ABSTRACT
INTRODUCTION: The effect of social drivers of health (SDOH) on readmissions and costs after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is poorly understood. Policies such as the Hospital Readmissions Reduction Program have targeted overall readmission reduction, using value-based strategies to improve healthcare quality. However, the implications of SDOH on these outcomes are not yet understood. We hypothesized that the area deprivation index (ADI) as a surrogate for SDOH would markedly influence readmission rates and healthcare costs in the 90-day postprocedural period for THA and TKA. METHODS: We used the 100% US fee-for-service Medicare claims data from 2019 to 2021. Patients were identified using diagnosis-related groups. Our primary outcomes included 90-day unplanned readmission after hospital discharge and cost of care, treated as "high cost" if > 1 standard deviation above the mean. The relationships between ADI and primary outcomes were estimated with logistic regression models. RESULTS: A total of 628,399 patients were included in this study. The mean age of patients was 75.6, 64% were female, and 7.8% were dually eligible for Medicaid. After full covariate adjustment, readmission was higher for patients in more deprived areas (high Area Deprivation Index (ADI)) (low socioeconomic status (SES) group OR: 1.30 [95% confidence intervals 1.23, 1.38]). ADI was associated with high cost before adjustment (low SES group odds ratio 1.08 [95% confidence intervals 1.04, 1.11], P < 0.001), although, after adjustment, this association was lost. DISCUSSION: This analysis highlights the effect of SDOH on readmission rates after THA and TKA. A nuanced understanding of neighborhood-level disparities may facilitate targeted strategies to reduce avoidable readmissions in orthopaedic surgery. Regarding cost, although there is some association between ADI and cost, this study may illustrate that ADI for THA and TKA is not sufficiently granular to identify the contribution of social drivers to elevated costs.
ABSTRACT
BACKGROUND: Recent mandates from the Center for Medicare and Medicaid Services (CMS) require United States hospitals to disclose healthcare service pricing. Yet, there's a gap in understanding how state-level factors affect hospital service pricing, like total shoulder arthroplasty (TSA). Comprehending these influences can help policymakers and healthcare providers manage costs and improve care access for vulnerable populations. The purpose of this study was to examine the effect of state characteristics such as partisan lean, Certificate of Need (CON) status, and Medicaid expansion, on TSA price. METHODS: TSA price data was extracted from the Turquoise Health Database using CPT code 23472. State partisan lean was determined by evaluating each state during the 2020 election year for its legislature (both senate and house), governor, presidential vote, and Insurance Commissioner affiliation, categorizing states as either "Republican-leaning" or "Democratic-leaning." CON status, Medicaid expansion, area deprivation index (ADI), and population density information was obtained from publicly available sources. Multivariable regression models were used to assess the relationship between these factors and TSA price. RESULTS: The study included 2,068 hospitals nationwide. The median (IQR) price of TSA across these hospitals was $12,607 ($9,185). In the multivariable analysis, hospitals in Republican-leaning states were associated with a significantly greater price of +$210 (p = 0.0151), while Medicaid expansion was also associated with greater price +$1,878 (p < 0.0001). CON status was associated with a significant reduction in TSA prices of -$2,880 (p < 0.0001). In North Carolina an ADI >85 was associated with a reduction in price (p = 0.0045), while urbanization designation did not significantly impact TSA price (p = 0.8457). CONCLUSION: This cross-sectional observational study found that Republican-leaning states and Medicaid expansion were associated with increased TSA prices, while an ADI >85 and CON laws were associated with reduced TSA prices.
ABSTRACT
Background: Artificial intelligence (AI) in medicine has primarily focused on diagnosing and treating diseases and assisting in the development of academic scholarly work. This study aimed to evaluate a new use of AI in orthopaedics: content generation for professional medical education. Quality, accuracy, and time were compared between content created by ChatGPT and orthopaedic surgery clinical fellows. Methods: ChatGPT and 3 orthopaedic adult reconstruction fellows were tasked with creating educational summaries of 5 total joint arthroplasty-related topics. Responses were evaluated across 5 domains by 4 blinded reviewers from different institutions who are all current or former total joint arthroplasty fellowship directors or national arthroplasty board review course directors. Results: ChatGPT created better orthopaedic content than fellows when mean aggregate scores for all 5 topics and domains were compared (P ≤ .001). The only domain in which fellows outperformed ChatGPT was the integration of key points and references (P = .006). ChatGPT outperformed the fellows in response time, averaging 16.6 seconds vs the fellows' 94 minutes per prompt (P = .002). Conclusions: With its efficient and accurate content generation, the current findings underscore ChatGPT's potential as an adjunctive tool to enhance orthopaedic arthroplasty graduate medical education. Future studies are warranted to explore AI's role further and optimize its utility in augmenting the educational development of arthroplasty trainees.
ABSTRACT
Background: The optimal duration and choice of antibiotic for fracture-related infection (FRI) is not well defined. This study aimed to determine whether antibiotic duration (≤6 vs >6 weeks) is associated with infection- and surgery-free survival. The secondary aim was to ascertain risk factors associated with surgery- and infection-free survival. Methods: We performed a multicenter retrospective study of patients diagnosed with FRI between 2013 and 2022. The association between antibiotic duration and surgery- and infection-free survival was assessed by Cox proportional hazard models. Models were weighted by the inverse of the propensity score, calculated with a priori variables of hardware removal; infection due to Staphylococcus aureus, Staphylococcus lugdunensis, Pseudomonas or Candida species; and flap coverage. Multivariable Cox proportional hazard models were run with additional covariates including initial pathogen, need for flap, and hardware removal. Results: Of 96 patients, 54 (56.3%) received ≤6 weeks of antibiotics and 42 (43.7%) received >6 weeks. There was no association between longer antibiotic duration and surgery-free survival (hazard ratio [HR], 0.95; 95% CI, .65-1.38; P = .78) or infection-free survival (HR, 0.77; 95% CI, .30-1.96; P = .58). Negative culture was associated with increased hazard of reoperation or death (HR, 3.52; 95% CI, 1.99-6.20; P < .001) and reinfection or death (HR, 3.71; 95% CI, 1.24-11.09; P < .001). Need for flap coverage had an increased hazard of reoperation or death (HR, 3.24; 95% CI, 1.61-6.54; P = .001). Conclusions: The ideal duration of antibiotics to treat FRI is unclear. In this multicenter study, there was no association between antibiotic treatment duration and surgery- or infection-free survival.
ABSTRACT
INTRODUCTION: Racial and ethnic disparities in orthopaedic surgery are well documented. However, the extent to which these persist in fracture care is unknown. This study sought to assess racial disparities in the postoperative surgical and medical management of patients after diaphyseal tibia fracture fixation. METHODS: Patients with surgically treated tibial shaft fractures from October 1, 2015, to December 31, 2020, were identified in the MarketScan® Medicaid Database. Exclusion criteria included concurrent fractures or amputation. Outcomes included 2-year postoperative complications, reoperation rates, and filled prescriptions. Surgically-treated Black and White cohorts were propensity-score matched using nearest-neighbor matching on patient demographics, comorbidities, fracture pattern and severity, and fixation type. Chi-square tests and survival analyses (Kaplan-Meier and Cox proportional hazard models) were conducted. RESULTS: 5,472 patients were included, 2,209 Black and 3,263 White patients. After matching, 2,209 were retained in each cohort. No significant differences in complication rates were observed in the matched Black vs White cohorts. Rates of reoperation, however, were significantly lower in Black as compared to White patients (28.5 % vs. 35.5 % rate, risk difference = 7.0 % (95 % confidence interval (CI): 4.2 % to 9.7 %)). Implant removal was also significantly lower in Black (17.9 %) vs. White (25.1 %) patients (Risk difference = 7.2 %, (95 %CI: 4.8 % to 9.6 %)). The adjusted hazard ratio comparing the reoperation rate in Black versus White patients was 0.77 (95 %CI: 0.69-0.82, p < 0.0001). Significantly lower proportions of Black vs White patients filled at least one prescription for benzodiazepine, antidepressants, strong opiates, or antibiotics at every time point post-index. DISCUSSION: Fewer resources were used in post-operative management after surgical treatment of tibial shaft fractures for Black versus White Medicaid-insured patients. These results may be reflective of the undertreatment of complications after tibia fracture surgery for Black patients and highlight the need for further interventions to address racial disparities in trauma care.
Subject(s)
Healthcare Disparities , Medicaid , Postoperative Complications , Tibial Fractures , Adult , Female , Humans , Male , Middle Aged , Young Adult , Black or African American/statistics & numerical data , Fracture Fixation/statistics & numerical data , Fracture Fixation/methods , Fracture Fixation, Internal , Healthcare Disparities/statistics & numerical data , Healthcare Disparities/ethnology , Medicaid/statistics & numerical data , Postoperative Care , Postoperative Complications/epidemiology , Reoperation/statistics & numerical data , Retrospective Studies , Tibial Fractures/surgery , United States/epidemiology , White/statistics & numerical dataABSTRACT
BACKGROUND: The purpose of this study is to systematically review the evidence in the literature to ascertain the functional outcomes, range of motion (ROM), and complication and reoperation rates after revision reverse shoulder arthroplasty (RSA) for a failed primary total shoulder arthroplasty (TSA) or hemiarthroplasty (HA). METHODS: Two independent reviewers performed the literature search based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the EMBASE, MEDLINE, and The Cochrane Library databases. Studies were included if they reported clinical outcomes for revision RSA for a failed primary TSA or HA. RESULTS: Our review found 23 studies including 1041 shoulders (627 TSA and 414 HA) meeting our inclusion criteria. The majority of patients were female (66.1%), with an average age of 69.0 years (range: 39-93 years) and a mean follow-up of 46.3 months. American Shoulder and Elbow Surgeons and visual analog scale pain scores improved from 32.6 to 61.9 and 6.7 to 2.7, respectively. ROM results include forward flexion, abduction, and external rotation, which improved from 59.4° to 107.7°, 50.7° to 104.4°, and 19.8° to 26.3°, respectively. Only 1 of the 10 studies reporting internal rotation found a statistically significant difference, with the mean internal rotation improving from S1-S3 preoperatively to L4-L5 postoperatively for patients undergoing HA. The overall complication rate and reoperation rate were 23.4% and 12.5%, respectively. The most common complications were glenoid component loosening (6.0%), fracture (periprosthetic, intraoperative, or other scapula fractures) (n = 4.7%), and infection (n = 3.3%). CONCLUSIONS: Revision RSA for a failed primary TSA and HA has been shown to result in excellent functional outcomes and improved ROM, suggesting that patients who have failed TSA or HA may benefit from a revision RSA.
ABSTRACT
BACKGROUND: Although risk calculators are used to prognosticate postoperative outcomes following revision total hip and knee arthroplasty (total joint arthroplasty [TJA]), machine learning (ML) based predictive tools have emerged as a promising alternative for improved risk stratification. This study aimed to compare the predictive ability of ML models for 30-day mortality following revision TJA to that of traditional risk-assessment indices such as the CARDE-B score (congestive heart failure, albumin (< 3.5 mg/dL), renal failure on dialysis, dependence for daily living, elderly (> 65 years of age), and body mass index (BMI) of < 25 kg/m2), 5-item modified frailty index (5MFI), and 6MFI. METHODS: Adult patients undergoing revision TJA between 2013 and 2020 were selected from the American College of Surgeons National Surgical Quality Improvement Program database and randomly split 80:20 to compose the training and validation cohorts. There were 3 ML models - extreme gradient boosting, random forest, and elastic-net penalized logistic regression (NEPLR) - that were developed and evaluated using discrimination, calibration metrics, and accuracy. The discrimination of CARDE-B, 5MFI, and 6MFI scores was assessed individually and compared to that of ML models. RESULTS: All models were equally accurate (Brier score = 0.005) and demonstrated outstanding discrimination with similar areas under the receiver operating characteristic curve (AUCs, extreme gradient boosting = 0.94, random forest = NEPLR = 0.93). The NEPLR was the best-calibrated model overall (slope = 0.54, intercept = -0.004). The CARDE-B had the highest discrimination among the scores (AUC = 0.89), followed by 6MFI (AUC = 0.80), and 5MFI (AUC = 0.68). Albumin < 3.5 mg/dL and BMI (< 30.15) were the most important predictors of 30-day mortality following revision TJA. CONCLUSIONS: The ML models outperform traditional risk-assessment indices in predicting postoperative 30-day mortality after revision TJA. Our findings highlight the utility of ML for risk stratification in a clinical setting. The identification of hypoalbuminemia and BMI as prognostic markers may allow patient-specific perioperative optimization strategies to improve outcomes following revision TJA.
ABSTRACT
OBJECTIVES: Postoperative delirium is an acute neurocognitive complication that can have adverse effects on outcomes of geriatric patients after undergoing hip fracture surgery. The objective of this study was to examine the efficacy of preoperative steroids in preventing postoperative delirium after hip fracture surgery. DATA SOURCES: A systematic review and meta-analysis was performed using PubMed, SPORTDiscus, CINAHL, MEDLINE, and Web of Science from database inception until September 28, 2023. STUDY SELECTION: Inclusion criteria were randomized controlled trials of patients who underwent surgical intervention for hip fracture, were examined for postoperative delirium, and used preoperative steroids. DATA EXTRACTION: Data included the risk of postoperative delirium, postoperative all-cause infection, and postoperative hyperglycemia. Articles were graded via the Cochrane Collaboration's tool. DATA SYNTHESIS: Statistical analysis included a random-effects binary model with relative risk, 95% confidence intervals along with a defined "number needed to treat" threshold (number needed to treat). RESULTS: Four randomized controlled trials were included from 128 articles initially retrieved. Patients (n = 416; average age: 82.2 ± 2.2 years) underwent surgical intervention for hip fracture after receiving either preoperative steroids (n = 209) or control interventions (n = 207). There was a statistically significant decrease in the incidence of postoperative delirium among patients who received preoperative steroids (12.9%; 27 cases) as compared with patients who received control interventions (26.7%; 55 cases) after hip fracture surgery ( P < 0.001; RR: 0.84). The absolute risk difference was 13.8%, and the number needed to treat was 7.2 patients. There was no statistically significant difference in the risk of postoperative all-cause infection among patients who received preoperative steroids as compared with patients who received normal saline as placebo after hip fracture surgery ( P = 0.850; RR: 0.96). CONCLUSIONS: The utilization of preoperative steroids seems to decrease the risk of postoperative delirium after hip fracture surgery in elderly adults. Furthermore, this decreased risk of postoperative delirium was not associated with a significant increase in postoperative infection, indicating possible safety of preoperative steroid administration. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Subject(s)
Delirium , Hip Fractures , Postoperative Complications , Preoperative Care , Randomized Controlled Trials as Topic , Humans , Hip Fractures/surgery , Delirium/prevention & control , Delirium/etiology , Preoperative Care/methods , Aged , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Aged, 80 and overABSTRACT
INTRODUCTION: Existing research has established a correlation between post-traumatic mental health conditions, including anxiety and depression, and various aspects of recovery, such as pain exacerbations, reduced functional recovery, and lowered patient satisfaction. However, the influence of pre-existing mental health conditions on orthopaedic trauma outcomes has not been thoroughly investigated. The objective of this study was to systematically review literature addressing the association between pre-existing mental health conditions and patient outcomes following surgical interventions for lower extremity fractures in non-geriatric populations. METHODS: A systematic literature review was conducted using Medline, Embase, and Scopus databases following PRISMA-ScR guidelines to select studies that examined lower extremity orthopaedic trauma outcomes in relation to pre-existing mental health conditions. Studies that evaluated patients with surgically treated lower extremity fractures and a history of mental health conditions such as anxiety, depression, or mood disorders were included. Studies with a mean patient age above 65 years of age were excluded to focus on non-geriatric injury patterns. RESULTS: The systematic review identified 12 studies investigating the relationship between surgical outcomes of orthopaedic lower extremity fractures and pre-existing mental health disorders in non-geriatric populations. Studies included patients with pelvis, femur, tibia, and ankle fractures. A majority (83%) of these studies demonstrated that patients with pre-existing mental health diagnoses had inferior functional outcomes, heightened pain levels, or an increase in postoperative complications. DISCUSSION: The presence of pre-existing mental health conditions, particularly anxiety and depression, may predispose orthopaedic trauma patients to an elevated risk of suboptimal functional outcomes, increased pain, or complications after surgical intervention for lower extremity fractures. Future research should focus on interventions that mitigate the impact of mental health conditions on orthopaedic outcomes and patient wellness in this population.
Subject(s)
Ankle Fractures , Leg Injuries , Orthopedics , Humans , Aged , Mental Health , Leg Injuries/complications , Leg Injuries/surgery , Lower Extremity/surgery , Lower Extremity/injuries , PainABSTRACT
As the health care landscape evolves toward value-based care and emphasizes health-related social needs, the importance of developing health policies and digital health solutions that foster health equity and risk-based reimbursement strategies has grown. Orthopaedic surgery, catering to a diverse patient population but challenged by a lack of workforce diversity, encounters distinct opportunities and obstacles in adopting digital health technologies for delivering equitable, high-value care. The integration of health-related social needs into the emerging value-based care model and risk-based reimbursement policies is important. Furthermore, the potential of incorporating robust artificial intelligence governance and big data analytics to enhance patient outcomes and support orthopaedic surgeons in treating their patient populations should be studied. There are crucial considerations for creating comprehensive digital health platforms tailored for orthopaedic surgery, and the significance of specialty-specific advocacy and collaboration among clinicians, policymakers, and MedTech companies cannot be understated.
Subject(s)
Artificial Intelligence , Orthopedic Procedures , Humans , Delivery of Health CareABSTRACT
Background: Orthopedic Relief Services International (ORSI), in partnership with the Foundation for Orthopedic Trauma and the department of Orthopedic Surgery of La Paix University Hospital in Haiti, has developed a year-round Orthopedic Grand Round series. This series is moderated by Haitian faculty, features presentations by American orthopedic surgeons, and is broadcast to major state hospitals in Haiti for residents and attendings. Objective: To introduce clinical concepts and increase knowledge in an area that is medically underserved, especially in the field of orthopedics, through lectures that tailor to the educational needs of Haiti. Methods: Topics for lecture series are requested by Haitian attending orthopedic surgeons and residents in collaboration with American orthopedic surgeons to meet the educational needs of the residents in Haiti. These lectures reflect the case mix typically seen at state hospitals in Haiti and consider the infrastructural capacity of participating centers. Grand rounds are held an average of twice per month for an hour each, encompassing an educational lesson followed by an open forum for questions and case discussion. Feedback is taken from Haitian residents to ensure the sessions are beneficial to their learning. Findings and Conclusions: To date 95 sessions hosted by 32 lecturers have been completed over Zoom between the US and Haiti. The fourth year of the lecture series is currently ongoing with an expansion of topics. In an underserved medical area such as Haiti, programs that educate local surgeons are crucial to continuing the growth and development of the medical community. Programs like this have the potential to contribute to the educational infrastructure of countries in need, regardless of the specialty. The model of this program can be used to produce similar curricula in various specialties and areas around the world.
Subject(s)
Internship and Residency , Orthopedics , Teaching Rounds , Humans , Haiti , Hospitals, State , Curriculum , Orthopedics/educationABSTRACT
BACKGROUND: Reverse shoulder arthroplasty (RSA) is a widely performed surgical procedure to address various shoulder pathologies. Several studies have suggested that radiographic soft-tissue thickness may play a role in predicting complications after orthopedic surgery, but there have been limited studies determining the use of radiographic soft-tissue thickness in RSA. The purpose of this study was to evaluate whether radiographic soft-tissue thickness could predict clinical outcomes after RSA and compare the predictive capabilities against body mass index (BMI). We hypothesized that increased radiographic shoulder soft-tissue thickness would be a strong predictor of operative time, length of stay (LOS), and infection in elective RSA. MATERIAL AND METHODS: A retrospective review of patients undergoing RSA at an academic institution was conducted. Preoperative radiographic images were evaluated including measurements of the radius from the humeral head center to the skin (HS), deltoid radius-to-humeral head radius ratio (DHR), deltoid size, and subcutaneous tissue size. Different correlation coefficients were used to analyze various types of relationships, and the strength of these associations was classified based on predefined boundaries. Subsequently, multivariable linear and logistic regressions were performed to determine whether HS, DHR, deltoid size, and subcutaneous tissue size could predict LOS, operative time, or infection while controlling for patient factors. RESULTS: HS was the most influential factor in predicting both operative time and LOS after RSA, with strong associations indicated by standardized ß coefficients of 0.234 for operative time and 0.432 for LOS. Subcutaneous tissue size, deltoid size, and DHR also showed stronger predictive values than BMI for both outcomes. In terms of prosthetic joint infection, HS, deltoid size, and DHR were significant predictors, with HS demonstrating the highest predictive power (Nagelkerke R2 = 0.44), whereas BMI did not show a statistically significant association with infection. Low event counts resulted in wide confidence intervals for odds ratios in the infection analysis. CONCLUSION: Greater shoulder soft-tissue thickness as measured with concentric circles on radiographs is a strong predictor of operative time, LOS, and postoperative infection in elective primary RSA patients.
ABSTRACT
PURPOSE: Interfragmentary strain influences whether a fracture will undergo direct and indirect fracture healing. Orthopedic trauma surgeons modulate strain and create optimal biomechanical environments for specific fracture patterns using fixation constructs. However, objective intraoperative interfragmentary strain measurement does not currently inform fixation strategy in common practice. This review identifies potential methods and technologies to enable intraoperative strain measurement for guiding optimal fracture fixation strategies. METHODS: PubMed, Scopus, and Web of Science were methodologically queried for manuscripts containing terms related to "bone fracture," "strain," "measurement," and "intraoperative." Manuscripts were systematically screened for relevance and adjudicated by three reviewers. Relevant articles describing methods to measure interfragmentary strain intraoperatively were summarized. RESULTS: After removing duplicates, 1404 records were screened initially. There were 49 manuscripts meeting criteria for in-depth review. Of these, four reports were included in this study that described methods applicable to measuring interfragmentary strain intraoperatively. Two of these reports described a method using instrumented staples, one described optical tracking of Kirschner wires, and one described using a digital linear variable displacement transducer with a custom external fixator. CONCLUSION: The four reports identified by this review describe potential methods to quantify interfragmentary strain after fixation. However, further studies are needed to confirm the precision and accuracy of these measurements across a range of fractures and fixation methods. Additionally, described methods require the insertion and likely removal of additional implants into the bone. Ideally, innovations that measure interfragmentary strain intraoperatively would provide dynamic biomechanical feedback for the surgeon to proactively modulate construct stability.
Subject(s)
Fracture Fixation, Internal , Fractures, Bone , Humans , Fracture Fixation, Internal/methods , Fractures, Bone/surgery , Bone Wires , Fracture Healing , Decision Making , Biomechanical PhenomenaABSTRACT
INTRODUCTION: This is a retrospective study evaluating the use of a new six-item modified frailty index (MF-6) to predict short-term outcomes of patients receiving surgery for lower extremity fractures. METHODS: Patients older than 65 years undergoing open reduction and internal fixation for lower extremity, pelvic, and acetabulum fractures were identified from the American College of Surgeons National Surgical Quality Improvement Program. The MF-6 was calculated by assigning one point for each of six common conditions. Multivariable analysis was used to compare patients with an MF-6 of <3 and ≥3. Outcome measures included complications, mortality, readmission, revision surgery, and length of stay. An area under the curve receiver operator analysis was conducted to compare the MF-6 with MF-5, an existing five-item frailty index. RESULTS: Nine thousand four hundred sixty-three patients were included. Patients with an MF-6 of ≥3 were at markedly higher risk of discharge destination other than home (Exp[B] = 2.09), mortality (Exp[B] = 2.48), major adverse events (Exp[B] = 2.16), and readmission (Exp[B] = 1.82). Receiver-operating curve analysis demonstrated an area under the curve of 0.65 for mortality, 0.62 for major adverse events, and 0.62 for discharge destination other than home, all of which outperformed the MF-5. DISCUSSION: The MF-6 was correlated with a 30-day postoperative incidence of infectious complications, readmission, and discharge destination. MF-6 scores can be used to risk-stratify patient populations as shifts to value-based care continue to develop.
Subject(s)
Frailty , Hip Fractures , Spinal Fractures , Humans , Aged , Retrospective Studies , Frailty/complications , Patient Readmission , Postoperative Complications/etiology , Spinal Fractures/complications , Hip Fractures/surgery , Hip Fractures/complications , Lower ExtremityABSTRACT
OBJECTIVE: To assess the impact of severe obesity on 30-day adverse event rates, hospital length of stay (LOS), readmissions, and projected costs after operative fixation of tibia and femur fractures. METHODS: An analysis of the American College of Surgeons National Surgical Quality Improvement Project database from 2012 to 2019 of isolated femoral shaft and tibial shaft fracture fixation cases was conducted. Adverse events, LOS, readmission rates, and operative time were queried for severe obesity, defined as body mass index greater than 40, compared with other patients. Student t tests were used to assess continuous variables. Fisher exact test and odds ratios were used for categorical variables. A cost-analysis was also performed to quantify the effect of severe obesity on projected health care expenditures. RESULTS: A total of 10,436 patients were included with 7.0% of patients categorized as severely obese. Severely obese patients had higher infectious complication rates (9.0% vs. 6.7%, P = 0.013, OR 1.36, 95% CI 1.04-1.78), readmission rates (7.9% vs. 5.6%, P-value = 0.008, OR 1.44, 95% CI 1.08-1.91), longer LOS (5.8 days SD ±10.2 vs. 5.0 days SD ±7.9 days, P-value = 0.008), and longer operative times (mean 115 minutes ± 56 minutes SD vs. 103 minutes SD ±54 minutes, P-value = <0.001). Severe obesity resulted in an estimated $4258.07 additional health care expenditures per patient compared with nonobese patients. This amounted to a projected added total expenditure of $3.09 million USD in the overall cohort. CONCLUSION: Severe obesity is associated with significantly worse 30-day outcomes and higher readmission rates for patients undergoing operative fixation of tibial shaft and femoral shaft fractures. Health policy considerations should be made to incentivize care for this patient population, particularly in trauma where modification of risk factors before surgery is often not feasible. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Subject(s)
Femoral Fractures , Obesity, Morbid , Tibial Fractures , Humans , Obesity, Morbid/complications , Obesity, Morbid/epidemiology , Tibia , Retrospective Studies , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Tibial Fractures/complications , Femoral Fractures/epidemiology , Femur , Obesity/complications , Treatment OutcomeABSTRACT
BACKGROUND: The US Food and Drug Administration (FDA) oversees medical device regulation and oversight in the United States, and the majority of shoulder arthroplasty devices are cleared via the 510(k) pathway, in which a device demonstrates "substantial equivalence" to a previously cleared predicate. The purpose of this study was to determine an interconnected ancestral network of shoulder arthroplasty devices and determine equivalency ties to devices subsequently recalled by the FDA for design-related issues. METHODS: The FDA 510(k) database was used to identify all legally marketed shoulder arthroplasty devices from May 28, 1976, to July 1, 2021. Direct predicate information obtained via clearance summary documents associated with each device was used to generate an ancestral genealogy network for all shoulder arthroplasty devices cleared between July 1, 2020, and July 1, 2021. FDA design recalls were analyzed, and the number of descendant devices was calculated for each recalled device. RESULTS: An evaluation of all 476 510(k) premarket notification pathway-cleared shoulder devices since 1976 identified 0-313 descendant devices for each. Eighty of these devices (16.8%) have since been recalled, of which 10 recalls were directly related to implant design issues. Furthermore, among 29 of the most recently cleared devices (July 1, 2020-July 1, 2021), 16 (55.2%) claim predicates devices that have subsequently been withdrawn from the market because of design-related failures. CONCLUSIONS: Shoulder arthroplasty devices are linked together via an interconnected FDA 510(k) equivalency approval network dating back to 1976 despite substantive changes in material specifications and device design, many of which have since been recalled. Many of the cleared modern devices claim predicates based on subsequently recalled prostheses.
Subject(s)
Arthroplasty, Replacement, Shoulder , Humans , United States , Device Approval , Arthroplasty , United States Food and Drug Administration , Databases, FactualABSTRACT
OBJECTIVE: To compare the adverse event profile and patient comorbidity profile of lower extremity orthopaedic trauma patients admitted via interfacility transfer (IT) to direct admission (DA) patients from home. METHODS: A total of 39,497 patients from 2012 to 2019 were identified in the American College of Surgeon National Surgical Quality Improvement Program database. DA patients were compared with IT patients for differences in preoperative comorbidities, adverse events, length of stay, and readmissions in the 30-day postoperative period. Student t tests were used to assess continuous variables. Pearson χ 2 test and odds ratios (ORs) were used for categorical variables. RESULTS: The IT group comprised 7167 patients, and the DA group comprised 32,330 patients. IT patients were on average older (65.5 vs. 58.8 years, P < 0.01), more likely to be American Society of Anesthesiologists Status >2 ( P < 0.01), and had a worse comorbidity profile for numerous preoperative risk factors. IT patients had significantly higher rates of mortality [3.3% vs. 1.4%; odds ratio (OR) 2.29; 95% confidence interval (CI), 1.96-2.77], major complications (10.2% vs. 6.1%; OR 1.74; 95% CI, 1.60-1.91), significantly higher readmission rates (5.8% vs. 4.8%, P < 0.01, OR 1.22 95% CI, 1.09-1.36), and more infectious complications (7% vs. 4.7%; OR 1.54; 95% CI, 1.38-1.71) than DA patients. Transfer remained a significant factor predicting major adverse events in regression analysis controlling for patient characteristics and fracture type ( P < 0.01; B 1.197; 95% CI, 1.09-1.32). CONCLUSIONS: This study revealed that IT patients undergoing operative management of pelvic, acetabular, and lower extremity fractures are at a significantly increased risk of major complications, readmission, and have a higher morbidity burden than DA patients. As healthcare transitions to value-based care and bundled payments, hospitals that accept a high volume of ITs will face exposure to added risk and financial penalties without adequate policy protections. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Subject(s)
Fractures, Bone , Leg Injuries , Transition to Adult Care , Humans , United States/epidemiology , Patient Readmission , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Fractures, Bone/epidemiology , Fractures, Bone/surgery , Fractures, Bone/complications , Leg Injuries/complications , Risk Factors , Lower Extremity/surgery , Retrospective StudiesABSTRACT
Background: The clearance of medical devices by the US Food and Drug Administration (FDA) has remained largely unchanged since 1976, when the Medical Device Amendments Act established a system classifying devices into 3 categories based on safety risk to the consumer. The system allows for the clearance of many orthopedics devices through the 510(k) premarket pathway, which is based on "predicate ancestors," previously cleared devices that are "substantially equivalent." Purpose: We sought to trace the predicate ancestors of modern total knee arthroplasty (TKA) devices, specifically those recently cleared for marketing by the 510(k) pathway that claim substantial equivalence to prior devices, despite potential differences in material science and design. In addition, we aimed to document which TKA devices cleared by the 510(k) pathway have substantial equivalence to devices that have since been recalled by the FDA. Methods: To create a comprehensive list of TKA devices, we used FDA Classification Process Codes corresponding to knee arthroplasty to search the FDA's databases from May 28, 1976, the start of the 510(k) process, to May 1, 2021. Of 1309 resulting devices, 89 were excluded as not related to arthroplasty. For each of the remaining devices, we analyzed the descendant devices that claimed substantial equivalence, either directly or indirectly. We used data of recalled designs to determine both the absolute number of recalled devices and the number of currently cleared devices that presented substantial equivalence claims upon predicates that have since been recalled. Results: Of 1220 knee devices cleared or approved, 6 (0.5%) were approved through the premarket approval application (PMA) process, and 1214 (99.5%) were cleared through the 510(k) pathway. Of the 1214 cleared devices, 217 (17.9%) have been recalled and 204 (16.8%) have ties to at least 1 recalled predicate device linked through generational claims of substantial equivalence. We found 90 devices (7.4%) linked directly to a recalled predicate device. Conclusions: Most knee arthroplasty devices are cleared for marketing through reliance on a complex web of equivalency to previously cleared predicates. We found that many TKA devices thus connected were cleared decades apart, with multiple iterations of design and material modifications. Many currently marketed TKA devices have claimed equivalency to predicates that have been recalled. Our findings suggest the need for novel regulatory strategies that might further patient safety while balancing the unwanted effects of regulatory burden.
ABSTRACT
The advent of value-based care as a component of the United States health care system is part of a broader paradigm shifting away from fee-for-service payment models in favor of alternative reimbursement incentives tied to quality and outcome metrics. Bundled care models, gainsharing agreements, and other cost containment measures, although promising, may induce unintended systemwide consequences for orthopedic trauma surgeons who often specialize in tending to costly multiply injured patients and marginalized populations. This article reviews facets of value-based care applicable to orthopedic trauma surgery with an emphasis on public health and ethical considerations for policymakers and orthopedic surgeons.