Perioperative Complications and Health-related Quality of Life Outcomes in Severe Pediatric Spinal Deformity.

STUDY DESIGN: Prospective multicenter cohort study. OBJECTIVE: To evaluate perioperative complications and mid-term outcomes for severe pediatric spinal deformity. SUMMARY OF BACKGROUND DATA: Few studies have evaluated the impact of complications on health-related quality of life (HRQoL) outcomes in severe pediatric spinal deformity. METHODS: Patients from a prospective, multicenter database with severe pediatric spinal deformity (minimum of 100 degree curve in any plane or planned vertebral column resection (VCR)) with a minimum of 2-years follow-up were evaluated (n=231). SRS-22r scores were collected preoperatively and at 2-years postoperatively. Complications were categorized as intraoperative, early postoperative (within 90-days of surgery), major, or minor. Perioperative complication rate was evaluated between patients with and without VCR. Additionally, SRS-22r scores were compared between patients with and without complications. RESULTS: Perioperative complications occurred in 135 (58%) patients, and major complications occurred in 53 (23%) patients. Patients that underwent VCR had a higher incidence of early postoperative complications than patients without VCR (28.9% vs. 16.2%, P =0.02). Complications resolved in 126/135 (93.3%) patients with a mean time to resolution of 91.63 days. Unresolved major complications included motor deficit (n=4), spinal cord deficit (n=1), nerve root deficit (n=1), compartment syndrome (n=1), and motor weakness due to recurrent intradural tumor (n=1). Patients with complications, major complications, or multiple complications had equivalent postoperative SRS-22r scores. Patients with motor deficits had lower postoperative satisfaction subscore (4.32 vs. 4.51, P =0.03), but patients with resolved motor deficits had equivalent postoperative scores in all domains. Patients with unresolved complications had lower postoperative satisfaction subscore (3.94 vs. 4.47, P =0.03) and less postoperative improvement in self-image subscore (0.64 vs. 1.42, P =0.03) as compared to patients with resolved complications. CONCLUSION: Most perioperative complications for severe pediatric spinal deformity resolve within 2-years postoperatively and do not result in adverse HRQoL outcomes. However, patients with unresolved complications have decreased HRQoL outcomes.

Re-evaluating consensus and uncertainty among treatment options for early onset scoliosis: a 10-year update.

PURPOSE: Consensus and uncertainty in early onset scoliosis (EOS) treatment were evaluated in 2010. It is currently unknown how treatment preferences have evolved over the past decade. The purpose of this study was to re-evaluate consensus and uncertainty among treatment options for EOS patients to understand how they compare to 10 years ago. METHODS: 11 pediatric spinal surgeons (similar participants as in 2010) were invited to complete a survey of 315 idiopathic and neuromuscular EOS cases (same cases as in 2010). Treatment options included the following: conservative management, distraction-based methods, growth guidance/modulation, and arthrodesis. Consensus was defined as ≥ 70% agreement, and uncertainty was < 70%. Associations between case characteristics and consensus for treatments were assessed via chi-squared and multiple regression analyses. Case characteristics associated with uncertainty were described. RESULTS: Eleven surgeons [31.7 ± 7.8 years of experience] in the original 2010 cohort completed the survey. Consensus for conservative management was found in idiopathic patients aged ≤ 3, whereas in 2010, some of these cases were selected for surgery. There is currently consensus for casting idiopathic patients aged 1 or 2 with moderate curves, whereas in 2010, there was uncertainty between casting and bracing. Among neuromuscular cases with consensus for surgery, arthrodesis was chosen for patients aged 9 with larger curves. CONCLUSION: Presently, preferences for conservative management have increased in comparison to 2010, and casting appears to be preferred over bracing in select infantile cases. Future research efforts with higher levels-of-evidence should be devoted to elucidate the areas of uncertainty to improve care in the EOS population. LEVEL OF EVIDENCE: Level V.

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.

Curve Modulation and Apex Migration Using Shilla Growth Guidance Rods for Early-onset Scoliosis at 5-Year Follow-up.

BACKGROUND: The Shilla procedure was designed to correct and control early-onset spinal deformity while harnessing a child's remaining spinal growth. It allows for controlled axial skeletal growth within the construct, avoiding the need for frequent surgeries to lengthen implants. We hypothesized that curve characteristics evolve over time after initial apex fusion and placement of the Shilla implants. The purpose of this study was to identify trends in curve evolution after Shilla implantation and understand how these changes influence ultimate outcome. METHODS: A single-center, retrospective review of all patients with Shilla implants in place for ≥5 years yielded 21 patients. Charts and radiographs were reviewed to compare coronal curve characteristics preoperatively, postoperatively, and at last follow-up to note changes in the apex of the primary curve. Also noted were the development of adjacent compensatory curves, the overall vertical spinal growth, and the need for definitive spinal fusion once skeletal maturity was reached. RESULTS: Of the 21 patients, the curve apex migrated caudally in 12 patients (57%) and cephalad in 1 patient (5%), with a mean migration of 2.7 vertebral levels. Two patients (10%) developed new, significant compensatory curves (1 caudal and 1 cephalad). All patients demonstrated spinal growth in T1-S1 length following index surgery (mean, 45 mm). At skeletal maturity, 10 patients underwent definitive posterior spinal fusion and instrumentation, and 3 underwent implant removal alone. CONCLUSIONS: This study constitutes the longest follow-up of Shilla patients evaluating curve and implant behavior. Results of this review suggest that the apex of the fused primary curve shifts in approximately 62% of patients, with nearly all of these (92%) involving a distal migration. Compensatory curves did develop after Shilla placement as well. Overall, these findings represent adding-on distal to the apex after Shilla instrumentation rather than a crankshaft phenomenon about the apex. A better understanding of spinal growth mechanics and outcomes after Shilla placement may improve our ability to appropriately select patients and instrumentation levels. LEVEL OF EVIDENCE: Level III.

Growth-Friendly Spine Surgery in Escobar Syndrome.

BACKGROUND: The aims of this study were to characterize the spinal deformity of patients with Escobar syndrome, describe results of growth-friendly treatments, and compare these results with those of an idiopathic early-onset scoliosis (EOS) cohort to determine whether the axial stiffness in Escobar syndrome limited correction. METHODS: We used 2 multicenter databases to review the records of 8 patients with EOS associated with Escobar syndrome who had at least 2-year follow-up after initiation of growth-friendly treatment from 1990 to 2016. An idiopathic EOS cohort of 16 patients matched for age at surgery (±1 y), postoperative follow-up (±1 y), and initial curve magnitude (±10 degrees) was identified. A randomized 1:2 matching algorithm was applied (α=0.05). RESULTS: In the Escobar group, spinal deformity involved 7 to 13 vertebrae and ranged from no vertebral anomalies in 3 patients to multiple segmentation defects in 6 patients. Mean age at first surgery was 5 years (range, 1.4 to 7.8 y) with a mean follow-up of 7.5 years (range, 4.0 to 10 y). Mean major curve improved from 76 degrees at initial presentation, to 43 degrees at first instrumentation, to 37 degrees at final follow-up (both P<0.001). Mean pelvic obliquity improved from 16 degrees (range, 5 to 31 degrees) preoperatively to 4 degrees (range, 0 to 8 degrees) at final follow-up (P=0.005). There were no differences in the mean percentage of major curve correction between the idiopathic EOS and Escobar groups at the immediate postoperative visit (P=0.743) or final follow-up (P=0.511). There were no differences between the cohorts in T1-S1 height at initial presentation (P=0.129) or in growth per month (P=0.211). CONCLUSIONS: Multiple congenital fusions and spinal curve deformity are common in Escobar syndrome. Despite large areas of congenital fusion, growth-friendly constructs facilitate spinal growth and improve curve correction. These results are comparable to those in idiopathic EOS. LEVEL OF EVIDENCE: Level III-case-control study.

Radiographic Outcomes of Shilla Growth Guidance System and Traditional Growing Rods Through Definitive Treatment.

STUDY DESIGN: Retrospective review of a multicenter database. OBJECTIVES: To compare the radiographic outcomes of patients who had undergone the Shilla Growth Guidance System (SGGS) and traditional growing rod (GR) treatment for management of early-onset scoliosis (EOS) through definitive treatment. SUMMARY OF BACKGROUND DATA: The efficacy of surgical treatment of EOS can only be determined after definitive treatment has been completed. We wanted to review our experience with the SGGS and GR for management of EOS through definitive treatment. METHODS: Patients who had surgical treatment with SGGS or GR and had undergone definitive treatment were included. The patients were matched by age, preoperative curve magnitude, and diagnosis. The study population consisted of 36 patients (18 in each group) whose mean age at initial surgery was as follows: SGGS, 7.9 years; and GR, 7.7 years (not significant [NS]). Length of follow-up after initial surgery was 6.1 years for SGGS and 7.4 years for GR (NS). Definitive treatment was posterior spinal fusion (15 SGGS, 17 GR), implant removal (3 SGGS), or completion of lengthenings (1 GR). RESULTS: The preoperative curve was 61 degrees for SGGS and 65 degrees for GR (NS). After index surgery, the major curve decreased to 24 degrees (-37 degrees) for SGGS and 38 (-27 degrees) for GR (p < .05). At last follow-up, the major curve was 34 degrees (44%) for SGGS and 36 degrees (45%) for GR (NS). The initial T1-T12 length for SGGS was 188 mm and for GR, 181 mm; at last follow-up, SGGS was 234 mm (46 mm increase) and GR was 233 mm (52 mm increase) (NS). CONCLUSION: Our analysis shows the final radiographic outcomes (and changes) and complications (implant-related and infection) between the SGGS and GR groups were not statistically different. The main difference between the two groups was the threefold difference in overall surgeries.

A Comparison of SHILLA GROWTH GUIDANCE SYSTEM and Growing Rods in the Treatment of Spinal Deformity in Children Less Than 10 Years of Age.

BACKGROUND: The purpose of this study was to compare the outcomes of the SHILLA GROWTH GUIDANCE SYSTEM and "intermittent distraction growing rod" (IDGR) in the treatment of children (less than 10 y of age) with progressive spinal deformity. This was a multicenter retrospective study of the SHILLA used as an alternative treatment to IDGR to support an HDE submission for Food and Drug Administration approval. METHODS: Inclusion criteria were progressive scoliosis in a patient less than 10 years of age at index procedure. The study population consisted of 19 SHILLA and 6 IDGR patients whose mean age was 6.1 and 5.8 years, respectively. Group demographics were similar between the 2 groups. RESULTS: The initial major curve magnitude was 70.3 degrees for SHILLA and 68.3 degrees for IDGR, which decreased postoperatively to 22.4 degrees (68.1% improvement) and 32.2 degrees (52.9% improvement). During the first 4 years the correction for SHILLA varied from 40.5% to 53.4% and for IDGR from 40.9% to 56.9%. At last follow-up, T1-S1 length was 32.9 cm for SHILLA (4.2 increase from preoperation) and 34.0 cm (5.0 cm increase from preoperation) for IDGR. Average growth per month from T1-S1: SHILLA 0.14 cm, IDGR 0.11 cm. Sagittal T2-T12 preoperatively was 36.3 degrees for SHILLA and 30.0 degrees for IDGR. There were 29 reoperations in 12 of the 19 SHILLA patients (63.2%) and 40 reoperations in all 6 of the IDGR patients (100%) related to the index procedure. CONCLUSIONS: The SHILLA GROWTH GUIDANCE SYSTEM compares favorably with traditional IDGR constructs in terms of correction of the major curve, spinal length and growth, and maintenance of sagittal alignment. The >4-fold decrease in additional surgeries makes the SHILLA an attractive alternative to minimize comorbidities associated with additional surgeries. LEVELS OF EVIDENCE: Level III.

Utility of an allograft tendon for scoliosis correction via the costo-transverse foreman.

Current convex tethering techniques for treatment of scoliosis have centered on anterior convex staples or polypropylene tethers. We hypothesized that an allograft tendon tether inserted via the costo-transverse foramen would correct an established spinal deformity. In the pilot study, six 8-week-old pigs underwent allograft tendon tethering via the costo-transverse foreman or sham to test the strength of the transplanted tendon to retard spine growth. After 4 months, spinal deformity in three planes was induced in all animals with allograft tendons. In the treatment study, the allograft tendon tether was used to treat established scoliosis in 11 8-week-old pigs (spinal deformity > 50°). Once the deformity was observed (4 months) animals were assigned to either no treatment group or allograft tendon tether group and progression assessed by monthly radiographs. At final follow-up, coronal Cobb angle and maximum vertebral axial rotation of the treatment group was significantly smaller than the non-treatment group, whereas sagittal kyphosis of the treatment group was significantly larger than the non-treatment group. In sum, a significant correction was achieved using a unilateral allograft tendon spinal tether, suggesting that an allograft tendon tethering approach may represent a novel fusion-less procedure to correct idiopathic scoliosis. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:183-192, 2017.

Final Fusion After Growing-Rod Treatment for Early Onset Scoliosis: Is It Really Final?

BACKGROUND: Final fusion is thought to be the end point for patients with early onset scoliosis following treatment with the use of growing rods. But is it? The purpose of this study was to determine the incidence and cause of any reoperation after final fusion. METHODS: A multicenter database of patients with early onset scoliosis was retrospectively analyzed to identify patients treated with growing rods with a minimum of 2 years of follow-up after final fusion. All reoperations were recorded. Reoperation was defined as a return to the operating room for any complication related to the final fusion surgery or etiology of the spinal deformity. RESULTS: One hundred (84%) of 119 patients met the inclusion criteria: for 38 of the patients, the etiology of scoliosis was neuromuscular; for 31, syndromic; for 22, idiopathic; and for 9, congenital. The mean age at final fusion was 12.2 years (range, 8.5 to 18.7 years). The mean follow-up after final fusion was 4.3 years (range, 2 to 11.2 years). Twenty (20%) of the patients had 30 complications requiring reoperation (57 procedures). There was a mean of 1.5 complications per patient after final fusion. Eight patients with neuromuscular scoliosis, 8 with syndromic, 4 with idiopathic, and no patient with congenital scoliosis required reoperation. Nine (9%) of the patients experienced infection (33 reoperation procedures); 6 (6%) had instrumentation failure (8 procedures); 5 (5%) had painful or prominent instrumentation (6 procedures); 3 (3%) each had coronal deformity (3 procedures), pseudarthrosis (3 procedures), or sagittal deformity (3 procedures); and 1 (1%) had progressive crankshaft chest wall deformity requiring a thoracoplasty (1 procedure). CONCLUSIONS: A higher-than-anticipated percentage of patients treated with growing rods required unplanned reoperation following final fusion. Long-term follow-up after final fusion is necessary to determine true final results. Patients and parents need to be counseled regarding the possibility of further surgery after final fusion. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Shilla Growth Guidance for Early-Onset Scoliosis: Results After a Minimum of Five Years of Follow-up.

BACKGROUND: The Shilla growth guidance technique was developed to allow growth during treatment of a child's spinal deformity without requiring repeated surgery for lengthening procedures. Dual stainless-steel rods are fixed posteriorly to the corrected apex via pedicle screws with a limited fusion at the apex and are combined with sliding pedicle screws to allow vertebral growth in a cephalad and caudad direction. METHODS: A retrospective study of the original forty patients treated with the Shilla method for a severe deformity of a growing spine was performed to determine the efficacy of the procedure. RESULTS: The etiology of the spinal deformity in the forty patients was idiopathic in nine, congenital in one, neuromuscular in sixteen, and syndromic in fourteen. The average age at the index surgery was six years and eleven months, and the average duration of follow-up for the thirty-three eligible patients was seven years (range, four years and nine months to ten years and nine months). The curves averaged 69° (range, 40° to 115°) preoperatively and 38.4° (range, 16° to 74°) at the time of the most recent follow-up or prior to definitive spinal instrumentation and fusion. Complications included secondary infections (six patients), alignment issues (eight patients), and implant-related problems (twenty-four patients), with some patients experiencing more than one complication. CONCLUSIONS: The Shilla growth guidance technique is a method of scoliosis treatment that allows spinal growth while controlling the deformity without scheduled repeated surgical procedures. The complication rate is high (73%) but acceptable, and children with a wide variety of diagnoses can be safely treated with the Shilla procedure.

Growing Rods Versus Shilla Growth Guidance: Better Cobb Angle Correction and T1-S1 Length Increase But More Surgeries.

STUDY DESIGN: Retrospective comparison. OBJECTIVES: To compare treatment of early-onset scoliosis (EOS) with Shilla growth guidance versus distraction-based dual growing rods (GR). SUMMARY OF BACKGROUND DATA: We are not aware of any prior studies comparing the Shilla procedure with other surgical procedures in the treatment of EOS. METHODS: The authors performed a multicenter case-matched comparison of patients with EOS treated with Shilla versus dual spine-spine GR from 1995 to 2009. A total of 36 Shilla patients from 3 centers were matched with 36 GR patients from the database by age at index surgery (±1 year), preoperative Cobb angle (±15°), and diagnosis (neuromuscular, congenital, idiopathic, or syndromic). Average follow-up was similar between groups (GR, 4.3 years; Shilla, 4.6 years; p = .353). RESULTS: Average Cobb angle improvement preoperatively to latest follow-up was 36° (range, 72° to 36°) in the GR group versus 23° (range, 69° to 45°) in the Shilla group (p = .0124). T1-S1 length increased 8.8 cm in patients treated with GR, compared with 6.4 cm in Shilla patients (p = .0170). Shilla patients had fewer surgeries (2.8) than patients in the GR group (7.4) (p < .001) but had a higher rate of unplanned surgeries for implant complications (Shilla, 1.3; GR, 0.5; p = .0151). When revisions for implant complications done at the time of scheduled lengthenings and revisions for construct maintenance were included, the groups did not differ significantly in the number of procedures for implant complications (Shilla, 1.4; GR, 1.5; p = .9451). The overall complication rate did not differ significantly between groups (Shilla, 1.9 [range, 0-7]; GR, 1.3 [range, 0-9]; p = .2085). CONCLUSIONS: The GR group had a greater improvement in Cobb angle and a greater increase in T1-S1 length than Shilla. The GR patients had more surgeries but Shilla patients had more unplanned procedures. The rate of complications overall did not differ significantly between groups.

Development and initial validation of the Classification of Early-Onset Scoliosis (C-EOS).

BACKGROUND: Early-onset scoliosis is a heterogeneous condition, with highly variable manifestations and natural history. No standardized classification system exists to describe and group patients, to guide optimal care, or to prognosticate outcomes within this population. A classification system for early-onset scoliosis is thus a necessary prerequisite to the timely evolution of care of these patients. METHODS: Fifteen experienced surgeons participated in a nominal group technique designed to achieve a consensus-based classification system for early-onset scoliosis. A comprehensive list of factors important in managing early-onset scoliosis was generated using a standardized literature review, semi-structured interviews, and open forum discussion. Three group meetings and two rounds of surveying guided the selection of classification components, subgroupings, and cut-points. Initial validation of the system was conducted using an interobserver reliability assessment based on the classification of a series of thirty cases. RESULTS: Nominal group technique was used to identify three core variables (major curve angle, etiology, and kyphosis) with high group content validity scores. Age and curve progression ranked slightly lower. Participants evaluated the cases of thirty patients with early-onset scoliosis for reliability testing. The mean kappa value for etiology (0.64) was substantial, while the mean kappa values for major curve angle (0.95) and kyphosis (0.93) indicated almost perfect agreement. The final classification consisted of a continuous age prefix, etiology (congenital or structural, neuromuscular, syndromic, and idiopathic), major curve angle (1, 2, 3, or 4), and kyphosis (-, N, or +) variables, and an optional progression modifier (P0, P1, or P2). CONCLUSIONS: Utilizing formal consensus-building methods in a large group of surgeons experienced in treating early-onset scoliosis, a novel classification system for early-onset scoliosis was developed with all core components demonstrating substantial to excellent interobserver reliability. This classification system will serve as a foundation to guide ongoing research efforts and standardize communication in the clinical setting.

The Shilla growth guidance technique for early-onset spinal deformities at 2-year follow-up: a preliminary report.

BACKGROUND: The Shilla growth guidance technique has been developed to treat spinal deformities without the necessity of repeated operative lengthenings. The dual stainless steel rods are fixed to the corrected apex of the curve by pedicle screws with limited fusion about the apex. Vertebral growth occurs in a cephalad and caudad direction through extraperiosteally placed sliding pedicle screws. A retrospective review of patients treated with the Shilla growth guidance technique for early-onset spinal deformity was performed to study patients with >2-year follow-up and describe outcome parameters. METHODS: From a cohort of 38 patients, 10 patients with a mean age of 7 + 6 years were identified as qualifying for 2-year follow-up inclusion. RESULTS: The average preoperative curve of 70.5 degrees was corrected to 27 degrees at 6 weeks follow-up and maintained at 2-year follow-up. The space available for lung improved an average of 13%. Truncal height (C7 to S1) increased an average of 12%. One patient required rod revision, 1 required rod change to a smaller size rod, and 1 required rod replacement. Two patients required wound debridement for low-grade infection in the early-postoperative period for a total of 5 procedures beyond the index correction. No patient had changes neurologically as a result of surgery. Patients were braced for the first 3 months postoperatively while the fusion was incorporating then not thereafter. CONCLUSIONS: At 2-year follow-up, the Shilla procedure has allowed children correction of their spinal deformity with an acceptable complication rate and ability to grow brace free without repeated trips to the operating room for lengthenings. These patients would have had 49 scheduled lengthening procedures after their initial correction if treated by conventional distraction growing rod methods. LEVEL OF EVIDENCE: IV case series of therapeutic study investigating results of treatment.

Evaluating the extent of clinical uncertainty among treatment options for patients with early-onset scoliosis.

BACKGROUND: Literature guiding the management of early-onset scoliosis consists primarily of studies with a low level of evidence. Evaluation of clinical equipoise (i.e., when there is no known superiority among treatment modalities) allows for prioritization of research efforts. The objective of this study was to evaluate areas of clinical uncertainty among pediatric spine surgeons regarding the treatment of early-onset scoliosis. METHODS: Fourteen experienced pediatric spine surgeons participated in semistructured interviews to identify clinical variables that influence decision making in the treatment of early-onset scoliosis. A series of case scenarios of 315 patients with idiopathic and neuromuscular early-onset scoliosis was then developed to be representative of those encountered in clinical practice. Using an online survey, eleven surgeons selected their choice of eight treatment options for each case scenario. Associations between case characteristics and treatment choices were assessed with chi-square and logistic regression analysis. Participants then reviewed the areas of treatment uncertainty identified in the survey, nominated additional research questions of interest, and ranked their interest to further explore the identified research questions. RESULTS: Collective equipoise was identified in numerous scenarios in the survey spanning a range of ages and magnitudes of scoliosis, and additional questions were identified during the nominal group technique. Areas that had the greatest clinical uncertainty included the management of patients who have finished treatment with a growing-rod, timing of rod-lengthening intervals, and indications for spine-based and rib-based proximal instrumentation anchors. The use of rib anchors compared with spine-based anchors was ranked highly for consideration in future clinical trials. CONCLUSIONS: Variability in decision making with regard to the optimum treatment of certain subsets of patients with early-onset scoliosis reflects gaps in the available evidence. Structured consensus methods identified priorities for higher levels of research in this area of scoliosis. Higher-level studies, including randomized trials, should focus on answering the questions highlighted in this report.

Early onset scoliosis: modern treatment and results.

BACKGROUND: Early onset scoliosis (EOS) is a potentially fatal, challenging group of diseases the management of which has markedly changed in the last decade. The purpose of this review is to provide the reader with a brief description of each of these new therapeutic modalities, their indications for use, and early clinical results. METHODS: A systematic review of peer-reviewed publications and abstracts related to the treatment of EOS in the last decade was carried out and synthesized into a review of modern treatment methods. RESULTS: Recent advances in techniques and understanding of preserving the thoracic space have improved the morbidity and mortality of children with progressive EOS. Derotational casting may be used in younger patients with curves between 25 and 60 degrees. The vertical expandable prosthetic titanium rib is best suited for patients with thoracic insufficiency syndrome. Single or dual growing rods may be used alone or in combination with vertical expandable prosthetic titanium rib to treat patients with progressive EOS who are not candidates for casting. Shilla technique is an alternative to growing rods that avoids the morbidity of repeated lengthenings but is not as well proven as the techniques described above. Other methods such as automatic growing rods and growth modulation techniques are still investigational, and their role needs to be defined after further study. CONCLUSIONS: Recent advances have improved the treatment of children with EOS. Treatment continues to be challenging with complication rates higher than treatment of idiopathic scoliosis. LEVEL OF EVIDENCE: Level V.

Does bone morphogenetic protein increase the incidence of perioperative complications in spinal fusion? A comparison of 55,862 cases of spinal fusion with and without bone morphogenetic protein.

STUDY DESIGN: Retrospective review of a multi-institutional, multisurgeon database. OBJECTIVE: Assess for associations between bone morphogenetic protein (BMP) use and rate of complications in spinal fusion. SUMMARY OF BACKGROUND DATA: BMP is commonly used in spinal surgery to augment fusion; however, there is limited evidence demonstrating its associated complications. METHODS: We performed a retrospective analysis of all fusion cases submitted by members of the Scoliosis Research Society from 2004 to 2007. We stratified on the basis of the use of BMP and evaluated for complications and associated characteristics. RESULTS: A total of 55,862 cases of spinal fusion were identified with BMP used in 21% (11,933) of the cases. Excluding anterior cervical fusions, there were no significant differences between fusions with and without BMP with regard to overall complications (8.4% vs. 8.5%; P = 0.5), wound infections (2.4% vs. 2.4%; P = 0.8), or epidural hematomas/seromas (0.2% vs. 0.2%; P = 0.3). Anterior cervical fusions with BMP were associated with more overall complications (5.8% vs. 2.4%; P < 0.001) and more wound infections (2.1% vs. 0.4%; P < 0.001) than fusions without BMP. On multivariate analysis for thoracolumbar and posterior cervical fusions, BMP use was not a significant predictor of complications (P = 0.334; odds ratio = 1.039; 95% confidence interval = 0.961-1.124; covariates were BMP use, patient age, revision vs. primary surgery). Multivariate analysis for anterior cervical spinal fusion demonstrated that BMP use remained a significant predictor of complications (P < 0.001, odds ratio = 1.6; 95% confidence interval = 1.516-1.721), after adjusting for the effects of patient age and whether the surgery was a revision procedure. CONCLUSION: BMP use with anterior cervical fusion was associated with an increased incidence of complications. Use of BMP was not associated with more complications in thoracolumbar and posterior cervical fusions.

Correlation of higher preoperative American Society of Anesthesiology grade and increased morbidity and mortality rates in patients undergoing spine surgery.

OBJECT: Patients with varied medical comorbidities often present with spinal pathology for which operative intervention is potentially indicated, but few studies have examined risk stratification in determining morbidity and mortality rates associated with the operative treatment of spinal disorders. This study provides an analysis of morbidity and mortality data associated with 22,857 cases reported in the multicenter, multisurgeon Scoliosis Research Society Morbidity and Mortality database stratified by American Society of Anesthesiologists (ASA) physical status classification, a commonly used system to describe preoperative physical status and to predict operative morbidity. METHODS: The Scoliosis Research Society Morbidity and Mortality database was queried for the year 2007, the year in which ASA data were collected. Inclusion criterion was a reported ASA grade. Cases were categorized by operation type and disease process. Details on the surgical approach and type of instrumentation were recorded. Major perioperative complications and deaths were evaluated. Two large subgroups--patients with adult degenerative lumbar disease and patients with major deformity--were also analyzed separately. Statistical analyses were performed with the chi-square test. RESULTS: The population studied comprised 22,857 patients. Spinal disease included degenerative disease (9409 cases), scoliosis (6782 cases), spondylolisthesis (2144 cases), trauma (1314 cases), kyphosis (831 cases), and other (2377 cases). The overall complication rate was 8.4%. Complication rates for ASA Grades 1 through 5 were 5.4%, 9.0%, 14.4%, 20.3%, and 50.0%, respectively (p = 0.001). In patients undergoing surgery for degenerative lumbar diseases and major adult deformity, similarly increasing rates of morbidity were found in higher-grade patients. The mortality rate was also higher in higher-grade patients. The incidence of major complications, including wound infections, hematomas, respiratory problems, and thromboembolic events, was also greater in patients with higher ASA grades. CONCLUSIONS: Patients with higher ASA grades undergoing spinal surgery had significantly higher rates of morbidity than those with lower ASA grades. Given the common application of the ASA system to surgical patients, this grade may prove helpful for surgical decision making and preoperative counseling with regard to risks of morbidity and mortality.

Rates of new neurological deficit associated with spine surgery based on 108,419 procedures: a report of the scoliosis research society morbidity and mortality committee.

STUDY DESIGN: Retrospective review of a prospectively collected, multicenter database. OBJECTIVE: To assess rates of new neurologic deficit (NND) associated with spine surgery. SUMMARY OF BACKGROUND DATA: NND is a potential complication of spine surgery, but previously reported rates are often limited by small sample size and single-surgeon experiences. METHODS: The Scoliosis Research Society morbidity and mortality database was queried for spinal surgery cases complicated by NND from 2004 to 2007, including nerve root deficit (NRD), cauda equina deficit (CED), and spinal cord deficit (SCD). Use of neuromonitoring was assessed. Recovery was stratified as complete, partial, or none. Rates of NND were stratified based on diagnosis, age (pediatric < 21; adult ≥ 21), and surgical parameters. RESULTS: Of the 108,419 cases reported, NND was documented for 1064 (1.0%), including 662 NRDs, 74 CEDs, and 293 SCDs (deficit not specified for 35 cases). Rates of NND were calculated on the basis of diagnosis. Revision cases had a 41% higher rate of NND (1.25%) compared with primary cases (0.89%; P < 0.001). Pediatric cases had a 59% higher rate of NND (1.32%) compared with adult cases (0.83%; P < 0.001). The rate of NND for cases with implants was more than twice that for cases without implants (1.15% vs. 0.52%, P < 0.001). Neuromonitoring was used for 65% of cases, and for cases with new NRD, CED, and SCD, changes in neuromonitoring were reported in 11%, 8%, and 40%, respectively. The respective percentages of no recovery, partial, and complete recovery for NRD were 4.7%, 46.8%, and 47.1%, respectively; for CED were 9.6%, 45.2%, and 45.2%, respectively; and for SCD were 10.6%, 43%, and 45.7%, respectively. CONCLUSION: Our data demonstrate that, even among skilled spinal deformity surgeons, new neurologic deficits are inherent potential complications of spine surgery. These data provide general benchmark rates for NND with spine surgery as a basis for patient counseling and for ongoing efforts to improve safety of care.

Morbidity and mortality associated with spinal surgery in children: a review of the Scoliosis Research Society morbidity and mortality database.

OBJECT: Currently, few studies regarding morbidity and mortality associated with operative treatment of spinal disorders in children are available to guide the surgeon. This study provides more detailed morbidity and mortality data with an analysis of 23,918 pediatric cases reported in the multicenter, multisurgeon Scoliosis Research Society morbidity and mortality database. METHODS: The Scoliosis Research Society morbidity and mortality database was queried for the years from 2004 to 2007. The inclusion criterion was age 18 years or younger. Cases were categorized by operation type and diagnosis. Details on the surgical approach, use of neurophysiological monitoring, and type of instrumentation were recorded. Major perioperative complications and deaths were evaluated. Statistical analysis was performed with chi-square testing, with a p value < 0.05 considered significant. RESULTS: A total of 23,918 patients were included. The mean age was 13 ± 3.6 years (± SD). Spinal pathology included the following: scoliosis (in 19,642 patients), kyphosis (in 1455), spondylolisthesis (in 748), trauma (in 478), and other (in 1595 patients). The overall complication rate was 8.5%. Major complications included wound infections (2.7%), new neurological deficits (1.4%), implant-related complications (1.6%), and hematomas (0.4%). The most common medical complications were respiratory related (0.9%). Morbidity rates differed based on pathology, with patients undergoing treatment for kyphosis and spondylolisthesis having higher overall rates of morbidity (14.7% and 9.6%, respectively). Patients undergoing revision procedures (2034) or corrective osteotomies (2787) were more likely to suffer a complication or new neurological deficit. The majority of these deficits improved at least partially. Thirty-one deaths were reported for an overall rate of 1.3 per 1000. Respiratory complications were the most common cause of mortality (13 cases). Twenty-six of the deaths occurred in children undergoing scoliosis correction. CONCLUSIONS: Spinal surgery in children is associated with a range of complications depending on the type of operation. Mortality rates for all indications and operations were low. Patients undergoing more aggressive corrective procedures for deformity are more likely to suffer complications and new neurological deficits.