Severe (>100 Degrees) Thoracic Adolescent Idiopathic Scoliosis - A Comparison of Surgical Approaches.

STUDY DESIGN: Retrospective. OBJECTIVE: Severe curves >100° in adolescent idiopathic scoliosis (AIS) are rare and require careful operative planning. The aim of this study was to assess baseline, perioperative, and 2-year differences between anterior release with posterior instrumentation (AP), posterior instrumentation with posterior column osteotomies (P), and posterior instrumentation with 3-column vertebral osteotomies (VCR). METHODS: Two scoliosis datasets were queried for primary cases of severe thoracic AIS (≥100°) with 2-year follow-up. Pre- and 2-year postoperative radiographic measures (2D and estimated 3D kyphosis), clinical measurements, and SRS-22 outcomes were compared between three approaches. RESULTS: Sixty-one patients were included: 16 AP (26%), 38 P (62%), 7 VCR (11%). Average age was 14.4 ± 2.0 years; 75.4% were female. Preoperative thoracic curve magnitude (AP: 112°, P: 115°, VCR: 126°, P = 0.09) and T5-T12 kyphosis (AP: 38°, P: 59°, VCR: 70°, P = 0.057) were similar between groups. Estimated 3D kyphosis was less in AP vs P (-12° vs 4°, P = 0.016). Main thoracic curves corrected to 36° in AP vs 49° and 48° for P and VCR, respectively (P = 0.02). Change in estimated 3D kyphosis was greater in AP vs P and VCR (34° vs 13°, P = 0.009; 34° vs 7°, P = 0.046). One incomplete spinal cord injury had residual deficits (P; 1/61, 1.6%). All SRS-22 domains improved postoperatively. CONCLUSION: All approaches obtained satisfactory coronal and sagittal correction, but AP had smaller residual coronal deformity and greater kyphosis restoration than the other approaches. This information may help inform the decision of whether to include an anterior release for large thoracic AIS curves.

Intraoperative neuromonitoring predicts postoperative deficits in severe pediatric spinal deformity patients.

PURPOSE: To evaluate intraoperative monitoring (IOM) alerts and neurologic deficits during severe pediatric spinal deformity surgery. METHODS: Patients with a minimum Cobb angle of 100° in any plane or a scheduled vertebral column resection (VCR) with minimum 2-year follow-up were prospectively evaluated (n = 243). Preoperative, immediate postoperative, and 2-year postoperative neurologic status were reported. Radiographic data included preoperative and 2-year postoperative coronal and sagittal Cobb angles and deformity angular ratios (DAR). IOM alert type and triggering event were recorded. SRS-22r scores were collected preoperatively and 2-years postoperatively. RESULTS: IOM alerts occurred in 37% of procedures with three-column osteotomy (n = 36) and correction maneuver (n = 32) as most common triggering events. Patients with IOM alerts had greater maximum kyphosis (101.4° vs. 87.5°) and sagittal DAR (16.8 vs. 12.7) (p < 0.01). Multivariate regression demonstrated that sagittal DAR independently predicted IOM alerts (OR 1.05, 95% CI 1.02-1.08) with moderate sensitivity (60.2%) and specificity (64.8%) using a threshold value of 14.3 (p < 0.01). IOM alerts occurred more frequently in procedures with new postoperative neurologic deficits (17/24), and alerts with both SSEP and TCeMEP signals were associated with new postoperative deficits (p < 0.01). Most patients with new deficits experienced resolution at 2 years (16/20) and had equivalent postoperative SRS-22r scores. However, patients with persistent deficits had worse SRS-22r total score (3.8 vs. 4.2), self-image subscore (3.5 vs. 4.1), and function subscore (3.8 vs. 4.3) (p ≤ 0.04). CONCLUSION: Multimodal IOM alerts are associated with sagittal kyphosis, and predict postoperative neurologic deficits. Most patients with new deficits experience resolution of their symptoms and have equivalent 2-year outcomes. LEVEL OF EVIDENCE: II.

Trans-sacral interbody fixation in long fusions to the sacrum for adult spinal deformity: complications and fusion rates at minimum two years follow-up.

PURPOSE: This study aims to investigate the fusion rate and complications associated with trans-sacral interbody fusion (TSIF) in long fusions to the sacrum for adult spinal deformity (ASD) over a two year follow-up period. Potential predictor variables associated with pseudarthrosis were also examined. METHODS: A retrospective clinical review was conducted on a consecutive series of ASD patients who underwent long fusions to the sacrum, with TSIF performed as a same-day or staged procedure. Patient demographics, bone mineral density, operative details, perioperative and late complications, and fusion rates were reviewed. Univariate analysis was used to identify the risk factors associated with pseudarthrosis. RESULTS: The study included 43 patients with an average age of 55.3 ± 8.9 years. The perioperative complication rate was 28%, with 12% of the complications directly related to TSIF. The late complication rate was 33%, with 16% related to TSIF. The most common complications were pseudarthrosis (14%) and postoperative ileus (7%). The overall radiographic fusion rate at two years was 86%. Univariate analysis revealed that revision surgery was significantly associated with pseudarthrosis (p = 0.027). Over the follow-up period, patients who underwent TSIF during long posterior fusions to the sacrum showed improvement in overall SRS scores, ODI scores, and SF-36 physical health and mental health (p < 0.05). CONCLUSION: TSIF is a relatively safe and minimally invasive method for achieving interbody fusion at the lumbosacral junction in the treatment of ASD, with acceptable fusion rates and a low complication rate. However, TSIF is not recommended for revision reconstruction in ASD.

Inducing Angiogenesis in the Nucleus Pulposus.

Bone morphogenetic protein (BMP) gene delivery to Lewis rat lumbar intervertebral discs (IVDs) drives bone formation anterior and external to the IVD, suggesting the IVD is inhospitable to osteogenesis. This study was designed to determine if IVD destruction with a proteoglycanase, and/or generating an IVD blood supply by gene delivery of an angiogenic growth factor, could render the IVD permissive to intra-discal BMP-driven osteogenesis and fusion. Surgical intra-discal delivery of naïve or gene-programmed cells (BMP2/BMP7 co-expressing or VEGF165 expressing) +/- purified chondroitinase-ABC (chABC) in all permutations was performed between lumbar 4/5 and L5/6 vertebrae, and radiographic, histology, and biomechanics endpoints were collected. Follow-up anti-sFlt Western blotting was performed. BMP and VEGF/BMP treatments had the highest stiffness, bone production and fusion. Bone was induced anterior to the IVD, and was not intra-discal from any treatment. chABC impaired BMP-driven osteogenesis, decreased histological staining for IVD proteoglycans, and made the IVD permissive to angiogenesis. A soluble fragment of VEGF Receptor-1 (sFlt) was liberated from the IVD matrix by incubation with chABC, suggesting dysregulation of the sFlt matrix attachment is a possible mechanism for the chABC-mediated IVD angiogenesis we observed. Based on these results, the IVD can be manipulated to foster vascular invasion, and by extension, possibly osteogenesis.

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.

Intraoperative Antibiotic Use in Patients With Early-onset Scoliosis: Current Practices and Trends.

BACKGROUND: Best Practice Guidelines (BPGs) regarding antibiotic prophylaxis in early-onset scoliosis (EOS) patients were published in September 2019. Recommendations included using intravenous cefazolin and topical vancomycin for all index procedures, plus gram-negative coverage for neuromuscular patients. Guideline adherence is unknown. This study aimed to characterize antibiotic prophylaxis at the time of index growth-friendly procedures and assess changes in practice patterns over time. MATERIALS AND METHODS: This retrospective review of data collected through a multicenter study group included EOS patients undergoing index growth-friendly procedures between January 2018 and March 2021, excluding revisions, lengthenings, and tetherings. Demographics, clinical measurements, intraoperative antibiotics, and 90-day complications were recorded. Descriptive and univariate statistics were utilized. Antibiotic prophylaxis from April 2018 through September 2019 and October 2019 through March 2021 were compared with evaluate change after BPG publication. RESULTS: A total of 562 patients undergoing growth-friendly procedures were included. The most common scoliosis types included neuromuscular (167, 29.7%), syndromic (134, 23.8%), and congenital (97, 17.3%). Most index procedures involved magnetically controlled growing rods (417, 74%) followed by vertical expandable prosthetic titanium rib or traditional growing rods (105, 19%). Most patients received cefazolin alone at index procedure (310, 55.2%) or cefazolin with an aminoglycoside (113, 20.1%). Topical antibiotics were used in 327 patients (58.2%), with most receiving vancomycin powder. There was increased use of cefazolin with an aminoglycoside after BPG publication (16% vs. 25%) ( P =0.01). Surgical site infections occurred in 12 patients (2.1%) within 90 days of index procedure, 10 pre-BPGs (3%), and 2 post-BPGs (0.9%), with no significant difference in surgical site infection rate by type of antibiotic administered ( P >0.05). CONCLUSIONS: Historical variability exists regarding antibiotic prophylaxis during index growth-friendly procedures for EOS. There continues to be variability following BPG publication; however, this study found a significant increase in antibiotic prophylaxis against gram-negative bacteria after BPG publication. Overall, greater emphasis is needed to decrease variability in practice, improve compliance with consensus guidelines, and evaluate BPG efficacy. LEVEL OF EVIDENCE: Level III-retrospective.

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.

Myelopathic Patients Undergoing Severe Pediatric Spinal Deformity Surgery Can Improve Neurologic Function to That of Non-Myelopathic Patients by 1-Year Postoperative.

STUDY DESIGN: Multi-center, prospective, observational cohort. OBJECTIVE: To compare myelopathic vs. non-myelopathic ambulatory patients in short- and long-term neurologic function, operative treatment, and patient-reported outcomes. METHODS: Pediatric deformity patients from 16 centers were enrolled with the following inclusion criteria: aged 10-21 years-old, a Cobb angle ≥100° in either the coronal or sagittal plane or any sized deformity with a planned 3-column osteotomy, and community ambulators. Patients were dichotomized into 2 groups: myelopathic (abnormal preoperative neurologic exam with signs/symptoms of myelopathy) and non-myelopathic (no clinical signs/symptoms of myelopathy). RESULTS: Of 311 patients with an average age of 14.7 ± 2.8 years, 29 (9.3%) were myelopathic and 282 (90.7%) were non-myelopathic. There was no difference in age (P = 0.18), gender (P = 0.09), and Risser Stage (P = 0.06), while more patients in the non-myelopathic group had previous surgery (16.1% vs. 3.9%; P = 0.03). Mean lower extremity motor score (LEMS) in myelopathic patients increased significantly compared to baseline at every postoperative visit: Baseline: 40.7 ± 9.9; Immediate postop: 46.0 ± 7.1, P = 0.02; 1-year: 48.2 ± 3.7, P < 0.001; 2-year: 48.2 ± 7.7, P < 0.001). The non-myelopathic group had significantly higher LEMS immediately postoperative (P = 0.0007), but by 1-year postoperative, there was no difference in LEMS between groups (non-myelopathic: 49.3 ± 3.6, myelopathic: 48.2 ± 3.7, P = 0.10) and was maintained at 2-years postoperative (non-myelopathic: 49.2 ± 3.3, myelopathic: 48.2 ± 5.7, P = 0.09). Both groups improved significantly in all SRS domains compared to preoperative, with no difference in scores in the domains for pain (P = 0.12), self-image (P = 0.08), and satisfaction (P = 0.83) at latest follow-up. CONCLUSION: In severe spinal deformity pediatric patients presenting with preoperative myelopathy undergoing spinal reconstructive surgery, myelopathic patients can expect significant improvement in neurologic function postoperatively. At 1-year and 2-year postoperative, neurologic function was no different between groups. While non-myelopathic patients had significantly higher postoperative outcomes in SRS mental-health, function, and total-score, both groups had significantly improved outcomes in every SRS domain compared to preoperative.

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.

Lumbar spine intervertebral disc gene delivery of BMPs induces anterior spine fusion in lewis rats.

Minimally invasive techniques and biological autograft alternatives such as the bone morphogenetic proteins (BMPs) can reduce morbidity associated with spinal fusions. This study was a proof-of-concept for gene-therapy-mediated anterior spine fusion that could be adapted to percutaneous technique for clinical use. Isogeneic bone marrow stromal cells genetically programmed to express b-galactosidase (LACZ, a marker gene), BMP2, BMP7, a mixture of BMP2 and BMP7 infected cells (homodimers, HM), or BMP2/7 heterodimers (HT) were implanted into the discs between lumbar vertebrae 4 and 5 (L4/5) and L5/6 of male Lewis rats. Spine stiffening was monitored at 4, 8 and 12 weeks using noninvasive-induced angular displacement (NIAD) testing. At 12 weeks isolated spines were assessed for fusion and bone formation by palpation, biomechanical testing [four-point bending stiffness, moment to failure in extension, and in vitro angular displacement (IVAD)], faxitron x-rays, microCT, and histology. Progressive loss of NIAD occurred in only the HT group (p < 0.001), and biomechanical tests correlated with the NIAD results. Significant fusion occurred only in the HT group (94% of animals with one or both levels) as assessed by palpation (p < 0.001), which predicted HT bone production assessed by faxitron (p ≤ 0.001) or microCT (p < 0.023). Intervertebral bridging bone was consistently observed only in HT-treated specimens. Induced bone was located anterior and lateral to the disc space, with no bone formation noted within the disc. Percutaneous anterior spine fusions may be possible clinically, but induction of bone inside the disc space remains a challenge.

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.

Development of consensus-based best practice guidelines for response to intraoperative neuromonitoring events in high-risk spinal deformity surgery.

PURPOSE: To expand on previously described intraoperative aids by developing consensus-based best practice guidelines to optimize the approach to intraoperative neuromonitoring (IONM) events associated with "high-risk" spinal deformity surgery. METHODS: Consensus was established among a group of experienced spinal deformity surgeons by way of the Delphi method. Through a series of iterative surveys and a final virtual consensus meeting, participants expressed their agreement (strongly agree, agree, disagree, and strongly disagree) with various items. Consensus was defined as ≥ 80% agreement ("strongly agree" or "agree"). Near-consensus was defined as ≥ 60% but < 80%. Equipoise was ≥ 20% but < 60%, and consensus to exclude was < 20%. RESULTS: 15 out of 15 (100%) invited surgeons agreed to participate. Final consensus supported inclusion of 105 items (53 in Response Algorithm, 13 in Ongoing Consideration of Etiology, 31 in Real-Time Data Scenarios, 8 in Patterns of IONM Loss), which were organized into a final set of best practice guidelines. CONCLUSION: Detailed consensus-based best practice guidelines and aids were successfully created with the intention to help organize and direct the surgical team in exploring and responding to neurological complications during high-risk spinal deformity surgery. LEVEL OF EVIDENCE: Level V.

Establishing consensus: determinants of high-risk and preventative strategies for neurological events in complex spinal deformity surgery.

PURPOSE: To establish expert consensus on various parameters that constitute elevated risk during spinal deformity surgery and potential preventative strategies that may minimize the risk of intraoperative neuromonitoring (IONM) events and postoperative neurological deficits. METHODS: Through a series of surveys and a final virtual consensus meeting, the Delphi method was utilized to establish consensus among a group of expert spinal deformity surgeons. During iterative rounds of voting, participants were asked to express their agreement (strongly agree, agree, disagree, strongly disagree) to include items in a final set of guidelines. Consensus was defined as ≥ 80% agreement among participants. Near-consensus was ≥ 60% but < 80% agreement, equipoise was ≥ 20% but < 60%, and consensus to exclude was < 20%. RESULTS: Fifteen of the 15 (100%) invited expert spinal deformity surgeons agreed to participate. There was consensus to include 22 determinants of high-risk (8 patient factors, 8 curve and spinal cord factors, and 6 surgical factors) and 21 preventative strategies (4 preoperative, 14 intraoperative, and 3 postoperative) in the final set of best practice guidelines. CONCLUSION: A resource highlighting several salient clinical factors found in high-risk spinal deformity patients as well as strategies to prevent neurological events was successfully created through expert consensus. This is intended to serve as a reference for surgeons and other clinicians involved in the care of spinal deformity patients. LEVEL OF EVIDENCE: Level V.

Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study.

STUDY DESIGN: Prospective cohort. OBJECTIVE: To prospectively evaluate PROs up to 5-years after complex ASD surgery. METHODS: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures. RESULTS: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values (P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without. CONCLUSIONS: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.

The Scoli-RISK 1 results of lower extremity motor function 5 years after complex adult spinal deformity surgery.

INTRODUCTION: Neurologic complications after complex adult spinal deformity (ASD) surgery are important, yet outcomes are heterogeneously reported, and long-term follow-up of actual lower extremity motor function is unknown. OBJECTIVE: To prospectively evaluate lower extremity motor function scores (LEMS) before and at 5 years after surgical correction of complex ASD. DESIGN: Retrospective analysis of a prospective, multicenter, international observational study. METHODS: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers around the world. Inclusion criteria were Cobb angle of > 80°, corrective osteotomy for congenital or revision deformity and/or 3-column osteotomy. Among patients with 5-year follow-up, comparisons of LEMS to baseline and within each follow-up period were made via documented neurologic exams on each patient. RESULTS: Seventy-seven (28.3%) patients had 5-year follow-up. Among these 77 patients with 5-year follow-up, rates of postoperative LEMS deterioration were: 14.3% hospital discharge, 10.7% at 6 weeks, 6.5% at 6 months, 9.5% at 2 years and 9.3% at 5 years postoperative. During the 2-5 year window, while mean LEMS did not change significantly (-0.5, p = 0.442), eight (11.1%) patients deteriorated (of which 3 were ≥ 4 motor points), and six (8.3%) patients improved (of which 2 were ≥ 4 points). Of the 14 neurologic complications, four (28.6%) were surgery-related, three of which required reoperation. While mean LEMS were not impacted in patients with a major surgery-related complication, mean LEMS were significantly lower in patients with neurologic surgery-related complications at discharge (p = 0.041) and 6 months (p = 0.008) between the two groups as well as the change from baseline to 5 years (p = 0.041). CONCLUSIONS: In 77 patients undergoing complex ASD surgery with 5-year follow-up, while mean LEMS did not change from 2 to 5 years, subtle neurologic changes occurred in approximately 1 in 5 patients (11.1% deteriorated; 8.3% improved). Major surgery-related complication did not result in decreased LEMS; however, those with neurologic surgery-related complications continued to have decreased lower extremity motor function at 5 years postoperative. These results underscore the importance of long-term follow-up to 5 years, using individual motor scores rather than group averages, and comparing outcomes to both baseline and last follow-up.

Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.

OBJECTIVE: Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes. METHODS: The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22. RESULTS: The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD. CONCLUSIONS: The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

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.