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

Abstract

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.

Time and Travel Burden Associated with Hexapod-Assisted Correction of Lower Extremity Deformity

“…A 2022 analysis of the burden of care following index hexapod application showed an average $35,986.88 (range $27,363.52-$52,546.37) spent in the 12-months following post-index surgery for those aged <17 with congenital deformity. Reid, et al, found this group of 168 patients, with an average duration of care similar to ours at 149.5 days, also had an average 22.26 outpatient physical therapy appointments and average 8.94 outpatient imaging procedure [14].…”

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

“…In this narrow, perioperative time period, patients with deep infection with nonunions were not different from patients with deep infection without nonunions, when analyzing adjusted means for costs or complications; however, in our second manuscript looking at the 2-year post-index period, patients with deep infection and nonunion did have greater post-operative care requirements and complication risks in the time frame from day after surgery to two years post-index [ 23 ].…”

“…This study focuses on the intra-operative period when HRF systems are first applied to the patient (defined herein as the “index”), and is designed to describe the pathology, diagnosis, comorbidities, complications, costs, healthcare utilization and hospital discharge disposition of patients with HRF application during these early intraoperative time points. The post-operative outcomes, from index to 2-year post-application, are described in a separate publication [ 23 ].…”