Study designProspective multicentric study.ObjectiveThoracolumbar fractures without neurologic deficit are challenging situations in terms of treatment decision making. We aimed to analyze the occurrence of adverse events (AEs) after surgical and nonsurgical treatment and its impact on functional outcomes.Methods198 patients from a prospective multicentric database were included. The occurrence of adverse events and treatment failure within 2 years of follow up were recorded. ODI was compared between patients with and without adverse events at six months, 1 year and 2 years follow up. Multivariable regression analysis was conducted to assess the association between post-treatment adverse events and ODI at 1-year follow-up.Results46 adverse events were recorded (23.2%). Higher categories of the Charlson Comorbidity Index (CCI) (P = 0.006), unemployment or retirement (P = 0.027), and current smoking (P = 0.008) were significantly associated with the occurrence of adverse events whereas no significant differences were observed in terms of treatment decision (conservative vs surgical). ODI values were significantly higher in patients with adverse events at the 6-month and 1-year follow-up visits without significant differences at 2 years follow up. Treatment failure was observed in only 5 patients.ConclusionWe found association between the occurrence of AE and higher ODI at 6-months and one-year follow up. Additionally, a higher CCI and smoking status were associated with higher likelihood to develop adverse events in our cohort.

Study DesignCross-sectional survey.ObjectivesA cornerstone of classification systems is good reliability amongst different groups of classification users. Thus, the aim of this international validation study was to assess the reliability of the new AO Spine DGOU Osteoporotic Fracture Classification (OF classification) stratified by surgical specialty, work-setting, work-experience, and trauma center level.Methods320 spine surgeons were asked to rate 27 cases according to the OF classification at 2 time points, 4 weeks apart (assessment 1 and 2) in this online-webinar based validation process. The kappa statistic (κ) was calculated to assess the inter-observer reliability and the intra-rater reproducibility.ResultsA total of 7798 (90.3%) ratings were recorded in assessment 1 and 6621 (76.6%) ratings in assessment 2. Global inter-rater reliability was moderate in both assessments (κ = 0.57; κ = 0.58). Participants with a work-experience of >20 years showed the highest inter-rater agreement in both assessments globally (κ = 0.65; κ = 0.67). Participants from a level-1 trauma center showed the highest agreement (κ = 0.58), whereas participants working at a tertiary trauma center showed higher grade of agreement in the second assessment (κ = 0.66). Participants working in academia showed the highest agreement in assessment 2 (κ = 0.6). Surgeons with academic background and surgeons employed by a hospital showed substantial intra-rater agreement in the second assessment.ConclusionsThe AO Spine-DGOU Osteoporotic Fracture Classification showed moderate to substantial inter-rater agreement as well as intra-rater reproducibility regardless of work-setting, surgical experience, level of trauma center and surgical specialty.

Background context: Many efforts have been made to determine what is the best treatment strategy for neurologically intact patients with TL burst fractures: surgery or nonoperative management. Studies comparing clinical outcomes have produced mixed and inconclusive results creating lack of consensus in the expert community.

Purpose: Therefore, it is necessary to explore other important components of healthcare such as economics to settle this controversial debate. The goal of the current study was to perform a cost-utility analysis comparing surgical treatment to nonoperative treatment for neurologically intact TL burst fractures (AOSpine classification types A3 and A4) from a societal perspective in a multicenter and international setting.

Study design/setting: We performed a cost-utility analysis from a societal perspective comparing the cost-utility of surgical treatment versus nonsurgical treatment of thoracolumbar (TL) burst fractures in neurologically intact patients.

Patient sample: Patient demographics and all clinical and outcome data were taken from an observational, prospective multicenter cohort study comparing surgical versus nonsurgical treatment of TL burst fractures in neurological intact patients.

Outcome measures: The ICER was calculated comparing surgical versus nonsurgical treatment for the full analysis population with a 1-year time horizon, two-year time horizon as well as the working-life time horizon. Costs were taken from the clinical study, patient diaries with productivity loss documented, current scientific literature in addition to national and international healthcare costing guidelines and databases.

Methods: The mean difference in cost between the two treatment groups were calculated, firstly by applying the central limit theorem, and secondly by using bootstrapping. To calculate the average cost per patient in each treatment group, the Kaplan-Meier Sample Average (KMSA) estimator was used in order to take account of the censored patients. To evaluate the derived models and to explore uncertainty, sensitivity analysis was used.

Results: Eleven sites from different regions (North America, Europe, Middle east, and Asia) completed the recruitment and follow-up for 213 patients. One hundred and thirty patients were treated surgically (61.0%) and eighty-three patients (39.0%) were treated nonsurgically. At 1-year, the ICER for surgical treatment was $191,648.00 USD per QALY. Compared to a willingness to pay threshold of $100,000, surgical treatment was not cost-effective within the 1-year timeframe. At 2-years, the nonsurgical group had visited the surgeon or general practitioner more often (0.31 vs 0.25). The nonsurgical group had visited physiotherapist and other allied health more often (3.68 vs 1.68). The utilization of NSAIDs and opioids remained higher in the nonsurgical group (2.66 vs 2.39) (1.52 vs 0.75). The average workdays lost remained higher in the nonsurgical group (143.12 vs 114.78). The caregiver days taken off work remained higher in the nonsurgical group (29.86 vs 2.39). At 2 years, surgical treatment showed to be a dominant strategy with a $28,978.50 savings per QALY. At lifetime horizon, surgical treatment remained the cost-effective strategy at $25,530.18 savings per QALY.

Conclusion: Our cost-utility analysis showed surgical management to be cost-effective at 2 years compared to nonoperative management in neurologically intact TL burst fractures from a societal perspective. This finding was maintained through the working-lifetime horizon. Surgical treatment became cost-effective largely due to the greater productivity loss of patients and caregivers within the nonsurgical group. This investigation highlights the viability for surgical management of TL burst fractures to provide societal benefit especially when productivity is valued.