Multisite Study of the Management of Musculoskeletal Infection After Trauma: The MMUSKIT Study.

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.

Outcomes and Complications of Revision Reverse Shoulder Arthroplasty Following Failed Primary Anatomical Shoulder Arthroplasty or Hemiarthroplasty: A Systematic Review.

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 following 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 PRISMA guidelines, utilizing 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 1,041 shoulders (627 TSA, 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) with a mean follow-up of 46.3 months. ASES and VAS pain scores improved from 32.6 to 61.9 and 6.7 to 2.7, respectively. ROM results including forward flexion, abduction and external rotation that improved from 59.4° to 107.7°, 50.7° to 104.4°, and 19.8° to 26.3° respectively. Only one out of the ten studies reporting internal rotation found a statistically significant difference with 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%). CONCLUSION: Revision RSA for a failed primary TSA and HA has been shown to result in excellent functional outcomes and improved ROM suggesting patients who have failed TSA or HA may benefit from a revision RSA.

Prediction of 30-Day Mortality Following Revision Total Hip and Knee Arthroplasty: Machine Learning Algorithms Outperform CARDE-B, 5-Item, and 6-Item Modified Frailty Index Risk Scores.

BACKGROUND: Although risk calculators are used to prognosticate postoperative outcomes following revision total hip and knee 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 of <25 kg/m2), 5-item (5MFI), and 6-item modified frailty index (6MFI). METHODS: Adult patients undergoing revision TJA between 2013 and 2020 were selected from the ACS-NSQIP database and randomly split 80:20 to compose the training and validation cohorts. There were three ML models - extreme gradient boosting (XGB), random forest (RF), 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 (AUC) under the receiver operating characteristic curve (XGB = 0.94, RF = 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.

The Utilization of Preoperative Steroids Safely Decreases the Risk of Postoperative Delirium in Geriatric Patients After Hip Fracture Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

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.

The association of pre-existing mental health conditions and patient outcomes after lower extremity orthopaedic trauma: a scoping review.

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.

Leveraging Artificial Intelligence and Digital Health to Address Health-Related Social Needs and Optimize Risk-Based Value in Orthopaedic Surgery.

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.

Haitian State Hospital Orthopedic Grand Rounds Series: A Virtual Curriculum to Address Global Surgery Needs.

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.

Association between radiographic soft-tissue thickness and increased length of stay, operative time, and infection rate after reverse shoulder arthroplasty.

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.

Interfragmentary strain measurement post-fixation to guide intraoperative decision making: a narrative review.

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.

Use of a Six-Item Modified Frailty Index to Predict 30-day Adverse Events, Readmission, and Mortality in Older Patients Undergoing Surgical Fixation of Lower Extremity, Pelvic, and Acetabular Fractures.

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.

Severe Obesity Worsens 30-Day Surgical Outcomes and Projected Costs in Operative Femoral Shaft and Tibial Shaft Fractures.

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.

Shoulder arthroplasty device clearance: an ancestral network analysis.

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.

Interfacility Transfer Patients With Pelvic, Acetabular, and Lower Extremity Fractures Are at Higher Risk for Major Complications and Readmissions.

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.

The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.

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.

Value-Based Care in Orthopedic Trauma.

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.

Orthopaedic Urgent Care Versus the Emergency Department: Cost Implications for Low-energy Fracture Care.

INTRODUCTION: This study compared costs, length of visit, and utilization trends for patients with fractures seen in an immediate care orthopaedic center (I-Care) versus the emergency department (ED) in a major metropolitan area. METHODS: A retrospective chart review of consecutive patients seen on an outpatient basis in the ED and I-Care over a 6-month period was conducted. Patient demographics, procedures done, care category, estimated costs, and disposition information were included for statistical analysis. Within the low-acuity fracture care group, a cost-comparison analysis was conducted. RESULTS: A total of 610 patients met inclusion criteria with 311 seen in I-Care and 299 in the ER. I-Care patients were more likely to have low-acuity injuries compared with ED patients (60.1% versus 18.1%, P < 0.001). The length of visit was longer for patients seen in the ED compared with I-Care (6.1 versus 1.43 hours, P value < 0.001). A cost analysis of low-acuity patients revealed that an estimated $62,150 USD could have been saved in healthcare costs by the initial diversion of low-acuity patients seen in the ER to I-Care during the study period. DISCUSSION: These results suggest that the I-Care orthopaedic urgent care model is a more cost-effective and more efficient alternative to the ED for patients with fractures requiring procedural treatment and low-acuity patients managed on an outpatient basis.

Treatment of a Chronic Elbow Dislocation With an Internal Fixator.

SUMMARY: There are a variety of ways to treat chronic elbow dislocations, including repeat closed reduction and immobilization, transarticular pinning, temporary bridge plating, hinged or rigid external fixation, and internal fixator application. Although each have distinct advantages and disadvantages, avoiding recurrent instability is critical. The internal-fixator is a relatively new option to maintain a stable, concentric reduction and facilitate early range of motion. This article and accompanying video describe the surgical technique of using an internal joint stabilizer for treatment of a chronically unstable ulnohumeral joint.

Staged Reconstruction of a Moore Type 4 Fracture Dislocation, Parts 1 and 2.

SUMMARY: High-energy tibial plateau fractures are associated with knee fracture dislocations and concomitant ligamentous injury. Both bony and ligamentous injuries can require surgical fixation, often requiring a multidisciplinary team and staged treatment. This article and accompanying video describe the workup and treatment of a Moore type 4 tibial plateau rim compression fracture with posterolateral corner and anterior cruciate ligament rupture that underwent open reduction internal fixation of the tibial plateau with posterolateral corner reconstruction and then staged anterior cruciate ligament reconstruction with quad tendon autograft.

The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.

BACKGROUND: In the United States, the most overwhelming medical devices, including hip arthroplasty devices, are cleared for human use by demonstration of "substantial equivalence" to a predicate, previously approved marketed device. This study examined the predicate approval lineages of modern hip arthroplasty devices. METHODS: The FDA 510(k) and premarket approval databases were searched to identify all approved hip arthroplasty devices since the database's inception in May 28, 1976. Ancestral predicate lineages were created using approval documentation, and FDA recall data were used to identify recalled devices. RESULTS: Evaluating 2,118 hip arthroplasty devices approved from 1976 to 2020, we found that the number of descendant devices for each approved device varied from 0 to 242. Many descendant devices served as predicates for other devices, leading to frequent indirect connections of equivalency across a wide range of implants. Two hundred forty-six (11.6%) devices were recalled for various reasons, with 34 (1.6%) related to implant design. Evaluating the predicate lineage of 51 hip arthroplasty devices approved between May 1, 2019, and May 1, 2020, 32 of 51 (62.7%) devices were linked, directly or indirectly, to predicates which were recalled for design issues. CONCLUSIONS: The lineage of hip arthroplasty device predicates reflects a complex ancestral web of equivalency across a wide range of implants, although their material and design properties may be different. Several currently approved devices were approved on substantial equivalence claims to products that were subsequently recalled from the market for implant design issues. These findings present several policy considerations for regulators, physicians, and the medical device industry.