A New Look at Vertebral Body Tethering (VBT): Through the Modified Clavien-Dindo-Sink (mCDS) Classification.

INTRODUCTION: Anterior vertebral body tethering (AVBT) is increasingly popular as an option for surgical treatment of idiopathic scoliosis (IS). While the technology remains new, it is important for families and patients to be able to compare it to the current standard of care, posterior spinal fusion (PSF). The purpose of this study is to describe the complication rate of AVBT in IS using the mCDS and to compare it to the recently reported complication rate of PSF in IS. METHODS: A multicenter pediatric spine deformity database was queried for all idiopathic scoliosis patients who underwent vertebral body tethering. There were 171 patients with a minimum 9-month follow-up included in this study. Complications were retrospectively graded by 2 attending pediatric spine surgeons using the mCDS classification system. RESULTS: Data from 171 patients with idiopathic scoliosis was available for analysis, with 156/171 (91%) of patients being female and an average age of 12.2 years old at surgery. There were 156 thoracic tethers (1 with an LIV below L2), 5 lumbar tethers, 9 staged double tethers, and only 1 patient with same-day double tether. Fifty-five (55) (32%) patients experienced a total of 69 complications. The most common complication type for VBT by mCDS was Grade IIIb, encompassing 29/69 (42%) of complications. The second most frequent complication grade was Grade I at 23/69 (33%). Thirty-four (34) out of 69 (49%) of the VBT complications reported required either procedural/surgical intervention or admission to the ICU. CONCLUSIONS: This is the first study to directly compare the complication profile of VBT to PSF using the mCDS. Forty-nine percent (49%) of the VBT complications reported were at least Grade III, while only 7% of complications in the control PSF cohort from the literature were Grade III or higher. The mCDS complication classification brings light to the early learning experience of a new technique compared to the widely accepted standard of PSF for IS. LEVEL OF EVIDENCE: III - Retrospective comparative study.

Institutional Variability in Anesthesia Time for Mehta Casting in Early-Onset Scoliosis (EOS).

PURPOSE: Mehta casting is a potentially curative intervention for early-onset scoliosis (EOS) that typically requires multiple anesthetics. The Food and Drug Administration (FDA) reported that >3 hours of anesthesia under the age of 3 years old may alter brain development; however, no standard exists for the duration of anesthesia during casting. The purpose of this study is to quantify the variability in anesthesia during Mehta casting. We hypothesize that significant institutional variability exists and may be attributed to modifiable factors. METHODS: An EOS registry was used to identify patients who underwent at least one Mehta casting procedure. Anesthesia exposure was quantified, and site variability was assessed by patient characteristics, cast placement, procedure type, and equipment used. RESULTS: Our cohort consisted of 208 patients from 5 institutions (age 2.6±1.4 y). There were 1097 Mehta casting procedures, with 5.4±3.6 castings per patient. Of these patients, 106 (51%) were female, with an average age of 2.11±1.29 years old at the time casting was initiated. Patient etiologies included 154 idiopathic (74.0%), 22 syndromic (10.6%), 18 congenital (8.7%), 11 neuromuscular (5.3%), and 3 unknown (1.4%). Anesthesia time was 69±31 minutes and varied significantly between sites (59±14 to 117±46 min; P <0.001). Cumulative anesthesia time for patients under 3 years was 320±197 minutes with 120/161 (74.5%) patients exceeding 3 hours. Anesthesia time was lower after the FDA warning in 2016 compared with pre-2016 (71±30 vs. 66±32, P =0.008). CONCLUSIONS: Patients undergoing Mehta casting are at significant risk of exceeding 3 hours of anesthesia, which the FDA has stated may be harmful for children <3 years. Significant site variability indicates that standardization protocols should be developed to encourage best practices and minimize anesthetic times. LEVEL OF EVIDENCE: Prognostic Level II.

Does Transitioning to a Brace Improve HRQoL After Casting for Early Onset Scoliosis?

BACKGROUND: Serial casting is favored for the initial treatment of early onset scoliosis (EOS), but there is concern about significant morbidity and caregiver burden. Studies have examined the utility of bracing as an alternative to casting, but little is known about differences in health-related quality of life (HRQoL) between treatments. We hypothesized that patients with a diagnosis of idiopathic EOS experience an improvement in HRQoL when transitioning from serial casting to bracing as measured by the 24-Item Early Onset Scoliosis Questionnaire (EOSQ). METHODS: Subjects with idiopathic EOS were retrospectively identified from a multicenter database. EOSQ scores were compared before treatment, after index casting, after transition out of cast to brace, and at the most recent follow-up. Available major curve magnitudes were also compared during these time points. Data were compared using repeated-measures ANOVA with post hoc Bonferroni correction. RESULTS: Sixty-six subjects met the inclusion criteria. Thirty-seven (56%) subjects were male and the average age at the time of index treatment was 1.9 (0.37-6.4) years. The average follow-up was 3.2 (0.90-6.8) years. In 57 subjects, the major curve magnitude improved from a mean of 33 (CI 28-37) degrees before treatment initiation to 27 (CI 23-30) degrees after casting and to 24 (CI 20-29) degrees at the most recent follow-up. The HRQoL subdomain showed a significant decrease in HRQoL during casting treatment 75.7 (CI 72.9-78.5) from pre-index treatment 84.9 (CI 81.4-88.5), during brace treatment 84.8 (CI 81.8-88.0) and at most recent follow-up 87.0 (CI 83.6-90.3) ( P <0.001). The parental impact subdomain improved from the beginning to the end of treatment (77.7 to 87.7, P =0.001) (n=64). Satisfaction improved from casting to bracing (73.4 to 86.7, P <0.001) (n=63) and to the most recent follow-up (73.4 to 87.9, P <0.001). CONCLUSION: Patients treated with casting for EOS experience reversible declines in HRQoL. After patients transition from casting to bracing, EOSQ scores recover to pretreatment baseline levels and are maintained at follow-up. This information must be balanced with the effectiveness of treatment for EOS with either method and customized for each patient. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Comparison of Distal Spine Anchors and Distal Pelvic Anchors in Children With Hypotonic Neuromuscular Scoliosis Treated With Growth-friendly Instrumentation.

BACKGROUND: Lower preoperative pelvic obliquity (PO) and L5 tilt have been associated with good radiographic outcomes when the fusion ended short of the pelvis in children with neuromuscular scoliosis (NMS). Our purpose was to identify indications to exclude the pelvis in children with hypotonic NMS treated with growth-friendly instrumentation. METHODS: This was a multicenter retrospective review. Children with spinal muscular atrophy and muscular dystrophy treated with dual traditional growing rod, magnetically controlled growing rod, or vertical expandable prosthetic titanium rib with minimum 2-year follow-up after the index surgery were identified. RESULTS: A total of 125 patients met the inclusion criteria. Thirty-eight patients had distal spine anchors (DSAs) and 87 patients had distal pelvic anchors (DPAs) placed at the index surgery. Demographics and length of follow-up were similar between the groups but there was a greater percentage of DPA patients who were nonambulatory [79 patients (91%) vs. 18 patients (47%), P <0.0001]. Preindex radiographic measures were similar except the DSA patients had a lower PO (11 vs. 19 degrees, P =0.0001) and L5 tilt (8 vs. 12 degrees, P =0.001). Postindex and most recent radiographic data were comparable between the groups. There was no difference in the complication and unplanned returns to the operating room rates.Subanalysis of the DSA group based on ambulatory status showed similar radiographic measures except the ambulatory patients had a lower PO at all time points (preindex: 5 vs. 16 degrees, P =0.011; postindex: 6 vs. 10 degrees, P =0.045; most recent follow-up: 5 vs. 14 degrees, P =0.028). Only 1 ambulatory DSA patient had a PO ≥10 degrees at most recent follow-up compared with 6 nonambulatory DSA patients. Three (8%) DSA patients, all nonambulatory, underwent extension of their instrumentation to the pelvis. CONCLUSIONS: Pelvic fixation should be strongly considered in nonambulatory children with hypotonic NMS treated with growth-friendly instrumentation. At intermediate-term follow-up, revision surgery to include the pelvis was rare but DSAs do not seem effective at maintaining control of PO in nonambulatory patients. DSA and DPA were equally effective at maintaining major curve control, and complication and unplanned returns to the operating room rates were similar. LEVEL OF EVIDENCE: Level III-therapeutic.

Timely completion of spinal fusion: A multidisciplinary quality improvement initiative to improve operating room efficiency.

BACKGROUND: Failure to complete surgery within the scheduled timeframe impairs operating room efficiency leading to patient dissatisfaction and unplanned labor costs. We sought to improve timely completion (within 30 min of scheduled time) of first-case spine fusion surgery (for idiopathic scoliosis) from a baseline of 25%-80% over 12 months. We also targeted timely completion of perioperative stages within predetermined target completion times. METHODS: The project was conducted in three overlapping phases over 16 months. A simplified process map outlining five sequential perioperative stages, preintervention baselines (N = 24) and time targets were defined. A multidisciplinary team conducted a series of tests of change addressing the aims. The key drivers included effective scheduling, team communications, family engagement, data collection veracity, standardized pathways, and situational awareness. Data collected by an independent data collector and from electronic medical records were analyzed using control charts and statistical process control methods. RESULTS: Post-intervention, timely case completion increased from 25% to 68% (N = 49) (95% CI 15.1-62.7), (p = 0.003) and was sustained (N = 14). Implementation of prediction model for case-scheduling decreased difference between scheduled and actual case end-time (33 vs. 53 min [baseline]) and variance [lower/upper control limits ([-26, 51] vs. [-109, 216] min [baseline]). Average start time delay decreased from 6 to 2 min and on-time surgical starts improved from 50% to 70% (95% CI 3.2-41.6%). Timely completion increased for anesthesia induction (60% to 85%), surgical procedure (26% to 48%) and emergence from anesthesia (44% to 80%) but not for intraoperative patient preparation (30% to 25%) perioperative stages. Families reported satisfaction with preoperative processes (N = 14), and no untoward intraoperative safety events occurred. CONCLUSIONS: Application of QI methodology reduced time variation of several tasks and improved timely completion of spine surgery. Beyond the study period, sustained team behavior, adaptive changes, and vigilant monitoring are imperative for continued success.

When Will You Succeed Casting Patients With Early-onset Scoliosis? Prospective Evaluation of Predictive Radiographic Parameters.

BACKGROUND: In a recent retrospective study, in cast correction of the major curve correlated with final curve size in patients with early-onset scoliosis treated with casting. We therefore sought to perform a prospective study with controlled methodology to determine if there are parameters associated with reduction of coronal deformity. METHODS: A prospective, observational study was conducted between 2014 and 2019 at selected sites willing to comply with a standard radiographic and follow-up protocol. Radiographic data was collected at time points of precast, in traction, initial in-cast, and at minimum 1 year follow-up. Multivariate linear regression models were utilized to control for potential confounders using a stepwise procedure. Twenty-nine patients met inclusion criteria. RESULTS: On multivariate analysis, traction major curve (P=0.043) and initial in-cast (P=0.011) major curve Cobb angles were independently associated with final out of cast major curve Cobb angle. The only factor that was independently associated with failure to cure (<15-degree major curve) was traction major curve Cobb angle (P=0.046). A threshold traction major curve Cobb angle of 20 degrees was found to have good accuracy with 81% sensitivity and 73% specificity (receiver operator curve area: 0.869, P<0.001). A traction major curve Cobb angle over 20 degrees would accurately predict failure of casting treatment to cure scoliosis in 79% of cases. A threshold in-cast major curve Cobb angle of 21 degrees was found to have slightly less accuracy than traction with 69% sensitivity, 82% specificity, and 74% accuracy (receiver operator curve area: 0.830, P=0.004). CONCLUSIONS: Radiographic measurements in traction and initially in the cast are predictive of curve size at follow-up for children with early-onset scoliosis treated with casting. The standardization and utility of traction films should be further explored. LEVEL OF EVIDENCE: Level II.

The Effect of Surgeon Experience on Outcomes Following Growth Friendly Instrumentation for Early Onset Scoliosis.

BACKGROUND: The purpose of this study was to utilize a multicenter, multisurgeon cohort to assess the effect of surgeon experience on outcomes of growth friendly instrumentation (GFI) in early onset scoliosis (EOS). We hypothesized that unplanned return to the operating room (UPROR), estimated blood loss (EBL), and surgical time would be greater amongst early career surgeons (ECSs) when compared with advanced career surgeons (ACSs). METHODS: An international pediatric spine database was queried for patients ages 2 to 10 years treated by posterior distraction-based GFI with at least of 2-year follow up. Two groups were created for analysis based on surgeon experience: ECSs (with ≤10 y of experience) and ACSs (with >10 y of experience). The primary outcome was UPROR. Additional outcomes included: operating room time, EBL, neurological deficits, infection rate, hardware failure, and the Early Onset Scoliosis Questionnaire (EOSQ-24). Subgroup analysis was performed for further assessment based on procedure type, superior anchor type, etiology, and curve severity. RESULTS: A total of 960 patients met inclusion criteria including 243 (25.3%) treated by ECS. Etiology, sex, superior anchor, and EOSQ-24 scores were similar between groups (P>0.05). There were no clinically significant differences in patient age or preoperative major coronal curve. UPROR (35.8% vs. 32.7%, P=0.532), infection (17.0% vs. 15.6%, P=0.698), operating room time (235 vs. 231 min, P=0.755), and EBL (151 vs. 155 mL, P=0.833) were comparable between ECS and ACS groups. The frequency of having at least 1 complication was relatively high but comparable among groups (60.7% vs. 62.6%, P=0.709). EOSQ-24 subdomain scores were similar between groups at 2-year follow-up (P>0.05). Subgroup analysis revealed that ECS had increased surgical time compared with ACS in severe curves >90 degrees (270 vs. 229 min, P=0.05). CONCLUSIONS: This study represents the first multicenter assessment of surgeon experience on outcomes in EOS. Overall, surgeon experience did not significantly influence UPROR, complication rates, EBL, or surgical time associated with GFI in this cohort of EOS patients. LEVEL OF EVIDENCE: Level III.

Prioritizing Elective Surgical Cases During a Pandemic or Global Crisis: The Elective-Pediatric Orthopedic Surgical Timing (E-POST) Score.

BACKGROUND: As the first wave of the COVID-19 pandemic stabilized and resources became more readily available, elective surgery was reinitiated and hospitals realized that there was little guidance on how to prioritize elective cases. METHODS: A prioritization tool was formulated based on clinically relevant elements and previous literature. Nine pediatric orthopaedic surgeons from North American institutions evaluated 25 clinical scenarios on 2 occasions separated in time. Intra-rater and inter-rater reliability were calculated [intraclass correlation coefficient (ICC)]. Surgeons also ranked the importance of each element and how confident they were with scoring each factor. RESULTS: Intra-rater ICC for total score showed good to excellent consistency; highest at 0.961 for length of stay (LOS) and lowest at 0.705 for acuity. Inter-rater ICC showed good to excellent agreement for American Society of Anesthesiologists score, LOS, duration of surgery, and transfusion risk and moderate agreement for surgical acuity and personal protective equipment (PPE) use. Transfusion risk and duration of surgery were deemed least important, and surgeons were least confident in scoring PPE and transfusion risk. Based on findings, the novel Elective-Pediatric Orthopedic Surgical Timing (E-POST) score for prioritizing elective cases was developed, consisting of 5 factors: surgical acuity, global health status, LOS, duration of surgery, and PPE requirement. CONCLUSIONS: The E-POST numeric total score or subscore may help objectively prioritize elective cases during a global crisis. LEVEL OF EVIDENCE: Level V.

Mortality in Early-Onset Scoliosis During the Growth-friendly Surgery Era.

INTRODUCTION: Early-onset scoliosis (EOS) is a spinal deformity that occurs in patients 9 years of age or younger. Severe deformity may result in thoracic insufficiency, respiratory failure, and premature death. The purpose of this study is to describe the modern-day natural history of mortality in patients with EOS. METHODS: The multicenter Pediatric Spine Study Group database was queried for all patients with EOS who are deceased, without exclusion. Demographics, underlying diagnoses, EOS etiology, operative and nonoperative treatments or observation, complications, and date of death were retrieved. Descriptive statistics and survival analysis with Kaplan-Meier curves were performed. RESULTS: There were 130/8009 patients identified as deceased for a registry mortality rate of 16 per 1000 patients. The mean age at death was 10.6 years (range: 1.0 to 30.2 y) and the most common EOS etiology was neuromuscular (73/130, 56.2%; P<0.001). Deceased patients were more likely be treated operatively than nonoperatively or observed (P<0.001). The mean age of death for patients treated operatively (12.3 y) was older than those treated nonoperatively (7.0 y) or observed (6.3 y) (P<0.001) despite a larger deformity and similar index visit body mass index and ventilation requirements. Kaplan-Meier analysis confirmed an increased survival time in patients with a history of any spine operation compared with patients without a history of spine operation (P<0.0001). Operatively treated patients experienced a median of 3.0 complications from diagnosis to death. Overall, cardiopulmonary related complications were the most common (129/271, 47.6%; P<0.001), followed by implant-related (57/271, 21.0%) and wound-related (26/271, 9.6%). The primary cause of death was identified for 78/130 (60.0%) patients, of which 57/78 (73.1%) were cardiopulmonary related. CONCLUSIONS: This study represents the largest collection of EOS mortality to date, providing surgeons with a modern-day examination of the effects of surgical intervention to better council patients and families. Both fatal and nonfatal complications in children with EOS are most likely to involve the cardiopulmonary system. LEVEL OF EVIDENCE: Level IV-therapeutic.

Best Practice Guidelines for Surgical Site Infection in High-risk Pediatric Spine Surgery: Definition, Prevention, Diagnosis, and Treatment.

BACKGROUND: Prior "best practice guidelines" (BPG) have identified strategies to reduce the risk of acute deep surgical site infection (SSI), but there still exists large variability in practice. Further, there is still no consensus on which patients are "high risk" for SSI and how SSI should be diagnosed or treated in pediatric spine surgery. We sought to develop an updated, consensus-based BPG informed by available literature and expert opinion on defining high-SSI risk in pediatric spine surgery and on prevention, diagnosis, and treatment of SSI in this high-risk population. MATERIALS AND METHODS: After a systematic review of the literature, an expert panel of 21 pediatric spine surgeons was selected from the Harms Study Group based on extensive experience in the field of pediatric spine surgery. Using the Delphi process and iterative survey rounds, the expert panel was surveyed for current practices, presented with the systematic review, given the opportunity to voice opinions through a live discussion session and asked to vote regarding preferences privately. Two survey rounds were conducted electronically, after which a live conference was held to present and discuss results. A final electronic survey was then conducted for final voting. Agreement ≥70% was considered consensus. Items near consensus were revised if feasible to achieve consensus in subsequent surveys. RESULTS: Consensus was reached for 17 items for defining high-SSI risk, 17 items for preventing, 6 for diagnosing, and 9 for treating SSI in this high-risk population. After final voting, all 21 experts agreed to the publication and implementation of these items in their practice. CONCLUSIONS: We present a set of updated consensus-based BPGs for defining high-risk and preventing, diagnosing, and treating SSI in high-risk pediatric spine surgery. We believe that this BPG can limit variability in practice and decrease the incidence of SSI in pediatric spine surgery. LEVEL OF EVIDENCE: Not applicable.

Use of Vancomycin Powder in the Surgical Treatment of Early Onset Scoliosis Is Associated With Different Microbiology Cultures After Surgical Site Infection.

BACKGROUND: The use of vancomycin powder has been shown to decrease risk of surgical site infection (SSI) in early onset scoliosis (EOS). While there is potential benefit in SSI reduction, there is also theoretical risk in creating increased bacterial resistance to standard treatment regimens. However, the effects of topical vancomycin powder on microbiology in these patients has not been studied. METHODS: A multicenter database for EOS patients was retrospectively analyzed. All patients that underwent surgical treatment with traditional growing rods, magnetically controlled growing rods, vertical expandable prosthetic titanium rib, and Shilla for EOS performed after 2010 were identified (n=1115). Patients that sustained at least 1 SSI after guided growth surgery were assessed (n=104, 9.3%). Patients with culture and antibiotic details were included (n=55). Patients that received vancomycin powder at index surgery were compared with patients that did not. A multivariate regression model was used to control for potential confounders. RESULTS: There were 55 patients included in this study, including 26 males (47%) and 29 females (53%). Mean age at index surgery was 7.2±6.9 years. Vancomycin powder was utilized in 18 cases (33%). Mean time from index surgery to SSI was 2.0±1.3 years. There were 2 cases of wound dehiscence (4%), 7 cases of superficial infection (13%), and 46 cases of deep infection (84%).There were significant differences in overall microbiology results between vancomycin and no vancomycin cohorts (P=0.047). On univariate analysis, the vancomycin powder cohort had a significantly high incidence of cultures without growth (n=7, 39% vs. n=4, 11%, relative risk: 2.063, 95% confidence interval: 0.927-4.591, P=0.028). This association remained significant on multivariate analysis (adjusted odds ratio: 9.656, 95% confidence interval: 1.743-53.494, P=0.009). CONCLUSIONS: In EOS patients undergoing procedures complicated by SSI, the use of vancomycin powder was independently associated with increased risk of no culture growth. Surgeons and infectious disease physicians should be aware and adjust diagnostic and treatment strategies appropriately. LEVEL OF EVIDENCE: Level III-retrospective cohort study.

Improvement of Pulmonary Function Measured by Patient-reported Outcomes in Patients With Spinal Muscular Atrophy After Growth-friendly Instrumentation.

BACKGROUND: Children with spinal muscular atrophy (SMA) sustain a progressive reduction in pulmonary function (PF) related to both muscular weakness and the concomitant effects of spinal deformity on the thorax. Growth-friendly instrumentation is commonly utilized for younger patients with scoliosis and SMA to halt the progression of spinal curvature, but its effect on PF in these patients has not previously been investigated. Using the change in Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24) PF subdomain scores, the authors will investigate whether PF improves in patients with SMA after a growth-friendly intervention. METHODS: This was a multicenter retrospective cohort study from 2 international registries of patients with SMA undergoing spinal deformity surgery from 2005 to 2015. Data collected were age, sex, degree of major coronal curve, type of growth-friendly construct, forced vital capacity (FVC), and EOSQ-24 scores at the patient's preoperative, 1-year postoperative, and 2-year postoperative visits. Differences in EOSQ-24 PF scores and FVC between baseline and postoperative assessment were examined by paired tests. RESULTS: A total of 74 patients were identified (mean age, 7.6±2.3 y, major curve 68.1±22.4 degrees, 51.4% female individuals). The mean EOSQ-24 PF scores improved significantly from 70.6 preoperatively to 83.6 at 1 year (P=0.092) and 86.5 at 2 years postoperatively (P=0.020). The scores in patients with rib-based constructs showed steeper increases at 1-year assessments than those in patients with spine-based constructs. The mean paired FVC value decreased from 63.9% predicted preoperatively, to 57.6% predicted at 1 year postoperatively (P=0.035), and 61.9% predicted preoperatively, to 56.3% predicted at 2 years postoperatively (P=0.178). CONCLUSIONS: Patients with SMA who received growth-friendly instrumentation did experience improvements in PF as measured by EOSQ-24 assessing the caregivers' perception. Given the uncertain reliability of PFTs in this young population, EOSQ-24 is an important tool for measuring improvements in health-related quality of life. LEVEL OF EVIDENCE: Level III-retrospective study.

Contouring the magnetically controlled growing rods: impact on expansion capacity and proximal junctional kyphosis.

OBJECTIVE: To quantitatively determine the relationship between the contouring of the magnetically controlled growing rods (MCGR), their expansion capacity and the risk of developing proximal junctional kyphosis in early onset scoliosis (EOS). MCGRs allow gradual expansion and correction of the spinal deformity in EOS while reducing the need for repeated surgeries. As the expansion of the MCGRs is controlled externally, several factors can impact the discrepancy between the intended and actual expansions of the rods. The expansion capacity of the growing rods as a function of the expanded length has been tested in experimental setups; however, no study has evaluated the role of contouring of the MCGRs on its function and long-term surgical outcome. METHODS: A total of 25 EOS patients, a total of 48 MCGRs, with right thoracic curves, were studied retrospectively. All patients had two view spinal radiographs at pre-operative, after MCGR implantation, and after 6 lengthening visits. The first post-operative radiographs were used to calculate the 3D contour of the MCGR at the proximal end. 2D ultrasound images before and after lengthening visits were used to measure the rod lengthening at each visit. The relationship between the increase in the rod length and rod curvature was determined. Finally, the rod curvature was correlated to the changes in proximal junctional kyphosis (PJK) angle between the pre-operative and the most recent follow-up, i.e., after 6 visits. RESULTS: The average rod 3D angle at the proximal end was 13.5° ± 9.7° [0°-37.2°]. The overall increased length after six lengthening visits for the rod at the concave side was 18.8 mm and at the convex side was 16.9 mm. 62% of the patients with a contoured rod at the proximal end developed a PJK exceeding 10° whereas in patients with a straight rod PJK occurred in 9.1%. CONCLUSIONS: Contouring the MCGR impacts both the mechanics of the rod expansion and the prevalence of PJK in EOS patient population.

Serial Casting in Neuromuscular and Syndromic Early-onset Scoliosis (EOS) Can Delay Surgery Over 2 Years.

BACKGROUND: The primary goal in managing early-onset scoliosis (EOS) is delaying/preventing surgical intervention while allowing improved spinal growth and chest wall and lung development to improve life expectancy. The effectiveness of serial casting for patients with neuromuscular and syndromic EOS is unclear. METHODS: Patients from 2 multicenter registries who underwent serial casting for nonidiopathic scoliosis (NIS) were reviewed retrospectively. Comparisons were made between precasting and postcasting major and compensatory curves and spine height. The need for surgical intervention and any treatment complications were documented. Risk factors for major curve progression from baseline to casting cessation were evaluated via univariate analysis. RESULTS: Forty-four patients (23 females; 21 males) with NIS (26 syndromic, 18 neuromuscular) and a mean age of 3.2 years at baseline were included. Mean follow-up and casting duration was 3.9 and 2.0 years, respectively. There were no statistically significant differences between mean precasting and postcasting major curve (55 vs. 60 degrees; P=0.348), minor curve (31 vs. 33 degrees; P=0.510), or rib-vertebra angle difference (18 vs. 29 degrees; P=0.840). However, thoracic height (15.5 vs. 16.8 cm; P=0.031) and lumbar height (8.9 vs. 9.8 cm; P=0.013) were significantly greater upon casting cessation. Currently, 13 patients (30%) have had successful casting (improvement of major curve ≥10 degrees) while 24 patients (55%) experienced major curve progression (worsening), and 19 patients (43%) required surgical intervention. Mean time from first casting to surgery was 34.5±15.1 months. There were no statistically significant predictors for major curve progression on univariate analysis. CONCLUSIONS: Spinal deformity progression despite casting and the subsequent need for surgical intervention for NIS were significantly higher compared with those reported for idiopathic EOS. However, serial casting did afford a substantial delay in surgical intervention. Ultimately, serial casting for neuromuscular or syndromic EOS is an effective strategy for delaying surgical intervention, despite suboptimal radiographic outcomes. LEVEL OF EVIDENCE: Level III.

Characterizing Use of Growth-friendly Implants for Early-onset Scoliosis: A 10-Year Update.

BACKGROUND: Growth-friendly treatment of early-onset scoliosis (EOS) has changed with the development and evolution of multiple devices. This study was designed to characterize changes in the use of growth-friendly implants for EOS from 2007 to 2017. METHODS: We queried the Pediatric Spine Study Group database for patients who underwent index surgery with growth-friendly implants from July 2007 to June 2017. In 1298 patients, we assessed causes of EOS; preoperative curve magnitude; age at first surgery; patient sex; construct type; lengthening interval; incidence of "final" fusion for definitive treatment; and age at definitive treatment. α=0.05. RESULTS: From 2007 to 2017, the annual proportion of patients with idiopathic EOS increased from 12% to 33% (R=0.58, P=0.006). Neuromuscular EOS was the most common type at all time points (range, 33% to 44%). By year, mean preoperative curve magnitude ranged from 67 to 77 degrees, with no significant temporal changes. Mean (±SD) age at first surgery increased from 6.1±2.9 years in 2007 to 7.8±2.5 years in 2017 (R=0.78, P<0.001). As a proportion of new implants, magnetically controlled growing rods increased from <5% during the first 2 years to 83% in the last 2 years of the study. Vertically expandable prosthetic titanium ribs decreased from a peak of 48% to 6%; growth-guidance devices decreased from 10% to 3%. No change was seen in mean surgical lengthening intervals (range, 6 to 9 mo) for the 614 patients with recorded lengthenings. Final fusion was performed in 88% of patients who had undergone definitive treatment, occurring at a mean age of 13.4±2.4 years. CONCLUSIONS: From 2007 to 2017, neuromuscular EOS was the most common diagnosis for patients treated with growth-friendly implants. Patient age at first surgery and the use of magnetically controlled growing rods increased during this time. Preoperative curve magnitude, traditional growing rod lengthening intervals, and rates of final fusion did not change. LEVEL OF EVIDENCE: Level II.

Establishing Consensus on the Best Practice Guidelines for Use of Halo Gravity Traction for Pediatric Spinal Deformity.

BACKGROUND: Although halo gravity traction (HGT) has been used to treat children with severe spinal deformity for decades, there is a distinct lack of high-quality evidence to speak to its merits or to dictate ideal manner of implementation. In addition, no guidelines exist to drive research or assist surgeons in their practice. The aim of this study was to establish best practice guidelines (BPG) using formal techniques of consensus building among a group of experienced pediatric spinal deformity surgeons to determine ideal indications and implementation of HGT for pediatric spinal deformity. METHODS: The Delphi process and nominal group technique were used to formally derive consensus among leaders in pediatric spine surgery. Initial work identified significant areas of variability in practice for which we sought to garner consensus. After review of the literature, 3 iterative surveys were administered from February through April 2018 to nationwide experts in pediatric spinal deformity. Surveys assessed anonymous opinions on ideal practices for indications, preoperative evaluation, protocols, and complications, with agreement of 80% or higher considered consensus. Final determination of consensus items and equipoise were established using the Nominal group technique in a facilitated meeting. RESULTS: Of the 42 surgeons invited, responses were received from 32, 40, and 31 surgeons for each survey, respectively. The final meeting included 14 experts with an average 10.5 years in practice and average 88 annual spinal deformity cases. Experts reached consensus on 67 items [indications (17), goals (1), preoperative evaluations (5), protocols (36), complications (8)]; these were consolidated to create final BPG in all categories, including statements to help dictate practice such as using at least 6 to 8 pins under 4 to 8 lbs of torque, with a small, tolerable starting weight and reaching goal weight of 50% TBW in ∼2 weeks. Nine items remained items of equipoise for the purposes of guiding future research. CONCLUSIONS: We developed consensus-based BPG for the use and implementation of HGT for pediatric spinal deformity. This can serve as a measure to help drive future research as well as give new surgeons a place to begin their practice of HGT. LEVEL OF EVIDENCE: Level V-expert opinion.

Early Onset Scoliosis: Is there an Improvement in Quality of Life With Conversion From Traditional Growing Rods to Magnetically Controlled Growing Rods?

BACKGROUND: Modern treatment of early onset scoliosis (EOS) includes implantation of traditional growing rods (TGR) or magnetically controlled growing rods (MCGR) for posterior-based distraction if nonoperative treatment plans failed. The recent MCGR innovation has largely been expected to improve patient and family burden by avoiding frequent return to the operating room. At least one study has shown no HRQoL difference between TGR and MCGR, but none have specifically investigated a cohort of conversion patients whose families have experienced both. METHODS: An EOS database was queried for all patients treated with TGR, MCGR, and those converted from TGR to MCGR who had at least 1 pretreatment and 1 posttreatment HRQoL assessment (EOSQ-24). Data on demographics, diagnoses, and major curve size, as well as EOSQ-24 domain scores were studied. RESULTS: There were 156 TGR, 114 MCGR, and 32 conversion patients, with an average of 2.0 years between first and final EOSQ-24 surveys. There was no significant difference in outcome in any EOSQ-24 domain between the converts and the other 2 treatment groups. There was a significant post-op improvement in MCGR versus TGR in transfers and energy level (P=0.01; P=0.01). CONCLUSIONS: Although patient families and their surgeons may subjectively report improved HRQoL after conversion from TGR lengthenings to in-office MCGR lengthenings, these improvements were seen in transfer and fatigue domains, not burden or satisfaction. Although the EOSQ-24 is a well-validated EOS metric, it may not be sensitive enough to overcome the QoL floor-effect associated with the diagnosis itself, or perhaps the improvement in QoL must be assessed over a longer interval to assess meaningful change. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Cost-effectiveness of intravenous acetaminophen and ketorolac in adolescents undergoing idiopathic scoliosis surgery.

BACKGROUND: Enhanced recovery after surgery protocols increasingly use multimodal analgesia after major surgeries with intravenous acetaminophen and ketorolac, despite no documented cost-effectiveness of these strategies. AIMS: The goal of this prospective cohort study was to model cost-effectiveness of adding acetaminophen or acetaminophen + ketorolac to opioids for postoperative outcomes in children having scoliosis surgery. METHODS: Of 106 postsurgical children, 36 received only opioids, 26 received intravenous acetaminophen, and 44 received acetaminophen + ketorolac as analgesia adjuncts. Costs were calculated in 2015 US $. Decision analytic model was constructed with Decision Maker® software. Base-case and sensitivity analyses were performed with effectiveness defined as avoidance of opioid adverse effects. RESULTS: The groups were comparable demographically. Compared with opioids-only strategy, subjects in the intravenous acetaminophen + ketorolac strategy consumed less opioids (P = .002; difference in mean morphine consumption on postoperative days 1 and 2 was -0.44 mg/kg (95% CI -0.72 to -0.16); tolerated meals earlier (P < .001; RR 0.250 (0.112-0.556)) and had less constipation (P < .001; RR 0.226 (0.094-0.546)). Base-case analysis showed that of the 3 strategies, use of opioids alone is both most costly and least effective, opioids + intravenous acetaminophen is intermediate in both cost and effectiveness; and opioids + intravenous acetaminophen and ketorolac is the least expensive and most effective strategy. The addition of intravenous acetaminophen with or without ketorolac to an opioid-only strategy saves $510-$947 per patient undergoing spine surgery and decreases opioid side effects. CONCLUSION: Intravenous acetaminophen with or without ketorolac reduced opioid consumption, opioid-related adverse effects, length of stay, and thereby cost of care following idiopathic scoliosis in adolescents compared with opioids-alone postoperative analgesia strategy.

Observed Length Increases of Magnetically Controlled Growing Rods are Lower Than Programmed.

BACKGROUND: Magnetically controlled growing rods (MCGRs) are increasingly used in the treatment of early onset scoliosis (EOS). Few studies have reported whether desired lengthening can reliably be achieved, or if prior spine instrumentation and large tissue depths affect lengthening. In this clinical study of EOS patients, it was hypothesized that increases in rod length would equal programmed increases, patients with prior spine instrumentation would lengthen less than patients without prior surgery, and larger tissue depths would decrease lengthening success. METHODS: A retrospective chart review was conducted on EOS patients with single and dual MCGRs placed between April 2014 to September 2015 and distracted at a single institution. Rod distraction was measured at each visit using ultrasound. Differences between programmed and actual distraction for each patient, and between groups with and without prior spine instrumentation, were determined by 2-tailed t tests. Regression and correlation were used to determine the relationship between tissue depth and length increases. RESULTS: Thirty-one patients were included, 18 males, 13 females, age 8.1 (±2.5) years, with major curves measuring 60 (±14.6) degrees at time of MCGR insertion. In the 12 patients with prior instrumentation, time from initial growing rod placement to MCGR insertion was 23.1 (±10.6) months. The number of surgical procedures before MCGR insertion was 2.8 (±2.0). Total length increase relative to the programmed distraction was 86% (±21) (P<0.001). Length increases for patients with and without prior surgery were 87% (±23) and 86% (±19), respectively (P>0.9). Total lengthening was inversely proportional to tissue depth (r=0.38, P<0.01); the decrease in lengthening achieved was 2.1%/mm of tissue depth. CONCLUSIONS: Increases in rod length were 14% lower than the programmed distraction. Prior instrumentation did not impact the amount of rod distraction. Greater distance between the rod and the skin surface negatively affected the magnitude of distraction.

What is the Risk of Developing Proximal Junctional Kyphosis During Growth Friendly Treatments for Early-onset Scoliosis?

BACKGROUND: Rib-based and spine-based systems are commonly used distraction-based growth friendly treatments for early-onset scoliosis (EOS). Our primary purpose was to determine the risk of developing postoperative proximal junctional kyphosis (PJK) during distraction-based growth friendly surgery. METHODS: A multicenter, retrospective, radiographic comparison was performed for a group of 40 children with EOS who were treated with posterior distraction-based implants. PJK was defined as proximal junction sagittal angle (PJA)≥10 degrees and PJA at least 10 degrees greater than preoperative. RESULTS: Eight subjects (20%) at immediate postoperative follow-up and 11 subjects (27.5%) at minimum 2-year follow-up had developed PJK. The risk of developing PJK between rib-based and spine-based growing systems was not significantly different at immediate postoperative (17% vs. 25%) or at final (25% vs. 31%) follow-ups.Further analysis combining both treatment groups demonstrated that PJK subjects were significantly older at time of initial surgery (7.1 y PJK vs. 5.0 y no PJK). Radiographic comparisons between PJK versus no PJK: Preoperative scoliosis (69.9 vs. 76.0 degrees), thoracic kyphosis (45.1 vs. 28.7 degrees), lumbar lordosis (53.1 vs. 44.0 degrees), PJA (2.2 vs. 2.8 degrees), sagittal vertical axis (1.5 vs. 2.6 cm), pelvic incidence (52.8 vs. 47.4 degrees), pelvic tilt (14.3 vs. 8.7 degrees), and sacral slope (37.7 vs. 35.9 degrees). At both initial postoperative and at final follow-up visits, a significant difference was found for cervical lordosis 32.2 versus 14.0 degrees and 42.0 versus 16.6 degrees, respectively. Risk ratio for developing PJK at final follow-up was 2.8 for subjects with preoperative thoracic hyperkyphosis and was 3.1 for subjects with high pelvic incidence (P<0.05). CONCLUSIONS: The risk of developing PJK during distraction-based growth friendly treatment for EOS was 20% immediately after implantation and 28% at minimum 2-year follow-up, with no difference observed between rib-based and spine-based treatment groups. As this study identifies a significant risk of developing PJK during the treatment of EOS, it allows clinicians to preoperatively council patients and their families about this possible complication. In addition, several potential risk factors for the development of postoperative PJK were identified, but should be investigated further in future studies. LEVEL OF EVIDENCE: Level III-therapeutic study (retrospective, comparative).