%. The differences may reflect the baseline differences noted between the two study populations. The overall performance of the algorithm supports the utility of the algorithm and validation presented here. The freely available digital application for the algorithm is available here: https://sorg-apps. shinyapps.io/extremitymetssurvival/. Show less
Background Anterior knee pain, which has a prevalence of 4% to 49% after TKA, may be a cause of patient dissatisfaction after TKA. To limit the occurrence of anterior knee pain, patellar... Show moreBackground Anterior knee pain, which has a prevalence of 4% to 49% after TKA, may be a cause of patient dissatisfaction after TKA. To limit the occurrence of anterior knee pain, patellar denervation with electrocautery has been proposed. However, studies have disagreed as to the efficacy of this procedure. Questions/purposes We evaluated patients undergoing bilateral, simultaneous TKA procedures without patellar resurfacing to ask: (1) Does circumferential patellar cauterization decrease anterior knee pain (Kujala score) postoperatively compared with non-cauterization of the patella? (2) Does circumferential patellar cauterization result in better functional outcomes based on patient report (VAS score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score) than non-cauterization of the patella? (3) Is there any difference in the complication rate (infection, patellar maltracking, fracture, venous thromboembolism, or reoperation rate) between cauterized patellae and non-cauterized patellae? Methods Seventy-eight patients (156 knees) were included in this prospective, quasi-randomized study, with each patient serving as his or her own control. Patellar cauterization was always performed on the right knee during simultaneous, bilateral TKA. Five patients (6%) were lost to follow-up before the 2-year minimum follow-up interval. A single surgeon performed all TKAs using the same type of implant, and osteophyte excision was performed in all patellae, which were left unresurfaced. Patellar cauterization was performed at 2 mm to 3 mm deep and approximately 5 mm circumferentially away from the patellar rim. The preoperative femorotibial angle and degree of osteoarthritis (according to the Kellgren-Lawrence grading system) were measured. Restoration of the patellofemoral joint was assessed using the anterior condylar ratio. Clinical outcomes, consisting of clinician-reported outcomes (ROM and Kujala score) and patient-reported outcomes (VAS pain score, Oxford knee score, and Knee Injury and Osteoarthritis Outcome Score), were evaluated preoperatively and at 1 month and 2 years postoperatively. Preoperatively, the radiologic severity of osteoarthritis, based on the Kellgren-Lawrence classification, was not different between the two groups, nor were the baseline pain and knee scores. The mean femorotibial angle of the two groups was also comparable: 189 degrees +/- 4.9 degrees and 191 degrees +/- 6.3 degrees preoperatively (p = 0.051) and 177 degrees +/- 2.9 degrees and 178 degrees +/- 2.1 degrees postoperatively (p = 0.751) for cauterized and non-cauterized knees, respectively. The preoperative (0.3 +/- 0.06 versus 0.3 +/- 0.07; p = 0.744) and postoperative (0.3 +/- 0.06 versus 0.2 +/- 0.07; p = 0.192) anterior condylar ratios were also not different between the cauterized and non-cauterized groups. Results At the 2-year follow-up interval, no difference was observed in the mean Kujala score (82 +/- 2.9 and 83 +/- 2.6 for cauterized and non-cauterized knees, respectively; mean difference 0.3; 95% confidence interval, -0.599 to 1.202; p = 0.509). The mean VAS pain score was 3 +/- 0.9 in the cauterized knee and 3 +/- 0.7 in the non-cauterized knee (p = 0.920). The mean ROM was 123 degrees +/- 10.8 degrees in the cauterized knee and 123 degrees +/- 10.2 degrees in the non-cauterized knee (p = 0.783). There was no difference between cauterized and non-cauterized patellae in the mean Knee Injury and Osteoarthritis Outcome Score for symptoms (86 +/- 4.5 versus 86 +/- 3.9; p = 0.884), pain (86 +/- 3.8 versus 86 +/- 3.6; p = 0.905), activities (83 +/- 3.2 versus 83 +/- 2.8; p = 0.967), sports (42 +/- 11.3 versus 43 +/- 11.4; p = 0.942), and quality of life (83 +/- 4.9 versus 83 +/- 4.7; p = 0.916), as well as in the Oxford knee score (40 +/- 2.1 versus 41 +/- 1.9; p = 0.771). Complications were uncommon and there were no differences between the groups (one deep venous thromboembolism in the cauterized group and two in the control group; odds ratio 0.49, 95% CI, 0.04-5.56; p = 0.57). Conclusions Patellar cauterization results in no difference in anterior knee pain, functional outcomes, and complication rates compared with non-cauterization of the patella in patients who undergo non-resurfaced, simultaneous, bilateral, primary TKA with a minimum of 2 years of follow-up. We do not recommend circumferential patellar cauterization in non-resurfaced patellae in patients who undergo TKA. Show less
Background Most patients have high expectations about restoration of the knee function after TKA, expecting a more active life after retirement. However, 20% to 30% of patients report that their... Show moreBackground Most patients have high expectations about restoration of the knee function after TKA, expecting a more active life after retirement. However, 20% to 30% of patients report that their expectations are not met postoperatively. Among those unmet expectations may be the anticipation to engage in sexual activity after surgery, but few studies have evaluated sexual activity after arthroplasty. Questions/purposes In this study, our purposes were (1) to evaluate the anticipation and the fulfillment of sexual activity after TKA in men and women, and (2) to identify prognostic factors for the fulfillment of anticipated postoperative sexual activity. Methods This was a prospective, multicenter study of all 1371 patients scheduled for TKA between June 2012 and July 2015. The study was part of the Longitudinal Leiden Orthopaedics Outcomes of Osteoarthritis Study (LOAS). After screening according to LOAS inclusion criteria, 1213 respondents remained. Our primary study endpoint was whether sexual expectations were met 1 year after TKA; we used the sexual-activity-expectation question from the Hospital for Special Surgery (HSS) Knee Replacement Expectations Survey, which allows the patient to score the result on a 5-point scale. To assess postoperative fulfillment of sexual activity 1 year after TKA, we asked the patient to score the current status of sexual activity on the same 5-point scale: 1 (back to normal), 2 (large improvement), 3 (moderate improvement), 4 (slight improvement), and 5 (does not apply). Patients with incomplete data on the preoperative expectation- and postoperative fulfillment-question of sexual activity were excluded, leaving 71% (866 of 1213) patients for analysis. The difference between the pre- and postoperative scores determined whether expectations of sexual activity were unfulfilled (lower than expected) or fulfilled/exceeded (neutral or higher than expected). Pre- and postoperatively, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Short Form-12 Mental and Physical Component Summary scores (SF-12 MCS and SF-12 PCS), the EuroQoL-5 Dimensions (EQ-5D), and the EQ-5D VAS scale were used. Multivariate regression models were used for analysis. Results Preoperatively, 54% patients (467 of 866) anticipated postoperative sexual activity after recovery from surgery. Both genders showed that the proportion who anticipated "back to normal" sexual activity decreased with higher age. Likewise, postoperative fulfillment of anticipated sexual activity was found in 58% (111 of 191 for men; 159 of 276 for women). Younger women (younger than 65 years of age) experienced fulfillment more often compared with younger men. A positive postoperative change in functional and health status was associated with fulfilled/exceeded scores of patients anticipating postoperative sexual activity. A better preoperative health status, the EQ-5D VAS score (odds ratio [OR] 1.02 [95% CI 1.01 to 1.03]; p = 0.006), was associated with a higher likelihood of fulfillment of anticipated postoperative sexual activity. Conclusion In both men and women, two of five patients who anticipated postoperative sexual activity indicated that their expectation of sexual activity was not met 1 year after TKA. These patients had worse functional recovery scores compared with patients who achieved the anticipated level of sexual activity. The latter is associated with functional recovery.Surgeons should be aware that many patients anticipate restoration of normal sexual activity, and that this may be the expectation for patients of all ages and for women and men alike.The results underscore the need for more qualitative research to understand this topic in greater depth. Show less
Background Patellofemoral arthroplasty (PFA) is one option for the treatment of isolated patellofemoral osteoarthritis, but there are limited data regarding the procedure and results. Because... Show moreBackground Patellofemoral arthroplasty (PFA) is one option for the treatment of isolated patellofemoral osteoarthritis, but there are limited data regarding the procedure and results. Because isolated patellofemoral arthritis is relatively uncommon, available case series generally are small, and even within national registries, sample sizes are limited. Combining data from multiple registries may aid in assessing worldwide PFA usage and survivorship. Questions/purposes We combined and compared data from multiple large arthroplasty registries worldwide to ask: (1) What proportion of patients undergoing primary knee arthroplasty have PFA? (2) What are the patient and prosthesis characteristics associated with PFA in common practice, as reflected in registries? (3) What is the survivorship free from revision of PFA and what are the reasons for and types of revisions? Methods Data were provided by eight registries that are members of the International Society of Arthroplasty Registries (ISAR) who agreed to share aggregate data: Australia, New Zealand, Canada, Sweden, Finland, Norway, the Netherlands, and the United States. De-identified data were obtained for PFA performed from either the beginning of year 2000, or the earliest recorded implantation date after that in each individual registry when PFA data collection commenced, up to December 31, 2016. This included patient demographics, implant use, all-cause revision rate (determined by cumulative percent revision [CPR]), and reasons for and type of revision. Results During the data collection period, 6784 PFAs were performed in the eight countries. PFAs comprised less than 1% of primary knee replacements in all registries. Patient demographics were comparable in all countries. Patients were generally more likely to be women than men, and the mean age ranged from 50 years to 60 years. All registries showed a high rate of revision for PFA. The 5-year CPR for any reason ranged from 8.0% (95% CI 4.5 to 11.5) in Norway to 18.1% (95% CI 15.5 to 20.7) in the Netherlands. The most common reason for revision across all countries was disease progression (42%, 434 of 1034). Most PFAs (83%, 810 of 980) were revised to a TKA. Conclusions The revision risk of PFA in all registries surveyed was more than three times higher than the reported revision risk of TKA at the same times. The survivorship of PFA is similar to that of the no-longer-used procedure of metal-on-metal conventional hip replacement. Although there may be potential functional benefits from PFA, these findings of consistent and alarmingly high rates of revision should create concern, particularly as this procedure is often used in younger patients. Show less
Background The number of revisions after TKA is expected to rise because of aging populations in many countries and because patients are undergoing TKA at younger ages. Aseptic loosening is a major... Show moreBackground The number of revisions after TKA is expected to rise because of aging populations in many countries and because patients are undergoing TKA at younger ages. Aseptic loosening is a major reason for late revision, which can be predicted by radiostereometric analysis (RSA) of small groups of patients at 2 years of follow-up. RSA is therefore an ideal tool to assess new TKA designs before they are introduced to the market, although not every TKA design has been studied with RSA. If RSA-tested TKA designs have lower 10-year revision rates in national registries than non-RSA-tested TKA designs, RSA testing of all new designs could be advocated. Questions/purposes In this study, we asked: Is there a difference in the all-cause revision rate between non-RSA-tested and RSA-tested TKA designs registered in national knee arthroplasty registries at 5 and 10 years of follow-up? Methods Knee arthroplasty registries were identified through the European Federation of National Associations of Orthopaedics and Traumatology webpage and through a manual internet search. Inclusion criteria were a minimum follow-up duration of 10 years and available revision or survival data per TKA design. Twenty-six registries were identified; seven were included comprising 339 TKA designs, of which 236 designs were classified as RSA-tested and 103 as non-RSA-tested. Six registries were excluded because no report was published. One registry was excluded because no fixation method was mentioned (79 TKA designs). Another registry was excluded because there was no 10-year data available (22 non-RSA-tested designs; 10 RSA-tested designs). Eleven registries were excluded because they did not provide revision rates per design and had not reached 10 years follow-up. The revision rates with their standard errors were extracted per design. We used the data from a recent meta-analysis to identify whether a TKA design was previously tested with RSA. This meta-analysis found 53 RSA studies comprising 70 different TKA designs. The prosthesis model, fixation method and insert type were extracted from these RSA-studies. The design characteristics of the TKA reported in the knee arthroplasty registries were also extracted, and if possible, matched to the TKA designs reported in the RSA-studies. At 5 years of follow-up, 191 TKA designs were identified as non-RSA-tested and 92 were identified as RSA-tested. At 10 years of follow-up, 154 TKA designs and 74 TKA designs were classified as non-RSA-tested and RSA-tested, respectively. A random-effects model using the Metafor Package in R statistics was used to estimate the pooled revision rate at 5 and 10 years of follow-up for both groups. The difference in revision rates between groups at 5 and 10 years of follow-up was estimated by including RSA as a factor in the random-effects model. Results Mean all-cause revision rates at 5 years for non-RSA-tested and RSA-tested implants were 3.6% (95% CI 3.4 to 3.8) and 2.9% (95% CI 2.7 to 3.0), with a mean difference of 0.6% favoring RSA-tested implants (95% CI 0.4 to 0.8; p < 0.001). Mean all-cause revision rates at 10 years for non-RSA-tested and RSA-tested implants were 5.5% (95% CI 5.2 to 5.9) and 4.4% (95% CI 4.1 to 4.7), with a mean difference of 0.9% favoring RSA-tested implants (95% CI 0.4 to 1.3; p < 0.001). Conclusions Although there are exceptions, across registries, TKA designs that have been tested in an RSA setting have a slightly lower (about 1%) mean all-cause revision rate at 5-year and 10-year follow-up than those tested in a non-RSA setting.Acknowledging the inherent limitations of this observational study, a risk difference of 1% could potentially translate into an approximate 20% decrease in revision burden up to 10 years, which may have a profound impact on patient morbidity and health-related costs. Show less
BackgroundLocal treatment of pelvic Ewing's sarcoma may be challenging, and intergroup studies have focused on improving systemic treatments rather than prospectively evaluating aspects of local... Show moreBackgroundLocal treatment of pelvic Ewing's sarcoma may be challenging, and intergroup studies have focused on improving systemic treatments rather than prospectively evaluating aspects of local tumor control. The Euro-EWING99 trial provided a substantial number of patients with localized pelvic tumors treated with the same chemotherapy protocol. Because local control included surgical resection, radiation therapy, or a combination of both, we wanted to investigate local control and survival with respect to the local modality in this study cohort.Questions/purposes(1) Do patients with localized sacral tumors have a lower risk of local recurrence and higher survival compared with patients with localized tumors of the innominate bones? (2) Is the local treatment modality associated with local control and survival in patients with sacral and nonsacral tumors? (3) Which local tumor- and treatment-related factors, such as response to neoadjuvant chemotherapy, institution where the biopsy was performed, and surgical complications, are associated with local recurrence and patient survival in nonsacral tumors? (4) Which factors, such as persistent extraosseous tumor growth after chemotherapy or extent of bony resection, are independently associated with overall survival in patients with bone tumors undergoing surgical treatment?MethodsBetween 1998 and 2009, 1411 patients with previously untreated, histologically confirmed Ewing's sarcoma were registered in the German Society for Pediatric Oncology and Hematology Ewing's sarcoma database and treated in the Euro-EWING99 trial. In all, 24% (339 of 1411) of these patients presented with a pelvic primary sarcoma, 47% (159 of 339) of which had macroscopic metastases at diagnosis and were excluded from this analysis. The data from the remaining 180 patients were reviewed retrospectively, based on follow-up data as of July 2016. The median (range) follow-up was 54 months (5 to 191) for all patients and 84 months (11 to 191) for surviving patients. The study endpoints were overall survival, local recurrence and event-free survival probability, which were calculated with the Kaplan-Meier method and compared using the log-rank test. Hazard ratios (HRs) with their respective 95% CIs were estimated in a multivariate Cox regression model.ResultsSacral tumors were associated with a reduced probability of local recurrence (12% [95% CI 1 to 22] versus 28% [95% CI 20 to 36] at 5 years, p = 0.032), a higher event-free survival probability (66% [95% CI 51 to 81] versus 50% [95% CI 41 to 58] at 5 years, p = 0.026) and a higher overall survival probability (72% [95% CI 57 to 87] versus 56% [95% CI 47 to 64] at 5 years, p = 0.025) compared with nonsacral tumors. With the numbers available, we found no differences between patients with sacral tumors who underwent definitive radiotherapy and those who underwent combined surgery and radiotherapy in terms of local recurrence (17% [95% CI 0 to 34] versus 0% [95% CI 0 to 20] at 5 years, p = 0.125) and overall survival probability (73% [95% CI 52 to 94] versus 78% [95% CI 56 to 99] at 5 years, p = 0.764). In nonsacral tumors, combined local treatment was associated with a lower local recurrence probability (14% [95% CI 5 to 23] versus 33% [95% CI 19 to 47] at 5 years, p = 0.015) and a higher overall survival probability (72% [95% CI 61 to 83] versus 47% [95% CI 33 to 62] at 5 years, p = 0.024) compared with surgery alone.Even in a subgroup of patients with wide surgical margins and a good histologic response to induction treatment, the combined local treatment was associated with a higher overall survival probability (87% [95% CI 74 to 100] versus 51% [95% CI 33 to 69] at 5 years, p = 0.009), compared with surgery alone.A poor histologic response to induction chemotherapy in nonsacral tumors (39% [95% CI 19 to 59] versus 64% [95% CI 52 to 76] at 5 years, p = 0.014) and the development of surgical complications after tumor resection (35% [95% CI 11 to 59] versus 68% [95% CI 58 to 78] at 5 years, p = 0.004) were associated with a lower overall survival probability in nonsacral tumors, while a tumor biopsy performed at the same institution where the tumor resection was performed was associated with lower local recurrence probability (14% [95% CI 4 to 24] versus 32% [95% CI 16 to 48] at 5 years, p = 0.035), respectively.In patients with bone tumors who underwent surgical treatment, we found that after controlling for tumor localization in the pelvis, tumor volume, and surgical margin status, patients who did not undergo complete (defined as a Type I/II resection for iliac bone tumors, a Type II/III resection for pubic bone and ischium tumors and a Type I/II/III resection for tumors involving the acetabulum, according to the Enneking classification) removal of the affected bone (HR 5.04 [95% CI 2.07 to 12.24]; p < 0.001), patients with a poor histologic response to induction chemotherapy (HR 3.72 [95% CI 1.51 to 9.21]; p = 0.004), and patients who did not receive additional radiotherapy (HR 4.34 [95% CI 1.71 to 11.05]; p = 0.002) had a higher risk of death. The analysis suggested that the same might be the case in patients with a persistent extraosseous tumor extension after induction chemotherapy (HR 4.61 [95% CI 1.03 to 20.67]; p = 0.046), although the wide CIs pointing at a possible sparse-data bias precluded any definitive conclusions.ConclusionPatients with sacral Ewing's sarcoma appear to have a lower probability for local recurrence and a higher overall survival probability compared with patients with tumors of the innominate bones. Our results seem to support a recent recommendation of the Scandinavian Sarcoma Group to locally treat most sacral Ewing's sarcomas with definitive radiotherapy. Combined surgical resection and radiotherapy appear to be associated with a higher overall survival probability in nonsacral tumors compared with surgery alone, even in patients with a wide resection and a good histologic response to neoadjuvant chemotherapy. Complete removal of the involved bone, as defined above, in patients with nonsacral tumors may be associated with a decreased likelihood of local recurrence and improved overall survival. Persistent extraosseous tumor growth after induction treatment in patients with nonsacral bone tumors undergoing surgical treatment might be an important indicator of poorer overall survival probability, but the possibility of sparse-data bias in our cohort means that this factor should first be validated in future studies.Level of EvidenceLevel III, therapeutic study. Show less
BackgroundA preoperative estimation of survival is critical for deciding on the operative management of metastatic bone disease of the extremities. Several tools have been developed for this... Show moreBackgroundA preoperative estimation of survival is critical for deciding on the operative management of metastatic bone disease of the extremities. Several tools have been developed for this purpose, but there is room for improvement. Machine learning is an increasingly popular and flexible method of prediction model building based on a data set. It raises some skepticism, however, because of the complex structure of these models.Questions/purposesThe purposes of this study were (1) to develop machine learning algorithms for 90-day and 1-year survival in patients who received surgical treatment for a bone metastasis of the extremity, and (2) to use these algorithms to identify those clinical factors (demographic, treatment related, or surgical) that are most closely associated with survival after surgery in these patients.MethodsAll 1090 patients who underwent surgical treatment for a long-bone metastasis at two institutions between 1999 and 2017 were included in this retrospective study. The median age of the patients in the cohort was 63 years (interquartile range [IQR] 54 to 72 years), 56% of patients (610 of 1090) were female, and the median BMI was 27 kg/m(2) (IQR 23 to 30 kg/m(2)). The most affected location was the femur (70%), followed by the humerus (22%). The most common primary tumors were breast (24%) and lung (23%). Intramedullary nailing was the most commonly performed type of surgery (58%), followed by endoprosthetic reconstruction (22%), and plate screw fixation (14%). Missing data were imputed using the missForest methods. Features were selected by random forest algorithms, and five different models were developed on the training set (80% of the data): stochastic gradient boosting, random forest, support vector machine, neural network, and penalized logistic regression. These models were chosen as a result of their classification capability in binary datasets. Model performance was assessed on both the training set and the validation set (20% of the data) by discrimination, calibration, and overall performance.ResultsWe found no differences among the five models for discrimination, with an area under the curve ranging from 0.86 to 0.87. All models were well calibrated, with intercepts ranging from -0.03 to 0.08 and slopes ranging from 1.03 to 1.12. Brier scores ranged from 0.13 to 0.14. The stochastic gradient boosting model was chosen to be deployed as freely available web-based application and explanations on both a global and an individual level were provided. For 90-day survival, the three most important factors associated with poorer survivorship were lower albumin level, higher neutrophil-to-lymphocyte ratio, and rapid growth primary tumor. For 1-year survival, the three most important factors associated with poorer survivorship were lower albumin level, rapid growth primary tumor, and lower hemoglobin level.ConclusionsAlthough the final models must be externally validated, the algorithms showed good performance on internal validation. The final models have been incorporated into a freely accessible web application that can be found at https://sorg-apps.shinyapps.io/extremitymetssurvival/. Pending external validation, clinicians may use this tool to predict survival for their individual patients to help in shared treatment decision making.Level of EvidenceLevel III, therapeutic study. Show less
Background Obstetric brachial plexus injuries result from traction injuries during delivery, and 30% of these children have persisting functional limitations related to an external rotation deficit... Show moreBackground Obstetric brachial plexus injuries result from traction injuries during delivery, and 30% of these children have persisting functional limitations related to an external rotation deficit of the shoulder. Little is known about the long-term effect of soft-tissue procedures of the shoulder in patients with obstetric brachial plexus injuries. Questions/purposes (1) After soft-tissue release for patients with passive external rotation less than 20 degrees and age younger than 2 years and for patients older than 2 years with good external rotation strength, what are the improvements in passive external rotation and abduction arcs at 1 and 5 years? (2) For patients who underwent staged tendon transfer after soft-tissue release, what are the improvements in active external rotation and abduction arcs at 1 and 5 years? (3) For patients with passive external rotation less than 20 degrees and no active external rotation, what are the improvements in active external rotation and abduction arcs at 1 and 5 years? Methods This was a retrospective analysis of a longitudinally maintained institutional database. Between 1996 and 2009, 149 children underwent a soft-tissue procedure of the shoulder for an internal rotation contracture. The inclusion criteria were treatment with an internal contracture release and/or tendon transfer, a maximum age of 18 years at the time of surgery, and a minimum follow-up period of 2 years. Six patients were older than 18 years at the time of surgery and 31 children were seen at our clinic until 1 year postoperatively, but because they had good clinical results and lived far away from our center, these children were discharged to physical therapists in their hometown for annual follow-up. Thus, 112 children (59 boys) were available for analysis. Patients with passive external rotation less than 20 degrees and age younger than 2 years and patients older than 2 years with good external rotation strength received soft-tissue release only (n = 37). Of these patients, 17 children did not have adequate active external rotation, and second-stage tendon transfer surgery was performed. For patients with passive external rotation less than 20 degrees with no active external rotation, single-stage contracture release with tendon transfer was performed (n = 68). When no contracture was present (greater than 20 degrees of external rotation) but the patient had an active deficit (n = 7), tendon transfer alone was performed; this group was not analyzed. A functional assessment of the shoulder was performed preoperatively and postoperatively at 6 weeks, 3 months, and annually thereafter and included abduction, external rotation in adduction and abduction, and the Mallet scale. Results Internal contracture release resulted in an improvement in passive external rotation in adduction and abduction of 29 degrees (95% confidence interval, 21 to 38; p < 0.001) and 17 degrees (95% CI, 10 to 24; p < 0.001) at 1 year of follow-up and 25 degrees (95% CI, 15-35; p < 0.001) and 15 degrees (95% CI, 7 to 24; p = 0.001) at 5 years. Because of insufficient strength of the external rotators after release, 46% of the children (17 of 37) underwent an additional tendon transfer for active external rotation, resulting in an improvement in active external rotation in adduction and abduction at each successive follow-up visit. Patients with staged transfers had improved active function; improvements in active external rotation in adduction and abduction were 49 degrees (95% CI, 28 to 69; p < 0.05) and 45 degrees (95% CI, 11 to 79; p < 0.001) at 1 year of follow-up and 38 degrees (95% CI, 19 to 58; p < 0.05) and 23 degrees (95% CI, -8 to 55; p < 0.001) at 5 years. In patients starting with less than 20 degrees of passive external rotation and no active external rotation, after single-stage contracture release and tendon transfer, active ROM was improved. Active external rotation in adduction and abduction were 75 degrees (95% CI, 66 to 84; p < 0.001) and 50 degrees (95% CI, 43 to 57; p < 0.001) at 1 year of follow-up and 65 degrees (95% CI, 50 to 79; p < 0.001) and 40 degrees (95% CI, 28 to 52; p < 0.001) at 5 years. Conclusion Young children with obstetric brachial plexus injuries who have internal rotation contractures may benefit from soft-tissue release. When active external rotation is lacking, soft-tissue release combined with tendon transfer improved active external rotation in this small series. Future studies on the degree of glenohumeral deformities and functional outcome might give more insight into the level of increase in external rotation. Show less
Background Accelerometer-based navigation is a handheld navigation tool that was introduced to offer a simpler technique compared with more-cumbersome computer-assisted surgery (CAS). Considering... Show moreBackground Accelerometer-based navigation is a handheld navigation tool that was introduced to offer a simpler technique compared with more-cumbersome computer-assisted surgery (CAS). Considering the increasing number of adopters, it seems important to evaluate the potential clinical benefits of this technology compared with conventional TKA.Questions/purposes In this systematic review, we asked: (1) Is accelerometer-based navigation more accurate than conventional TKA? (2) Does accelerometer-based navigation provide better functional outcome than conventional TKA? (3) Does accelerometer-based navigation increase surgical time or decrease the risk of complications or reoperations compared with conventional TKA?Methods This systematic review included all comparative prospective and retrospective studies published in the MEDLINE/PubMed and Cochrane libraries over the last 10 years. Inclusion criteria were all studies in English that compared accelerometer-based navigation with conventional TKA. Eleven studies met these criteria with 621 knees in accelerometer-based navigation group and 677 knees in conventional TKA group. Results related to alignment, objective and subjective functional scores, duration of surgery, complications and reoperations were extracted and compared between accelerometer-based-navigation and conventional TKA. Methodological quality was assessed using Methodological Index for Non-Randomized Studies (MINORS) tool (for nonrandomized control trials) and Cochrane Risk of Bias (for randomized control trials (RCTs). All studies with fair or better quality were included. Four RCTs and six nonrandomized studies comparing accelerometer-based navigation to conventional TKA were found.Results Inconsistent evidence on mechanical axis alignment was found, with five of nine studies slightly favoring the accelerometer-based navigation group, and the other four showing no differences between the groups. Only two of eight studies favored accelerometer-based navigation in terms of tibial component alignment in the coronal plane; the other six found no between-group differences. Similarly, mixed results were found regarding other metrics related to component alignment; a minority of studies favored accelerometer-based navigation by a smallmargin, and most studies found no between-group differences. Only three studies evaluated functional outcome and none of them showed a difference in range of motion or patient-reported outcomes. Most studies, six of seven, found no between-group differences concerning surgical time; one study demonstrated a slight increase in time with accelerometer-based navigation. There were no between-group differences in terms of the risk of complications, which generally were uncommon in both groups, and no reoperations or revisions were reported in either group.Conclusions We found conflicting evidence about whether accelerometer-based navigation reduces the number of coronal-plane outliers or improves alignment to a clinically important degree, and we found no evidence that it improves patient-reported outcomes or reduces the risk of complications or reoperations. Accelerometer-based navigation may increase surgical time. The overall quality of the evidencewas low, which suggested that any observed benefits were over-estimated. Given the absence of higher-quality evidence demonstrating compelling benefits of this accelerometer-based navigation technology, it should not bewidely adopted. Show less
Overbeek, C.L.; Kolk, A.; Groot, J.H. de; Visser, C.P.J.; Zwaal, P. van der; Jens, A.; ... ; Nelissen, R.G.H.H. 2019
Background In approximately 29% to 34% of all patients with subacromial pain syndrome (SAPS) there is no anatomic explanation for symptoms, and behavioral aspects and/or central pain mechanisms may... Show moreBackground In approximately 29% to 34% of all patients with subacromial pain syndrome (SAPS) there is no anatomic explanation for symptoms, and behavioral aspects and/or central pain mechanisms may play a more important role than previously assumed. A possible behavioral explanation for pain in patients with SAPS is insufficient active depression of the humerus during abduction by the adductor muscles. Although the adductor muscles, specifically the teres major, have the most important contribution to depression of the humerus during abduction, these muscles have not been well studied in patients with SAPS.Questions/purposes Do patients with SAPS have altered contraction patterns of the arm adductors during abduction compared with asymptomatic people?Methods SAPS was defined as nonspecific shoulder pain lasting for longer than 3 months that could not be explained by specific conditions such as calcific tendinitis, full-thickness rotator cuff tears, or symptomatic acromioclavicular arthritis, as assessed with clinical examination, radiographs, and magnetic resonance arthrography. Of 85 patients with SAPS who met the prespecified inclusion criteria, 40 were eligible and agreed to participate in this study. Thirty asymptomatic spouses of patients with musculoskeletal complaints, aged 35 to 60 years, were included; the SAPS and control groups were not different with respect to age, sex, and hand dominance. With electromyography, we assessed the contraction patterns of selected muscles that directly act on the position of the humerus relative to the scapula (the latissimus dorsi, teres major, pectoralis major, and deltoid muscles). Cocontraction was quantified through the activation ratio ([AR]; range, -1 to 1). The AR indicates the task-related degree of antagonist activation relative to the same muscle's degree of agonist activation, equaling 1 in case of sole agonist muscle activation and equaling -1 in case of sole antagonistic activation (cocontraction). We compared the AR between patients with SAPS and asymptomatic controls using linear mixed-model analyses. An effect size of 0.10 < AR < 0.20 was subjectively considered to be a modest effect size.Results Patients with SAPS had a 0.11 higher AR of the teres major (95% CI, 0.01-0.21; p = 0.038), a 0.11 lower AR of the pectoralis major (95% CI, -0.18 to -0.04; p = 0.003), and a 0.12 lower AR of the deltoid muscle (95% CI, -0.17 to -0.06; p < 0.001) than control participants did. These differences were considered to be modest. With the numbers available, we found no difference in the AR of the latissimus dorsi between patients with SAPS and controls (difference = 0.05; 95% CI, -0.01 to 0.12; p = 0.120).Conclusions Patients with SAPS showed an altered adductor cocontraction pattern with reduced teres major activation during abduction. The consequent reduction of caudally directed forces on the humerus may lead to repetitive overloading of the subacromial tissues and perpetuate symptoms in patients with SAPS. Physical therapy programs are frequently effective in patients with SAPS, but targeted approaches are lacking. Clinicians and scientists may use the findings of this study to assess if actively training adductor cocontraction in patients with SAPS to unload the subacromial tissues is clinically effective. The efficacy of training protocols may be enhanced by using electromyography monitoring. Show less
Background Anatomic and surgical complexity make pelvic and sacral bone sarcoma resections challenging. Positive surgical margins are more likely to occur in patients with pelvic and sacral bone... Show moreBackground Anatomic and surgical complexity make pelvic and sacral bone sarcoma resections challenging. Positive surgical margins are more likely to occur in patients with pelvic and sacral bone sarcomas than in those with extremity sarcomas and are associated with an increased likelihood of local recurrence. Intraoperative navigation techniques have been proposed to improve surgical accuracy in achieving negative margins, but available evidence is limited to experimental (laboratory) studies and small patient series. Only one small historically controlled study is available. Because we have experience with both approaches, we wanted to assess whether navigation improves our ability to achieve negative resection margins.Questions/purposes Are navigated resections for pelvic and sacral primary bone sarcomas better able to achieve adequate surgical margins than nonnavigated resections?Methods Thirty-six patients with pelvic or sacral sarcomas treated with intraoperative navigation were retrospectively compared with 34 patients undergoing resections without navigation. All patients underwent resections between 2000 and 2017 with the intention to achieve a wide margin. Patients in the navigation group underwent surgery between 2008 and 2017; during this period, all resections of pelvic and sacral primary bone sarcomas with the intention to achieve a wide margin were navigation-assisted by either CT fluoroscopy or intraoperative CT. Patients in the control group underwent surgery before 2008 (when navigation was unavailable at our institution), to avoid selection bias. We did not attempt to match patients to controls. Nonnavigated resections were performed by two senior orthopaedic surgeons (with 10 years and > 25 years of experience). Navigated resections were performed by a senior orthopaedic surgeon with much experience in surgical navigation. The primary outcome was the bone and soft-tissue surgical margin achieved, classified by a modified Enneking system. Wide margins (>= 2 mm) and wide-contaminated margins, in which the tumor or its pseudocapsule was exposed intraoperatively but further tissue was removed to achieve wide margins, were considered adequate; marginal (0-2 mm) and intralesional margins were considered inadequate.Results Adequate bone margins were achieved in more patients in the navigated group than in the nonnavigation group (29 of 36 patients [81%] versus 17 of 34 [50%]; odds ratio, 4.14 [95% CI, 1.43-12.01]; p = 0.007). With the numbers available, we found no difference in our ability to achieve adequate soft-tissue margins between the navigation and nonnavigation group (18 of 36 patients [50%] versus 18 of 34 [54%]; odds ratio, 0.89 [95% CI, 0.35-2.27]; p = 0.995).Conclusions Intraoperative guidance techniques improved our ability to achieve negative bony margins when performing surgical resections in patients with pelvic and sacral primary bone sarcomas. Achieving adequate soft-tissue margins remains a challenge, and these margins do not appear to be influenced by navigation. Larger studies are needed to confirm our results, and longer followup of these patients is needed to determine if the use of navigation will improve survival or the risk of local recurrence. Show less
