Higher pedicle screw density does not improve curve correction in Lenke 2 adolescent idiopathic scoliosis.

PURPOSE: Higher pedicle screw density posterior spinal fusion (PSF) constructs have not been shown to result in improved curve correction in Lenke 1 and 5 adolescent idiopathic scoliosis (AIS) but do increase cost. The purpose of this study questioned whether higher screw density constructs improved curve correction and maintenance of correction in Lenke 2 AIS. Secondary goals were to identify predictive factors for correction and postoperative magnitude of curves in Lenke 2 AIS. METHODS: We identified patients 11 to 17 years old who underwent primary PSF for Lenke 2 AIS between 2007 and 2017 who had minimum follow-up of 2 years. Demographic and radiographic data were collected to perform regression and elimination analysis. RESULTS: Thirty patients (21 females, 9 males) were analyzed. Average age and SD at time of surgery was 14.0 ± 1.8 years (range, 11-17 years), and median follow-up was 2.8 years (IQR 2.1-4.0 years). Implant density did not predict final postoperative curve magnitude. Predictors of final postoperative curve magnitude were sex and preoperative curve magnitude. Predictors of percentage of correction of major curve were sex and age at the time of surgery. Predictors of final postoperative thoracic kyphosis were sex and percent flexibility preop. Females had lower final postoperative major curve magnitude, a higher percent curve correction, and lower postoperative thoracic kyphosis. CONCLUSIONS: Increased implant density is not predictive of postoperative curve magnitude in Lenke 2 AIS. Predictors of postoperative curve magnitude are sex and preoperative curve magnitude. LEVEL OF EVIDENCE: Level III, retrospective observational.

Image-guided pedicle screws using intraoperative cone-beam CT and navigation. A cost-effectiveness study.

Image-guided surgery using intraoperative cone-beam CT and navigation improves screw placement accuracy rates. However, this technology is associated with high acquisition costs. The aim of this study is to evaluate the costs of revision surgery from symptomatic pedicle screw malposition to justify whether the costs of acquiring intraoperative navigation justify the expected benefits. This is a retrospective cost-effectiveness analysis of consecutive patients who had pedicle screw instrumentation using intraoperative cone-beam CT and navigation compared with patients who underwent freehand pedicle screw instrumentation at our institution over 4 years. The costs associated with revision surgery for symptomatic pedicle screw malposition (excess length of stay, intensive care, theatre time, implants and additional outpatient appointments) were calculated. A total of 19 patients had symptomatic screw malpositioning requiring revision surgery. None of these patients had screws inserted under navigation. Revision surgery accounted for an extra 304 bed days and an additional 97 h theatre time. The total extra spent over 4 years was £464,038. When compared to the costs of revision surgery for screw malpositioning, it was cost neutral to acquire and maintain this technology. Intraoperative image-guided surgery reduces reoperation rates for symptomatic screw malposition and is cost-effective in high volume centers with improved patients outcomes. High acquisition and maintenance cost of such technologies is economically justifiable.

Post-operative bracing after pedicle screw fixation for thoracolumbar burst fractures: A cost-effectiveness study.

PURPOSE: While frequently prescribed to patients following fixation for spine trauma, the utility of spinal orthoses during the post-operative period is poorly described in the literature. In this study, we calculated rates of reoperation and performed a decision analysis to determine the utility of bracing following pedicle screw fixation for thoracic and lumbar burst fractures. METHODS: Pubmed was searched for articles published between 2005 and 2015 for terms related to pedicle screw fixation of thoracolumbar fractures. Additionally, a database of neurosurgical patients operated on within the authors institution was also used in the analysis. Incidences of significant adverse events (wound revision for either dehiscence or infection or re-operation for non-union or instability due to hardware failure) were determined. Pooled means and variances of reported parameters were obtained using a random-effects, inverse variance meta-analytic model for observational data. Utilities for surgical outcome and complications were assigned using previously published values. RESULTS: Of the 225 abstracts reviewed, 48 articles were included in the study, yielding a total of 1957 patients. After including patients from the institutional registry, together a total of 2081 patients were included in the final analysis, 1328 of whom were braced. Non-braced patients were older then braced patients, although this only approached significance (p=0.051). Braced patients had significantly lower rates of re-operation for non-union or clinically significant hardware failure (1.3% vs. 1.8%, p<0.001) although the groups had comparable rates of operative wound dehiscence and infection (p=1.000). These two approaches yielded comparable utility scores (p=0.120). Costs between braced and non-braced patients were comparable excluding the cost of the brace (p=0.256); hence, the added cost of the brace suggests that bracing post-operatively is not a cost effective measure. CONCLUSIONS: Bracing following operative stabilization of thoracolumbar fracture does not significantly improve stability, nor does it increase wound complications. Moreover, our data suggests that post-operative bracing may not be a cost-effective measure.

Comparison of low density and high density pedicle screw instrumentation in Lenke 1 adolescent idiopathic scoliosis.

BACKGROUND: The correlation between implant density and deformity correction has not yet led to a precise conclusion in adolescent idiopathic scoliosis (AIS). The aim of this study was to evaluate the effects of low density (LD) and high density (HD) pedicle screw instrumentation in terms of the clinical, radiological and Scoliosis Research Society (SRS)-22 outcomes in Lenke 1 AIS. METHODS: We retrospectively reviewed 62 consecutive Lenke 1 AIS patients who underwent posterior spinal arthrodesis using all-pedicle screw instrumentation with a minimum follow-up of 24 months. The implant density was defined as the number of screws per spinal level fused. Patients were then divided into two groups according to the average implant density for the entire study. The LD group (n = 28) had fewer than 1.61 screws per level, while the HD group (n = 34) had more than 1.61 screws per level. The radiographs were analysed preoperatively, postoperatively and at final follow-up. The perioperative and SRS-22 outcomes were also assessed. Independent sample t tests were used between the two groups. RESULTS: Comparisons between the two groups showed no significant differences in the correction of the main thoracic curve and thoracic kyphosis, blood transfusion, hospital stay, and SRS-22 scores. Compared with the HD group, there was a decreased operating time (278.4 vs. 331.0 min, p = 0.004) and decreased blood loss (823.6 vs. 1010.9 ml, p = 0.048), pedicle screws needed (15.1 vs. 19.6, p < 0.001), and implant costs ($10,191.0 vs. $13,577.3, p = 0.003) in the LD group. CONCLUSIONS: Both low density and high density pedicle screw instrumentation achieved satisfactory deformity correction in Lenke 1 AIS patients. However, the operating time and blood loss were reduced, and the implant costs were decreased with the use of low screw density constructs.

Cost-Utility Analysis of Pedicle Screw Removal After Successful Posterior Instrumented Fusion in Thoracolumbar Burst Fractures.

STUDY DESIGN: A cost-utility analysis (CUA). OBJECTIVE: The aim of this study was to determine the cost-effectiveness of pedicle screw removal after posterior fusion in thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Pedicle screw instrumentation is a standard fixation method for unstable thoracolumbar burst fracture. However, removal of the pedicle screw after successful fusion remains controversial because the clinical benefits remain unclear. CUA can help clinicians make appropriate decisions about optimal health care for pedicle screw removal after successful fusion in thoracolumbar burst fractures. METHODS: We conducted a single-center, retrospective, longitudinal matched-cohort study of prospectively collected outcomes. In total, 88 consecutive patients who had undergone pedicle screw instrumentation for thoracolumbar burst fracture with successful fusion confirmed by computed tomography (CT) were used in this study. In total, 45 patients wanted to undergo implant removal surgery (R group), and 43 decided not to remove the implant (NR group). A CUA was conducted from the health care perspective. The direct costs of health care were obtained from the medical bill of each patient. Changes in health-related quality of life (HRQoL) scores, validated by Short Form 6D, were used to calculate quality-adjusted life-years (QALYs). Total costs and gained QALY were calculated at 1 year (1 year) and 2 years (2 years) compared with baseline. Results are expressed as an incremental cost-effectiveness ratio (ICER). Different discount rates (0%, 3%, and 5%) were applied to both cost and QALY for sensitivity analysis. RESULTS: Baseline patient variables were similar between the two groups (all P > 0.05). The additional benefits of implant removal (0.201 QALY at 2 years) were achieved with additional costs ($2541 at 2 years), equating to an ICER of $12,641/QALY. On the basis of the different discount rates, the robustness of our study's results was also determined. CONCLUSION: Implant removal after successful fusion in a thoracolumbar burst fracture is cost-effective until postoperative year 2. LEVEL OF EVIDENCE: 3.

What would be the annual cost savings if fewer screws were used in adolescent idiopathic scoliosis treatment in the US?

OBJECTIVE: There is substantial heterogeneity in the number of screws used per level fused in adolescent idiopathic scoliosis (AIS) surgery. Assuming equivalent clinical outcomes, the potential cost savings of using fewer pedicle screws were estimated using a medical decision model with sensitivity analysis. METHODS: Descriptive analyses explored the annual costs for 5710 AIS inpatient stays using discharge data from the 2009 Kids' Inpatient Database (Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality), which is a national all-payer inpatient database. Patients between 10 and 17 years of age were identified using the ICD-9-CM code for idiopathic scoliosis (737.30). All inpatient stays were assumed to represent 10-level fusions with pedicle screws for AIS. High screw density was defined at 1.8 screws per level fused, and the standard screw density was defined as 1.48 screws per level fused. The surgical return for screw malposition was set at $23,762. A sensitivity analysis was performed by varying the cost per screw ($600-$1000) and the rate of surgical revisions for screw malposition (0.117%-0.483% of screws; 0.8%-4.3% of patients). The reported outcomes include estimated prevented malpositioned screws (set at 5.1%), averted revision surgeries, and annual cost savings in 2009 US dollars, assuming similar clinical outcomes (rates of complications, revision) using a standard- versus high-density pattern. RESULTS: The total annual costs for 5710 AIS hospital stays was $278 million ($48,900 per patient). Substituting a high for a standard screw density yields 3.2 fewer screws implanted per patient, with 932 malpositioned screws prevented and 21 to 88 revision surgeries for implant malposition averted, and a potential annual cost savings of $11 million to $20 million (4%-7% reduction in the total cost of AIS hospitalizations). CONCLUSIONS: Reducing the number of screws used in scoliosis surgery could potentially decrease national AIS hospitalization costs by up to 7%, which may improve the safety and efficiency of care. However, such a screw construct must first be proven safe and effective.

Economic evaluation comparing intraoperative cone beam CT-based navigation and conventional fluoroscopy for the placement of spinal pedicle screws: a patient-level data cost-effectiveness analysis.

BACKGROUND CONTEXT: Pedicle screws are routinely used in contemporary spinal surgery. Screw misplacement may be asymptomatic but is also correlated with potential adverse events. Computer-assisted surgery (CAS) has been associated with improved screw placement accuracy rates. However, this technology has substantial acquisition and maintenance costs. Despite its increasing usage, no rigorous full economic evaluation comparing this technology to current standard of care has been reported. PURPOSE: Medical costs are exploding in an unsustainable way. Health economic theory requires that medical equipment costs be compared with expected benefits. To answer this question for computer-assisted spinal surgery, we present an economic evaluation looking specifically at symptomatic misplaced screws leading to reoperation secondary to neurologic deficits or biomechanical concerns. STUDY DESIGN/SETTING: The study design was an observational case-control study from prospectively collected data of consecutive patients treated with the aid of CAS (treatment group) compared with a matched historical cohort of patients treated with conventional fluoroscopy (control group). PATIENT SAMPLE: The patient sample consisted of consecutive patients treated surgically at a quaternary academic center. OUTCOME MEASURES: The primary effectiveness measure studied was the number of reoperations for misplaced screws within 1 year of the index surgery. Secondary outcome measures included were total adverse event rate and postoperative computed tomography usage for pedicle screw examination. METHODS: A patient-level data cost-effectiveness analysis from the hospital perspective was conducted to determine the value of a navigation system coupled with intraoperative 3-D imaging (O-arm Imaging and the StealthStation S7 Navigation Systems, Medtronic, Louisville, CO, USA) in adult spinal surgery. The capital costs for both alternatives were reported as equivalent annual costs based on the annuitization of capital expenditures method using a 3% discount rate and a 7-year amortization period. Annual maintenance costs were also added. Finally, reoperation costs using a micro-costing approach were calculated for both groups. An incremental cost-effectiveness ratio was calculated and reported as cost per reoperation avoided. Based on reoperation costs in Canada and in the United States, a minimal caseload was calculated for the more expensive alternative to be cost saving. Sensitivity analyses were also conducted. RESULTS: A total of 5,132 pedicle screws were inserted in 502 patients during the study period: 2,682 screws in 253 patients in the treatment group and 2,450 screws in 249 patients in the control group. Overall accuracy rates were 95.2% for the treatment group and 86.9% for the control group. Within 1 year post treatment, two patients (0.8%) required a revision surgery in the treatment group compared with 15 patients (6%) in the control group. An incremental cost-effectiveness ratio of $15,961 per reoperation avoided was calculated for the CAS group. Based on a reoperation cost of $12,618, this new technology becomes cost saving for centers performing more than 254 instrumented spinal procedures per year. CONCLUSIONS: Computer-assisted spinal surgery has the potential to reduce reoperation rates and thus to have serious cost-effectiveness and policy implications. High acquisition and maintenance costs of this technology can be offset by equally high reoperation costs. Our cost-effectiveness analysis showed that for high-volume centers with a similar case complexity to the studied population, this technology is economically justified.

Cost-effectiveness Analysis of Existing Pedicle Screws Reusing Technique in Extension Revision Operation for Adjacent Segmental Stenosis After Lumbar Posterolateral Fusion.

STUDY DESIGN: Retrospective case-control study. OBJECTIVE: A cost-effectiveness analysis was performed by comparing patients who received extension revision operations for adjacent segment disease (ASD) reusing the pedicle screws extracted from fused segments with patients who received conventional surgery. SUMMARY OF BACKGROUND DATA: ASD often required extension revision surgery, and during extension surgery, pedicle screws may be reused by extracting from the fused segments of primary surgery. METHODS: Study examined 37 patients who received extension revision surgery for ASD from January 2003 to December 2013. For the fixation of extended segments during revision operation, in 16 cases the pedicle screws extracted from fused segments were reused (group R), and in 21 cases new pedicle screws were used (group C) as a conventional method. Clinical outcomes were evaluated by means of visual analog scale scores for lumbago and leg pain, and the Korean Oswestry Disability Index. Radiologic outcomes were evaluated from the extent of bone union. The total operating costs in the two groups were compared. RESULTS: Visual analog scale scores for lumbago and leg pain, and the Korean Oswestry Disability Index measured at final follow-up averaged 3.6 and 3.8, and 19.9 in group R, and 3.8 and 3.1, and 21.1 in group C, respectively (P = 0.280, P = 0.387, P = 0.751). For radiologic outcomes, there was one case of nonunion in each group. The cost of surgery was 5332 US dollars in group R, and 6109 US dollars in group C, respectively (P = 0.036). CONCLUSION: Reusing pedicle screws extracted from the fused segments during extension revision operation for ASD can reduce the cost of surgery, and achieves clinical and radiological results similar to those of the conventional operation. LEVEL OF EVIDENCE: 4.

The effect of metal density in thoracic adolescent idiopathic scoliosis.

PURPOSE: Determine impact of metal density on curve correction and costs in thoracic adolescent idiopathic scoliosis (AIS). Ascertain if increased metal density is required for larger or stiffer curves. METHODS: Multicentre retrospective case series of patients with Lenke 1-2 AIS treated with single-stage posterior only surgery using a standardized surgical technique; constructs using >80 % screws with variable metal density. All cases had >2-year follow up. Outcomes measures included coronal and sagittal radiographic outcomes, metal density (number of instrumented pedicles vs total available), fusion length and cost. RESULTS: 106 cases included 94 female. 78 Lenke 1. Mean age 14 years (9-26). Mean main thoracic (MT) Cobb angle 63° corrected to 22° (66 %). No significant correlations were present between metal density and: (a) coronal curve correction rates of the MT (r = 0.13, p = 0.19); (b) lumbar curve frontal correction (r = -0.15, p = 0.12); (c) correction index in MT curve (r = -0.10, p = 0.32); and (d) correction index in lumbar curve (r = 0.11, p = 0.28). Metal density was not correlated with change in thoracic kyphosis (r = 0.22, p = 0.04) or lumbosacral lordosis (r = 0.27, p = 0.01). Longer fusions were associated with greater loss of thoracic kyphosis (r = -0.31, p = 0.003). Groups differing by preoperative curve size and stiffness had comparable corrections with similar metal density. The pedicle screw cost represented 21-29 % of overall cost of inpatient treatment depending on metal density. CONCLUSIONS: Metal density affects cost but not the coronal and sagittal correction of thoracic AIS. Neither larger nor stiffer curves necessitate high metal density.

Skipped versus consecutive pedicle screw constructs for correction of Lenke 1 curves.

PURPOSE: Thoracic pedicle screws provide superior curve correction to hook and wire constructs in adolescent idiopathic scoliosis, while increasing cost. The number of implants required for best correction and outcome has not yet been determined. METHODS: We retrospectively reviewed pre- and post-operative radiographs and self-reported outcome measures in an age- and curve-matched cohort of 40 patients with Lenke I AIS who underwent selective fusions between T3/4 and L1. Twenty patients were treated with thoracic pedicle screws at every level bilaterally (CON) and 20 patients with screws at every level on the concave side and skipped levels on the convex side of the curve (SKP). All patients had a minimum 2-year follow-up. Radiographs were assessed for coronal and sagittal curvatures, as well as thoracic torsion and vertebral rotation. Health-related quality of life was assessed using the SRS-22 instrument. Instrumentation cost data were collected for each case. RESULTS: Postoperative follow-up averaged 28 months for the CON group and 29 months for the SKP group. No statistically significant differences were found between groups with respect to age and pre- and post-operative radiographic parameters. Both constructs provided acceptable correction of the main thoracic curves (66.9 vs. 66.6 %, CON group and SKP group, respectively; p = 0.92), and spontaneous correction of the proximal thoracic (41.5 vs. 41.1 %; p = 0.92) and thoracolumbar/lumbar curves (54.8 vs. 54.3 %; p = 0.92). No significant difference was found in postoperative SRS-22 scores (96 vs. 94.3; p = 0.34). The CON group cost for instrumentation was significantly higher than the SKP group ($19,500 vs. $13,300; p = 0.002). There was no statistically significant difference in operating room times between groups. CONCLUSION: Both construct types provide excellent coronal correction and sagittal balance, with no significant differences in radiographic findings or clinical outcomes. A significant decrease in cost was found with use of skipped screw constructs.

Posterior-only correction of Scheuermann kyphosis using pedicle screws: economical optimization through screw density reduction.

INTRODUCTION: Posterior-only approach using pedicle screws' fixation has emerged as the preferred surgical technique for Scheuermann kyphosis (SK) correction. Insertion of multiple pedicle screws while increasing stability increases also the risk of complications related to screw malpositioning and surgical cost. The optimal screw density required in surgical correction of SK remains unclear. This study compares the safety and efficacy of low screw density (LSD) versus high screw density (HSD) technique used in posterior-only correction of SK. METHODS: Twenty-one patients underwent surgical correction of SK between 2007 and 2011 and were reviewed after a mean of 29 months. HSD technique (i.e., 100 % of available pedicles, averaged 25.2 ± 4 screws) was used in 10 cases and LSD technique (i.e., 54-69 % of available pedicles in a pre-determined pattern, averaged 16.8 ± 1.3 screws; p < 0.001) was used in 11 cases. Kyphosis correction was assessed by comparing thoracic kyphosis, lumbar lordosis and sagittal balance on preoperative and postoperative radiographs. Cost saving analysis was performed for each group. RESULTS: Preoperative thoracic kyphosis, lumbar lordosis and sagittal balance were similar for both groups. The average postoperative kyphosis correction was similar in both HSD and LSD groups (29° ± 9° vs. 34° ± 6°, respectively; p = 0.14). Complication occurred in four patients (19 %) in the HSD group and in two patients (9 %) in the LSD group (p = 0.56). Three patients required re-operation. Compared to HSD using LSD saves 4,200 pounds sterling per patient in hardware and 88,200 pounds sterling for the entire cohort. CONCLUSION: LSD technique is as safe and effective as HSD technique in posterior-only correction of SK. Implant-related cost could be reduced by 32 %.

Economic study: a cost-effectiveness analysis of an intraoperative compared with a preoperative image-guided system in lumbar pedicle screw fixation in patients with degenerative spondylolisthesis.

BACKGROUND CONTEXT: In spinal surgery, newly developed technology seems to play a key role, especially with the use of computer-assisted image-guided navigation, giving excellent results. However, these tools are expensive and may not be affordable for many facilities. PURPOSE: To compare the cost-effectiveness of preoperative versus intraoperative CT (computed tomography) guidance in spinal surgery. STUDY DESIGN: A retrospective economic study. METHODS: A cost-effectiveness study was performed analyzing the overall costs of a population of patients operated on for lumbar degenerative spondylolisthesis using an image-guided system (IGS) based on a CT scan. The population was divided into two groups according to the type of CT data set acquisition adopted: Group I (IGS based on a preoperative spiral CT scan), Group II (IGS based on an intraoperative CT scan-O-Arm system). The costs associated with each procedure were assessed through a process analysis, where clinical procedures were broken down into single phases and the related costs from each phase were evaluated. No benefits in any form have been or will be received from commercial parties directly or indirectly related to the subject of this article. RESULTS: Four hundred ninety-nine patients met the criteria for this study. In total, 2,542 screws were inserted with IGS. Baseline data were similar for the two groups, as were hospitalization and complications. The surgical time was 119±43 minutes in Group I and 92±31 minutes in Group II. The full cost of the two procedures was analyzed: the mean cost, using the O-Arm system (Group II), was found to be €255.83 (3.80%) less than the cost of Group I. Moreover, the O-Arm system was also used in other surgical procedures as an intraoperative control, thus reducing the final costs of radiologic examinations (a reduction of around 550 CT scans/year). CONCLUSIONS: In conclusion, the authors of the study are of the opinion that the surgical procedure of pedicle screw fixation, using a CT-based computer-guidance system with support of the O-Arm system, allows a shortening of procedure time that might improve the clinical result. However, the present study failed to determine a clear cost-effectiveness with respect to other CT-based IGS.