Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advancedTM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population.

PURPOSE: To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II. METHODS: The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates. RESULTS: Both TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively. CONCLUSION: In terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups. REGISTRATION: Registration was completed at ClinicalTrials.gov NCT03635320.

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.

Surgical treatment, complications, reoperations, and healthcare costs among patients with clavicle fracture in England.

INTRODUCTION: The clinical and economic burden of clavicle fractures in England is not well documented. This study evaluated rates of surgical treatment, post-surgical complications, reoperations and costs in patients with clavicle fractures using the Clinical Practice Research Datalink (CPRD) database. METHODS: CPRD data were linked to National Health Service Hospital Episode Statistics data. Patients with a diagnosis of clavicle fracture between 2010-2018 were selected in CPRD (date of fracture = index date). Of those, patients with surgical intervention within 180 days from index fracture were identified. Rates of post-surgical complications (i.e., infection, non-union, and mal-union), reoperations (for device removal or for postoperative complications), post-operative costs and median time to reoperations were evaluated up to 2 years after surgery. RESULTS: 21,340 patients with clavicle fractures were identified (mean age 35.0 years(standard deviation (SD): 26.5), 66.7% male). Surgery was performed on 672 patients (3.2% of total cohort) at an average 17.1 (SD: 25.2) days post-fracture. Complications (i.e., infection, non-union, or malunion) affected 8.1% of surgically treated clavicle fracture patients; the rate of infection was 3.5% (95% CI, 1.7%- 5.2%), non-union 4.4% (95% CI, 2.4%-6.5%), and mal-union 0.3% (95% CI, 0%-0.7%). Adjusting for age, gender, comorbidities and time to surgery, the all-cause reoperation rate was 20.2% (13.2%-30.0%) and the adjusted rate of reoperation for implant removal was 17.0% (10.7%-25.9%)-84% of all-cause reoperations were thus performed for implant removal. Median time to implant removal was 254 days. The mean cost of reoperations for all causes was £5,000. The most expensive reoperations were for cases that involved infection (mean £6,156). CONCLUSIONS: Complication rates following surgical clavicle fracture care averaged 8.1%. However, reoperation rates exceed 20%, the vast majority of reoperations being performed for device removal. Technologies to alleviate secondary device removal surgeries would address a significant clinical unmet need.

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.

Complications and its impact in patients with closed and open tibial shaft fractures requiring open reduction and internal fixation.

Aim: To evaluate the rates of infection and nonunion and determine the impact of infections on healthcare resource use and costs following open and closed fractures of the tibial shaft requiring open reduction internal fixation. Methods: Healthcare use and costs were compared between patients with and without infections following pen reduction internal fixation using MarketScan® databases. Results: For commercial patients, the rates of infection and nonunion ranged from 1.82 to 7.44% and 0.48 to 8.75%, respectively, over the 2-year period. Patients with infection had significantly higher rates of hospital readmissions, emergency room visits and healthcare costs compared with patients without infection. Conclusion: This real-world study showed an increasing rate of infection up to 2 years and infection significantly increased healthcare resource use and costs.

Complications in type III open tibial shaft fractures treated with open reduction and internal fixation.

Aim: To estimate rates of fracture-related infection (FRI) and nonunion and assess the healthcare burden associated with FRI among patients with open reduction and internal fixation (ORIF) for Type III open tibial shaft fractures (TSFs). Methods: Patients with type III TSF requiring ORIF were identified using MarketScan® Database. Healthcare utilization and total costs were compared using generalized linear models. Results: The rates of FRI and nonunion were 35.99 and 36.94%, respectively, at 365 days. Patients with FRI had a significantly higher rate of readmission, emergency room visit and total healthcare costs compared with patients without FRI. Conclusion: Patients with an ORIF procedure for Type III TSF have a high risk of FRI and nonunion and; FRI significantly increased the healthcare burden.

Reoperations in intramedullary fixation of pertrochanteric hip fractures.

Objective: This study evaluated the frequency of reoperation within 1 year of initial intramedullary fixation for patients with pertrochanteric hip fracture and compared 1-year healthcare resource utilization and cost burden for patients with and without reoperation. Methods: This is a retrospective evaluation of medical claims from the US Centers for Medicare and Medicaid Standard Analytic File. Patients aged ≥65 years who underwent fixation with an intramedullary implant for a pertrochanteric fracture between 2013 and 2015 were included. Healthcare resources that were evaluated included skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), readmissions, and outpatient hospital visits. All-cause payments for these services comprised overall cost burden. Generalized Linear Models were used to evaluate healthcare resources and cost burden over 1-year post-surgery and to adjust for confounding between patients with and without a reoperation. Results: A total of 6,423 Medicare patients were included in the analysis. Mean (SD) age was 82.4 (7.8) years, 76.0% were female, and 93.3% were white. A second hip surgery within 1 year after the index fixation procedure was performed in 414 patients (6.4%): 121 (29.2%) contralateral, 115 (27.8%) ipsilateral, and 178 (43.0%) without specified laterality. After adjusting for confounding factors, Medicare patients with ipsilateral reoperations had statistically significantly higher readmissions (100% vs 32.5%, p < 0.0001), outpatient hospital visits (96.4% vs 88.8%, p = 0.018), admissions to a SNF (88.5% vs 80.4%, p = 0.024), and admissions to an IRF (38.8% vs 22.0%, p < 0.0001) compared to patients without reoperations. The adjusted mean total all-cause payments ($90,162 vs $55,131, p < 0.0001) during the 1-year follow-up were statistically significantly higher among patients with reoperations as compared to patients without reoperations. Conclusions: Patients who require a second hip surgery after initial fixation with an intramedullary implant for pertrochanteric hip fractures have significantly higher 1-year healthcare resource utilization and 63.5% higher costs than patients without reoperation.

Trends in adolescent lumbar disk herniation.

The authors have retrospectively studied the trends in etiology, symptoms, and rate of recurrence for adolescents with disk herniations to determine the age at onset of symptoms, mechanism of injury, familial history, pattern of symptoms, level of herniation, method of treatment, and rate of recurrence. The review revealed a higher incidence of adolescent lumbar disk herniations in female patients and a higher percentage of patients with a family history than previously reported. Leg pain continues to be the primary presenting symptom in this group of patients and is often not recognized as the radicular pain of a herniated disk by the primary care physician. This reflects a lack of understanding of the relationship of the presenting symptoms to the pathology of the herniated nucleus pulposus, causing a delay in referral to the spine specialist.