Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

INTRODUCTION: Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies. METHODS: This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction). RESULTS: As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care). CONCLUSIONS: A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

Characterizing the Native Microbiome Using Next-Generation Sequencing of Bilateral 'Aseptic' Knees.

BACKGROUND: Next generation sequencing (NGS) has proven ability to identify organisms beyond those identified through traditional culture-based techniques in cases of suspected prosthetic joint infection. However, there is concern that some microorganisms identified may represent the natural joint microbiome rather than pathogenic agents. This work sought to evaluate the presence of microorganisms identified with NGS in bilateral native, presumed "aseptic" knees with osteoarthritis. METHODS: There were 40 patients undergoing primary unilateral (30) or bilateral (10) total knee arthroplasty enrolled prospectively. During surgery, samples of fluid and tissue were obtained from operative knees, and joint fluid was obtained from nonoperative knees. Samples were sent for NGS analysis and processed according to manufacturer protocols. Patient age, body mass index, comorbidities, prior history of injections, and grade of arthritis were evaluated for association with positive NGS results. RESULTS: There were 3 of 80 samples (3.8%) that demonstrated positive NGS. There were two of these that had multiple microorganisms identified (1 knee with 4 microorganisms; 1 knee with 2 microorganisms). An additional 2 samples had positive NGS results below the manufacturer's threshold for reporting. The most common organism identified was Cutibacterium acnes, present in 2 of the 3 positive samples. No patient baseline characteristics were associated with positive NGS results. CONCLUSIONS: Some native knee joints with osteoarthritis have positive microorganisms identified with NGS. The presence of microorganisms in the native knee has important implications for better understanding the native joint microbiome as well as utilization of NGS in cases of suspected prosthetic joint infection.

Fluorescence guidance improves the accuracy of radiological imaging-guided surgical navigation.

BACKGROUND: Imaging-based navigation technologies require static referencing between the target anatomy and the optical sensors. Imaging-based navigation is therefore well suited to operations involving bony anatomy; however, these technologies have not translated to soft-tissue surgery. We sought to determine if fluorescence imaging complement conventional, radiological imaging-based navigation to guide the dissection of soft-tissue phantom tumors. METHODS: Using a human tissue-simulating model, we created tumor phantoms with physiologically accurate optical density and contrast concentrations. Phantoms were dissected using all possible combinations of computed tomography (CT), magnetic resonance, and fluorescence imaging; controls were included. The data were margin accuracy, margin status, tumor spatial alignment, and dissection duration. RESULTS: Margin accuracy was higher for combined navigation modalities compared to individual navigation modalities, and accuracy was highest with combined CT and fluorescence navigation (p = 0.045). Margin status improved with combined CT and fluorescence imaging. CONCLUSIONS: At present, imaging-based navigation has limited application in guiding soft-tissue tumor operations due to its inability to compensate for positional changes during surgery. This study indicates that fluorescence guidance enhances the accuracy of imaging-based navigation and may be best viewed as a synergistic technology, rather than a competing one.

Differential item functioning to validate setting of delivery compatibility in PROMIS-global health.

PURPOSE: Patient-reported outcomes measures (PROMs) such as PROMIS are increasingly utilized in healthcare to assess patient perception and functional status, but the effect of delivery setting remains to be fully investigated. To our knowledge, no current study establishes the absence of differential item functioning (DIF) across delivery setting for these PROMIS- Global Health (PROMIS-GH) measures among orthopedic patients. We sought to investigate the correlation of PROMIS-GH scores across in-clinic versus remote delivery by evaluating DIF within the Global Physical Health (GPH) and Global Mental Health (GMH) items. We hypothesize that the setting of delivery of the GPH and GMH domains of PROMIS-GH will not impact the results of the measure, allowing direct comparison between the two delivery settings. METHODS: Five thousand and seven hundred and eighty-five complete PROMIS-Global Health measures were analyzed retrospectively using the 'Lordif' package on the R platform. DIF was measured for GPH and GMH domains across setting of response (in-clinic vs remote) during the pre-operative period, immediate post-operative period, and 1-year post-operative period using Monte Carlo estimation. McFadden pseudo-R2 thresholds (> 0.02) were used to assess the magnitude of DIF for individual PROMIS items. RESULTS: No GPH or GMH items contained in the PROMIS-GH instrument yielded DIF across in-clinic vs remote delivery setting during the pre-operative, immediate post-operative, or 1-year post-operative window. CONCLUSION: The GPH and GMH domains within the PROMIS-GH instrument may be delivered in the clinic or remotely with comparable accuracy. This cross-delivery setting validation analysis may aid to improve the quality of patient care by allowing mixed platform PROMIS-GH data tailored to individual patient circumstance.

Does Time to Reimplantation After Explant for Prosthetic Joint Infection Influence the Likelihood of Successful Outcomes at 2 Years?

BACKGROUND: Consensus recommendations are lacking regarding appropriate timing of reimplantation following 2-stage resection arthroplasty for prosthetic joint infections (PJIs). We investigated whether the time from resection arthroplasty to reimplantation was associated with treatment outcome at 2 years. METHODS: Retrospective cohort review was conducted for 101 patients undergoing resection arthroplasty with an antibiotic spacer for PJI at a single tertiary academic referral institution. Time from explantation and spacer placement to reimplantation was categorized into 3 groups: <12, 12-18, and >18 weeks. Baseline patient and treatment course characteristics across these groups were obtained. Multivariate binary logistic regression was used to characterize association between treatment failure and time to reimplantation, controlling for American Society of Anesthesiologists (ASA) score and prior revision surgery. RESULTS: Time to reimplantation (TTR) >18 weeks demonstrated statistically significant increased odds of treatment failure, after controlling for ASA score and prior revision surgery (odds ratio 7.00, confidence interval 2.14-25.42, P = .002). After excluding patients requiring second spacer or Girdlestone prior to replant, this increased odds of failure remained (odds ratio 4.12, confidence interval 1.18-15.37, P = .029). TTR groups were similar with respect to demographics, except for ASA (2.96 for time to reimplantation >18 weeks vs 2.55 for time to reimplantation <12 weeks; P = .011). Patients with TTR >18 weeks were more likely to have an unplanned readmission during the spacer period (48%, 19%, and 6% for time to reimplantation >18, 12-18, and 0-12 weeks, respectively; P < .002). CONCLUSION: Although decision regarding TTR is largely patient specific, surgeons should be aware that TTR >18 weeks may be associated with higher rates of treatment failure at 2 years.

Cross-specialty PROMIS-global health differential item functioning.

PURPOSE: To investigate the functioning of the PROMIS-Global Health (PROMIS-GH) across clinical setting, patient age, and medical complexity by evaluating differential item functioning (DIF) within the Global Physical Health (GPH) and Global Mental Health (GMH) domains. To our knowledge, no study demonstrates lack of differential item functioning (DIF) for PROMIS-GH across these populations. We hypothesize that the PROMIS-GH domains of GMH and GPH will perform similarly when compared across these populations. METHODS: Seven thousand nine hundred and seventy four complete PROMIS Global Health measures were retrospectively analyzed using the 'Lordif' package on the R platform. DIF was investigated for both GMH and GPH across clinical environment (Orthopedic Surgery, Family Medicine, & Internal Medicine), age group (≤ 53, > 53-66, > 66), and Charlson Comorbidity Index (CCI:0, CCI:1, CCI:2 +) using quasi Monte Carlo estimation. To assess the significance of DIF, Wald tests were used with the Benjamini & Hochberg procedure. RESULTS: No items contained in the GMH or GPH demonstrated DIF across age groups, medical complexity, or clinical environment. CONCLUSION: Items assessing the domains of GMH and GPH within the PROMIS-GH function comparably across treatment setting, age category, and medical comorbidities. The PROMIS-Global Health holds potential to facilitate interdisciplinary patient care and patient optimization prior to surgical intervention.

Is the Proportion of Patients with "Successful" Outcomes After Two-stage Revision for Prosthetic Joint Infection Different When Applying the Musculoskeletal Infection Society Outcome Reporting Tool Compared with the Delphi-based Consensus Criteria?

BACKGROUND: There are a variety of criteria for defining successful treatment after two-stage exchange arthroplasty for prosthetic joint infection (PJI). To accurately assess current practices and improve techniques, it is important to first establish reliable, clinically relevant, reproducible criteria for defining persistent infection and "successful" outcomes. QUESTION/PURPOSE: Is the proportion of patients considered to have successful management of PJI after two-stage resection arthroplasty smaller using 2019 Musculoskeletal Infection Society Outcome Reporting Tool (MSIS ORT) criteria than when using a Delphi-based criterion? METHODS: Patients were retrospectively identified by Current Procedural Technology codes for resection arthroplasty with placement of an antibiotic spacer for infected THA or TKA between April 1, 2011 and January 1, 2018 at a tertiary academic institution. The initial review identified 180 procedures during this time period. Nine patients had documented transition of care outside the system, 16 did not meet the MSIS criteria for chronic PJI, and 34 patients were excluded for lack of documented 2-year follow-up. The mean follow-up duration of the final cohort of 121 procedures in 120 patients was approximately 3.7 ± 1.7 years. Forty percent (49 of 121) of the procedures were performed on the hip and 60% (72 of 121) were performed on the knee. The mean time from primary THA or TKA to explantation was 4.6 years. The mean age of the patients at the time of explantation was 66 years. The mean time from spacer placement to replantation was 119 days. The final 121 patient records were reviewed by a single reviewer and outcomes were subsequently assigned to "successful" and "unsuccessful" outcomes based on the MSIS ORT and Delphi-based consensus criterion, two previously published and validated multidimensional definition schemes. Chi-squared and t-test analyses were performed to identify differences between "successful" and "unsuccessful" outcomes with respect to patient baseline characteristics using each outcome-reporting criterion. RESULTS: Overall, the MSIS ORT classified a smaller proportion of patients as having a "successful" treatment outcome after two-stage exchange arthroplasty for PJI than the Delphi-based consensus method did (MSIS: 55% [63 of 114], Delphi: 70% [71 of 102]; relative risk 0.79 [0.65-0.98]; p = 0.03). However, there were no differences when stratified by hips (MSIS: 55% [26 of 47], Delphi: 74% [29 of 39]; relative risk 0.74 [0.54-1.02]; p = 0.07) and knees (MSIS: 55% [37 of 67], Delphi: 67% [42 of 63]; relative risk 0.83 [0.63-1.09]; p = 0.19). Notably, the disease of 16% of the patients (19 of 121) was not classifiable per the Delphi method because these patients never underwent reimplantation. CONCLUSION: The present study demonstrated that the MSIS criteria detect fewer instances of "successful" infection management after two-stage resection arthroplasty for PJI than the Delphi method in this cohort. Based on these findings, researchers and surgeons should aim for standardized reporting after intervention for PJI to allow for a better comparison of outcomes across different studies and ultimately allow for improved techniques and approaches to the treatment of PJI. LEVEL OF EVIDENCE: Level III, diagnostic study.

Do Patient Engagement Platforms in Total Joint Arthroplasty Improve Patient-Reported Outcomes?

BACKGROUND: Web-based patient engagement portals are increasing in popularity after total hip and knee arthroplasty (THA and TKA). The literature is mixed regarding patient utilization of these modalities and potential clinical benefit. We sought to determine which demographic factors are associated with increased platform participation and to quantify the impact of a web-based patient portal on patient-reported outcome measures (PROMs). METHODS: We performed a retrospective analysis of consecutive primary THA (n = 554) and TKA (n = 485) at a single academic institution with minimum follow-up of 12 months. Patients were divided into those who opted-in and those who opted-out of portal use. Global health and joint-specific PROMs were collected preoperatively and postoperatively. Linear mixed effects modeling, bivariate analysis, and logistic regression were utilized. RESULTS: Of the 1039 included patients, 60.6% (336) THA and 62.7% (304) TKA patients enrolled in the portal. Those who opted-in were younger (P < .001, P < .003), had higher body mass index (P = .024, P = .011), and had a higher household income (P < .001, P < .001) in THA and TKA cohorts, respectively. Portal participation in the TKA but not the THA cohort was associated with significant improvement in physical function (P = .017) and joint-specific function (P = .045). For THA patients who opted-in, increased portal logins were associated with more rapid improvement and higher functional scores (P = .013). CONCLUSION: There is an inherent difference between patients who opt-in to and those who opt-out of web-based portals. Added resources and support provided by portals may translate to improved PROMs for TKA patients but not THA patients.

Does Productivity-Based Physician Compensation Affect Surgical Rates for Elective Arthroplasty Surgery?

BACKGROUND: Surgeon compensation models could potentially influence the utilization of elective procedures. We assessed whether transitioning from salaried to a relative value unit (RVU) productivity-based physician compensation model changed the surgical rate and patient selection in elective total hip and knee arthroplasty (THA and TKA) procedures. METHODS: Our institution transitioned from salaried to RVU productivity-based reimbursement in July 2016. We performed a retrospective analysis on patients undergoing primary THA and TKA from July 2014 to July 2018 before and after the transition (salary period n = 820; RVU period n = 1188). Beta regression was used to determine the reimbursement structure as a predictor of surgery. The surgical rate was defined as the number of primary THA and TKA procedures per reimbursement period divided by all arthroplasty and osteoarthritis outpatient clinic encounters. RESULTS: There was a surgical rate of 15.8% (95% confidence interval [CI] 13.8%-17.8%) THA and 16.7% (95% CI 15.1%-18.1%) TKA procedures during RVU reimbursement compared to 11.1% (95% CI 9.8%-12.8%) THA and 11.7% (95% CI 10.5%-12.8%) TKA procedures during the salaried period (P < .001). The adjusted odds of undergoing a THA or TKA procedure increased in the RVU compared to the salaried model (THA odds ratio 1.48, 95% CI 1.43-1.53; TKA odds ratio 1.50, 95% CI 1.46-1.55; P < .001). There were no significant differences in patient age, gender, race, body mass index, or Charlson Comorbidity Index in salaried vs RVU productivity periods (P > .05 for all covariates). CONCLUSIONS: Productivity-based physician compensation may encourage higher rates of elective arthroplasty procedures without broadening patient selection.

A SANE Approach to Outcome Collection? Comparing the Performance of Single- Versus Multiple-Question Patient-Reported Outcome Measures After Total Hip Arthroplasty.

BACKGROUND: Several patient-reported outcome measures (PROMs) exist to measure outcomes after total hip arthroplasty (THA) but can be limited by patient-perceived burden and completion rates. We analyzed whether the modified single assessment numerical evaluation (M-SANE), a one-question PROM, would perform similarly to multiple-question PROMs among patients undergoing primary THA. METHODS: Patients undergoing THA completed the Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10), the Hip Disability and Osteoarthritis Outcomes Score Junior (HOOS-Jr), and M-SANE questionnaires both preoperatively and postoperatively. The M-SANE assessment asked patients to assess their hip on a scale from 0 to 10, with 10 being the best possible score. Validity of M-SANE compared with other PROMs was determined by Spearman's correlation and floor and ceiling effects. Responsiveness was analyzed using standardized response mean (SRM). RESULTS: One hundred and thirty six patients with at least 1-year follow-up were reviewed. The average M-SANE score improved from 3.3 preoperatively to 7.1 at one year postoperatively. There was moderate to strong correlation at one-year follow-up between the M-SANE and HOOS-Jr (ρ = 0.75, P < .001) and PROMIS-10 physical component summary (ρ = 0.63, P < .001). Floor and ceiling effects of the M-SANE (floor 2.0%, ceiling 21.3%) were comparable to the HOOS-Jr (floor 0.0%, ceiling 20.8%). The responsiveness of the M-SANE after THA (SRM = 1.06, 95% CI: 0.79-1.33) was comparable to HOOS-Jr (SRM = 1.33, 95% CI: 1.08-1.59) and superior to PROMIS-10 physical component summary (SRM = 0.65, 95% CI: 0.55-0.74). CONCLUSION: The M-SANE has performed similarly across multiple psychometric properties compared with more burdensome PROMs in assessing longitudinal patient-reported outcomes after THA.

A One-Question Patient-Reported Outcome Measure Is Comparable to Multiple-Question Measures in Total Knee Arthroplasty Patients.

BACKGROUND: Patient-reported outcome measures (PROMs) are important for tracking outcomes following total knee arthroplasty (TKA) but can be limited by time constraints and patient compliance. We sought to evaluate the utility of the one-question, modified single assessment numerical evaluation (M-SANE) score in TKA patients compared to legacy PROMs. METHODS: Patients undergoing TKA completed the Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10), the Knee Disability and Osteoarthritis Outcomes Score Junior (KOOS Jr), and M-SANE (modified-SANE) assessments both preoperatively and postoperatively. The M-SANE score asked patients to rate their native or prosthetic knee on a scale from 0 to 10, with 10 being the best function. M-SANE validity was determined by the Spearman's correlation between the collected PROMs and the Bland-Altman plots. PROM responsiveness was assessed using the standardized response mean. RESULTS: In total, 217 patients completed PROMs preoperatively and at 1 year postoperatively. Floor and ceiling effects of the M-SANE were higher than other PROMs but still relatively low (4%-11%). There was a moderate to strong correlation at nearly all time points between the M-SANE and KOOS Jr (ρ = 0.44-0.78, P < .001). There was a weak correlation between the M-SANE and PROMIS physical component summary at the preoperative evaluation (ρ = 0.28) but a strong correlation at 1-year follow up (0.65, P < .001). The long-term responsiveness of the M-SANE to TKA (standardized response mean [SRM] = 0.98, 95% confidence interval [CI] 0.80-1.17) was comparable to both the KOOS Jr (SRM = 1.19, 95% CI 1.00-1.38) and PROMIS physical component summary (SRM = 0.82, 95% CI 0.74-0.91). Bland-Altman plots demonstrated that the M-SANE and KOOS Jr capture combined knee pain and functionality differently. CONCLUSION: The M-SANE score was comparable to validated multiple-question PROMs in TKA patients. The demonstrated validity of the M-SANE, as well as its comparable responsiveness to more lengthy PROMs, highlights its use as a one-question PROM for assessment of patient undergoing TKA.

Comparing five front-of-pack nutrition labels' influence on consumers' perceptions and purchase intentions.

In 2011, a National Academy of Medicine report recommended that packaged food in the U.S. display a uniform front-of-package nutrition label, using a system such as a 0-3 star ranking. Few studies have directly compared this to other labels to determine which best informs consumers and encourages healthier purchases. In 2013, we randomized adult participants (N=1247) in an Internet-based survey to one of six conditions: no label control; single traffic light; multiple traffic light; Facts Up Front; NuVal; or 0-3 star ranking. We compared groups on purchase intentions and accuracy of participants' interpretation of food labels. There were no differences in the nutritional quality of hypothetical shopping baskets across conditions (p=0.845). All labels improved consumers' abilities to judge the nutritional quality of foods relative to no label, but the best designs varied by outcomes. NuVal and multiple traffic light labels led to the greatest accuracy identifying the healthier of two products (p<0.001), while the multiple traffic light also led to the most accurate estimates of saturated fat, sugar, and sodium (p<0.001). The single traffic light outperformed other labels when participants compared nutrient levels between similar products (p<0.03). Single/multiple traffic light and Facts Up Front labels led to the most accurate calories per serving estimations (p<0.001). Although front-of-package labels helped participants more accurately assess products' nutrition information relative to no label, no conditions shifted adults' purchase intentions. Results did not point to a clearly superior label design, but they suggest that a 3-star label might not be best for educating consumers.

The Impact of the Coronavirus Disease 2019 Pandemic on US Total Knee and Hip Arthroplasty Procedures in 2020.

Background: The coronoavirus disease 2019 (COVID-19) pandemic had profound impact on elective procedures in the United States. We characterized the longer-term decline and recovery of hip and knee arthroplasty procedures following the onset of the COVID-19 pandemic in the United States. Methods: We conducted a retrospective analysis of patients undergoing primary and revision total knee and hip arthroplasty (TKA and THA) in the United States between 2014 and 2020 using claims from a large national commercial payer data set contaivning deidentified information from patients with commercial health coverage. We calculated the percentage of cases lost by month using a forecast model to predict TKA and THA volumes in the absence of COVID-19. We then calculated the association between COVID-19 positivity rates and THA/TKA procedures by state and month. Results: There was a large initial decline in procedures, with primary TKA and THA volumes declining by 93.2% and 87.1% in April 2020, respectively, with revisions seeing more modest declines. Cases quickly recovered with volumes exceeding expected levels in summer months. However, cumulative 2020 volumes remained below expected with 9.7% and 7.5% of expected primary TKA and THA cases lost, respectively. Higher state COVID-19 positivity rates were associated with lower primary TKA, THA, and revision knee procedure rates. Conclusions: After the initial decline in March and April, knee and hip arthroplasty cases resumed quickly; however, by the end of 2020, the annual procedure volume had still not recovered fully. The loss in case volume within states was worse in months with higher COVID-19 positivity rates.

The Impact of Preoperative Medical Evaluation in an Orthopaedic Perioperative Medical Clinic on Total Joint Arthroplasty Outcomes: An Observational Study.

BACKGROUND: A preoperative medical evaluation (PME) in total joint arthroplasty (TJA) is routine despite considerable variation and uncertainty regarding its benefits. The orthopaedic department in our academic health system established a perioperative medical clinic (PMC) to standardize perioperative management and to study the effect of this intervention on total hip arthroplasty (THA) and total knee arthroplasty (TKA) outcomes. This observational study compared the impact of a PME within 30 days prior to surgery at the PMC (Periop30) versus elsewhere ("Usual Care") on postoperative length of stay (LOS), extended LOS (i.e., a stay of >3 days), and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Physical Health (GPH) score improvement in TJA. METHODS: We stratified adult patients (≥18 years of age) who underwent primary TJA between January 2015 and December 2020 into Periop30 or Usual Care. We utilized univariate tests (a chi-square test for categorical variables and a t test for continuous variables) to assess for differences in patient characteristics. For both TKA and THA, LOS was assessed with use of multivariable negative binomial regression models; extended LOS, with use of binary logistic regression; and PROMIS-10 GPH score, with use of mixed-effects models with random intercept and slope. Interaction terms between the focal predictor (Periop30, yes or no) and year of surgery were included in all models. RESULTS: Periop30 comprised 82.3% of TKAs (1,911 of 2,322 ) and 73.8% of THAs (1,876 of 2,541). For THA, the Periop30 group tended to be male (p = 0.005) and had a higher body mass index (p = 0.001) than the Usual Care group. The Periop30 group had a higher rate of staged bilateral THA (10.6% versus 7.5%; p = 0.028) and a lower rate of simultaneous bilateral TKA (5.1% versus 12.2%; p < 0.001) than the Usual Care group. Periop30 was associated with a lower mean LOS for both TKA (43.46 versus 54.15 hours; p < 0.001) and THA (41.07 versus 57.94 hours; p < 0.001). The rate of extended LOS was lower in the Periop30 group than in the Usual Care group for both TKA (15% versus 26.5%; p < 0.001) and THA (13.3% versus 27.4%; p < 0.001). There was no significant difference in GPH score improvement between Periop30 and Usual Care for either TKA or THA. CONCLUSIONS: Periop30 decreased mean LOS and the rate of extended LOS for TJA without an adverse effect on PROMIS-10 GPH scores. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Examining the Relationship Between Value and Patient Satisfaction With Treatment in Total Joint Arthroplasty.

Background: A shift toward performance, cost, outcomes, and patient satisfaction has occurred with healthcare reform promoting value-based programs. The purpose of this study was to evaluate the relationship between patient satisfaction and value with treatment in a cohort of patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA). Methods: Value was determined by the relationship of treatment outcome with episodic cost. Measurements included both clinical outcomes and patient-reported outcomes. Participating surgeons took part in the modified Delphi method resulting in an algorithm measuring patient value. Treatment outcome, cost, and resultant value (outcome/cost) of both TKA and THA were evaluated using binomial logistic regression by adjusting for age, gender, body mass index, Charlson comorbidity index, tobacco, education, and income with patient-reported satisfaction as the outcome. Results: This study had a total of 909 patients (TKA n = 438; THA n = 471), with an average age of 67 (TKA) and 65 (THA) years. Patient satisfaction shared a significant positive relationship with treatment outcome for TKA (odds ratio [OR] = 1.53, confidence interval [CI] = 1.35-1.73, P < .001) and THA (OR = 1.93, CI = 1.62-2.29, P < .001). Higher value was associated with a significantly higher odds of patient satisfaction for both TKA (OR = 1.39, CI = 1.25-1.54, P < .001) and THA (OR = 1.70, CI = 1.47-1.97, P < .001). Conclusions: This study showed a positive relationship between treatment outcome but not cost with subsequent value and patient satisfaction. This method provides a promising approach to comprehensively evaluate outcomes, cost, and value of total joint arthroplasty procedures. This approach can help predict the probability of value-driven patient satisfaction.

Neoadjuvant Therapies Do Not Reduce Epidermal Growth Factor Receptor (EGFR) Expression or EGFR-Targeted Fluorescence in a Murine Model of Soft-Tissue Sarcomas.

PURPOSE: ABY-029, an epidermal growth factor receptor (EGFR)-targeted, synthetic Affibody peptide labeled with a near-infrared fluorophore, is under investigation for fluorescence-guided surgery of sarcomas. To date, studies using ABY-029 have occurred in tumors naïve to chemotherapy (CTx) and radiation therapy (RTx), although these neoadjuvant therapies are frequently used for sarcoma treatment in humans. The goal of this study was to evaluate the impact of CTx and RTx on tumor EGFR expression and ABY-029 fluorescence of human soft-tissue sarcoma xenografts in a murine model. PROCEDURES: Immunodeficient mice (n = 98) were divided into five sarcoma xenograft groups and three treatment groups - CTx only, RTx only, and CTx followed by RTx, plus controls. Four hours post-injection of ABY-029, animals were sacrificed followed by immediate fluorescence imaging of ex vivo adipose, muscle, nerve, and tumor tissues. Histological hematoxylin and eosin staining confirmed tumor type, and immunohistochemistry staining determined EGFR, cluster of differentiation 31 (CD31), and smooth muscle actin (SMA) expression levels. Correlation analysis (Pearson's correlation coefficients, r) and linear regression (unstandardized coefficient estimates, B) were used to determine statistical relationships in molecular expression and tissue fluorescence between xenografts and treatment groups. RESULTS: Neoadjuvant therapies had no broad impact on EGFR expression (|B|≤ 7.0, p ≥ 0.4) or on mean tissue fluorescence (any tissue type, (|B|≤ 2329.0, p ≥ 0.1). Mean tumor fluorescence was significantly related to EGFR expression (r = 0.26, p = 0.01), as expected. CONCLUSION: Results suggest that ABY-029 as an EGFR-targeted, fluorescent probe is not negatively impacted by neoadjuvant soft-tissue sarcoma therapies, although validation in humans is required.

Deep Surgical Site Infection after Fracture Has a Profound Effect on Functional Outcomes.

Background: Fracture-related infection is one of the most challenging complications in orthopaedic trauma surgery. However, the effect of infection on functional and pain-related outcomes has not been well established. The aims of this study were to evaluate functional recovery for patients with fracture and a deep surgical site infection compared with patients with fracture without infection and to evaluate whether pain severity, social support, and preinjury mental health have a moderating effect on the magnitude and direction of the relationship between deep surgical site infection and functional recovery. Methods: This is a secondary retrospective cohort study using prospectively collected data from the VANCO trial (Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection) and the OXYGEN (Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery) trial. In this study, 2,116 patients with tibial plateau, pilon, or calcaneal fractures at high risk for infection were included. Patients were divided into cohorts of patients who experienced a deep surgical site infection and those who did not. The primary outcome measure was the functional outcome using the Veterans RAND 12-Item Health Survey (VR-12). Results: After controlling for covariates, deep surgical site infection was independently associated with functional outcome, with a 3.3-point reduction in the VR-12 Physical Component Score, and pain severity was independently associated with functional outcome, with a 2.5-point reduction in the VR-12 Physical Component Score. Furthermore, the Brief Pain Inventory pain severity demonstrated an important moderating effect on the relationship between infection and functional outcome. In patients with lower pain scores, infection had a large negative impact on functional outcome, whereas, in patients with higher pain scores, infection had no significant impact on functional outcome. Furthermore, the functional outcome in the entire cohort remains at only 61% of baseline. Conclusions: This study documents the negative impact of postoperative infection on functional recovery after injury, as well as the novel finding of pain severity as an important moderating factor. This study emphasizes not only the importance of developing effective interventions designed to reduce postoperative infection, but also the role that factors that moderate pain severity plays in limiting recovery of physical function. Level of evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The Relationship Between the Timing of Knee Osteoarthritis Diagnoses and Arthroscopic Partial Meniscectomy.

BACKGROUND: There is ongoing debate regarding the efficacy of arthroscopic partial meniscectomy (APM) for meniscus tears in patients with knee osteoarthritis (OA). Some insurance payers will not authorize APM in patients with knee OA. The purpose of this study was to assess the timing of knee OA diagnoses in patients undergoing APM. METHODS: A large commercial national claims data set containing deidentified information from October 2016 to December 2020 was used to identify patients undergoing arthroscopic partial meniscectomy. Data were analyzed to determine whether patients in this group had a diagnosis of knee OA within 12 months before surgery and for the presence of a new diagnosis of knee OA at 3, 6, and 12 months after APM. RESULTS: Five lakhs thousand nine hundred twenty-two patients with a mean age of 54.0 ± 8.52 years, with the majority female (52.0%), were included. A total of 197,871 patients underwent APM without a diagnosis of knee OA at the time of the procedure. Of these patients, 109,427 (55.3%) had a previous diagnosis of knee OA within 12 months preceding surgery, and 24,536 (12.4%), 15,596 (7.9%), and 13,301 (6.7%) patients were diagnosed with knee OA at 3, 6, and 12 months after surgery, respectively. CONCLUSION: Despite evidence against APM in patients with knee OA, more than half of the patients (55.3%) had a previous diagnosis of OA within 12 months of surgery and 27.0% received a new diagnosis of knee OA within one year of surgery. A notable number of patients had a diagnosis of knee OA either before or shortly after APM.

The Effect of Intra-articular Hyaluronic Acid Injections and Payer Coverage on Total Knee Arthroplasty Procedures: Evidence From Large US Claims Database.

Background: There is debate regarding the efficacy of intra-articular (IA) hyaluronic acid (HA) injections for the management of knee osteoarthritis (OA). This study aimed to determine if IA HA utilization and payer coverage of viscosupplementation affected the prevalence of total knee arthroplasty (TKA) procedures and the age of TKA patients. Methods: We performed a retrospective analysis from 2014 to 2020 using a large national commercial claims data set. We analyzed the number of TKA procedures and the age of the patients in states that covered IA HA vs those with limited coverage. Mixed random effects and slopes models were used to identify the impact of the IA HA injections. Results: Of 7,335,301 patients with knee OA, 440,606 (6.0%) received a TKA procedure at an average age of 59 years. The rate of TKA procedures increased by 0.56% per year (95% confidence interval [CI] 0.46-0.66; P < .001). Payer coverage of IA HA injections had no effect on TKA prevalence (P = .926). The age of surgical patients increased yearly by 0.15 years (95% CI 0.12-0.18; P < .001), regardless of IA HA injections (P = .990). After controlling for demographics and comorbidities, patients that received an IA HA injection had a higher probability of receiving a subsequent TKA (odds ratio = 2.83; 95% CI 2.80-2.87; P < .001); this finding was conditional of patients' age at the first diagnosis of knee OA. Conclusions: Additional clinical trials should be employed to identify the role of HA injections in the treatment armamentarium for knee OA.

Evaluation of the Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system as a guide to surgical technique selection.

BACKGROUND CONTEXT: The role of fusion in degenerative spondylolisthesis (DS) is controversial. The Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system was developed to assist surgeons in surgical technique selection based on individual patient characteristics. This system has not been clinically validated as a guide to surgical technique selection. PURPOSE: The purpose of this study was to determine if outcomes vary with different surgical techniques across the CARDS categories. STUDY DESIGN/SETTING: Prospective cohort study performed at one Swiss and one American spine center. PATIENT SAMPLE: Five hundred eight patients with DS undergoing surgical treatment. OUTCOME MEASURES: Core Outcomes Measure Index (COMI) at 3 months and 12 months postoperatively. METHODS: Patients undergoing surgery for DS were enrolled at 2 institutions and classified according to the CARDS system using dynamic radiographs. The Core Outcome Measure Index (COMI) was completed preoperatively, and 3 and 12 months postoperatively. Surgical technique was classified as uninstrumented (decompression alone or decompression with uninstrumented fusion) or instrumented (decompression with pedicle screw instrumentation with or without interbody fusion). Unadjusted analyses and mixed effect models compared COMI scores between the two surgery technique groups (uninstrumented vs instrumented), stratified by CARDS category over time. Reoperation rates were also compared between the surgery technique groups stratified by CARDS category. Partial funding was given through NASS grant for clinical research. RESULTS: Five hundred five out of 508 patients enrolled in the study had sufficient data to be classified according to CARDS. Seven percent were classified as CARDS A, 28% as CARDS B, 48% as CARDS C, and 17% as CARDS D (CARDS A most "stable," CARDS D least "stable"). One hundred and thirty-three patients (26%) underwent decompression alone, 30 (6%) underwent decompression and uninstrumented fusion, 42 (8%) underwent decompression and posterolateral instrumented fusion, and 303 (60%) underwent decompression with posterolateral and interbody instrumented fusion. Patients in the least "stable" categories tended to be less likely to be treated with an uninstrumented technique (CARDS D 19% vs 32% for the other categories, p=.10). There were no significant differences in 3 or 12-month COMI scores between surgical technique groups stratified by CARDS category in the unadjusted or adjusted analyses. In the unadjusted analyses, there was a trend towards less improvement in 12-month COMI change score in the CARDS D patients in the uninstrumented group compared to the instrumented group (-2.7 vs -4.1, p=.10). Reoperation rates were not significantly different between the surgical technique groups stratified by CARDS category. CONCLUSIONS: In general, outcomes for uninstrumented and instrumented surgical techniques were similar across the CARDS categories. Surgeons likely took factors included in CARDS into account during surgical technique selection. This resulted in a low number of CARDS D (n=15) patients being treated with uninstrumented techniques, which limited the statistical power of this analysis. As such, this study does not validate CARDS as a useful classification system for surgical technique selection in DS.