Association of Radiographic Soft Tissue Thickness With Revision Total Ankle Arthroplasty Following Primary Total Ankle Arthroplasty: A Minimum of 5-year Follow-up.

Background: The incidence of primary total ankle arthroplasty (TAA) is rising, with a corresponding increase in revision surgeries. Despite this, research on risk factors for revision TAA following primary TAA remains limited. Radiographic soft tissue thickness has been explored as a potential predictor for outcomes in hip, knee, and shoulder arthroplasty, but its role in TAA has not been assessed. This study aimed to assess the predictive value of radiographic soft tissue thickness for identifying patients at risk of requiring revision surgery following primary TAA. Methods: A retrospective study was conducted on 323 patients who underwent primary TAA between 2003 and 2019. Radiographic measurements of soft tissue thickness were obtained from preoperative radiographs. Two novel radiographic measures of soft tissue thickness were developed and assessed (tibial tissue thickness and talus tissue thickness). Clinical variables including age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, diabetes, smoking status, primary diagnosis, and implant type were recorded. Logistic regression analysis was used to assess the predictive value of soft tissue thickness and BMI for revision TAA. Results: The rate of revision surgery was 4.3% (14 of 323 patients). Patients requiring revision had significantly greater tibial tissue (3.54 vs 2.48 cm; P = .02) and talus tissue (2.79 vs 2.42 cm; P = .02) thickness compared with those not requiring revision. Both the tibial tissue thickness (odds ratio 1.16 [1.12-1.20]; P < .01) and the talus tissue thickness (odds ratio: 1.10 [1.05-1.15]; P < .01) measurements were significant predictors of revision TAA in multivariable logistic regression models. However, BMI was not a significant predictor of revision TAA. The two metrics demonstrated excellent interrater reliability. Conclusion: Greater soft tissue thickness was a better predictor of revision TAA compared with BMI. These findings suggest that radiographic soft tissue thickness may be a valuable tool for assessing the risk of the need for revision TAA following primary TAA. Further research is needed to validate and explore the potential impact on clinical practice. Level of Evidence: Level III, comparative study.

Diabetic management and infection risk in total ankle arthroplasty.

BACKGROUND: As total ankle arthroplasty (TAA) increases in popularity nationwide for the management of end-stage arthritis, it is essential to understand ways to mitigate the risk of infection. Diabetes increases the risk of infection due to compromised immunity and impaired wound-healing mechanisms. However, there is limited research on how diabetic management, inclusive of medications and glucose control, may impact infection risks post-TAA. This study aims to demonstrate the impact of diabetic management on the occurrence of periprosthetic joint infection (PJI) following TAA. METHODS: This was a retrospective study of patients who underwent a TAA at a single academic institution from March 2002 to May 2022. Patients with diabetes who developed an intraarticular infection following TAA were propensity score matched (1:3) to diabetic patients who did not. Data collection included demographics, implant types, diabetic medications, and preoperative hemoglobin A1c. PJI was diagnosed based on Musculoskeletal Infection Society (MSIS) criteria. Statistical analyses assessed differences in medication use, glucose control, and infection rates between groups. RESULTS: Of the 1863 patients who underwent TAA, 177 patients had a diagnosis of diabetes. The infection rate in patients with diabetes (2.8%) was higher than the total cohort rate (0.8%). Five patients with diabetes developed a PJI at an average of 2.2 months postoperatively. This cohort (n = 5) was compared to propensity score-matched controls (n = 15). There was no significant difference in diabetic medication use. Patients who developed PJI had higher rates of uncontrolled diabetes (60.0% vs. 6.7%) and average A1c levels (7.02% vs. 6.29%) compared to controls. CONCLUSION: Our findings suggest that the elevated risk of PJI observed in individuals with diabetes subsequent to TAA may be attributed not solely to the presence of diabetes, but to inadequate glycemic control. Effectively managing blood glucose levels is imperative for achieving favorable outcomes following TAA. LEVEL OF EVIDENCE: III.

Revision Total Ankle Arthroplasty Using the INBONE II System.

BACKGROUND: The utilization of total ankle arthroplasty (TAA) for managing severe ankle osteoarthritis has become increasingly common, leading to a higher occurrence of revision TAA procedures because of failure of primary TAA. This study aims to examine the clinical results associated with revision TAA using the INBONE II system. Given the growing number of TAA revision procedures and a focus on motion-preserving salvage options, we evaluated our early experience with revision TAA. METHODS: A retrospective analysis was conducted on a group of 60 presumed noninfected patients who underwent revision TAA with the INBONE II system. Detailed information was collected on patient demographics, implant characteristics, concurrent procedures, and complications. The implant survival was estimated using Kaplan-Meier analysis. RESULTS: The study revealed high complication rates but generally fair clinical outcomes for revision TAA using the INBONE II system. Complications were observed in 22 patients (36.7%), including persistent pain (n = 6), nerve injury/impingement (n = 5), infection (n = 3), fracture (n = 3), implant failure (n = 3), impaired wound healing (n = 2), and osteolysis (n = 3). The 3-year survivorship rate from reoperation was 92.0% (82.7%-100.0%) whereas the 3-year survivorship rate from major complications was 90.4% (80.8%-100.0%). CONCLUSION: We report high complication rates but generally fair clinical results for revision TAA utilizing the INBONE II system.

Younger Patients Undergoing Total Ankle Arthroplasty Experience Higher Complication Rates and Worse Functional Outcomes.

BACKGROUND: Although many patients with posttraumatic ankle arthritis are of a younger age, studies evaluating the impact of age on outcomes of primary total ankle arthroplasty (TAA) have revealed heterogenous results. The purpose of the present study was to determine the effect of age on complication rates and patient-reported outcomes after TAA. METHODS: We retrospectively reviewed the records of 1,115 patients who had undergone primary TAA. The patients were divided into 3 age cohorts: <55 years (n = 196), 55 to 70 years (n = 657), and >70 years (n = 262). Demographic characteristics, intraoperative variables, postoperative complications, and patient-reported outcome measures were compared among groups with use of univariable analyses. Competing-risk regression analysis with adjustment for patient and implant characteristics was performed to assess the risk of implant failure by age group. The mean duration of follow-up was 5.6 years. RESULTS: Compared with the patients who were 55 to 70 years of age and >70 years of age, those who were <55 years of age had the highest rates of any reoperation (19.9%, 11.7%, and 6.5% for the <55, 55 to 70, and >70-year age groups, respectively; p < 0.001), implant failure (5.6%, 2.9%, and 1.1% for the <55, 55 to 70, and >70-year age groups, respectively; p = 0.019), and polyethylene exchange (7.7%, 4.3%, and 2.3% for the <55, 55 to 70, and >70-year age groups, respectively; p = 0.021). Competing-risk regression revealed a decreased risk of implant failure for patients who were >70 of age compared with those who were <55 years of age (hazard ratio [HR], 0.21 [95% confidence interval (CI), 0.05 to 0.80]; p = 0.023) and for patients who were 55 to 70 years of age compared with those who were <55 years of age (HR, 0.35 [95% CI, 0.16 to 0.77]; p = 0.009). For all subscales of the Foot and Ankle Outcome Score (FAOS) measure except activities of daily living, patients who were <55 years of age reported the lowest (worst) mean preoperative and postoperative scores compared with those who were 55 to 70 years of age and >70 years of age (p ≤ 0.001). Patients who were <55 years of age had the highest mean numerical pain score at the time of the latest follow-up (23.6, 14.4, 12.9 for the <55, 55 to 70, and >70-year age groups, respectively; p < 0.001). CONCLUSIONS: Studies involving large sample sizes with intermediate to long-term follow-up are critical to reveal age-related impacts on outcomes after TAA. In the present study, which we believe to be the largest single-institution series to date evaluating the effect of age on outcomes after TAA, younger patients had higher rates of complications and implant failure and fared worse on patient-reported outcome measures. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

Comparison of Radiographic Talar Loosening Rates Between Salto-Talaris and INBONE II.

BACKGROUND: Despite substantial increase in total ankle arthroplasty (TAA) nationwide, there are few studies comparing flat-cut vs chamfer-cut talar systems in TAA with regard to radiographic aseptic loosening rates of the implant. METHODS: This retrospective study included 189 Salto-Talaris TAA and 132 INBONE II primary TAA with a minimum 1-year follow-up. Patient characteristics were obtained including gender, age at surgery, body mass index (BMI), smoking status, primary diagnosis, surgical time, and the presence of diabetes. Radiographic evidence for aseptic loosening was assessed. Statistical analysis was performed for comparison in outcomes between Salto-Talaris and INBONE II. RESULTS: The mean age of the study population was 63.5 ± 9.8 years at surgery. Mean follow-up was 4.9 ± 3.0 years. Radiographic aseptic loosening of the tibial implant showed no significant difference between the 2 groups: Salto-Talaris, 18%, and INBONE II, 18.9% (P = .829). Aseptic loosening of the talar implant also showed no significant difference between the 2 groups: Salto-Talaris, 1.6%, and INBONE II, 1.5% (P = .959). No variables, including the implant type, were found to contribute to the aseptic loosening rate of either the tibia or talus. CONCLUSION: In our cohort, we observed no difference in radiographic implant aseptic loosening between Salto-Talaris and INBONE II systems. LEVEL OF EVIDENCE: Level IV, retrospective case series study.

A Propensity Score Matched Exploration of Infection in Primary Total Ankle Arthroplasty.

BACKGROUND: Infection is a serious complication of primary total ankle arthroplasty (TAA) and can lead to implant failure and revision surgery. Various demographic, comorbidity, and surgical factors have been associated with an increased risk of infection. However, the evidence base remains limited, and further research is needed regarding infection in TAA. This study aims to analyze risk factors of infection and explore outcomes following infected TAA. METHODS: A retrospective cohort study was conducted using data from a single institution from 2002 to 2022. Patients who underwent primary TAA and had subsequent infection were identified through annual registry surveillance and matched using propensity score matching (PSM) based on various demographic, comorbidity, and surgical factors. Demographics were compared between the matched groups using Mann-Whitney U test and Fisher exact test. The outcomes following infection were identified and summarized using descriptive statistics. RESULTS: A total of 1863 patients who underwent primary TAA were identified, and 19 were diagnosed with an infection. The identifiable overall infection rate was 1.0%. After PSM, there were no significant differences in the difference in age, gender, BMI, and smoking status between the infected and control cohort. There was a statistically significant increase in the rate of diabetes in the infected cohort. The subsequent surgical intervention resulted in limb salvage in 18 (94.7%) cases. Out of the total number of cases, 2-stage revision to total ankle replacement was performed in 7 cases, whereas revision to arthrodesis and isolated polyethylene exchange were each carried out in 4 cases. One patient had to undergo amputation; however, at the time of the most recent follow-up, all patients were found to be free of infection. CONCLUSION: This study demonstrated high rates of a history of smoking and diabetes in the infected TAA cohort. The diabetes rate in the infected group was significantly higher than the noninfected controls. Two-stage revision to total ankle replacement was performed in 7 cases, and revision to arthrodesis and isolated polyethylene exchange were each carried out in 4 cases. Overall, a high rate of limb salvage was reported. LEVEL OF EVIDENCE: Level III, case-control study.

Republication of "Osteochondral Lesions of the Talus: Current Concepts in Diagnosis and Treatment".

Osteochondral lesions of the talus (OLTs) are a difficult pathologic entity to treat. They require a strong plan. Lesion size, location, chronicity, and characteristics such as displacement and the presence of subchondral cysts help dictate the appropriate treatment required to achieve a satisfactory result. In general, operative treatment is reserved for patients with displaced OLTs or for patients who have failed nonoperative treatment for 3 to 6 months. Operative treatments can be broken down into cartilage repair, replacement, and regenerative strategies. There are many promising treatment options, and research is needed to elucidate which are superior to minimize the morbidity from OLTs.

Preoperative incongruent subtalar joint predicts less favorable clinical outcome in total ankle arthroplasty.

BACKGROUND: This study aimed to determine the clinical effect of incongruent subtalar joint space on total ankle arthroplasty (TAA). METHODS: Thirty-four consecutive patients who underwent TAA were grouped according to the status of subtalar joint incongruency. A comparison of clinical and radiographic parameters between groups as well as multiple regression analysis was performed to identify contributing factors to the final functional outcome. RESULTS: The final American Orthopaedic Foot and Ankle Society (AOFAS) score was significantly higher in the congruent group compared to that of the incongruent group (p = 0.007). There were no significant differences between the two groups in measured radiographic angles. In multiple regression analysis, the female sex (p = 0.006) and incongruency of the subtalar joint (p = 0.013) were found to be significant contributing factors to the final AOFAS score. CONCLUSIONS: A thorough preoperative investigation should be taken into the state of the subtalar joint for TAA.

Clinical Outcomes and Complications of Simultaneous or Sequential Bilateral Total Ankle Arthroplasty: A Single-Center Comparative Cohort Study.

BACKGROUND: The risk-benefit profiles of simultaneous total ankle arthroplasty (TAA) compared with sequential TAA continue to be debated. There are limited case series reporting outcomes after bilateral TAA, with no previous comparison of simultaneous TAA with sequential TAA. Patients with bilateral pathology represent a unique population with an overall more debilitating condition. Thus, we aimed to compare bilateral simultaneous and sequential TAAs, including perioperative complications and patient-reported outcome measures. METHODS: We performed a comparative cohort study of patients who underwent primary bilateral TAA, performed in a simultaneous or sequential fashion, from 2007 to 2019 at a single academic center. Data on patient demographic characteristics, comorbidities, perioperative complications, reoperations, and implant failures were collected. Patient-reported outcome measures included preoperative and postoperative visual analog scale (VAS) scores for pain, Short Form-36 Health Survey (SF-36) scores, and Short Musculoskeletal Function Assessment (SMFA) scores. RESULTS: A total of 50 patients (100 ankles) were included, with 25 patients (50 ankles) each in the bilateral simultaneous and sequential cohorts. The mean follow-up was 52.2 ± 27.3 months (range, 24 to 109 months). The mean time between sequential TAAs was 17.5 ± 20.1 months (range, 3 to 74 months). The mean patient age was 64.3 ± 10.6 years (range, 21 to 76 years), and 32 (64.0%) were men. The majority of patients (28 patients [56.0%]) had primary osteoarthritis. Both cohorts had equivalent preoperative patient-reported outcome measures and experienced improvements in all measures, which were maintained at the final follow-up with no significant between-group differences (all p > 0.05). There were no differences between the simultaneous TAA group and the sequential TAA group in perioperative complication rates (22.0% compared with 24.0%; p = 0.7788), reoperations (12.0% compared with 10.0%; p = 0.7354), 5-year reoperation-free survival (88.0% compared with 90.0%; p = 0.4612), or failure-free survival (100%). One patient in the simultaneous TAA cohort required metal component revision at 8 years postoperatively. CONCLUSIONS: The patient-reported outcome measures, complications, and prosthesis survival of patients who underwent bilateral simultaneous TAA were comparable with those of patients who underwent bilateral sequential TAA. We advocate that simultaneous bilateral TAA is a safe and effective method for the treatment of bilateral end-stage ankle osteoarthritis. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Midterm Prospective Evaluation of Structural Allograft Transplantation for Osteochondral Lesions of the Talar Shoulder.

BACKGROUND: In cases of large osteochondral lesions of the talus (OLTs), fresh structural or bulk osteochondral allograft transplantation has yielded favorable outcomes in several retrospective and few prospective case series. The purpose of this study was to prospectively evaluate patients who received fresh structural allograft transplantation of the talar shoulder. METHODS: A prospective evaluation of patients who received a fresh structural allograft of an OLT was performed. Preoperative imaging included magnetic resonance imaging (MRI) and/or computed tomography (CT) with plain radiographs. The following patient-reported outcomes questionnaires were administered preoperatively and yearly after surgery: 36-Item Short-Form Health Survey (SF-36), visual analog scale (VAS) for pain, and the Short Musculoskeletal Functional Assessment (SMFA). Preoperative and postoperative imaging were evaluated for allograft assimilation, evidence of arthritic changes, or functional range of motion abnormalities. RESULTS: Thirty-one patients with a mean age of 41.4 years (±14.1, range 18-69) underwent structural fresh osteochondral allograft transplantation to the talar shoulder and were included in this study. The mean follow-up was 56.2 months (±36.1, range 24-142). The majority of patients were female (n=17, 54.8%), reported some history of prior ankle trauma (n=21, 67.7%), and underwent prior ankle surgery (n=23, 74.2%). The mean lesion size on CT scan was 1879 mm3 (n = 27) compared to the mean lesion size of 3877 mm3 (n = 21) on MRI. There was a significant improvement in the mean preoperative VAS score (P < .0001), SF-36 score (P < .0005), SMFA bother index (P < .0015), and the SMFA function index (P < .0001) at final follow-up. A total of 15 (48.4%) patients underwent an additional surgery following their osteochondral allograft transplant, most commonly arthroscopic debridement or removal of hardware, performed at an average of 25.2 (±13.0) from their index procedure. There was one failure that required a total ankle replacement. The overall graft survival rate was 96.8%. CONCLUSION: Fresh, structural allograft transplantation resulted in significant improvement in patient-reported postoperative pain and function in patients suffering from OLTs. The graft survival rate was 96.8% at a mean of 56.2 months follow-up, with half of patients requiring a second procedure. LEVEL OF EVIDENCE: Level IV, prospective case series.

Treatment of Navicular Stress Fractures With an Algorithmic Approach.

BACKGROUND: Navicular stress fractures are becoming increasingly more common. There is no universal consensus on treatment. We provide an algorithm that we feel will be useful in determining treatment. METHODS: A retrospective study was performed on all patients having operative treatment of navicular stress fractures during a 10-year period. Acute fractures were treated with open reduction internal fixation. Chronic fractures greater than 3 months were treated with open reduction and internal fixation (ORIF) and iliac crest bone grafting. Chronic fractures with evidence of sclerosis, avascular changes, or those who failed previous surgery were treated with ORIF, iliac crest bone grafting, as well as vascular bone grafting. Patients' pain scores were recorded and a return-to-sports scale was used. Radiographic union was compared among the 3 groups using computed tomographic (CT) scans or radiographs. RESULTS: Forty-three patients were identified. Fifteen received ORIF alone, 12 were treated with ORIF and bone graft, and 16 had ORIF with vascularized bone grafting. No difference was found among the median age of the 3 groups. In terms of radiographic healing, 3 patients in the ORIF group received radiographs alone. All other patients had follow-up CT scans. ORIF alone group had 80% union, ORIF with bone graft had 75% union, and ORIF with vascularized bone grafting had 100% union. Return to sports did not show any difference among the 3 groups. CONCLUSION: The algorithm dividing navicular stress fractures into 3 distinct groups with different operative techniques helped us address these difficult cases. Vascularized bone grafting certainly appeared to be beneficial for the more difficult cases. LEVEL OF EVIDENCE: Level IV, case series.

Avascular Necrosis of the Talus After Subchondroplasty.

BACKGROUND: Subchondroplasty (SCP) is a relatively new procedure, developed in 2007 for the treatment of bone marrow lesions (BMLs), that has shown promising results in the knee through several different case series. The foot and ankle literature, however, is sparse, with only a few documented case reports or case series. At our institution, we have identified several patients with complications after this specific procedure. As a result, we report our case series of patients who developed talar avascular necrosis (AVN) after undergoing SCP. METHODS: A retrospective review was performed of patients who underwent SCP for a talar BML at our facility or who were referred to our facility after undergoing SCP at an outside institution. Patients were included if they developed radiographic evidence of talar AVN after the procedure. Patient demographics, comorbidities, concomitant intraoperative procedures, complications, and subsequent interventions were reviewed. RESULTS: Seven patients were identified as having radiographic evidence of talar AVN after SCP. Average time interval was 23 months postoperative from index procedure to radiographic confirmation of AVN. Two of the index procedures were performed at our institution, whereas 5 of the index procedures were performed at outside institutions and referred for further management. Three patients had documented risk factors for AVN before the SCP procedure. All 7 patients were symptomatic from the AVN. CONCLUSION: We identified 7 patients who went on to develop talar AVN after having undergone SCP. LEVEL OF EVIDENCE: Level IV, case series.

Effect of Gender Differences on Patient-Reported Outcomes and Complications in Total Ankle Replacement.

BACKGROUND: The purpose of this study was to evaluate gender differences in patient outcomes and complications following total ankle replacement (TAR). METHODS: Consecutive patients who underwent primary TAR from July 2007 through May 2016 were prospectively followed and retrospectively reviewed. Demographic, operative, patient-reported outcomes (PROs), and complication data were collected and analyzed. PROs included the visual analog scale (VAS), 36-Item Short-Form Health Survey (SF-36), American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale, and Short Musculoskeletal Function Assessment (SMFA). A total of 475 patients were evaluated, including 248 males (52.2%) and 227 females (47.8%) with an average of 56.8 months follow-up. RESULTS: Women were more likely to have inflammatory arthritis (13.7% vs 2.8%; P < .01) and significantly worse preoperative SF-36 total, SF-36 mental health component, AOFAS total, AOFAS pain, SMFA function, and SMFA bother scores (all P < .05). Both genders demonstrated significant improvement in PROs at 1, 2, and 5 years. The magnitude of improvement was similar between genders for all PROs (all P < .05) with the exception of SF-36 physical function, which was greater in men. Females underwent more nonrevision reoperations (32.2% vs 22.6%; P = .0191), but there was no significant difference in failure rates (male 7.3% vs female 3.5%; P = .07). The reoperation and failure rates at 2 years postoperation were 10.1% and 1.6% for men and 18.5% and 0.9% for women, respectively. CONCLUSION: Women undergoing TAR were more likely to have worse preoperative PROs and higher rates of nonrevision reoperations, which remains true when controlling for their increased incidence of inflammatory arthritis. However, women reported similar improvements in PROs and had similar prosthetic survival rates as men. Increased understanding of these disparities, combined with gender-based interventions, may further advance patient outcomes. LEVEL OF EVIDENCE: Level III, therapeutic, retrospective comparative series.

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.

Economic Analysis and Clinical Outcomes of Short-Stay Versus Inpatient Total Ankle Replacement Surgery.

BACKGROUND: We aimed to perform an economic analysis and compare the clinical outcomes between inpatient and short-stay designation total ankle replacement (TAR). METHODS: We performed a retrospective study on 178 consecutive patients undergoing primary inpatient versus short-stay designation TAR during the 2016 and 2017 fiscal years. Patient demographics, concomitant procedures, perioperative complications, patient-reported outcomes, and perioperative costs were collected. RESULTS: The mean age of our cohort was 62.5 ± 9.6 years (range, 30-88 years), with a significant difference in age (64.1 vs 58.5 years) (P = .005) and Charlson Comorbidity Index (3.3 ± 1.9 vs 2.3 ± 1.4; P = .002) for the inpatient and short-stay designation groups, respectively. At a mean follow-up of 29.6 ± 11.8 months (range, 12-52.3 months), there was no difference in complications between groups (P = .97). The inpatient designation TAR group had a worse baseline Short Musculoskeletal Functional Assessment (SMFA) function score (76.1; 95% CI, 70.5-81.6) than the short-stay designation TAR group (63.9; 95% CI, 52.5-75.3) while achieving similar final postoperative SMFA function scores for the inpatient (55.2; 95% CI, 51.1-59.2) and short-stay (56.2; 95% CI, 48.2-64.2) designation TAR groups (P > .05). However, the inpatient designation TAR group showed a significantly greater mean improvement in SMFA function score (20.9; 95% CI, 19.4-22.4) compared with the short-stay designation TAR group (7.7; 95% CI, 3.7-11.1) (P = .0442). The total direct cost was significantly higher for the inpatient designation group ($15 340) than the short-stay designation group ($13 002) (P < .001). CONCLUSION: While inpatient designation TARs were more comorbid, short-stay designation TARs were associated with a 15.5% reduction in perioperative costs, comparable complication rates, and similar final postoperative patient-reported outcome scores compared with inpatient TARs. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Biomechanical Effect on Joint Stability of Including Deltoid Ligament Repair in an Ankle Fracture Soft Tissue Injury Model With Deltoid and Syndesmotic Disruption.

BACKGROUND: The current operative standard of treatment for bimalleolar equivalent ankle fracture is open reduction and internal fixation (ORIF) of the lateral malleolus followed by syndesmotic stabilization if indicated. There is controversy surrounding the indication and need for deltoid ligament repair in this setting. The purpose of this study was to quantify the biomechanical effect of deltoid ligament repair in an ankle fracture soft tissue injury model. METHODS: Nine fresh-frozen cadaveric specimens were included in this study. Each leg was tested under 5 conditions: intact, syndesmosis and deltoid ligament sectioned, syndesmosis fixed, deltoid repaired, and both the syndesmosis and deltoid ligament repaired. Anterior, posterior, lateral, and medial drawer and rotational stresses were applied to the foot, and the resulting talus displacement was documented. RESULTS: Isolated deltoid repair significantly reduced anterior displacement to normal levels. Displacement with lateral drawer testing was not significantly corrected until both structures were repaired. Deltoid repair and syndesmosis fixation each reduced internal rotation significantly with further reduction to normal levels when both were repaired. External rotation remained elevated relative to the intact condition regardless of which structures were repaired. CONCLUSION: There is existing controversy regarding the importance of deltoid ligament repair in the setting of ankle fractures. The findings of this biomechanical study indicate that deltoid ligament repair enhances ankle stability in ankle fractures with both syndesmotic and deltoid disruption. CLINICAL RELEVANCE: Concomitant deltoid ligament repair in addition to stabilization of fracture and syndesmosis may improve long-term functioning of the ankle joint and clinical outcomes.

The MARBLE Study Protocol: Modulating ApoE Signaling to Reduce Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction.

BACKGROUND: Perioperative neurocognitive disorders (PND) are common complications in older adults associated with increased 1-year mortality and long-term cognitive decline. One risk factor for worsened long-term postoperative cognitive trajectory is the Alzheimer's disease (AD) genetic risk factor APOE4. APOE4 is thought to elevate AD risk partly by increasing neuroinflammation, which is also a theorized mechanism for PND. Yet, it is unclear whether modulating apoE4 protein signaling in older surgical patients would reduce PND risk or severity. OBJECTIVE: MARBLE is a randomized, blinded, placebo-controlled phase II sequential dose escalation trial designed to evaluate perioperative administration of an apoE mimetic peptide drug, CN-105, in older adults (age≥60 years). The primary aim is evaluating the safety of CN-105 administration, as measured by adverse event rates in CN-105 versus placebo-treated patients. Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity. METHODS: 201 patients undergoing non-cardiac, non-neurological surgery will be randomized to control or CN-105 treatment groups and receive placebo or drug before and every six hours after surgery, for up to three days after surgery. Chart reviews, pre- and postoperative cognitive testing, delirium screening, and blood and CSF analyses will be performed to examine effects of CN-105 on perioperative adverse event rates, cognition, and neuroinflammation. Trial results will be disseminated by presentations at conferences and peer-reviewed publications. CONCLUSION: MARBLE is a transdisciplinary study designed to measure CN-105 safety and efficacy for preventing PND in older adults and to provide insight into the pathogenesis of these geriatric syndromes.

Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails.

Background. Tibiotalocalcaneal (TTC) arthrodesis is a common treatment option for hindfoot arthritis and deformity. Loss of compression over time with statically locked nails may contribute to nonunion. A novel retrograde intramedullary nail with an internal pseudoelastic component has recently been used to provide sustained dynamic compression (SDC). The purpose of this study was to compare fusion rates and time to union between the SDC and nondynamized (ND) nails. Methods. All patients who underwent TTC arthrodesis with an intramedullary nail at a single institution from 2013 to 2017 and who had at least 1 year of follow-up were included in this study. Baseline patient and operative characteristics were collected and compared between the sustained SDC and ND nail groups. The rate of successful fusion, time to union, and complications were compared between the groups. Results. The SDC cohort had a significantly faster time to union by 3.9 months (P = .049). The SDC cohort had a higher fusion rate (78.0%) compared with the ND nail cohort (75.0%), although this was not statistically significant (P = .75). The SDC nail was used significantly (P < .05) more often in patients with known risk factors for nonunion, including female sex, smoking, revision surgery, prior trauma, and patients requiring 3D cage implants for significant bone loss. There were no differences between the groups in terms of complications. Conclusion. The SDC nail has been shown to achieve successful arthrodesis in a population at high risk for nonunion, using less hardware, and at a faster rate than ND nails. Level of Evidence: Level III: Retrospective, comparative study.