Medical Malpractice Trends in Foot and Ankle Surgery.

Medical malpractice lawsuits can place significant economic and psychologic burden on a provider. Orthopedic surgery is one of the most common subspecialties involved in malpractice claims. There is currently no study examining malpractice lawsuits within foot and ankle surgery. Accordingly, the purpose of this work is to examine trends in malpractice claims in foot and ankle surgery. The Westlaw legal database was queried for lawsuits pertaining to foot and ankle surgery from 2008 to 2018. Only cases involving medical malpractice were included for analysis. All available details pertaining to the cases were collected. This included plaintiff demographic and geographic data. Details regarding the cases were also collected such as anatomical location, pathology, complications, and case outcomes. Forty-nine malpractice lawsuits pertaining to foot and ankle were identified. Most plaintiffs in these cases were adult females, and the majority of cases occurred in the northeast (53.1%). The most common anatomical region involved in claims involved the forefoot (29%). The majority of these claims involved surgery (65%). Infection was the most common complication seen in claims (22%). The jury ruled in favor of the defendant surgeon in most cases (73%). This is the first study to examine trends in medical malpractice within foot and ankle surgery. Infection was the most frequent complication seen in claims and forefoot surgery was the most common anatomic location. A large portion of claims resulted after nonoperative treatment. A better understanding of the trends within malpractice claims is crucial to developing strategies for prevention.

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.

BACKGROUND: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants. MATERIALS AND METHODS: The US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature. RESULTS: Among 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion. CONCLUSION: Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants. LEVEL OF EVIDENCE: Level IV; Case Series from Large Database Analysis; Treatment Study.

Total ankle arthroplasty and ankle arthrodesis in rheumatic disease patients: An analysis of outcomes and complications using the National Inpatient Sample (NIS) database.

INTRODUCTION: Rheumatoid arthritis (RA), can manifest as an inflammatory arthropathy in the ankle. As a result, this study sought to examine the role of RA with respect to complications in patients undergoing either total ankle arthroplasty or ankle arthrodesis by utilizing the National Inpatient Sample to assess for correlations. METHODS: Admissions for TAA and AA were extracted from the National Inpatient Sample using primary ICD-9-CM diagnosis codes. Patients aged 18-65 years with a duration of hospital stay of >3 days and isolated complications were included. Multivariable regression was then performed within matched groups to determine differences. RESULTS: There was decreased risk of myocardial infarction, pulmonary embolism, surgical site infection, and urinary tract infection in patients with RA. Postoperative development of pneumonia was seen at a higher rate in patients with RA. CONCLUSION: RA is not associated with a markedly increased complication burden in the appropriately chosen surgical candidate for ankle arthrodesis and ankle arthroplasty.

Comparison of 3D Printed Spherical Implants versus Femoral Head Allografts for Tibiotalocalcaneal Arthrodesis.

Successful tibiotalocalcaneal (TTC) arthrodesis can be difficult to achieve in patients with bulk bone defects even with the use of femoral head allograft. Retrograde intramedullary nail placement through custom 3-dimensional (3D) spherical implants is an innovative option for these patients. The purpose of this study was to compare fusion rates, graft resorption, and complication rates between patients undergoing TTC fusion with 3D sphere implants versus femoral head allografts. Patients who underwent TTC arthrodesis with an intramedullary nail along with a 3D spherical implant (n = 8) or femoral head allograft (n = 7) were included in this study. The rate of successful fusion of the tibia, calcaneus, and talar neck to the 3D sphere or femoral head allograft was compared between the groups. The rate of total fused articulations was significantly higher in the 3D sphere group (92%) than the femoral head allograft group (62%; p = .018). The number of patients achieving successful fusion of all 3 articulations was higher in the 3D sphere group (75%) than the femoral head allograft group (42.9%, p = .22). The rate of graft resorption was significantly higher in the femoral head allograft group (57.1%) than the 3D sphere group (0%, p = .016). There were no significant differences between the groups in terms of complications. These data demonstrate that the use of a custom 3D printed sphere implant is safe in patients with severe bone loss undergoing TTC arthrodesis with a retrograde intramedullary nail and may result in improved rates of successful arthrodesis.

3D kinematics of tibiotalar motion in patients with mobile bearing and fixed bearing total ankle arthroplasty: In vivo videofluoroscopic feasibility study.

BACKGROUND: As total ankle arthroplasty (TAA) is an increasingly common surgical intervention for patients with end-stage ankle arthritis, there is a need to better understand the dynamic performance of prosthetic implants during activities of daily living. Our purpose was to quantify and compare relative tibiotalar motion during gait in persons with a fixed-bearing (FB) and mobile-bearing (MB) total ankle arthroplasty. We hypothesized a FB prosthesis would have lower tibiotalar range of motion (ROM). METHODS: Patients at least 12 months postoperative with either a FB (n=5) or MB (n=3) total ankle arthroplasty were tested. We used high-speed biplanar videoradiography to quantify tibiotalar kinematics during self-selected gait. Angular and linear ROM in three axes were compared between the groups. RESULTS: ROM for dorsiflexion-plantarflexion, internal-external rotation, and inversion-eversion angles in FB subjects averaged 7.47±4.05°, 7.39±3.63°, and 4.51±2.13°, respectively. ROM in MB subjects averaged 6.74±2.04°, 6.28±4.51°, and 5.68±2.81°, respectively. Linear ROM along anteroposterior, mediolateral, and superior-inferior axes in FB subjects averaged 1.47±2.07 mm, 1.13±1.49 mm, and 0.28±0.30 mm, respectively. Linear ROM in MB subjects averaged 0.68±1.44 mm, 0.60±1.41 mm, and 0.20±0.13 mm, respectively. We found no significant difference between the two groups for any of these ROM parameters (p>0.05). CONCLUSION: Total ankle arthroplasty using either FB or MB design appears to confer similar ankle motion during the gait cycle in this biplanar fluoroscopic model. LEVEL OF EVIDENCE: Level IV, case series.

Risk Factors for Prolonged Opioid Use After Ankle Fracture Surgery.

BACKGROUND: The incidence of ankle fractures is increasing, and risk factors for prolonged opioid use after ankle fracture fixation are unknown. Accordingly, the purpose of this study was to investigate risk factors that lead to prolonged opioid use after surgery. METHODS: The Truven MarketScan database was used to identify patients who underwent ankle fracture surgery from January 2009 to December 2018 based on CPT codes. Patient characteristics were collected, and patients separated into 3 cohorts based on postoperative opioid use (no refills, refills within 6 months postoperative, and refills within 1 year postoperatively). The χ2 test and multivariate analysis were performed to assess the association between risk factors and prolonged use. RESULTS: In total, 34 691 patients were analyzed. Comorbidities most highly associated with prolonged opioid use include 2+ preoperative opioid prescriptions (odds ratio [OR] = 11.92; P < .001), tobacco use (OR = 2.03; P < .001), low back pain (OR = 1.81; P < .001), depression (OR = 1.48; P < .001), diabetes (OR = 1.34; P < .001), and alcohol abuse (OR = 1.32; P < .001). CONCLUSION: Opioid use after ankle fracture surgery is common and may be necessary; however, prolonged opioid use and development of dependence carries significant risk. Identifying those patients at an increased risk for prolonged opioid use can aid providers in tailoring their postoperative pain regimen. LEVELS OF EVIDENCE: Prognostic, Level III.

Body Mass Index (BMI) Cutoffs and Racial, Ethnic, Sex, or Age Disparities in Patients Treated With Total Ankle Arthroplasty.

Background: The rising prevalence of obesity among American adults has disproportionately affected Black adults and women. Furthermore, body mass index (BMI) has historically been used as a relative contraindication to many total joint arthroplasty (TJA) procedures, including total ankle arthroplasty. The purpose of this study was to investigate potential disparities in patient eligibility for total ankle arthroplasty based on race, ethnicity, sex, and age by applying commonly used BMI cutoffs to the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Methods: Patients in the ACS-NSQIP database who underwent TAA from 2011 to 2020 were retrospectively reviewed in a cross-sectional analysis. BMI cutoffs of <50, <45, <40, and <35 were then applied. The eligibility rate for TAA was examined for each BMI cutoff, and findings were stratified by race, ethnicity, sex, and age. Independent t tests, chi-squared tests, and Fisher exact tests were performed to compare differences at an α = 0.05. Results: A total of 1215 of 1865 TAA patients (65.1%) were included after applying the exclusion criteria. Black patients had disproportionately lower rates of eligibility at the most stringent BMI cutoff of <35 (P = .004). Hispanic patients had generally lower rates of eligibility across all BMI cutoffs. In contrast, Asian American and Pacific Islander patients had higher rates of eligibility at the BMI cutoffs of <35 (P = .033) and <40 (P = .039), and White non-Hispanic patients had higher rates of eligibility across all BMI cutoffs. Females had lower eligibility rates across all BMI cutoffs. Ineligible patients were also younger compared to eligible patients across all BMI cutoffs. Conclusion: Stringent BMI cutoffs may disproportionately disqualify Black, female, and younger patients from receiving total ankle arthroplasty. Level of Evidence: Level III, retrospective cross-sectional study.

Preoperative Depression is Associated With Increased Complications Following Ankle Fracture Surgery.

BACKGROUND: The effects of preoperative depression following ankle fracture surgery remains unknown. The purpose of this study is to investigate the relationship between preoperative depression and outcomes following ankle fracture surgery. METHODS: This retrospective study used the Truven MarketScan database to identify patients who underwent ankle fracture surgery from January 2009 to December 2018. Patients with and without a diagnosis of preoperative depression were identified based on International Classification of Diseases (ICD) codes. Chi-squared and multivariate analyses were performed to determine the association between preoperative depression and postoperative complications following ankle fracture surgery. RESULTS: In total, 107,897 patients were identified for analysis, 13,981 of whom were diagnosed with depression (13%). Preoperative depression was associated with the increased odds for postoperative infection (odds ratio [OR]: 1.33, confidence interval [CI]: 1.20-1.46), wound complications (OR: 1.13, CI: 1.00-1.28), pain-related postoperative emergency department visits (OR: 1.58, CI: 1.30-19.1), 30-day and 90-day readmissions (OR: 1.08, CI: 1.03-1.21 and OR: 1.13, CI: 1.07-1.18), sepsis (OR: 1.39, CI: 1.12-1.72), and postoperative development of complex regional pain syndrome (OR: 1.46, CI: 1.18-1.81). CONCLUSION: Preoperative depression is associated with increased complications following ankle fracture surgery. Further studies are warranted to investigate the degree to which depression is a modifiable risk factor. LEVEL OF EVIDENCE: 3.

The Rise of Total Ankle Arthroplasty Use: A Database Analysis Describing Case Volumes and Incidence Trends in the United States Between 2009 and 2019.

BACKGROUND: Ankle arthrodesis has been the mainstay treatment for end-stage ankle arthritis. The popularity of total ankle arthroplasty (TAA) has been on the rise due to improved implant design and postoperative outcomes. The purpose of this study was to describe the basic epidemiology and trends of annual procedure volumes and incidence in the general American population as well as in different population subgroups from 2009 to 2019. We hypothesize that the incidence of TAA has significantly risen while the median length of hospital stay has decreased nationwide. METHODS: The IBM MarketScan database was queried for patients who underwent TAA from January 2009 to December 2019 based on Current Procedural Terminology coding. Population estimates from the US Census Bureau were used to calculate the annual incidence of TAA. Procedural volume and incidence were calculated for annual sums, gender, age subgroups, inpatient and outpatient TAA, as well as in four statistical geographic regions in the United States. Median length of hospital stay was calculated and trended annually for inpatient TAA. RESULTS: A total of 41,060 primary TAAs were identified in the database from 2009 to 2019, in which 52.5% were performed in males. Annual volumes increased by 136.1%, from 2180 to 5147 procedures nationwide. Incidence reported per 100 000 population increased by 120.8%. Both inpatient and outpatient procedures have increased, by 242.5% and 86.6%, respectively. Median length of hospital stay decreased from 3 days in 2009 to 1 day in 2019 and did not differ between genders. Growth in incidence was demonstrated in males and females above the age of 54 years with the largest growth in annual incidence found between 65 and 74 years. Incidence rose in the South and West of the United States by 111.8% and 136.5%, respectively. CONCLUSION: We found that annual volumes and incidence rates of primary TAA has increased between 2009 and 2019. Although both inpatient and outpatient surgery have become more frequent, inpatient volumes and incidence have increased almost 3 times more than those of outpatient surgery. Length of hospital stay decreased over the study years. When adjusted for the same study period, the cumulative annual growth rates of TAA were found to be 2 times greater than total knee arthroplasty and 3.6 times greater than total hip arthroplasty. LEVEL OF EVIDENCE: Level III, retrospective database review.

Non-emergent Conditions of the Ankle, Hindfoot, and Midfoot in Elderly Patients Are as Mobility Limiting as Congestive Heart Failure.

BACKGROUND: Mobility limitations are well linked to increased morbidity and mortality. Older patients with chronic pathologies of the foot and ankle can suffer from significant mobility limitations; however, the magnitude of limitation experienced by this cohort is not well characterized. Conversely, the effects of congestive heart failure (CHF) on patient mobility are routinely assessed via the New York Heart Association (NYHA) classification. New York Heart Association classification is determined by a patient's physical activity limitation and is strongly correlated to functional status. We hypothesized that non-emergent conditions of the foot and ankle would be as mobility limiting as CHF. METHODS: Life-Space Mobility Assessments (LSAs) were prospectively collected from orthopaedic patients at their preoperative visits and from CHF patients at a cardiology clinic. Patients over the age of 50 years were included in this study. Congestive heart failure patients NYHA class II or greater were included. The non-emergent foot and ankle cohort included Achilles tendonitis, ankle joint cartilage defects, ankle arthritis, subtalar arthritis, and midfoot arthritis. Patient demographics and LSA scores were analyzed using Mann-Whitney U and chi-squared tests. RESULTS: A total of 96 elderly, non-emergent foot and ankle operative patients and 45 CHF patients met inclusion criteria. All medical comorbidities, except smoking status, were significantly more prevalent in the CHF cohort. No statistical difference was observed between CHF and preoperative foot and ankle LSA scores (56.1 vs 62.4, P = .320). Life-Space Mobility Assessment scores in the foot and ankle cohort were significantly improved relative to CHF patients, at 6-month and 1-year postoperative visits (P = .028, P < .0001, respectively). CONCLUSION: Non-emergent ankle, hindfoot, and midfoot pathology is associated with similar mobility limitation to that of NYHA class II and III CHF. Older patients undergoing elective foot and ankle procedures exceeded the mobility of CHF patients at 6 months post-operation, and the mobility gains persisted at 1-year post-operation. LEVELS OF EVIDENCE: Level II: Prospective cohort study.

Projections and Epidemiology of Total Ankle and Revision Total Ankle Arthroplasty in the United States to 2030.

Background: Total ankle arthroplasty (TAA) utilization is increasing in the United States. As the incidence of this procedure grows, it is important for providers to understand the future projections for ankle arthroplasty and more importantly revision total ankle arthroplasty (rTAA). Methods: The National Inpatient Sample (USA) was queried from 2005 to 2017 for all TAA and rTAA. Poisson and linear regression analysis was performed to project annual incidence of TAA and rTAA to 2030, with subgroup analyses on septic rTAA. Results: There were 5315 TAAs performed in 2017, a 564% (P < .001) increase when compared with the TAAs performed in 2005. From 2017 to 2030, the incidence of TAAs is projected to increase from 110% to 796% (P < .001). There were 1170 rTAAs performed in 2017, a 155% (P < .001) increase when compared with rTAAs performed in 2005. There was a 256% increase in the incidence of septic rTAAs from 2005 to 2017 with a projected increase between 22% and 120% by 2030. Conclusions: The incidence of both TAAs and rTAAs is projected to significantly increase over the next decade. Given the known risk factors of TAA and rTAA, these findings reinforce the need for thoughtful consideration when selecting patients for TAA.

Effect of Obesity on Patient-Perceived Outcomes After First Metatarsophalangeal Joint Arthrodesis.

BACKGROUND: While first metatarsophalangeal joint (MTPJ) arthrodesis is a common and effective procedure, there is a paucity of studies examining obesity's effect on outcomes of 1st MTPJ arthrodesis. This study's purpose was to evaluate patient-reported outcomes following 1st MTPJ arthrodesis in obese versus non-obese patients. METHODS: A retrospective cohort study of 94 patients undergoing first MTPJ fusion over the age of 18 with a diagnosis of hallux valgus or hallux rigidus was performed. Surgical and postoperative outcomes were examined preoperatively and at 6 and 12 months follow-up via Visual Analog Pain scale (VAS), and Short Form 36 (SF-36) surveys, and data were stratified into 2 patient groups: BMI < 30 (n = 62, mean age 63.9 ± 9.1 and ≥ 30 (n = 32, mean age 61.9 ± 8.4). RESULTS: Average overall VAS and SF-36 physical component scores improved significantly at 6 months (P < .001, .006) and 1 year postoperative visits (P < .001, .007) with no differences in survey scores, outcomes, or complications between weight groups. CONCLUSION: Our study showed first MTPJ fusion improves short-term pain and physical quality-of-life in arthritic obese and non-obese patients without differences in nonunion, complications, or patient-reported measures. LEVEL OF EVIDENCE: Level III, Prognostic, Case-Control Study.

Development of a selective small-molecule inhibitor of Kir1.1, the renal outer medullary potassium channel.

The renal outer medullary potassium (K+) channel, ROMK (Kir1.1), is a putative drug target for a novel class of loop diuretic that would lower blood volume and pressure without causing hypokalemia. However, the lack of selective ROMK inhibitors has hindered efforts to assess its therapeutic potential. In a high-throughput screen for small-molecule modulators of ROMK, we previously identified a potent and moderately selective ROMK antagonist, 7,13-bis(4-nitrobenzyl)-1,4,10-trioxa-7,13-diazacyclopentadecane (VU590), that also inhibits Kir7.1. Because ROMK and Kir7.1 are coexpressed in the nephron, VU590 is not a good probe of ROMK function in the kidney. Here we describe the development of the structurally related inhibitor 2,2'-oxybis(methylene)bis(5-nitro-1H-benzo[d]imidazole) (VU591), which is as potent as VU590 but is selective for ROMK over Kir7.1 and more than 65 other potential off-targets. VU591 seems to block the intracellular pore of the channel. The development of VU591 may enable studies to explore the viability of ROMK as a diuretic target.

Avascular Necrosis of the Talus.

Talar osteonecrosis results from trauma to the fragile blood supply to the talus. Many etiologies exist that can cause talar osteonecrosis, with the most common being talar neck fractures. Patients with talar osteonecrosis frequently present with progressive ankle pain and limited range of motion. Treatment strategy depends primarily on the stage of disease. Conservative care in the form of medications and bracing treatment can be beneficial for patients with low functional status and early disease stages. Surgical options also exist for early disease without talar collapse that can potentially preserve the tibiotalar joint. Once talar collapse develops, surgical treatment is move invasive and typically involves an arthrodesis or talus arthroplasty. Although some treatment guidelines exist based on the disease stage, talar osteonecrosis is a complex problem, and treatment strategy should always be determined on a case-by-case basis carefully examining all clinical aspects.

Complications Associated with the Surgical Management of Hallux Rigidus.

Hallux rigidus is the most common arthritic pathology of the foot. This review article discusses the pathophysiology and common clinical presentation of hallux rigidus. Furthermore, we discuss multiple classification systems that categorize the arthritic process and guide management. Surgical interventions include cheilectomy, Moberg osteotomy, synthetic cartilage implants, interpositional arthroplasty, and arthrodesis. The common complications are reviewed, and the rates of these complications highlighted. Surgical options for hallux rigidus globally have successful outcomes with low rates of complications when done on appropriate patients.

Management of Anterior Tibialis Tendon Ruptures.

Anterior tibialis tendon ruptures, while relatively infrequent ruptures, are commonly identified in delayed fashion, which can lead to significant impairments in patient gait and function. Surgical treatment is typically required to restore ankle dorsiflexion function and proper gait. Depending on various patient-specific factors, tendon quality and excursion, and chronicity, a range of treatment options are available to manage these patients, from nonsurgical care to surgical treatment. Surgical options include direct repair, local tendon transfer, autograft tendon reconstruction, and allograft tendon reconstruction. Additional procedures may need to be considered. Despite the variety of described surgical procedures, limited evidence-based guidelines are available to direct surgeons in the most optimal treatment for their patients. In addition to the relevant anatomy, biomechanics, and pathoanatomy, the reconstructive armamentarium is detailed and reviewed here, along with outcomes and potential complications, to guide surgeons in the most appropriate treatment for their patients.

Three-dimensional Printing in Orthopaedic Surgery: Current Applications and Future Developments.

Three-dimensional (3D) printing is an exciting form of manufacturing technology that has transformed the way we can treat various medical pathologies. Also known as additive manufacturing, 3D printing fuses materials together in a layer-by-layer fashion to construct a final 3D product. This technology allows flexibility in the design process and enables efficient production of both off-the-shelf and personalized medical products that accommodate patient needs better than traditional manufacturing processes. In the field of orthopaedic surgery, 3D printing implants and instrumentation can be used to address a variety of pathologies that would otherwise be challenging to manage with products made from traditional subtractive manufacturing. Furthermore, 3D bioprinting has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform how we treat patients with debilitating musculoskeletal injuries. Although costs can be high, as technology advances, the economics of 3D printing will improve, especially as the benefits of this technology have clearly been demonstrated in both orthopaedic surgery and medicine as a whole. This review outlines the basics of 3D printing technology and its current applications in orthopaedic surgery and ends with a brief summary of 3D bioprinting and its potential future impact.

From Patient to Procedure: The Process of Creating a Custom 3D-Printed Medical Device for Foot and Ankle Pathology.

Three-dimensional (3D) printing technology has advanced greatly over the past decade and is being used extensively throughout the field of medicine. Several orthopaedic surgery specialties have demonstrated that 3D printing technology can improve patient care and physician education. Foot and ankle pathology can be complex as the 3D anatomy can be challenging to appreciate. Deformity can occur in several planes simultaneously and bone defects either from previous surgery or trauma can further complicate surgical correction. Three-dimensional printing technology provides an avenue to tackle the challenges associated with complex foot and ankle pathology. A basic understanding of how these implants are designed and made is important for surgeons as this technology is becoming more widespread and the clinical applications continue to grow within foot and ankle surgery.Levels of Evidence: Level V.

Intermediate-term Patient-Reported Outcomes and Radiographic Evaluation Following Intramedullary- vs Extramedullary-Referenced Total Ankle Replacement.

BACKGROUND: The purpose of this study was to report on the radiographic outcomes, clinical outcomes, and implant survivorship following extramedullary-referenced (EMr) vs intramedullary-referenced (IMr) total ankle replacement (TAR). METHODS: From May 2007 to February 2018, a consecutive series of patients with end-stage tibiotalar osteoarthritis undergoing TAR was enrolled in this study. Analyses were performed comparing IMr vs EMr components for patient-reported outcomes data, pre- and postoperative radiographic ankle alignment, concomitant procedures, and complications. Kaplan-Meier survivorship analyses served to determine implant reoperation and revision surgery. A total of 340 TARs were included with 105 IMr TAR and 235 EMr TAR. The mean follow-up was 5.3 years (±2.5, range 2-12). RESULTS: The absolute value for preoperative coronal alignment was significantly greater for IMr compared to EMr TAR (13.0 vs 6.4 degrees; P < .0001), but both groups achieved near neutral alignment postoperatively (1.4 vs 1.5 degrees; P = .6655). The odds of having a concomitant procedure was 2.7 times higher in patients with an IMr TAR (OR 2.7, CI 1.7-4.4; P < .0001). There were similar improvements in patient-reported outcome scores at 1 year and final follow-up (all P > .05). The 5-year implant survivorship was 98.6% for IMr vs 97.5% for EMr at final follow-up. CONCLUSION: The IMr and EMr TAR components had comparable postoperative alignment, patient-reported outcome scores, and complications. The 5-year implant survivorship was similar between the IMr and EMr groups. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Analysis of 408 Total Ankle Arthroplasty Adverse Events Reported to the US Food and Drug Administration From 2015 to 2018.

Background. Total ankle arthroplasty (TAA) use has increased with newer generation implants. Current reports in the literature regarding complications use data extracted from high-volume centers. The types of complications experienced by lower-volume centers may not be reflected in these reports. The purpose of this study was to determine a comprehensive TAA adverse event profile from a mandatory-reporting regulatory database. Methods. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2015 to 2018 to determine reported adverse events for approved implants. Results. Among 408 unique TAA device failures, the most common modes of failure were component loosening (17.9%), intraoperative guide or jig error (15.4%), infection (13.7%), and cyst formation (12.7%). In addition, the percentage distribution of adverse event failure types differed among implants. Conclusion. The MAUDE database is a publicly available method that requires mandatory reporting of approved device adverse events. Using this report, we found general agreement in types of complications reported in the literature, although there were some differences, as well as differences between implants. These data may more accurately reflect a comprehensive profile of TAA complications as data were taken from a database of all device users rather than only high-volume centers.Levels of Evidence: NA.