Hospitalization for computer-assisted hexapod ring fixation application - analyses of patient variability, peri-operative complications, hospital costs, and discharge status.

BACKGROUND: Computer-assisted hexapod ring fixation systems (HRF) are used for multiple conditions and in very diverse patient populations. This study analyzes perioperative outcomes following HRF application based on patient etiology and clinical presentation. METHODS: Data from patients in the Premier Hospital Billing Database between 2007-2019 undergoing HRF application were analyzed for the duration of patients' hospitalizations. Patients were grouped based on etiology: acquired deformity, arthrosis, congenital deformity, deep infection, infected nonunion, fracture, nonunion, and other post-operative complications. Demographics, comorbidities, operating room time (ORT), length of stay (LOS), peri-operative complications, and hospital costs were estimated using generalized linear models. Logistic regression evaluated factors associated with peri-operative complications. RESULTS: One thousand eight hundred eighteen patients (average age: 46.9, standard deviation (SD) (19.6) - 38.9% female) were included in the study, and included 72% fracture cases, 9.6% deep infection, 10.2% deformity (acquired: 5.9%, congenital: 4.3%), 4.2% nonunions, 2% arthrosis and 1.4% other sequelas from prior fractures. Comorbidities varied across diagnosis categories and age, 40% adults and 86% pediatric had no comorbidities. Pediatric cases mostly suffered from obesity (16.1%) and pulmonary disease (10.7%). Complicated diabetes was present in 45.9% of arthropathy and 34.3% of deep infection patients. ORT, LOS and inflation-adjusted hospital costs for all patients averaged 277.7 min (95% Confidence interval (CI): 265.1-290.3), 7.07 days (95% CI: 6.6-7.5) and $41,507 (95%CI: $39,728-$43,285), respectively, but were highest in patients with deep infection (ORT: 369 min (95%CI: $321.0-$433.8); LOS: 14.4 days (95%CI: $13.7-$15.1); Cost: $54,666 (95%CI: $47,960-$63,553)). The probability of having an intraoperative complication averaged 35% (95%CI: 28%-43%) in adult patients with deep infection vs 7% (95%CI: 2%-20%) in pediatric cases treated for congenital deformity. The risk for intraoperative complications was mostly associated with preexisting comorbidities, an Elixhauser > 5 was the most predictive risk factor for complications (odds ratios: 4.53 (95%CI: 1.71-12.00, p = 0.002). CONCLUSIONS: There is important heterogeneity among HRF patients. Adults with HRF for fracture, deep infection and arthrosis are at far greater risk for peri-operative complications vs. patients with deformity, especially pediatric deformity cases, mostly due to existing comorbidities and age. Device-specific HRF clinical studies cannot be generalized beyond their exact patient population.

Two-year clinical and economic burden, risk and outcomes following application of software-assisted hexapod ring fixation systems.

BACKGROUND: Multiplanar external fixation systems that employ software-assisted deformity correction consist of rings connected by angled struts, defined as hexapod ring fixators (HRF). Costs and outcomes associated with the application of HRFs are not well documented. This study was designed to provide a nationwide baseline understanding of the clinical presentation, risks, outcomes and payer costs, and healthcare resource utilization (HCU) of patients requiring application of an HRF, from the day of, and up to 2 years, post-application. METHODS: Patients with HRF application ("index") between 2007 and 2019 within the IBM Marketscan® Commercial Claims database were identified and categorized based on diagnosis: acquired deformity, arthropathy, congenital deformity, deep infection, nonunion, fracture, and other post-operative fracture sequelae. Demographics, comorbidities at index, complications post-index, HCU, and payments were analyzed. Payments were estimated using a generalized linear model and were adjusted for inflation to the 2020 consumer price index. Rates of deep infection and amputation were estimated up to 2 years post-index using Poisson regressions, and risk factors for each were estimated using logistic regression models. RESULTS: Six hundred ninety-five patients were included in our study (including 219 fractures, 168 congenital deformities, 68 deep infections, 103 acquired deformities). Comorbidities at index were significantly different across groups: less than 2% pediatrics vs 18% adults had 3 or more comorbidities, < 1% pediatric vs 29% adults had diabetes. Index payments ranged from $39,250-$75,350, with 12-months post-index payments ranging from $14,350 to $43,108. The duration of the HRF application ranged from 96 days to 174 days. Amputation was observed in patients with deep infection (8.9, 95% confidence interval (CI): 3.2-23.9%), nonunion (5.0, 95%CI: 1.6-15.4%) or fracture (2.7, 95%CI: 0.9-7.6%) at index. Complicated diabetes was the main predictor for deep infection (odds ratio (OR): 5.14, 95%CI: 2.50-10.54) and amputation (OR: 5.26, 95%CI: 1.79-15.51). CONCLUSIONS: Findings from this longitudinal analysis demonstrate the significant heterogeneity in patients treated with HRF, and the wide range in treatment intensity, payments, and outcomes. Risks for deep infection and amputation were primarily linked to the presence of complicated diabetes at the time of HRF application, suggesting a need for careful management of comorbid chronic conditions in patients requiring HRF for orthopedic care.

Intramedullary Nail Breakage and Mechanical Displacement in Patients with Proximal Femoral Fractures: A Commercial and Medicare Supplemental Claims Database Analysis.

OBJECTIVE: This study evaluated the rates and patterns of intramedullary nail (IMN) breakage and mechanical displacement for proximal femur fractures and the factors associated with their occurrence. PATIENTS AND METHODS: Patients with subtrochanteric, intertrochanteric, or basicervical femoral neck fractures treated with IMN from 2016 to 2019 were identified from commercial and Medicare supplemental claims databases and were followed for up to two years. Kaplan-Meier analysis estimated the cumulative incidence of and patterns of breakage/mechanical displacement. Multivariable Cox regression models evaluated the factors associated with breakage/mechanical displacement. RESULTS: A total of 11,128 patients had IMN fixation for subtrochanteric, intertrochanteric, or basicervical femoral neck fractures: (mean SD) age 75.6 (16.4) years, 66.2% female, 74.3% Medicare supplemental vs 26.7% commercial insurance. Comorbidities included hypertension (62.9%), osteoporosis (27.3%), cardiac arrhythmia (23.1%), diabetes (30.7%), and chronic pulmonary disease (16.3%). Most fractures were closed (97.2%), intertrochanteric or basicervical femoral neck (80.1%), and not pathological (91.0%). The cumulative incidence of nail breakage over two years was 0.66% overall, 1.44% for combination fractures, 1.16% for subtrochanteric fractures, and 0.49% for intertrochanteric or basicervical fractures. The cumulative incidence of mechanical displacement was 0.37% overall, 0.43% for subtrochanteric fractures, 0.42% for combination fractures, and 0.36% for intertrochanteric or basicervical femoral neck fractures. Half of the breakages occurred within five months after surgery and half of the mechanical displacements occurred within 75 days. Age 50-64 (vs 75+) and subtrochanteric or pathological fracture were more commonly associated with nail breakage. Complicated hypertension was more commonly associated with mechanical displacement. CONCLUSION: The incidence of IMN breakage and mechanical displacement in US commercial and Medicare supplemental patients with proximal femur fractures from 2016 to 2019 was low (0.66% and 0.37%, respectively up to two years). Age 50-64 (vs 75+) and subtrochanteric or pathological fracture were more commonly associated with breakage. Complicated hypertension was associated with mechanical displacement.

Treatments, cost and healthcare utilization of patients with segmental bone defects.

BACKGROUND: Treatment of large segmental defects in skeletal long bones is challenging. Heterogeneity in patient presentation further increase the difficulty in designing and running randomized trials, hence the paucity of published data with large patient numbers. This study was designed to help understand patient presentation, costs and outcomes, using real world data sources. METHODS: Two data sources (Premier healthcare database (PHD) and IBM® MarketScan® Commercial Claims and Medicaid databases) were utilized, PHD for intraoperative and cost analyses, MarketScan for payer costs and longitudinal (2-year) outcomes. Patients were included in the analysis if they had diagnoses of osteomyelitis, non-union or open (acute) fractures, treated with bone graft and/or spacers, using either the Masquelet or external frames. Patient cohorts were defined by diagnosis at index (acute fracture, osteomyelitis, non-union) and descriptive statistics were conducted for patient variables (demographic, comorbidities) and outcomes. Risk of complications were estimated using logistic regression models. Hospital and payer costs for index and follow-up periods, were estimated using least means square estimators from generalized linear model outputs. All costs and payments were adjusted for inflation to 2019 consumer price-index. RESULTS: 904 patients were identified in PHD (414 fractures, 388 osteomyelitis and 102 nonunion patients). Main comorbidities at time of initial surgery were hypertension (32.7%) followed by obesity (22.1%), diabetes with complications (20.9%) and chronic pulmonary disease (20.6%). Significant variability in surgical operating room time and length of stay were observed, with averages of 484.7 minutes and 11.7 days, respectively. Two-year postoperative infection rates ranged from 33.1% - 58.5%, the highest infection rates being reflective of ongoing infections in patients initially treated for osteomyelitis. Amputation rates ranged from 10.0% in patients with bone loss due to acute factures to 14.5% in patients with osteomyelitis. Osteomyelitis patients were also the costliest, with 12-months hospital costs averaging US$ 156.818 (95%CI: 112,970-217,685). CONCLUSION: This study identified high complication rates and costs of segmental bone repair surgery. All patients with segmental bone defects had high costs and risks but patients with osteomyelitis were at significant risk for increased cost and complications, including amputation. Medical innovation is particularly important for this high-risk patient group.

Long bone fractures: treatment patterns and factors contributing to use of intramedullary nailing.

BACKGROUND: This study evaluated treatment patterns for long bone fractures and factors that contribute to use of intramedullary nails (IMN). METHODS: Patients from IBM MarketScan® Research Commercial and Medicare Databases with femoral/tibial/humeral fractures during inpatient admission between January 2016-July 2019 were identified. Patients were categorized by treatment (i.e., non-surgical/internal fixation [extramedullary internal fixation/plating]/IMN/external fixation). Four-year rates of IMN were reported by fracture type. Logistic regression evaluated factors contributing to IMN use. RESULTS: 14,961 femoral, 14,101 tibial, and 7,059 humeral fracture patients were identified (mean[SD] age was 45.3[18.9], 42.0[16.3], and 39.8[21.6] years and % female 50.8%, 47.7%, and 55.3%, respectively). Mean(SD) lengths of stay were 6.7(9.2), 5.9(7.0), and 5.8(10.3) days, rates of surgical treatment were 74.3%, 84.0%, and 62.7%, and rates of IMN among surgical patients were 46.6%, 27.1%, and 6.7% for femoral, tibial, and humeral fractures, respectively. IMN was the predominant treatment for femoral fractures over the past 4 years. Factors contributing to IMN use included open/closed diaphyseal fractures, pathological fractures, diagnoses of cancer or AIDS/HIV, and alcohol abuse. CONCLUSIONS: IMN was the predominant treatment for femoral fractures and use slightly increased for tibial/humeral fractures. Open/closed diaphyseal fractures, pathological fractures, cancer or AIDS/HIV, and alcohol abuse contributed to IMN use.