Medical complications and health-related quality of life in complex pediatric spine deformities exceeding 100 degrees or treated by 3CO.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To determine the incidence of medical complications in the pediatric population aged 10-20 years with baseline deformities exceeding 100 degrees or who had 3CO at surgery. Severe pediatric spine deformity poses a great challenge to the treating physician and carries a high complication rate. Pulmonary complications are among the most life threatening. The onus is on the treating surgeon to identify patients who are high risk and institute measures to mitigate the risk for successful outcomes. METHOD: Data of 251/311pts from FOX pediatric database from 17 international sites was queried for incidence of major medical complications. Comparative analysis was done to determine the impact of such complications on HRQoL using paired t-test. Risk factors associated with medical complications were assessed using Firth logistic regression. RESULTS: 251/311pts had min 2 year f/u. 142F/109 M, average age 14.61years (10-20). Etiologies included 96 Cong,94 Idiopathic, 14-Post TB, 12-NM,12-NF,10-syndromic,8 others. Curve types included Scoliosis-121, Kyphoscoliosis 72, Kyphosis 58. Coronal and sag cobb avg 88° ± 41.47 and 91.92° ± 39.17, respectively. Deformity apices were in the thoracic region in 88% of patients. Pre-op co-morbidities included 54 (21.5%) cardiopulmonary; 7(2.79%) Genitounrinary;13 (5.18%) GI;13 (5.18%) Anxiety/depression; neurological 24 (9.56%). HGT was utilized in 103pts (41%) at an average duration of 68 days. Mean OR time was 459 min, blood loss averaged 1465 ml. VCR was performed in 120(47.81%), PSO in 16 pts (6.37%), SPO in 145pts (57.77%), Thoracoplasty in 132 pts (52.8%). 96% had blood and other blood products transfusion (FFP and platelets). There were 35 post-op medical complications occurring in 29pts (11.6%). Event-specific cumulative incidence was 24 (9.6%) pulmonary, 5(2.0%) gastrointestinal, 3(1.2%) cardiovascular, 1(0.4%) genitourinary and 1(0.4%) other complication. There was no mortality. Osteotomy grade was found to be an independent predictor of pulmonary complication. Despite significant improvement in baseline SRS total and Domain scores at 2 year FU irrespective of medical complication, the improvement in SRS scores were blunted in the complication group. CONCLUSION: Medical complications are common among pediatric patients undergoing complex spine surgery for severe deformity. However, medical complications can be managed successfully. Although baseline HRQoL improved irrespective of medical complication status, clinical differences in the magnitude of the changes in HRQoL were observed in some domains.

The Effect of Prolonged Pre-Operative Halo Gravity Traction for Severe Spinal Deformities on the Cervical Spine Radiographs.

STUDY DESIGN: Retrospective review of consecutive series. OBJECTIVE: The study sought to assess the effect of prolonged pre-operative halo gravity traction (HGT) on the c-spine radiographs. METHODS: Data of 37 pediatric and adult patients who underwent ≥ 12wks pre-op HGT prior to definitive spine surgery from 2013-2015 at a single site in West Africa was reviewed. Radiographic assessment of the c-spine including ADI, SVA and C2-C7 Lordosis were done at pre HGT and at 4 weekly intervals. Paired T-Test was performed to evaluate changes in these parameters during HGT. RESULTS: 37pts, 18/19 (F/M). Average age 18.2yrs. Diagnoses: 22 idiopathic, 6 congenital, 3 Post TB, 2 NM and 4 NF. Average duration of HGT: 125 days. Baseline coronal Cobb:130 deg, corrected 30% in HGT; baseline sagittal Cobb:146 deg, corrected 32% post HGT. Baseline ADI (3.17 ± 0.63 mm) did not change at 4wks (P > 0.05) but reduced at 8wks (2.80 ± 0.56 mm) and 12wks (2.67 ± 0.51 mm) post HGT (P < 0.05). Baseline HGT SVA (20.7 ± 14.98 mm) significantly improved at 4wks (11.55 ± 10.26 mm), 8wks (7.54 ± 6.78 mm) and 12wks (8.88 ± 4.5 mm) (P < 0.05). Baseline C2-C7 lordosis (43 ± 20.1 deg) reduced at 4wks (26 ± 16.37 deg), 8wks (17.8 ± 14.77 deg) and 12wks (16.7 ± 11.33 deg) post HGT (P < 0.05). There was no incidence of atlanto-axial instability on flexion extension radiographs at any interval. CONCLUSION: Prolonged HGT, while providing partial correction of severe spine deformities, also appeared to have no adverse effect on atlanto-axial stability or cervical alignment. Therefore, HGT can be safely applied for several weeks in the preoperative management of severe spine deformities in pediatric/adult patients.

Surgical outcomes of severe spinal deformities exceeding 100° or treated by vertebral column resection (VCR). Does implant density matter?: an observational study of deformity groupings.

STUDY DESIGN: Prospective multicenter international observational study. OBJECTIVE: To investigate the effect of implant density on clinical outcomes in complex pediatric spine reconstruction. Implant density in spine deformity surgery has been a subject of much debate with some authors advocating higher density for better correction. Few studies have looked at the effect of implant density on severe curves > 100 deg or treated with vertebral column resection (VCR). METHODS: 250/311 pts with 2-year f/u enrolled in the FOX pediatric database from 17 international sites were queried for the impact of implant density and surgical outcomes. Patients were grouped into three implant density categories for comparative analysis Group 1 (density ≤ 1), Group 2 (1 < density < 1.5) and Group 3 (density; 1.5-2). RESULTS: 250 pts: 47 (Grp1)/99 (Grp2) /104 (Grp3); Pre-op age and etiology and curve types were similar in all groups, but body mass index (BMI) was higher in Grp3. Grps 1 and 2 had significantly higher sagittal deformity angular ratio (S-DAR) compared to Grp 3 (p < 0.001). Pre-op Halo Gravity Traction (HGT) was used in 55.3%/44.4%/31.7%, p = 0.017; Grp1/Grp2/Grp3, respectively. Average duration of surgery (min) was higher in Grp3 relative to Grp1 only: 352.5/456.5/515.0, p = 0.0029. Blood loss was similar in all Grps. Rate of VCR, PSO and SPO was similar in all Grps. Pre-op Coronal Cobb avg 96.1/83.6/88.6, p = 0.2342, attained similar correction after HGT (24.6%/27.2%/23.2%, p = 0.4864. Coronal Cobb corrections at 2-year follow-up (FU) were (37.1%/40.3%/53.5%, p = 0.0004). Pre-op sagittal Cobb was (105.4/101.9/75.9, p < 0.01.), achieved similar %correction in HGT (19.1%/22.3%/22.5%, p = 0.6851) and at 2-year FU (39.6%/41.4%/29.8%, p = 0.1916). After adjusting for C-DAR, S-DAR, pre-op coronal and sagittal Cobb, etiology, curve types, age, BMI and number of rods in multivariate analysis, the odds of developing post-operative implant complication was 11 times greater in group 1 compared to group 3 (OR = 11.17,95% CI 2.34-53.32). There was significant improvement in SRS scores in all Grps at 2-year FU. CONCLUSION: Although higher implant density was observed to be associated with greater curve correction and lower rates of post-operative implant-related complication and revision in heterogeneous case groups, the results may not imply causality of implant density on the outcomes in severe pediatric spine reconstruction.

One-stage multiple posterior column osteotomies and fusion and pre-op halo-gravity traction may result in a comparative and safer correction of complex spine deformity than vertebral column resection.

STUDY DESIGN: A retrospective review of prospectively collected from patients recruited at a single center. PURPOSE: To test whether safe and optimal correction can be obtained with preoperative halo-gravity traction and posterior spinal fusion with adjunctive procedures but without VCR. Posterior vertebral column resection(VCR) is gaining popularity for correction of severe spinal deformity. However, it is a highly technically demanding procedure with potential risk for complications and neurological injury. METHODS: In total, 72 patients with severe spinal deformity (Cobb angle > 100º) who underwent HGT followed by definitive PSF with PCO, with or without concave rib osteotomy and thoracoplasty. Demographic and surgical data were collected. Conventional coronal and sagittal radiographic measurements were obtained pre-traction, post-traction, post-op and at follow-up to determine the final deformity correction. Postoperative neurological and major complications were reviewed. We used Chi-square to compare proportion between groups and t test to compare groups in quantitative/ordinal variables. RESULTS: There were 72 patients (35 females, 37 males). The etiology was congenital (21),idiopathic (45), neurofibromatosis (2) and neuromuscular (4). The mean was: age 18 ± 4.6 years; duration of HGT 103 ± 35 days; coronal Cobb angle before traction 131.5 ± 21.4º vs 92. ± 15.9º after HGT (30% correction) and 72.8 ± 12.7º after fusion (47% correction); kyphosis angle before traction 134.7 ± 32.3º vs 97.1 ± 22.4º after HGT and 73.7 ± 21.3º post-fusion. Number of fusion levels 14 ± 1; EBL 1730 ± 744 cc; number of PCOs done 5 ± 2; number of concave rib osteotomies (2 ± 2). There were 16 patients with postoperative complications (22.2%), 10 medical, one wound infection, 2 implant related and 3 post-op neuro-deficits (all of whom recovered at follow-up). There was one death (cardiac arrest). CONCLUSION: HGT and one-stage posterior fusion with PCO, with or without concave rib resection and thoracoplasty, without VCR, achieved satisfactory correction of rigid complex spine deformity with minimal neurological complications. The results compare favorably with previous reports of similar deformities treated with VCR. LEVEL OF EVIDENCE: III.

Surgical management of complex post-tuberculous kyphosis among African patients: clinical and radiographic outcomes for a consecutive series treated at a single institution in West Africa.

STUDY DESIGN: Retrospective review of consecutive series. OBJECTIVE: To assess the clinical and radiographic outcomes after surgical management of post-tuberculous kyphosis. Post-tuberculous (TB) kyphosis can lead to progressive pulmonary and neurological deterioration. Surgery is indicated to decompress neural elements and correct the spine deformity. Although posterior vertebral column resection (PVCR) has been established as the treatment of choice for severe TB kyphosis, there is paucity of studies on the clinical outcomes among patients treated in West Africa. METHODS: Clinical and radiographic data of 57 patients (pts) who underwent surgical correction of post-TB kyphosis at a single site in West Africa between 2013 and 2018 (≥ 2-year follow-up in 36 pts, ≥ 1-year FU in 21 pts). Pre- and post-op SRS scores and radiographic outcomes were compared using Paired t test. RESULTS: 57 patients, 36M:21F. Mean age 19 (11-57 years). 22/57 pts (39.3%) underwent pre-op halo gravity traction (HGT) for an average duration of 86 days (8-144 days). HGT pts had a higher baseline regional kyphosis (125.1 ± 20.9) compared to non-HGT pts (64.6 ± 31.8, p < 0.001). Post-HGT regional kyphosis corrected to 101.2 ± 23 (24° correction). 53 pts (92.9%) underwent posterior-only surgery and 4 (7.0%) combined anterior-posterior surgery. 39 (68.4%) had PVCR, 11 (19.3%) PSO, and 16 (28.1%) thoracoplasty. Intraoperative neuromonitoring (IOM) signal changes occurred in 23/57 pts (≈ 40%), dural tear in 5 pts (8.8%), pleural tear in 3 pts (5.3%), ureteric injury in 1 pt (1.7%), and vascular injury in 1 pt (1.7%). Post-op complications included four (7.0%) infection, three (5.3%) implant related, two (3.5%) radiographic (one PJK and one DJK), one (1.7%) neurologic, one (1.7%) wound problem, and two (3.5%) sacral ulcers. IOM changes were similar in the VCR (48.7%) and non-VCR (23.5%) pts, p > 0.05. Complication rates were similar among HGT and non-HGT groups. Significant improvements from baseline were seen in the average SRS Total and domains scores and radiographic measurements for patients who attained 2-year follow-up. CONCLUSION: PVCR ± HGT can provide safe and optimal correction in cases of severe post-TB kyphosis with good clinical and radiographic outcomes in underserved regions.

New neurologic deficit and recovery rates in the treatment of complex pediatric spine deformities exceeding 100 degrees or treated by vertebral column resection (VCR).

STUDY DESIGN: Prospective multicenter international observational study. OBJECTIVE: To investigate incidence of new neurologic deficit (NND) and the long-term recovery patterns following complex pediatric spine deformity surgery. The SRS M&M reports identify pediatric patients as having higher rate of new neurologic deficit compared with adults, while congenital and neuromuscular deformities are associated with higher new neurologic risks. Very few studies have had the large numbers of pediatric patients with curves exceeding 100 deg to ascertain the new neurologic deficit (NND) rates and recovery patterns as it relates to curve laterality and diagnosis. METHOD: The FOX pediatric database from 17 international sites was queried for New Neurologic Deficit (NND) as characterized by change in American Spinal Injury Association (ASIA) Lower or Upper Extremity Motor Score. Recovery rates at specific intervals were recorded and related to the curve type and etiology. RESULTS: Data of 286 consecutive patients with normal pre-operative neurologic exams were reviewed. There were 160 females vs 125 males with an average age of 14.6 years. NND occurred in 27 patients (9.4%) in the immediate post-operative period. Diagnostic categories included idiopathic scoliosis (3 patients); idiopathic kyphoscoliosis(5 patients); congenital scoliosis (7 patients); congenital kyphoscoliosis (4 patients); congenital kyphosis (6 patients), other kyphosis (1 patient) and syndromic (1 patient). 1 patient was lost to follow-up (f/u) after discharge; 1 had chronic deficits at the first post-operative erect visit (from discharge to 9 months f/u) and was subsequently lost to follow-up; 2 patients were improving at 1-year f/u but lost to subsequent f/u. 16 patients had normal neurologic function by the time of the first post-operative erect visit, 21 patients at 1-year f/u and 21 patients at the 2-year f/u. 2 patients (0.69%) had improved NND at 2-year mark. CONCLUSION: A significant proportion of patients with complex spine deformity experience NND. However, significant improvement in neurologic function can be expected over time as seen in this study without additional surgical intervention in most cases. Congenital deformities accounted for 63% of the patients experiencing NND.

Characterization of complex vertebral transposition (gamma deformity) > 180 degrees: clinical and radiographic outcomes of halo gravity traction and vertebral column resection (VCR).

STUDY DESIGN: Prospective case series OBJECTIVE: Results of surgical treatment of complex vertebral transposition "Gamma Deformity" > 180 degrees with halo gravity traction (HGT) and vertebral column resection (VCR). We recently published a novel classification system for complex spine deformities of which complex vertebral transposition > 180 degrees (Gamma; type 3) was described. Halo gravity traction (HGT) has been shown to mitigate surgical risk in complex spine deformity correction and in some cases obviates the need for three-column osteotomy. However, we are not aware of report of its utilization in treating Gamma deformities with or without vertebral column resection (VCR). METHODS: A consecutive series of 13 patients with Gamma deformity (GD) were prospectively enrolled at a single site in West Africa. Standard radiographs and 3D computerized tomography (CT) were done to assess coronal and sagittal vertebral transposition (CVT and SVT). The HGT with 50% of body weight was applied over several weeks followed by VCR. Demographics, operative data, radiographic parameters, and complications data were collected. RESULTS: 13 pts with GD underwent HGT for an avg of 110 days prior to definitive surgery. Etiologies were Congenital-11 pts and Neurofibromatosis-2 pts. Average age: 17.8 years; Pts were reviewed at 3 months post-op and at minimum 2-year follow-up. Preop myelopathy was present in five patients. Pre-op CVT avg 75% and was corrected in all cases post-op. SVT avg 211 deg and improved with HGT by 36% and corrected to 53 deg (74% correction) post-op. Thoracic kyphosis avg -42 deg and averaged 48 deg post-op. Intra-op spinal cord monitoring (SCM) alerts occurred in 8 pts (61%). Post-operative LEM deficits occurred in 5 pts: 2 fully recovered by 3 months and 2 year follow-up, while the remaining 3 improved but had residual motor deficits at final follow-up. There was one post-operative mortality. CONCLUSION: The management of complex vertebral transposition (Gamma deformity) > 180 degrees with HGT prior to VCR is not only effective in some patients, but also associated with high SCM alerts and neurologic injury rates. Myelopathic patients with thoracic deformities are at higher risk of developing permanent neurologic deficits. Surgeons should be aware of this rare and unusual deformity and consider HGT and VCR bearing in mind the technical challenges and high complication rate.

Postoperative Pulmonary Complications in Complex Pediatric and Adult Spine Deformity: A Retrospective Review of Consecutive Patients Treated at a Single Site in West Africa.

STUDY DESIGN: Retrospective review of consecutive series. OBJECTIVES: This study sought to assess the incidence, risk factors, and outcomes of pulmonary complication following complex spine deformity surgery in a low-resourced setting in West Africa. METHODS: Data of 276 complex spine deformity patients aged 3 to 25 years who were treated consecutively was retrospectively reviewed. Patients were categorized into 2 groups during data analysis based on pulmonary complication status: group 1: yes versus group 2: no. Comparative descriptive and inferential analysis were performed to compare the 2 groups. RESULTS: The incidence of pulmonary complication was 17/276 (6.1%) in group 1. A total of 259 patients had no events (group 2). There were 8 males and 9 females in group 1 versus 100 males and 159 females in group 2. Body mass index was similar in both groups (17.2 vs 18.4 kg/m2, P = .15). Average values (group 1 vs group 2, respectively) were as follows: preoperative sagittal Cobb angle (90.6° vs 88.7°, P = .87.), coronal Cobb angle (95° vs 88.5°, P = .43), preoperative forced vital capacity (45.3% vs 62.0%, P = .02), preoperative FEV1 (forced expiratory volume in 1 second) (41.9% vs 63.1%, P < .001). Estimated blood loss, operating room time, and surgery levels were similar in both groups. Thoracoplasty and spinal osteotomies were performed at similar rates in both groups, except for Smith-Peterson osteotomy. Multivariate logistic regression showed that every unit increase in preoperative FEV1 (%) decreases the odds of pulmonary complication by 9% (OR = 0.91, 95% CI 0.84-0.98, P = .013). CONCLUSION: The observed 6.1% incidence of pulmonary complications is comparable to reported series. Preoperative FEV1 was an independent predictor of pulmonary complications. The observed case fatality rate following pulmonary complications (17%) highlights the complexity of cases in underserved regions and the need for thorough preoperative evaluation to identify high-risk patients.

A novel radiographic classification of severe spinal curvatures exceeding 100°: the Omega (Ω), gamma (γ) and alpha (α) deformities.

PURPOSE: For spine curvatures with Cobb angles > 100°, curve classification and characterization become more difficult with conventional radiographs. 3-D computerized axial tomography scans add relevant information to categorize and describe a new classification to aid preoperative assessment in communication and patient evaluation. The purpose of this study is to describe a radiographic classification system of curves exceeding 100°. METHODS: A consecutive series of patients with curves exceeding 100° underwent a full spine radiographic review using conventional radiographs and 3-D CT. A descriptive analysis was performed to categorize curves into 4 main types (1, 2, 3 and 4) and 6 subtypes (1C, 1S, 1CS, 2P, 2D and 2PD) based on the location of the Cobb angle of the major scoliotic and kyphotic deformity as well as the location of the upper/lower end vertebra relative to the apical vertebra. RESULTS: A total of 98 patients met the inclusion criteria. There were 51 males and 47 females with an average age of 17.8 ± 4.5 years. The diagnosis included idiopathic (48); congenital (24); neuromuscular (4); and neurofibromatosis (2). The mean major coronal and sagittal Cobb (kyphosis) were 131.2° ± 23.4° and 154 ± 45.6, respectively. The classification scheme yielded 4 main types (1, 2, 3 and 4) and 6 subtypes under types 1 and 2 (1C, 1S, 1CS, 2P, 2D and 2PD). CONCLUSIONS: Our study describes a novel method of classifying severe spinal curvatures exceeding 100° using erect AP/lateral radiographs and 3-D CT reconstructive images. We hope that the descriptive analysis and classification will expand our understanding of these complex deformities. These slides can be retrieved under Electronic Supplementary Material.

The Use of Halo Gravity Traction in the Treatment of Severe Early Onset Spinal Deformity.

STUDY DESIGN: Retrospective Review of Prospective cohort. OBJECTIVE: To describe the feasibility of preoperative halo gravity traction (HGT) with subsequent growing rod/guided growth (GR/GG) placement in early onset spinal deformity (EOSD). SUMMARY OF BACKGROUND DATA: In children with severe EOSD, primary implantation of GR/GG constructs is not always possible. We describe a staged protocol with preoperative HGT followed by GR/GG implantation. METHODS: EOSD patients treated with HGT prior to GR/GG implantation were included. HGT used traction up to 50% body weight for 4 to 29 weeks. Pulmonary function tests (PFTs) were performed before and after HGT. Coronal Cobb (CC) and Sagittal Cobb (SC) angles were measured on the Pre-HGT, Post-HGT and 6 week postop x-rays. RESULTS: Thirty patients were included. Average age at GR/GG implantation was 9 years. Most cases (n = 24, 80%) were idiopathic. Most pts had kyphoscoliosis (n = 16, 53.3%). Pre-HGT CC averaged 112 ±â€Š22° and SC averaged 106 ±â€Š26°. CC and SC improved 29% after HGT. There was a significant improvement in body mass index following HGT. CC improved further to 70 ±â€Š14° (36% vs. pre-HGT) and SC to 63 ±â€Š21° (41%) with GR/GG placement. HGT-related complications occurred in nine patients (30%); eight pin site infections, one cranial abscess. Most HGT complications were managed with local pin care and oral antibiotics. Halo revision was required in two pts (6.7%). There was no change in PFTs with HGT (P > 0.05). Averagely, 14 levels were spanned during GR/GG implantation; two patients required vertebral column resection. Surgical complications occurred in nine (30%) patients. At average 16 month follow-up, seven patients (23.3%) required reoperation. CONCLUSION: Preoperative HGT can make severe EOSD curves amenable to GR/GG implantation. HGT results in ∼30% correction with improvement to ∼35-40% following GR/GG. HGT has a 30% complication rate but most are pin-site infections managed with pin-site care and oral antibiotics; 6.7% of patients require revision. LEVEL OF EVIDENCE: 4.

Halo Gravity Traction Can Mitigate Preoperative Risk Factors and Early Surgical Complications in Complex Spine Deformity.

STUDY DESIGN: Retrospective review of prospective cohort. OBJECTIVE: We sought to examine the role of halo gravity traction (HGT) in reducing preoperative surgical risk. SUMMARY OF BACKGROUND DATA: The impact of HGT on procedure choice, preoperative risk factors, and surgical complications has not been previously described. METHODS: Patients treated with HGT before primary surgery were included. The FOCOS Score (FS) was used to quantify operative risk. FS was calculated using patient-factors (ASIA, body mass index, etiology), procedure-factors (PcF; osteotomy planned, number of levels fused, etc.), and curve magnitude (CM). Scores ranged from 0 to 100 with higher scores indicating increased risk. FS was calculated before and after HGT to see how changes in FS affected complication rates. RESULTS: A total of 96 patients were included. Halo-related complications occurred in 34% of patients but revision was required in only 8.3%. Average FS improved by 18 points after HGT. CM, PcF, and patient-factors all improved (P < 0.05). The greatest changes were in CM and PcF. The planned rate of three-column osteotomies dropped from 91% to 38% after HGT. FS (area under the curve [AUC]: 0.68, P = 0.023) and change in FS (AUC: 0.781, P < 0.001) was successfully able to predict the rate of surgical complications. A preoperative FS of 74 was identified as a cut-off for a higher rate of surgical complications (sensitivity 58.8%, specificity 74.7%). Patients with a reduction in FS <  = 10pts were five times more likely to have a complication (relative risk 5.2, 95% confidence interval: 1.9-14.6, P < 0.001). A multivariate regression showed that change in FS was an independent predictor of complication rates (P < 0.05). CONCLUSION: FS can successfully predict surgical risk in pediatric patients with complex spinal deformity. Preoperative HGT can reduce FS and surgical risk by improving CM, lowering three-column osteotomies use, and improving body mass index. A reduction in FS after HGT predicts a lower rate of surgical complications. LEVEL OF EVIDENCE: 3.