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Background Context: Sagittal spinopelvic alignment has been associated with patient-reported outcome measures and mechanical complication rates. Recently, it was claimed that linear numerical values of pelvic tilt and lumbar lordosis measurements may be misleading for patients that have different magnitudes of pelvic incidence. The use of "relative" measurements embedded in a weighted scoring of Global Alignment and Proportion (GAP) was proposed.Purpose: The purpose was to evaluate the GAP scorein an independent database.Study Design/setting: Retrospective Cohort Study PATIENT SAMPLE: Adult spinal deformity patients who underwent ≥7 levels posterior fusion to the pelvis between 2004 and 2014 were included.Outcome Measures: Mechanical Complication Rates.Methods: Demographic, clinical, surgical and radiographic patient characteristics were recorded. Cochran-Armitage tests were used to compare mechanical complication rates in GAP categories. Uni and multivariable logistic regression analyses were used to obtain crude and adjusted Odds Ratios, of predictor (GAP categories) and the outcome (mechanical complication), and Risk Ratios were calculated. The diagnostic performance of the GAP score was tested using the area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, negative predictive value and accuracy in predicting mechanical complications.Results: A total of 322 patients (285F, 37M) with a mean age of 58.2±9.6 were analyzed. Mean follow-up was 69.7 months (range 24 to 177). Mechanical complications occurred in 52.2% of the patients. Mechanical complication rates in proportioned (GAP-P), moderately (GAP-MD) and severely disproportioned (GAP-SD) patients were 21.8%, 55.1%, and 70.4%, respectively. AUC for the GAP score, at 2 years, was 0.682 (95% CI, 0.624 to 0.741, p<.001). AUC at minimum 5 years follow-up was similar at 0.708, while AUC at minimum 7- and 12-year follow-up were 78.5 and 90.7, respectively. Having a postoperative spinopelvic alignment of GAP-MD and GAP-SD resulted in 2.5 and 3.2 folds of relative risk in incurring a mechanical complication when compared to having a proportioned spinopelvic state, respectively.Conclusions: This study reports an association between the GAP Score and mechanical complications in an independent database. Increased association was noted as the years of follow-up increased. Aiming to achieve proportionate GAP Score postoperatively seems to be a viable option as lower GAP scores were associated with lower rates of mechanical complications, and vice versa. [ABSTRACT FROM AUTHOR]

Rod failure and pseudarthrosis are common complications following the surgical treatment of adult spinal defomity (ASD). Many strategies have been employed in mitigating these problems, such as interbody fusion, multiple rods, use of more effective biologics, and optimizing spinal alignment. We aimed to study the frequency and type of rod failures in a large ASD population over time. To study the frequency and type of rod failures in a large ASD population over time. Retrospective review of prospective data. This study included 647 adult spinal deformity patients surgically treated between 2008 and 2018. Rod failures. ASD patients with a fusion extended from minimum L1 to pelvis and min 2-year follow-up were included. Radiographs and records were examined to identify characteristics of the rod failures: timing, unilateral vs bilateral, vertebral level, unilateral progressing to bilateral failure, revision and failure rates over time. Among the study population, 647/1052 patients met inclusion criteria (age: 64±10 yrs., 78% F, BMI: 28.3±5.7, Mean follow-up: 37 months ±13). Surgeries for these patients were performed from 2008 to 2018. The UIV was T7 or above in 306 and T8 or below in 338 patients, most frequent UIV: T4 (121) and T10 (208). A total of 146 patients had a 3COs; 435 had interbody fusion with 187 ALIF, 202 TLIF,135 XLIF; 286 patients had BMP use post only and 203 had BMP use interbody and posteriorly. Overall rod failure rate was 135/647 (21%), of which 9.3% occurred before by 2 years postop. Mean days to failure was 795 day +/- 485 (Median 733). Most frequent failures were in the lower lumbar spine L3-4 (32) 24%, L4-5 (34) 25% and L5-S1 (44) 32%. Of the 97 Unilateral failures, 35 (36.1%) were revised and only 8 progressed to bilateral failure of which 6/8 were revised; 46 Bilateral failure, 24 (52.2%) were revised.Kaplan-Meier analysis shows a survival rate of 89.7% at 2 years with decrease of 5% per year. No significant difference was found between the first 5 years and last 5 years. Comparison of primary vs revision index procedures did not reveal any differences in time to failure nor time to revision. Use of BMP improved survival rate to 91.2% compared to no BMP 83.4% at 2 years. Rod failures remain a common complication when treating ASD with a rate of 21%. Among those rod failures, 9.3% occurred within 2 years. The most frequent sites of failure were in the lower lumbar spine. Unilateral failures underwent a lower rate of revision than bilateral. BMP increased rod survivability. Kaplan-Meier analysis demonstrated a survival rate of 89.7% at 2 years with a decrease of 5% per year. The failure rate has not improved when comparing the first 5 years. to last 5 years. We must continue to seek solutions to improve rod durability challenges to improve long-term outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Both bone graft and metallic implants have been used in combination with the necessary anterior rod or plate instrumentation to fill the voids left by vertebral body removal, with the ultimate goal of restoring stability. One type of device that has recently been introduced is an expandable titanium telescoping cage that is designed to be used as a strut implant to fill corpectomy defects. The use of these devices has met varying success. Acceptance by surgeons and spine biomechanicians has been limited by clinical failure with subsequent loss of reduction and increase in kyphosis. In order to further improve patient care, it is critical to evaluate the use of these implants through biomechanical as well as other modes of testing. Purpose: To compare and contrast the spinal fusion outcome of using allograft bone versus the expandable vertebral body replacement titanium implant in a lumbar corpectomy procedure. Study design: Controlled biomechanical study of lumbar spine fusion using bone graft and the expandable cage in an in vivo bovine model after a 4-month postoperative healing period (n=6). Animal model: Twelve Holstein calves aged 4–6 months with L3 and adjacent discs removed to create a simulated lumbar corpectomy defect. Outcome measures: Lumbar spine stability after corpectomy repair was quantified by biomechanical parameters. Strength of fusion was assessed by stiffness of ex vivo spine specimens in flexion-extension, lateral bending, and torsion obtained from biomechanical testing. Uniaxial strain at various positions on the surface of the anterior plate was measured during loading as an additional stability parameter. Loading tests were repeated after removal of the anterior instrumentation (plate and the screws). Methods: The calves were randomly allocated to groups for corpectomy defect repair with 1) Allograft metatarsal bone and thoracolumbar spine locking plate, n=6; or 2) Expandable vertebral body replacement device, and thoracolumbar spine locking plate, n=6. After a 4-month postoperative period, anterior-posterior and lateral radiographs were taken of the spine, followed by animal sacrifice and harvesting of the lumbar spine for biomechanical and histological testing. For biomechanical testing, uniaxial strain gauges were applied to the thoracolumbar spine locking plate to measure plate deformation during loading in a custom built fixture for application of flexion-extension, lateral bending, and torsion moments in an Instron materials testing machine. These loading tests were repeated with the thoracolumbar spine locking plate removed, thereby loading solely the fused segment. Results: At 4 months postoperative, the stiffness of the calf spines repaired by the metatarsal allograft and thoracolumbar spine locking plate was significantly greater than that of the spines repaired by the expandable cage and thoracolumbar spine locking plate. This finding was true for all three directions of loading (flexion-extension, left-right lateral bending, and torsion). Concordantly, the neutral zone, elastic zone, and range of motion of the spines repaired with the allograft bone were less than that of the spines repaired with the expandable cage. Greater strain values were observed from the gauges on the thoracolumbar spine locking plate of the spines using the expandable cage than the spines using allograft bone. This finding held for all gauge positions (anterior edge, anterior face, posterior edge, and posterior face at the longitudinal midpoint of the plate). After thoracolumbar spine locking plate removal and a repeat of the loading tests, a decrease in stiffness of the construct and a rise in the motion parameters were observed for both the allograft and cage groups. Conclusions: The use of allograft bone for corpectomy defect repair in the lumbar spine appears to contribute to a stiffer and perhaps more stable spine segment compared with using the expandable cage device for such a repair after a 4-month healing period in this in vivo calf model. These findings thus far are based upon the biomechanical data gathered. [Copyright &y& Elsevier]

RhBMP2 soaked in bovine tendon collagen and synthetic ceramics composite as well as rhBMP7/OP1 lyophilized in bovine bone collagen particles with additive carboxyl-methyl cellulose have been evaluated for posterolateral lumbar fusion (PLF). We investigated rhBMP6 delivered in autologous blood coagulum (ABC), a native carrier (scaffold), with and without allograft bone particles (ALLO) to induce new bone formation and promote posterolateral lumbar spine fusion (PLF) in rabbit and sheep. To evaluate the efficacy of RhBMP6 with autologous blood coagulum (ABC) alone or with ABC and allograft (ALLO) will induce a successful posterolateral spinal fusion in animal models. Preclinical evaluation of spine fusion in animal models. Multiple experimental groups of rats, rabbits and sheep. Radiographic and histologic evaluation for bone formation and spinal fusion. An autologous bone graft substitute (ABGS) was fabricated by dispersing rhBMP6 in ABC with and without ALLO and evaluated for bone induction in rat subcutaneous implants and to promote bone formation in posterolateral lumbar fusion in preclinical models. The cellular response of bone induction and the quantity and quality of newly formed bone were examined by histology, radiographs, micro-CT analyses at various time intervals. ABGS with and without ALLO induced new bone formation in rat implants. ALLO alone induced formation of multinucleated foreign body giant cells (FBGCs). However, ALLO plus ABC decreased the formation of FBGCs. The addition of rhBMP6 to ABC/ALLO, resulted in fewer or no FBGCs. In Rabbits, the groups with ABC alone or with ALLO did not fuse. The 50 micrograms rhBMP6 group only 2 out of 4 animals successfully fused. In the 100 micrograms, 200 micrograms and 400 micrograms rhBMP6 groups all animals successfully fused. In sheep, the groups with ABC or ABC with ALLO failed to fuse. In the rhBMP6 187.5 micro grams/ml group with ABC and instrumentation fusion was achieved in 83% (10/12 animals). In the 187.5 micro grams/ml group with ABC, ALLO and instrumentation, fusion was achieved in 93% (11/12 animals). Bone formation occurred uniformly within ABGS implants where the ALLO was replaced by the newly formed bone via creeping substitution. RhBMP6 with autologous blood coagulum (ABC) alone or with ABC and allograft (ALLO) induced a robust bone formation in posterolateral spinal fusion in preclinical models. RhBMP6 (Not approved for this indication). [ABSTRACT FROM AUTHOR]

Surgical treatment of severe pediatric spinal deformity is challenging and can have a high risk of neurologic injury. We investigated the incidence of intraoperative monitoring (IOM) alerts during surgery and the development of new neurologic deficits in a prospective multicenter cohort. The purpose of this study was to evaluate the frequency of IOM alerts during surgery for severe pediatric deformity and determine the incidence of new permanent deficits at 2 years postoperative. Prospective observational multicenter cohort of severe pediatric deformity patients treated surgically for minimum curves of 100° or planned vertebral column resection (VCR). Patients with a minimum spinal deformity curve of 100° or who were scheduled for a VCR procedure were prospectively enrolled at 17 sites. IOM alerts, radiographic parameters, surgical procedures, neurological status. Patients with severe spinal deformity with minimum curves of 100°; or planned VCR were followed for a minimum 2 years postoperative. We studied x-ray parameters, IOM changes, postop deficits and recovery at minimum 2 years. A total of 228 of the 312 patients enrolled had a minimum two years follow-up (QOLs and x-rays). Of these, 110 patients had a VCR and 1 a PSO. Two hundred twelve had a post-only approach and 16 a combined anterior/posterior. Two hundred twenty-eight patients had a total of 272 procedures including all stages; IOM alerts occurred in 102/272 procedures (38%). IOM alerts occurred in 98 pts (43%), with a total of 147 IOM alerts. An analysis was completed between a VCR, ant/post, coronal deformity angular ratio (C–DAR), the sagittal deformity angular ratio (S–DAR), and any IOM alert, SSEP, TCeMEP or both. Only S-DAR was predictive for any IOM alert (p<.0001). The common triggering events were 3 column osteotomies (N=34), correction maneuvers (N=30), hypotension (N=25), implant and instrumentation placement (N=20 and 19 respectively). Some alerts had multiple triggering events. A normal preoperative exam was present in 209 patients. A total of 190 patients remained neurologically normal postoperative; 19 had new deficits. At 2 years postop, 16/19 with new deficits returned to normal, 2 continued to have a deficit, and 1 was lost to follow-up. Analysis between ant/post, VCR, C-DAR and S-DAR indicated that S-DAR was associated (p=0.0035) with a new postoperative deficit. A total of 19 patients had a neurologic deficit preoperatively; postoperatively 6 improved to normal, 12 continued to have a deficit and 1 had a partial recovery. At 2 years, 13/19 with deficits preop totally recovered, 3 partially, 2 were the same, and 1 was lost to follow-up. Pediatric patients with severe deformity had a 43% incidence of IOM alerts but after addressing the alerts intraop, only 2 patients had new deficits at 2 years. Of the 19 patients with preoperative neurologic deficit, 16 patients improved or recovered. Neural monitoring should be mandatory in these cases. Sagittal DAR is associated with IOM alerts and new neurologic deficits. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The opioid crisis in the US has created a backlash from the government and third- party payors with headlines appearing daily in the media. We sought to understand the current opioid prescribing practices of adult spinal deformity surgeons in this difficult environment. We wanted to investigate the opioid prescribing practices of surgeons from neurosurgical and orthopedic disciplines treating adult spinal deformity Survey of the prescribing practices of surgeons treating adult spinal deformity. A total of 33 surgeons: 20 orthopedist and 13 neurosurgeons. Survey of opioid prescribing practices. A questionnaire was given to adult deformity surgeons with varied years of practice. Years in practice and residency specialty (ortho vs neuro) were noted. Various questions regarding prescribing practice were asked. Descriptive statistics were performed to show the prevalence of the different prescribing practices among the cohort. A total of 33 surgeons (20 ortho, 13 neuro) returned the survey. Years in practice were as follows: <5yrs, 4 (12.1%); 5-10yrs, 5 (15.2%); 10-15yrs,12 (36.4%); 15-20yrs, 8 (24.2%); and >20yrs, 4 (12.1%). The following questions were asked: Do you actively wean patients off narcotic medications before surgery? {Yes=18 (54.5%) [Neuro=4 (31%) and Ortho=14 (70%) (p=0.0270)]; No=15 (45.5%)}; Do you require them to be completely off of the narcotics? {Yes=0 No=33 (100%)}; Do you prescribe opioids to your patients postoperatively? {Yes=30 (90.9%) No=3 (9.1%)}; If no, who does? {Pain Management=2; Fellows=1 (Japan)}; If yes, do you have a cut-off time point postoperatively after which you no longer primarily prescribe narcotics? {Yes=28 (84.8%), No=2 (6.1%), N/A=3 (9.1%)}; If yes, how long do you prescribe? {6 weeks=5 (15.2%), 2 months=1 (3.0%), 3 months=19 (57.6%), 6 months=3 (9.1%), 1 year= None, indefinitely=2 (6.1%), N/A=3 (9.1%)}; Do you actively attempt to wean your patients off of opioids postoperatively? {Yes=30 (90.9%) [Neuro=10 (77%) and Ortho=20 (100%) (p=0.0242)], No=3 (9.1%)}. Differences between the group of surgeons in their training background of neurosurgery vs orthopedics was significantly different in actively weaning patients off narcotics either before or after surgery. Surgeons operating on adult deformity patients in 2018 are limiting the amount of narcotics given to surgical patients preoperatively and postoperatively. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Surgical treatment of severe pediatric deformity can be extremely challenging due to difficulties with instrumentation placement in small patients, stress on implants due to correction of severe deformities, and use of three column osteotomies. We investigated the instrumentation and fusion related complications in these complex spine deformity surgical cases. The purpose of this study was to evaluate the frequency and timing of revisions related to instrumentation or fusion in patients with severe pediatric deformity. Prospective observational multicenter cohort of severe pediatric deformity patients treated surgically. Patients with a minimum spinal deformity curve of 100° or who were scheduled for a VCR procedure were prospectively enrolled at 17 sites. Patient who had reached a minimum of 2 years postoperative were included for analysis. Postoperative complications associated with instrumentation and/or fusion, time of revisions and complications from index surgery Patients with severe spinal deformity (>100° or planned VCR) were included with a min. Two year f/u from 17 centers. Complications with or without revision due to pseudoarthrosis, instrumentation failure, infection requiring instrumentation removal and progression of deformity were all analyzed. A total of 228 of 312 patients had a min of 2 yrs f/u. Of these, 29 pts (13%) had complications associated with instrumentation or fusion. A total of 22 patients (10%) had 27 revisions. The average time for all revisions was 16 mos (0-36) after index surgery; 3 patients were revised 2x and 1 pt 3x. The 27 revisions included 5 patients with loss of fixation, revised an ave. of 21 mos po (1-35). Four patients with pseudarthrosis were revised an average of 21 mos po (13-28). One patient was revised for prominent instrumentation at 27 mos po, and 5 patients for deep infection between 1-27 mos, average 15 mos. Eight patients had revisions for deformity progression at an ave of 13 mos (1-36). One patient was revised for a malpositioned screw a few days po, and 1 at 12 mos po for implant/instrumentation failure. Eight patients had complications that did not require revision. These included 1 with prominent implants, 1 with a malpositioned screw in the disc space, 3 had progressive deformity including PJK , 1 patient for implant prominence, 1 for loss of fixation, and 2 implant failures. Pediatric patients with severe spinal deformity are at significant risk for revision surgery at a rate of 13% within 2 years. The average time for revision surgery was 16 mos po but was necessary as long 36 months after index surgery. Long term follow-up is necessary to evaluate failures in this patient population. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Multiple studies involving the outcomes of anterior interbody cages have been published, but the majority were by authors who designed the cage. No outcome studies with Bagby and Kuslich (BAK) cages implanted by a single-surgeon have either 3 years of follow-up or at least 25 patients. Purpose: To determine the 3- to 6-year clinical outcomes, including fusion rate, revision rate, complications and functional status of patients who underwent placement of anterior, stand-alone BAK cages by a single surgeon. Study design: This is a retrospective cohort study of patients who underwent anterior, stand-alone BAK cage placement by a single surgeon with a minimum of 3 years of follow-up. Patient sample: A total of 46 consecutive patients who underwent placement of anterior BAK cages from 1997 to 1999 were the study group. Outcome measures: Complications, fusion rate, revision rate, Prolo scores, Oswestry scores, pain scores, patient satisfaction. Methods: A retrospective review of charts of patients undergoing anterior stand-alone placement of BAK cages over the study period were reviewed. Demographic data were collected, and postoperative radiographs and clinic notes were reviewed. Patients were then contacted to complete a survey to determine Prolo and Oswestry scores, workers'' compensation status and general satisfaction with the procedure. Patients were also asked to undergo repeat radiographs of their lumbar spine to determine if the operative levels had fused. Results: Follow-up was available on 33 of 46 patients (72%). At least 10 patients (22%) required revision surgery. Ten patients (22%) had 14 total complications not requiring revision surgery. Seventy percent of patients had a fair or poor outcome as assessed by the Prolo rating system, and 58% of patients had at least “severe disability” according to the Oswestry outcome scale. Fifty percent of patients were satisfied with their surgery. Conclusions: This single-surgeon series of stand-alone BAK cages demonstrates significantly worse clinical outcomes than has been previously reported. The use of stand-alone BAK cages for degenerative disc disease should be reconsidered given the large number of patients with unacceptable outcomes. [Copyright &y& Elsevier]

Sagittal spino-pelvic alignment has been associated with patient-reported outcome measures and mechanical complication rates. Linear numerical values of pelvic tilt and lumbar lordosis measurements with different pelvic incidences may be misleading. The use of "relative" measurements embedded in a weighted scoring of Global Alignment and Proportion (GAP) has been described. The purpose of our study was to evaluate the validity of the GAP score in an independent database. The purpose of our study was to evaluate the validity of the GAP score in an independent database. Retrospective review of an independent adult spinal deformity data base from a single center. Adult spinal deformity patients from a single center who had >5 level fusion to the pelvis between 2004-2014. Demographic, clinical, surgical and radiographic parameters. ASD patients who underwent ≥5 levels fusion to the pelvis between 2004 to 2014 were included. Demographic, clinical, surgical and radiographic patient characteristics were recorded. Cochran-Armitage tests were used to determine mechanical complication trends across GAP categories. Uni /multivariable logistic regression analyses were used to obtain crude and adjusted odds ratios of predictor (GAP categories) and the outcome (mechanical complication). The diagnostic performance of the GAP score was tested using the area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, negative predictive value and accuracy in predicting mechanical complications. A total of 338 out of 657 patients (295F, 43M) with a mean age of 58±9.6 met the inclusion criteria. Mean follow-up was 55 months (24-138). Every mechanical complication was included from minor proximal compression fracture and iliac screw disengagement. Most common complications were rod failure in 25.4% (86/338) patients, 23 patients (6.8%) implant complication at the L-S junction, PJF in 45 patients (13.3%) and PJK in 20 pts (5.9%). Mechanical complication in proportioned (GAP-P), moderately (GAP-MD) and severely disproportioned (GAP-SD) patients were 23.8%, 55.7% and 66.1%, respectively. AUC for the GAP score was 0.653 (95% CI, 0.59 to 0.71, p<0.001). GAP Score demonstrated 60.5% sensitivity, 76.2% specificity, 89.1% positive predictive value, 37.4% negative predictive value and 64.2% accuracy in predicting mechanical complications. Postoperative alignment of GAP-MD and GAP-SD resulted in 3.6 and 4.6 folds of more odds in incurring a mechanical complication compared to proportioned GAP. This study validates the efficacy of GAP Score in predicting mechanical complications in an independent database. A trend was observed in which lower GAP scores were associated with lower rates of mechanical complications. Both the crude and adjusted odds ratios were high, showing the extent of effectiveness of this predictive tool. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

• A total of 18.6% of surgically treated adult spinal deformity patients indicated they were unsure or would not undergo surgery again. • Patients indicating they were unsure or wound not have surgery again had more postoperative complications requiring surgery than patients indicating they would have surgery again. • Patients indicating they were unsure or wound not have surgery again had worse postoperative PROs and fewer percentages reaching minimal clinically important difference for SRS-22r and ODI than patients indicating they would have surgery again. • At minimum 2 year follow up 93.0% of patients indicating they would have surgery again reported they were satisfied with the results of their back management compared 82.3% of unsure if they would have the same surgery again and 72.4% of patients that wound not have surgery again (p<.05). • Surgeons accurately identified patients indicating they would have surgery again (91.1%) but poorly identified patients indicating they wound not have surgery again (13.8%; p<.05). Adult spinal deformity (ASD) surgery can improve patient pain and physical function but is associated with high complication rates and long postoperative recovery. Accordingly, if given a choice, patients may indicate they would not undergo ASD surgery again. Evaluate surgically treated ASD patients to assess if given the option (1) would surgically treated ASD patients choose to undergo the same ASD surgery again, (2) would the treating surgeon perform the same ASD surgery again and if not why, (3) evaluate for consensus and/or discrepancies between patient and surgeon opinions for willingness to perform/receive the same surgery, and (4) evaluate for associations with willingness to undergo or not undergo the same surgery again and patient demographics, patient reported outcomes, and postoperative complications. Retrospective review of a prospective ASD study. Surgically treated ASD patients enrolled into a multicenter prospective study. Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36) physical component summary (PCS) and mental component summary (MCS), Oswestry Disability Index (ODI), numeric pain rating for back pain (NRS back) and leg pain (NRS leg), minimal clinically important difference (MCID) for SRS-22r domains and ODI, intraoperative and postoperative complications, surgeon and patient satisfaction with surgery. Surgically treated ASD patients prospectively enrolled into a multicenter study were asked at minimum 2-year postoperative, if, based upon their hospital and surgical experiences and surgical recovery experiences, would the patient undergo the same surgery again. Treating surgeons were then matched to their corresponding patients, blinded to the patients' preoperative and postoperative patient reported outcome measures, and interviewed and asked if (1) the surgeon believed that the corresponding patient would undergo the surgery again, (2) if the surgeon believed the corresponding patient was improved by the surgery and (3) if the surgeon would perform the same surgery on the corresponding patient again, and if not why. ASD patients were divided into those indicating they would (YES), would not (NO) or were unsure (UNSURE) if they would have same surgery again. Agreement between patient and surgeon willingness to receive/perform the same surgery was assessed and correlations between patient willingness for same surgery, postoperative complications, spine deformity correction, patient reported outcomes (PROs). A total of 580 of 961 ASD patients eligible for study were evaluated. YES (n=472) had similar surgical procedures performed, similar duration of hospital and ICU stay, similar spine deformity correction and similar postoperative spinal alignment as NO (n=29; p>.05). UNSURE (n=79) had greater preoperative depression and opioid use rates, UNSURE and NO had more postoperative complications requiring surgery, and UNSURE and NO had fewer percentages of patients reaching postoperative MCID for SRS-22r domains and MCID for ODI than YES (p<.05). Comparison of patient willingness to receive the same surgery versus surgeon perceptions on patient's willingness to receive the same surgery demonstrated surgeons accurately identified YES (91.1%) but poorly identified NO (13.8%; p<.05). If given a choice, 18.6% of surgically treated ASD patients indicated they were unsure or would not undergo the surgery again. ASD patients indicating they were unsure or would not undergo ASD surgery again had greater preoperative depression, greater preoperative opioid use, worse postoperative PROs, fewer patients reaching MCID, more complications requiring surgery, and greater postoperative opioid use. Additionally, patients that indicated they would not have the same surgery again were poorly identified by their treating surgeons compared to patients indicating they would be willing to receive the same surgery again. More research is needed to understand patient expectations and improve patient experiences following ASD surgery. [ABSTRACT FROM AUTHOR]

Background Context: Previous research on rates of spinal detection showed a low frequency of patients (5%) experienced delays and additional screening going through airport security. With continuous technology advances in screenings and the rise in cobalt chrome implantation, updated data on patient experiences was needed.Purpose: 1) Assess the rates of detection and additional screening by traditional metal detectors and full body scanners in patients with metal spinal implants, 2) Compare the rates of detection of various metal types (Titanium and cobalt-chrome, titanium only, and stainless steel) STUDY DESIGN: Retrospective PATIENT SAMPLE: All spine surgical follow-ups over survey period.Outcome Measures: Self-reported open questionnaire; frequency of airport screening, patients' feelings and attitudes towards screening.Methods: Patients were surveyed in the outpatient setting on exposure to metal detectors (Traditional and full-body scanners) after spinal surgery with metallic implants at a single institution. A total of 182 patients were identified and consented. The medical records were reviewed for details on implant material and location.Results: Mean age at surgery was 53 years (range=12-88) with a mean 5.9 levels fused (range 2-20). Mean time from surgery to survey was 34 months (range=2-351) and number of airport screenings was 5.8 (range=0-54). The most common implants were titanium/cobalt-chrome (Ti/CoCr) (n=96, 53%) and titanium only (n=72, 40%). Overall, 40% of patients reported a detector alert at an airport requiring processing delay and additional screening: 86% from full body scanners, 54% from traditional metal detectors, and 41% of patients reporting both. Full body scanners were more likely to detect implants compared to traditional metal detectors (OR 5.1, p<.0001). No significant difference in number of screenings between patients who set off detectors and patients who did not (p=.185). Twenty percent of patients reported trouble at non-airport locations with detectors due to their spinal implants, with 70% of these patients reporting additional manual screenings. There was no correlation between levels spanned by the construct and number of times detected by traditional metal detectors or full body scanners, and no significant difference between levels spanned by constructs, or construct locations, in patients who set off detectors and those who did not. There was no significant difference between Ti/CoCr vs. titanium or other constructs in positive screenings. Subanalysis of fusions <5 levels demonstrated Ti/CoCr implants did not have an impact on positive screenings vs. other metal types (OR 0.88, p=.756). Interestingly, there was a significant difference in age and the positive screenings (p=.0025). Patients 60+ years of age had statistically significant greater positive screening than patients 0 to 40 years and 41 to 60 years. This data raises the possibility the presence of total joint arthroplasties (Mean age of patients with arthroplasty 65.5 years, range 50-88) likely play a significant role in the frequency of positive screenings.Conclusions: 40% of patients had their spinal implants detected at airports and 20% reported detections at other non-airport locations. Full body scanners detect spinal implants more frequently compared to traditional metal detectors (86% vs. 54% of detections, respectively). There was no difference in rate of airport and non-airport detection in patients with cobalt chrome implants compared to other materials. The presence of total joint arthroplasties likely has a significant contribution to the detector alerts. [ABSTRACT FROM AUTHOR]

Background Context: Rod fractures (RF) and pseudarthrosis are a frequent occurrence after adult spinal deformity (ASD) surgery and may be problematic. However, not all RF signal nonunion and cause clinical concern. An improved understanding of the sequelae after RF occurrence is valuable for further management.Purpose: To characterize the radiographic findings, clinical outcomes, and revision rates between patients who developed unilateral RF (URF) and bilateral RF (BRF) following thoracolumbar posterior spinal fusions to the sacrum for ASD and identify patient characteristics associated with clinically significant RF that lead to subsequent revision surgeries and detection of nonunion.Study Design/setting: A retrospective single-center cohort study was performed.Patient Sample: Patients undergoing long-construct posterior spinal fusions to the sacrum performed at a single institution from 2004 to 2014 and developed a RF postoperatively were included.Outcome Measures: Patient demographics, radiographic parameters, surgical data, Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22), and revision rates.Methods: Inclusion criteria were ASD patients age >18 who had ≥5 vertebrae instrumented and fused posteriorly to the sacrum and development of RF. Data were compared among patients: who developed unilateral-nondisplaced RF (UNRF), unilateral-displaced RF (UDRF), bilateral-nondisplaced RF and bilateral-displaced RF (BDRF) at baseline and follow-up. ODI and SRS-22 scores were assessed at baseline, 1 year postoperatively, the time of RF occurrence, and latest follow-up.Results: Of 526 patients who met inclusion criteria, 96 (18.3%) developed RF (URF n=70 [73%]; BRF n=26 [27%]). Preoperative demographics and surgical parameters were similar between the groups. BRF patients had substantial loss of sagittal correction from 1-year postoperatively to the time of RF, including loss of sagittal vertical axis (4.8 cm vs. 2.2 cm; p<.001), loss of lumbar lordosis (14.8° vs. 4.9°; p=.010) and loss of pelvic incidence minus lumbar lordosis mismatch (PI-LL) mismatch (5.0° vs. 14.6°; p=.020) compared with those of URF patients. The BDRF group had more loss of ODI scores (13.4 vs. 4.2; p=.013), SRS pain score (0.8 vs. 0.2; p=.024), SRS function score (0.3 vs. 0; p=.020) and SRS subscore (0.4 vs. 0.1; p=.148) from 1-year postoperatively to the time of RF and underwent revision surgery more often than the UNRF group (87.5% vs. 4.8%; p<.0001). At final follow-up (median 2.8 years, range 1-10.3 years after RF detection), URF patients who did not undergo revision surgeries still maintained equivalent sagittal alignment correction (sagittal vertical axis, LL and PI-LL; all p>.05) and had similar, not worse, mean ODI scores, SRS Subscore and SRS pain compared with the time at RF and 1-year follow-up.Conclusions: RF are not uncommon after ASD operations. Asymptomatic, UNRF in our study did not jeopardize clinical outcomes or radiographic alignment parameters and, in most cases, did not represent a nonunion, as opposed to BRF. BRF patients exhibited loss of sagittal correction, loss of clinical outcome improvements, as measured by ODI, SRS pain and SRS Subscore at the time of RF, and were revised more often than URF patients. [ABSTRACT FROM AUTHOR]

Background Context: The postoperative recovery patterns of cervical deformity patients, thoracolumbar deformity patients, and patients with combined cervical and thoracolumbar deformities, all relative to one another, is not well understood. Clear objective benchmarks are needed to quantitatively define a "good" versus a "bad" postoperative recovery across multiple follow-up visits, varying deformity types, and guide expectations.Purpose: To objectively define and compare the complete 2-year postoperative recovery process among operative cervical only, thoracolumbar only, and combined deformity patients using area-under-the-curve (AUC) methodology.Study Design/setting: Retrospective review of 2 prospective, multicenter adult cervical and spinal deformity databases.Patient Sample: One hundred seventy spinal deformity patients.Outcome Measures: Common health-related quality of life (HRQOL) assessments across both databases included the EuroQol 5-Dimension Questionnaire and Numeric Rating Scale (NRS) back pain assessment. In order to compare disability improvements, the Neck Disability Index (NDI) and the Oswestry Disability Index (ODI) were merged into one outcome variable, the ODI-NDI. Both assessments are gauged on the same scale, with minimal question deviation. Sagittal Radiographic Alignment was also assessed at pre- and all postoperative time points.Methods: Operative deformity patients >18 years old with baseline (BL) to 2-year HRQOLs were included. Patients were stratified by cervical only (C), thoracolumbar only (T), and combined deformities (CT). HRQOL and radiographic outcomes were compared within and between deformity groups. AUC normalization generated normalized HRQOL scores at BL and all follow-up intervals (6 weeks, 3 months, 1 year, and 2 year). Normalized scores were plotted against follow-up time interval. AUC was calculated for each follow-up interval, and total area was divided by cumulative follow-up length, determining overall, time-adjusted HRQOL recovery (Integrated Health State, IHS). Multiple linear regression models determined significant predictors of HRQOL discrepancies among deformity groups.Results: One hundred seventy patients were included (27 C, 27 T, and 116 CT). Age, BMI, sex, smoking status, osteoporosis, depression, and BL HRQOL scores were similar among groups (p >. 05). T and CT patients had higher comorbidity severities (CCI: C 0.696, T 1.815, CT 1.699, p = .020). Posterior surgical approaches were most common (62.9%) followed by combined (28.8%) and anterior (6.5%). Standard HRQOL analysis found no significant differences among groups until 1-year follow-up, where C patients exhibited comparatively greater NRS back pain (4.88 vs. 3.65 vs. 3.28, p = .028). NRS Back pain differences between groups subsided by 2-years (p>.05). Despite C patients exhibiting significantly faster ODI-NDI minimal clinically important difference (MCID) achievement (33.3% vs. 0% vs. 23.0%, p < .001), all deformity groups exhibited similar ODI-NDI MCID achievement by 2-years (51.9% vs. 59.3% vs. 62.9%, p = 0.563). After HRQOL normalization, similar results were observed relative to the standard analysis (1-year NRS Back: C 1.17 vs. T 0.50 vs. CT 0.51, p < .001; 2-year NRS Back: 1.20 vs. 0.51 vs. 0.69, p = .060). C patients exhibited a worse NRS back normalized IHS (C 1.18 vs. T 0.58 vs. CT 0.63, p = .004), indicating C patients were in a greater state of postoperative back pain for a longer amount of time. Linear regression models determined postoperative distal junctional kyphosis (adjusted beta: 0.207, p = .039) and osteoporosis (adjusted beta: 0.269, p = .007) as the strongest predictors of a poor NRS back IHS (model summary: R2 = 0.177, p = .039).Conclusions: Despite C patients exhibiting a quicker rate of MCID disability (ODI-NDI) improvement, they exhibited a poorer overall recovery of back pain with worse NRS back scores compared with BL status and other deformity groups. Postoperative distal junctional kyphosis and osteoporosis were identified as primary drivers of a poor postoperative NRS back IHS. Utilization of the IHS, a single number adjusting for all postoperative HRQOL visits, in conjunction with predictive modelling may pose as an improved method of gauging the effect of surgical details and complications on a patient's entire recovery process. [ABSTRACT FROM AUTHOR]

Background Context: Cost-utility analysis, a special case of cost-effectiveness analysis, estimates the ratio between the cost of an intervention to the benefit it produces in number of quality-adjusted life years. Cervical deformity correction has not been evaluated in terms of cost-utility and in the context of value-based health care. Our objective, therefore, was to determine the cost-utility ratio of cervical deformity correction.Study Design: This is a retrospective review of a prospective, multicenter cervical deformity database. Patients with 1-year follow-up after surgical correction for cervical deformity were included. Cervical deformity was defined as the presence of at least one of the following: kyphosis (C2-C7 Cobb angle >10°), cervical scoliosis (coronal Cobb angle >10°), positive cervical sagittal malalignment (C2-C7 sagittal vertical axis >4 cm or T1-C6 >10°), or horizontal gaze impairment (chin-brow vertical angle >25°). Quality-adjusted life years were calculated by both EuroQol 5D (EQ5D) quality of life and Neck Disability Index (NDI) mapped to short form six dimensions (SF6D) index. Costs were assigned using Medicare 1-year average reimbursement for: 9+ level posterior fusions (PF), 4-8 level PF, 4-8 level PF with anterior fusion (AF), 2-3 level PF with AF, 4-8 level AF, and 4-8 level posterior refusion. Reoperations and deaths were added to cost and subtracted from utility, respectively. Quality-adjusted life year per dollar spent was calculated using standardized methodology at 1-year time point and subsequent time points relying on maintenance of 1-year utility.Results: Eighty-four patients (average age: 61.2 years, 60% female, body mass index [BMI]: 30.1) were analyzed after cervical deformity correction (average levels fused: 7.2, osteotomy used: 50%). Costs associated with index procedures were 9+ level PF ($76,617), 4-8 level PF ($40,596), 4-8 level PF with AF ($67,098), 4-8 level AF ($31,392), and 4-8 level posterior refusion ($35,371). Average 1-year reimbursement of surgery was $55,097 at 1 year with eight revisions and three deaths accounted for. Cost per quality-adjusted life year (QALY) gained to 1-year follow-up was $646,958 by EQ5D and $477,316 by NDI SF6D. If 1-year benefit is sustained, upper threshold of cost-effectiveness is reached 3-4.5 years after intervention.Conclusions: Medicare 1-year average reimbursement compared with 1-year QALYdescribed $646,958 by EQ5D and $477,316 by NDI SF6D. Cervical deformity surgeries reach accepted cost-effectiveness thresholds when benefit is sustained 3-4.5 years. Longer follow-up is needed for a more definitive cost-analysis, but these data are an important first step in justifying cost-utility ratio for cervical deformity correction. [ABSTRACT FROM AUTHOR]

Background Context: Risk factors associated with rod fracture (RF) following adult spinal deformity (ASD) surgery fused to the sacrum remain debatable, and the impact of RF on patient-reported outcomes (PROs) after ASD surgery has not been investigated.Purpose: We aimed to evaluate the prevalence of and risk factors for RF and determine PROs changes associated with RF after ASD surgery fused to the sacrum.Study Design/setting: A retrospective single-center cohort study was performed.Patient Sample: Patients undergoing long-construct posterior spinal fusions to the sacrum performed at a single institution by two senior spine surgeons from 2004 to 2014 were included.Outcome Measures: Patient demographics, radiographic parameters, and surgical factors were assessed for risk factors associated with RF. Oswestry Disability Index (ODI) and Scoliosis Research Society-30 (SRS-30) scores were assessed at baseline, 1 year postoperatively, and latest follow-up.Methods: Inclusion criteria were ASD patients age >18 who had ≥5 vertebrae instrumented and fused posteriorly to the sacrum and either development of RF or no development of RF with minimum 2-year follow-up. Patient characteristics, operative data, radiographic parameters, and PROs were analyzed at baseline and follow-up. Separate Cox proportional hazard models based on rod material and diameter were used to determine factors associated with RF.Results: Five hundred twenty-six patients (80%) were available for analysis. RF occurred in 97 (18.4%) patients (unilateral RF n=61 [63%]; bilateral RF n=36 [37%]). Risk factors for fracture of 5.5 mm cobalt chromium (CC) instrumentation (CC 5.5 model) included preoperative sagittal vertical axis (hazard ratio [HR] 1.07, 95% confidence interval [95% CI] 1.02-1.14 per 1-cm increase), preoperative thoracolumbar kyphosis (HR 1.02, 95% CI 1.01-1.04 per 1-degree increase), and number of levels fused for patients who received rhBMP-2 <12 mg per level fused (HR 1.48, 95% CI 1.20-1.82 per 1-level increase). Implants that were 5.5-mm CC constructs were at a higher risk for fracture than 6.35-mm stainless steel (SS) constructs (HR 8.49, 95% CI 4.26-16.89). The RF group had less overall improvement in SRS Satisfaction (0.93 vs. 1.32; p=.007) and SRS Self-image domain scores (0.72 vs. 1.02; p=.01). The bilateral RF group had less overall improvement in ODI (8.1 vs. 15.8; p=.02), SRS Subscore (0.51 vs. 0.85; p=.03), and SRS Pain domain scores (0.48 vs. 0.95; p=.02) compared with the non-RF group at final follow-up.Conclusions: The prevalence of all RF after index procedures was 18.4%, 37% for bilateral RF. Greater preoperative sagittal vertical axis, greater preoperative thoracolumbar kyphosis, increased number of vertebrae fused for patients who received rhBMP-2 <12 mg per level fused, and CC 5.5-mm rod were associated with RF. Less improvement in patient satisfaction and self-image was noted in the RF group. Furthermore, bilateral RF significantly affected PROs as measured by ODI and SRS Subscore at final follow-up. [ABSTRACT FROM AUTHOR]

Adult spinal deformity (ASD) is a complex pathology associated with high complication rates. Although complication rates have been previously reported, the interplay between timing and type of complications has not been fully analyzed. Provide benchmarks for the rates of complications by type and timing. Prospective multicenter database. Operatively treated ASD patients with 2-year follow-up. Rates of medical complications (cardiac, GI, infection, pulmonary, renal) and surgical complications (implant-related, operative, neurologic, radiographic) within 2 years postsurgery In the context of a prospective multicenter ASD database, standardized forms were used to collect data on surgery-related complications. Onsite research coordinators and central auditing helped ensure data capture completeness. Inclusion criteria were age >18 years, ASD and minimum 2-year follow-up. Date and type of complication were collected and classified into three severity groups (minor, major, major leading to reoperation). Only complications occurring before the 2-year visit were retained for analysis. A total of 997 out of 1,260 patients eligible for 2-year follow-up (79.1%) were captured. The mean age at the time of surgery was 60.4yo±14.3, 76.3% were female and 50.5% had a history of previous spine surgery. The vast majority of patients (98.9%) had treatment including a posterior procedure, 57.9% had decompression, 71.2% had at least one osteotomy, and 18.1% had a 3-column osteotomy. Interbody fusion (IBF) was used in 64.0%: 48.7% posterior (TLIF or PLIF), 38.3% anterior (ALIF) and 23.2% lateral (LLIF). The mean ASD surgical invasiveness index was 88.8±36.1; 66.3% of the patients were admitted postop to the ICU, with a median overall length of hospital stay of 7 days (IQR 5 to 9). The overall complication rate was 67.4% (N=672). A total of 247 patients (24.8%) experienced at least one complication the day of surgery (including intraoperatively), 359 (36.0%) between POD1 and 6-weeks postoperatively, 271 (27.2%) between 6 weeks and 1-year postoperatively, and finally 162 (16.3%) between 1- and 2-years postoperatively. Using Kaplan-Meier survival analysis, the rate of remaining complication-free was estimated at 70.9% by POD1, 59.0% by POD7, 51.4% by 30 days, 47.4% by 3 months, and 33.6% by 2-years postoperatively. Breakdown by severity of remaining complication-free revealed the following rates for minor | major | reop: by POD1= 87.3% | 90.1% | 97.4%; by POD7=78.4% | 86.8% | 95.8%; by 3 months= 71.6% | 81.0% | 86.7%; by 6 months = 70.3% | 80.1% | 86.7%; and by 2-years postop=64.5% | 75.1% | 77.0%. Stratification by type of complication demonstrated that most of the medical complications occurred within the first 60 days. Surgical complications followed two types of behavior: operative, wound and infection occurred early (within 60 days), while implant-related and radiographic complications happened at a constant rate over the 2-year period. Neurologic complications had a high occurrence with the first 60 days, followed by a continuous increase up to the 2-year visit. Only one-third of ASD patients remained complication-free 2-years postoperatively. Two patients out of ten had a complication requiring a reoperation/revision. Estimation of timing and type of complication associated with surgical treatment is crucial when counseling patients and planning treatment cost-effectiveness. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Previous reports indicate postoperative complications have minimal impact on long-term outcomes after ASD surgery. Little data has evaluated the impact of complications on specific heath domains during postoperative period. To evaluate the impact of specific complications on patient reported health domains compared to patients with no complications. Prospective, multicenter, propensity score matched analysis. ASD patients enrolled into a prospective multi-center study. Oswestry Disability Index, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), postoperative complications. Surgically treated ASD patients enrolled into a multicenter study were assessed for postoperative complications requiring surgery including wound (WOUND), pseudoarthrosis (PSEUDO), neurologic (NEURO) and malalignment (MAL) and matched to patients with no complications (NOCOMP) using inverse probability weighting for demographic, radiographic and surgical variables. Health domains for SRS-22r, and SF-36 were evaluated at regular time intervals, domain scores normalized to the date of revision surgery, and compared to patients with no complications at minimum 2-year follow-up. A total of 566 of 1130 were analyzed, average 3.6 yrs (range: 1.9 to 9). WOUND (n=12) compared to NOCOMP (n=390) had worse SF-36 physical function(21.7 vs 27.4), social function(19.6 vs 28.9), general health (-7.3 vs 8.9) and vitality (-0.9 vs 26.6,p < 0.05). PSEUDO (n=64) was worse than NOCOMP for SRS-22r function, 1.4 vs 2.1, and SF-36 social function, (17.1 vs 28.9) (p < 0.05). NEURO (n=28) was worse than NOCOMP for SRS-22r (0.9 vs 2.1), SF-36 bodily pain (14.7 vs 35.7) and social function (13.4 vs 28.9) (p < 0.05). MAL (n=72) was worse than NOCOMP for SRS-22r pain, (2.7 vs 3.4), function (1.2 vs 2.1), self-image (3.0 vs 3.9), SF-36 bodily pain (27.6 vs 35.7), physical function (18.7 vs 27.4), and social function (11.6 vs 28.9) (p < 0.05). Counter to previous reports, specific postoperative complications requiring surgery uniquely impact specific health domains, resulting in worse patient reported quality of life compared to ASD patients with no complications. Social function was negatively impacted for all complications, while wound complications negatively impacted patient perceived general health and vitality and patients with malalignment requiring surgery reported worse self-image. These data highlight new findings that postoperative complications have a negative impact on specific aspects of ASD quality of life that can undermine the potential benefits of ASD surgery. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Loss of lumbar curvature is often expressed as an angular regional loss. Previous work comparing adult spinal deformity (ASD) lumbar alignment to their age-and-PI adjusted normative value demonstrated that, contrary to general belief, a large proportion of the curvature is lost proximally (L1-L4). This study is a follow-up looking not only at regional angles, but also at the spinal contour collectively. Investigate the difference of lumbar shape between ASD and age-and-PI adjusted normative values. Retrospective review of an ASD registry. A total of 119 asymptomatic volunteers and 362 ASD patients. Sagittal alignment of the lumbar and thoracolumbar spine measures using vertebra pelvic angle from L5 to T10. Before studying ASD patients, 119 asymptomatic volunteers with full-body, free-standing radiographs were used to identify age-and-PI models of each vertebra pelvic angle (VPA) from L5 to T10, a validated methodology characterizing the detailed shape of the spine. Our study cohort was a registry of surgical primary ASD patients without coronal malalignment (SRS-Schwab Type=N). The formulas developed in the asymptomatic population were applied to the ASD group to calculate an age-and-PI normative spine shape for each patient. Loss of lumbar lordosis was defined as the offset between age-and-PI normative value and pre-operative spino-pelvic alignment. Patients were stratified into four groups by the amount of lordosis lost, ranging from "no loss" to "30° loss." Paired t-tests were performed to compare actual and normative VPA shapes within each group. Out of 1,495 patients enrolled in this registry, 453 were primary cases, and 653 were categorized as a Schwab type N, leading to a cohort of 362 patients (age=64.4±13, 57.1% F). Pre-operative alignment demonstrated a large variability with a mean PI-LL of 15°±21, distal LL=31°±15, and PI=55°±13. Compared to their age-and-PI normative values, ASD patients demonstrated a significant lordosis loss of 17°±19 with the following distribution: 14.1% no loss (mean: 0.1±2.3), 22.9% with 10° loss (mean: 9.9±2.9), 22.1% with 20° loss (mean: 20.0±2.8), and 29.3% with 30° loss (mean:33.8±6.0). Comparison of the VPAs (and therefore the shape) between each LL group and the normative shape demonstrated that the "no loss" patients had a lumbar spine slightly anterior to the normative shape from L4 to T10 (VPA difference of 2°). The shape of the "small deformity" group (10°) superimposed on the normative one from L5 to L2 (VPA with p>0.1) and became anterior at the L1 level. As the lordosis loss increased, the offset between ASD and normative shapes began to propagate to the distal levels and became significant extending caudally to the L3 level for the "20° loss" group and further down to L4 for the more severe group. As the deformity progresses and the loss of lordosis increases, the difference between ASD shape and normative shape happens first proximally and then progresses incrementally caudally with increasing deformity. Understanding the spinal contour and the location of this loss, in addition to regional parameters, may be key to achieving a sustainable correction by identifying optimal and personalized post-operative shape. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Adult cervical deformity (ACD) can have profound impact on health-related quality of life (HRQL). Operative treatment for ACD is associated with high complication rates due to the complexity of surgery and the frailty of the patients affected. Very few studies have focused on outcomes of operative ACD treatment. To assess whether operative treatment for ACD significantly improves HRQL at minimum 2-yr followup. Multicenter, prospective cohort study. Operatively treated ACD patients. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), EuroQol-5D (EQ-5D), and numeric rating scale (NRS) for neck and back pain. Operatively treated ACD patients were assessed at baseline, standardized follow-up intervals and through direct mailings. Patient-reported outcomes measures (PROMs) included: NDI, mJOA, EQ-5D and NRS for neck and back pain. Complications were classified as perioperative (=30 days) or delayed (>30 days). Analyses focused on patients with minimum 2-yr followup. Of 169 ACD patients, the 102 (60%) with minimum 2-yr followup (mean=3.4 yrs, SD=1.9 yrs, range=2 to 8.1 yrs) had a mean age of 62 yrs (SD=11) and 64% were women. Surgical approaches included anterior-only (22.8%), posterior-only (39.6%) and combined (37.6%). The mean numbers of vertebrae fused anteriorly and posteriorly were 4.3 (SD=1.1) and 9.4 (SD=3.4), respectively, with 16% having a 3-column osteotomy. PROMs significantly improved from baseline to last follow-up, including NDI (47.3 to 33.0), mJOA (12.0 to 12.8; for patients with baseline score 0.05). Overall, 58 (56.9%) patients had at least 1 complication, 41 (40.2%) had at least 1 perioperative complication, and 35 (34.3%) had at least 1 delayed complication. The most common complications included dysphagia (18.6%), distal junctional kyphosis (6.9%), instrumentation failure (6.9%), cardiac events (6.9%), dysphonia (4.9%), nerve sensory deficit (3.9%) and respiratory failure (3.9%). For patients with at least 2-yr follow-up, 12 patients underwent a total of 15 reoperations (9 had 1 and 3 had 2). Notably, the 67 patients who did not achieve 2-yr follow-up were similar to study patients based on demographics, comorbidities and baseline PROMs. Reflective of the frailty of this patient population, there were 18 deaths among the 67 patients without minimum 2-yr followup. These deaths occurred between 0.2 and 34.8 months following surgery. Although most occurred at least 6 months after surgery and likely were not directly related to surgery, 4 occurred within 4 months of surgery, including 1 due OSA/narcotics, 1 due to pneumonia, and 2 with unknown causes. This multicenter, prospective analysis demonstrates that operative treatment for ACD provides significant improvement of HRQL at minimum 2-yr (mean 3.4-yr) followup. These findings may prove useful for patient counseling in the context of the substantial impact of ACD. Further studies will be needed to assess the long-term durability and cost-effectiveness of surgical treatment for ACD. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Preoperative risk stratification is critical to determining which adult spinal deformity (ASD) patients may develop postop complications and to maximize surgical success. Currently it is unknown if a preoperative inflammatory state results in a higher risk for postop complications. This information can be used in risk stratification models to aid in complication avoidance. To determine if patients with preoperative elevated serum markers for inflammation have higher rates of postoperative complications Retrospective review of multicenter prospective ASD database. ASD patients. C-reactive protein (CRP), Erythrocyte sedimentation rate (ESR), complications by type and by severity of intervention: none, mild, moderate and severe. Demographic and surgical variables: age, estimated blood loss (EBL), operating room (OR) time, body mass index (BMI), America Society of Anesthesia physical classification scale (ASA), Charlson comorbidity index (CCI), Edmonton frailty scale (EF), 3-column osteotomy (3CO), number of post fusion levels. Preoperative labs were drawn on ASD patients and the inflammatory markers were CRP and ESR. CRP thresholds for cardiac risk: normal = 3. The CRP moderate and elevated values were combined into one group named elevated. Normal ESR thresholds: Male age 50, =20, Female >50, =30. Patients were stratified by having normal or elevated markers and rates of complications were compared between the groups. A multivariate model with CRP/ESR and demographic/surgical variables for postoperative complications. Health-related quality of life (HRQOL) metrics were compared The total number of patients with preoperative CRP was 159 and ESR was 158. CRP: normal=114 patients (71.7%), moderate elevation=28 (17.6%), severe elevation=17 (10.7%). Combined elevated=45/159(28.3%). Elevated ESR=25(15.8%), normal=133(84.2%). The elevated CRP group had significantly higher rate of moderate complication 13/45(28.9%) vs 16/114(14.0%), p=0.03 and severe complication 15/45 (33.3%) vs 17/114(14.9%, p=0.009. Elevated ESR patients had significantly higher rate of moderate complication 9/25 (36.0%) vs 20/133 (15.0%), p=0.01. In multivariable logistic regression elevated CRP had odds ratio for moderate complication of 3.3 (95% CI 1.4-7.6, p=0.006), and for severe complication of 2.3 (95% CI 1.05-5.1, p=0.037). Multivariable logistic regression for elevated ESR and moderate complication had odds ratio of 2.9 (95%CI 1.04-7.8, p=0.041). Elevated CRP also had significantly higher rate of wound complications (15.6% vs 3.5%, p=0.007) and MSK complications (11.1% vs 1.8%, p=0.01). Elevated ESR had significantly higher rate of cardiac complications (32.0% vs 13.5%, p=0.02) and neurological complications (24.0% vs 9.0%, p=0.03). Elevated CRP had worse preoperative leg pain, SRS Activity and VR12 PCS(p<0.05). Elevated ESR had worse baseline ODI (p=0.03). A preoperative inflammatory state as defined by elevated CRP and ESR is an independent risk factor for the development of moderate and severe postop complications. Having elevated preop CRP is 3.3 and 2.3 times more likely to have a moderate and severe complication, respectively. Elevated ESR is 2.9 times more likely to have a moderate complication. This data can be used in risk stratification models to aid in minimizing postoperative complications. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

As adult spinal deformity (ASD) prevalence increases in our ever-aging population there is a concomitant increase in poor bone quality. ASD surgery is expensive and carries a high complication profile. It is important to optimize modifiable preoperative risk factors, such as osteopenia or osteoporosis. Additional diagnostic modalities such as a DEXA can add cost, delay diagnosis, and can be an additional insurance hurdle. Some studies suggest HU's can be utilized as a proxy for frailty, but it is unclear if this is useful in risk stratification. Our goal was to evaluate the relationship between bone health as measured by HU's and PJK and identify a HU threshold in which PJK risk is increased. We hypothesize that HU will correlate with occurrence of PJK after ASD surgery. Retrospective review of a prospective, multicenter ASD database. Of 1,330 pts eligible, 997 (74.9%) had complete 2Y follow-up. Of these, 605 meet inclusion criteria with 110 (18.18%) patients having a PJK. Development of PJK within 2 years of surgery. Operative ASD patients (scoliosis >20, SVA>5cm, PT>25, or TK>60) with available baseline (BL) and 2-year (2Y) radiographic and HRQL data were included if they had a preop CT. HU were measured from axial views within the cancellous body (x3) at both L1 and UIV with the mean value calculated for each. Threshold linear regression with Bayesian information criteria was utilized to identify optimal cut-offs of risk factors for PJK. Multivariable analysis (MVA) controlled for PJK prophylaxis and surgeon. Additionally, risk factors identified were controlled against each other. Threshold regression identified that cut-offs of <125 HU for UIV, >63 years for age, >0.31 for ASD-FI, and >47° for preoperative T4-12 thoracic kyphosis, and <10 levels fused were predictive of PJK on bivariate analysis (P<0.05 for all). On MVA, age > 63 years old (OR 4.7; P = 0.003), female gender (OR 3.33; P=0.035), HU at UIV vertebrae <125 (2.83; P=0.008), ASD-FI >0.31 (OR 4.02; P=0.011), TK > 46° (OR 3.75; P=0.003), and < 10 levels fused (OR 3.31; P=0.0310) were associated with increased odds of PJK. Bone health as measured by HU appears to be an independent predictor of PJK after ASD surgery, specifically values <125 at the UIV. It also parallels frailty in prediction of PJK and can potentially be used as a proxy for frailty assessment. This can be easily measured and could help with risk stratification in the future. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Prior studies assessed the association between underlying neurological condition and worse outcomes following spinal surgery with recent emphasis of self-reported loss of balance (Imbalance) by Uribe et al. To investigate if patients with self-reported loss of balance have poorer outcomes following adult spinal deformity (ASD) surgery. Retrospective review of prospectively collected database. ASD patients with baseline and 2-year radiographic and patient-reported outcome measure (PROM) data were included. Demographics, radiographic outcomes, complications, and PROM were compared from baseline to 2-year follow up. Patients undergoing a long spinal fusion with no prior history of spine surgery were retained. Patients were grouped according to imbalance and unsteady gait. The groups were propensity matched by age, PI-LL, and surgical invasiveness score. Demographics, radiographic, complications and PROM were compared from baseline to 2-year post-op. A total of 212 patients were reported (106 patients in each group). The mean age (64 vs 63 years), BMI (27.2 vs 27.0 kg/m2), and gender (76% vs 87% female) were not significantly different for patients with imbalance and without imbalance respectively (all p >0.05). Patients in the imbalance group had a higher Frailty Index Score compared to patients without imbalance (3.74 vs 2.33, p <0.001). At baseline, the sagittal profile for both groups were comparable with regard to PT, PI-LL, and SVA. Patients with loss of balance had a significantly lower thoracic Cobb angle (25.27° vs 37.45°, p <0.001) and lumbar Cobb angle (37.03° vs 45.53°, p=0.004), although the global coronal alignment was similar (imbalance:41.51 mm vs 34.25 mm, p=0.155). Patients with imbalance had worse PROM measures, including ODI (45.15 vs 36.62), SF-36 Mental Component Score (44.04 vs 51.76), SF-36 Physical Component Score (30.17 vs 35.10), and SRS-22 Mental domain score (3.28 vs 3.80) (p <0.001 for all). Postoperatively, patients with imbalance had less PT correction (-1.45° vs -3.60°, p=0.039) for a comparable correction in their PI-LL (-11.93° vs-15.08°, p=0.144) by 2-year follow-up. Both groups demonstrated similar improvements in their coronal plane deformity. Imbalance patients had higher rates of radiographic PJK at 2-year follow-up (26.4% vs 14.2%, p=0.026). Furthermore, patients with reported imbalance have significantly higher rate of implant related complications (47.2% vs 34.0%, p=0.05). After controlling for age, baseline sagittal parameters, PI-LL correction and Charlson Comorbidity Index, patients with imbalance had 2.2 times increased odds of sustaining PJK by 2 years. Patients with a self-reported loss of balance and unsteady gait have significantly worse baseline frailty and PROMs, represented by poorer mental health and physical function. Although those patients had higher rates of PJK and implant-related complications, surgical intervention significantly improved their quality of life. Despite the improvement, they remained with lower PROMs by 2-year follow-up. Therefore, in the clinic setting and with limited institutional access to Frailty scores, asking patients if they have loss of balance or unsteady gait is a simple yet powerful question which may trigger their preoperative risk stratification and optimization. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Sacralization of L5 is a condition that affects 15% of the population. Because of the increased L5 articulations to the sacrum, it is unclear how pelvic incidence and spinopelvic parameters should be measured. Determine whether patients with L5 sacralization should be radiographically measured with relation to the L5 or S1 vertebrae. Retrospective analysis. Prospective multicenter adult spinal deformity database. ODI, SF36 PCS, radiographic spinopelvic parameters. Linear regression modeling was used to determine normative TPA and PI-LL based on PI and age in a database of asymptomatic subjects. In an adult spinal deformity database, patients with radiographic evidence of L5 sacralization, had PI, LL and TPA measured from the superior endplate S1 and then also from L5. Patients with instrumentation below L4 at baseline were excluded. The differences in TPA and PI-LL from normative were calculated in the sacralization cohort relative to L5 and S1 and correlated to ODI. Patients were grouped based on PI-LL Schwab modifier (0, +, ++) utilizing their L5 PI-LL and S1 PI-LL. Baseline ODI and SF36 PCS were compared across and within groups and their respective SRS Schwab class. Among 1,179 ASD patients, 276 (23.4%) had transitional anatomy, 176 with sacralized L5 (14.9%) and 100 (8.48%) with lumbarization of S1. The 176 with sacralized L5 were analyzed. PI (24.5 ± 11.0 vs 55.7 ± 12.0, p=0.001), TPA (11.2 ± 12.0 vs 20.3 ± 12.5, p=0.001) and PI-LL (0.67 ± 21.1 vs 11.4 ± 20.8, p=0.001) measured utilizing the L5 superior endplate were significantly smaller than those who were measured relative to S1. When measured from S1, 76 (43. %) of patients were SRS Schwab 0, 45 (25.6%) were Class +, and 55 (31.3%) were class ++ compared to 124 (70.5%), 22 (12.5%), and 30 (17.0%) measured from L5 respectively. There were significant differences in ODI and PCS as the Schwab grade increased regardless of L5 or S1 measurement. The L5 group had higher PCS functional scores for Schwab 0 and ++ relative to same grades in the S1 group. Offset from normative TPA (0.5 ± 11.1 vs 9.6 ± 10.8, p=0.001) and PI-LL (0.67 ± 21.1 vs 11.4 ± 20.8, p=0.001) were smaller when measuring from L5. Moreover, S1 measurements were more correlated with disability by ODI (TPA offset from normative, S1: R=0.326 vs L5: R=0.285; PI-LL Offset from normative, S1: R=0.318 vs L5: R=0.274). Measuring the PI at L5 in sacralized anatomy results in underestimating the PILL Schwab grade in a percentage of patients and less correlation with HRQLs. Patients with sacralized L5s should have spinopelvic parameters measured relative to S1. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Malalignment following adult spinal deformity (ASD) surgery can negatively impact clinical outcomes and increase risk of mechanical complications. Despite improved definition of ideal alignment for ASD surgery and increasingly sophisticated preoperative alignment planning tools, it remains unclear whether the preoperative goals for alignment are actually achieved with surgery. The objective of this study was to assess whether preoperative goals for sagittal alignment following ASD surgery are consistently achieved. Multicenter, prospective cohort study. Operatively treatedASD patients. Sagittal vertical axis (SVA), pelvic incidence to lumbar lordosis mismatch (PI-LL), T4-T12 thoracic kyphosis (TK). From 2018-2021, ASD patients were enrolled into a prospective ASD study based on three criteria: deformity severity (PI-LL>25°, TPA>30°, SVA>15cm, TCobb>70° or TLCobb>50°), procedure complexity (>12 levels fused, 3CO or ACR), and/or patient age (>65 and >7 levels fused). The operating surgeon documented sagittal alignment goals prior to surgery, including SVA, PI-LL mismatch and TK. Alignment goals were compared with achieved alignment at 6 weeks postop and the overall mean and SD were calculated for the offset (achieved minus goal) for each measure. Goal alignment was considered attained if the offset was within +/-1 SD of the goal. Demographic, surgical and baseline radiographic measures demonstrating significant association with achieving alignment goal on univariate analysis were used for multivariate regression analysis. The 266 enrolled patients had a mean age of 61.0 yrs (SD=14.6 yrs) and 68% were women. Mean number of instrumented levels was 13.6 (SD=3.8) and 24% had a 3-column osteotomy (3CO). Mean (SD) offsets were: SVA=-8.5 mm (45.6 mm), PI-LL=-4.6° (14.6°), TK=7.2° (14.7°), reflecting a tendency to undercorrect SVA and PI-LL relative to goal and to increase TK relative to goal. Surgeons achieved goal alignment (within 1 SD) for SVA, PI-LL, and TK in 74.4%, 71.4%, and 68.8% of cases, respectively. On regression analysis: goal SVA was more likely to be achieved with lower baseline SVA (OR=0.993, 95%CI=0.988-0.997, p=0.001) and greater baseline TK (OR=1.016, 95%CI=1.002-1.031, p=0.029); goal PI-LL was more likely to be achieved with greater patient age (OR=1.021, 95%CI=1.002-1.039, p=0.026) and history of previous TL spine surgery (OR=2.028, 95% CI=1.136-3.621, p=0.017); and goal TK was more likely to be achieved with lower baseline SVA (OR=0.995, 95%CI=0.991-0.999; p=0.014). The proportions of patients with achieved alignment within 1 SD of goal were not significantly different for patients with a UIV above T7 vs those with a UIV at or below T7 for SVA (p=0.20), PI-LL (p=0.49) or TK (p=0.06). Notably, patient-specific rods were used in 21 patients and were not associated with greater achievement of goal alignment for any parameter (p>0.8), with similar tendencies to undercorrect SVA and PI-LL and increase TK (p>0.6). Surgeons failed to achieve goal alignment of each sagittal parameter in ∼25% of patients operated for ASD, with a tendency to undercorrect SVA and PI-LL and increase TK. Patients at greatest risk tended to be those with more severe baseline deformity. Further advancements are needed to enable more consistent translation of preoperative alignment planning to the operating room. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Identifying the components needed for an optimal adult spinal deformity (ASD) surgical outcome could help inform surgeons and improve ASD treatment. However, defining the components that create an optimal outcome for ASD surgery is challenging because outcome metrics depend on multiple perspectives. A patient may receive a technically successful complication-free surgery but may report dissatisfaction with the treatment outcome. Conversely, a patient may incur multiple postoperative complications with high societal cost but report satisfaction with the surgical outcome. (1) Define an "optimal" ASD surgical outcome by integrating outcome metrics from multiple perspectives, and (2) identify the patient-specific and surgical components of ASD treatment that surgeons can employ to improve ASD surgery by creating a model that predicts a multi-perspective "optimal" surgical outcome. Prospective, multicenter analysis. ASD patients enrolled into a prospective multicenter study. Scoliosis Research Society-22r questionnaire (SRS-22r), Oswestry Disability Index (ODI), postoperative complications. Surgically treated ASD patients prospectively enrolled into a multicenter study from 2009-2018 were assessed at minimum 2-year follow-up for optimal outcome defined as (1) no major postoperative complication or complication requiring surgery, (2) patient reached MCID for ODI and SRS-22r subscore, and (3) patient satisfied and indicates would have the surgery again. Demographic, radiographic, PROM and surgical variables were assessed for associations with optimal outcome. Multivariate regression models were built based on level of upper instrumented vertebra (UIV) to identify variables that created a best fit predictive model for optimal outcome by R2 maximization and AIC/BIC minimization. Of 1291 patients, 788 (mean 3.5 years follow-up), were eligible for study and evaluated. Optimal outcome patients (OP; n=196) had less preoperative opioid use (47.5% vs 56.8%) and fewer histories of prior spine surgery (65.4% vs 77.3%) than nonoptimal outcome (NO; n=592), respectively (p 0.05). Creation of the best fit predictive model for optimal outcome demonstrated synergy between several modifiable variables including preoperative BMI and opioid and tobacco use, final SVA and scoliosis, and use of supplemental rods and PJF prophylaxis. Refining the model for specific surgeries based upon UIV demonstrated increased synergistic impact of the modifiable variables and predictive accuracy (thoracolumbar UIV R2 =0.41; upper thoracic UIV R2 =0.77). No single surgical or radiographic variable is independently predictive of an a priori defined multiperspective optimal outcome following ASD surgery. However, predictive modeling identified preoperative BMI, opioid and tobacco use, final SVA and scoliosis, and use of supplemental rods and PJF prophylaxis as variables surgeons can optimize and/or employ that act synergistically to predict an optimal ASD surgical outcome. Future research will focus on development of predictive models that highlight the synergistic effects of patient specific and interventional variables to improve surgical outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Despite studies reporting the efficacy of BMP to promote surgical spinal fusion, hospital systems and third-party payors continue to deny use of BMP, claiming high cost and lack of long term follow up. Perform a propensity score matched analysis of complications and cost-effectiveness for surgically treated adult spinal deformity (ASD) patients receiving BMP vs no BMP. Prospective, multicenter, propensity score matched analysis. ASD patients enrolled into a prospective multicenter study. Numeric rating scale (NRS) back and leg pain, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), Oswestry Disability Index (ODI), cost of care, cost/QALY, postoperative complications. Surgically treated ASD patients prospectively enrolled into a multicenter study from 2009-2018 were assessed for receiving BMP or NOBMP (iliac crest bone graft and allograft only) at the time of surgery. BMP and NOBMP cohorts were propensity score matched (PSM) for age, BMI, frailty, total levels fused, fusion to the pelvis, osteotomies, interbody fusion and supplemental rod use. Postoperative alignment, complications, rod fractures, patient-reported outcomes (PROMs), cost of care (based on DRG reimbursements adjusted to 2021 US dollars), were evaluated at minimum 3-year follow-up, and cost/QALY calculated at 1-,2-, and minimum 3-year follow-up. Of 888 patients, 483 (mean 4.2 years follow-up, range 2.9 to 8.8) were evaluated. Mean BMP dosage was 27.6 mg total (range 1 to 200), 2.2 mg/level posterior (range 0 to 25) and 1.7 mg/level interbody (range 0 to 18). BMP (n=407) had similar demographics, osteotomies, total and interbody levels fused, preop PROMs, follow-up duration, and pre- and postoperative spinal alignment as NOBMP (n=76; p>0.05). BMP had fewer implant failures (0.17/patient vs 0.33/patient; p 0.05). At last follow-up, BMP had better SF-36 social function (46.7 vs 43.9) and SF-36 mental component scores (51.5. vs 47.8) than NOBMP (p <0.05, respectively). BMP had lower mean total cost of care/patient ($78,679.61 vs $103,388.78) and lower cost/QALY ($22,455.48 vs $32,947.68) at last follow-up vs NOBMP, respectively (p < 0.05). Revision surgery rates were similar for BMP vs NOBMP (0.32 vs 0.42/patient, p=0.11); however, costs of revision surgery were less for BMP ($11,114.33) vs NOBMP ($22,912.53, p <0.05). Propensity score matched analysis demonstrated BMP use in ASD surgery at mean 4-year follow-up was associated with decreased implant fracture rates, lower treatment costs and better cost/QALY than NOBMP. Hospital systems, administrators and third-party payors should consider that the initial cost of BMP use at index surgery may be offset by decreased total cost of care and improve cost/QALY for ASD patients. Bone morphogenetic protein: Investigational. [ABSTRACT FROM AUTHOR]

Evidence on long-term surgical recovery in adult spinal deformity (ASD) patients who are both frail and have an invasive procedure is limited. This study aims to evaluate frail and invasive patients with 5-year recovery kinetics. We hypothesize that patients who are both frail and have invasive surgeries will have adverse postoperative recovery kinetics Retrospective review. A total of 133 ASD patients with complete HRQOL data at preoperative, 1-year, 2-year, 5-year follow-up were included. Integrated Health State Scores (IHS) in Oswestry Disability Index (ODI), Short-form 36 (SF-36) physical (PCS) and mental (MCS) component score, and Scoliosis Research Society (SRS)-22r measures ASD-FI scores were used to stratify non-frail (0.3) patients. ASD-SR scores were used to stratify low invasive (90) surgeries. Using ASD-FI and ASD-SR, patients were separated into four cohorts: non-frail low invasive (NFLI), frail low invasive (FLI), non-frail high invasive (NFHI), and frail high invasive (FHI). HRQOLs at 1 year, 2 years, and 5 years were normalized against preoperative values. AUC was calculated across time points to generate an integrated health state score (IHS). Multivariable linear regression was used to compare IHS scores of FLI, NFHI, and FHI to NFLI while controlling for age, gender, comorbidity, and radiographic alignment. Of 633 eligible ASD patients, 339 had 5-year follow-up. Of those, 125 patients with complete HRQOL data at preoperative, 1-year, 2-year, and 5-year visits were included; 27.2% (34) were NFLI, 20.0% (25) were FLI, 26.4% (33) were NFHI, and 26.4% (33) were FHI. Using NFLI as the referent, FLI and NFHI did not have differences in ODI, MCS, PCS or SRS-22r IHS scores (P >0.05). On multivariable analysis of integrated health scores, FHI had higher MCS (7.6 vs 5.47; P=0.0188), SRS activity (6.97 vs 5.67; P=0.0004), SRS pain (8.49 vs 6.4; P=0.001), SRS appearance (8.97 vs 6.81; P=0.0014), SRS satisfaction (11.71 vs 7.97; P=0.0033), and SRS total (7.49 vs. 6.09; P=0.0002), indicating more improved recovery over a 5-year period. Patients who were FHI had higher rates of complications (P <0.05). Despite having more complications, patients who were frail and underwent more invasive surgeries were more likely to have greater overall improvement in activity, pain, and satisfaction over a 5-year period relative to preoperative baseline. Our results suggest that frailty in combination with invasiveness do not hinder long-term postoperative recovery kinetics, in comparison to frailty or invasiveness alone. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Numerous studies have reported the interplay between spinal deformity and pelvis compensatory mechanisms, but little data exist evaluating the contribution of lower extremity compensation (LE) to maintain upright posture. We hypothesis that hip, knee and ankle compensation is proportional to the severity of the spinal deformity and varies by demographics. Evaluate the association between spinal alignment and lower limbs compensation. Multicenter, prospective cohort. This study included 288 patients treated for complex adult spinal deformity (ASD) with full body images available. Pelvic retroversion (PT), hip extension (SFA), knee flexion (KA), ankle dorsiflexion (AA), pelvic translation (P.Shift) and patient reported outcomes (ODI, PROMIS and SRS-22). Surgical ASD patients were enrolled into a prospective study based on three criteria: deformity severity (PI-LL>25°, TPA>30°, SVA>15cm, TCobb>70° or TLCobb>50°), procedure complexity (>12 levels fused, 3CO or ACR) and/or age (>65 and >7 levels fused). Associations between lower extremity compensation (hip extension, knee flexion, and ankle dorsiflexion) and the magnitude of spinal deformity, patient demographics, patient frailty, and patient-reported outcomes (ODI, SRS, PROMIS-CAT) were assessed via regressions and partial correlations. A total of 288/329 patients met inclusion criteria (60±15yo, 70.5% female), had moderate to severe spinal deformity (PI-LL:15±24, TPA:24±14, SVA:65±69mm, lumbar Cobb:34±24), and reported high pain (PROMIS pain interference; PI=62.7±7.8) and reduced physical function (PROMIS physical function; PF=35.6±7.6). Lower extremity compensation included pelvic retroversion (PT:24.1± 11.8), hip extension (SFA: 203±10.5), knee flexion (KA:5.5± 9.6), ankle dorsiflexion (AA: 5.3±4.5), and posterior pelvic translation (P.Shift: 30±51mm). Overall, lower extremity compensation increased with age (all p <0.001), BMI and frailty (all p <0.001, except SFA). For a similar PT, women had greater hip extension than men (SFA: 206 vs 200, p <0.001), with less KA (3.6 vs. 10.1, p <0.001), AA, and P.Shift. Lower extremity compensation increased with PI (r=0.2-0.45, p <0.001), TPA (r=0.5-0.9, p <0.001) and correlated with PROMS (ODI:0.26 - 0.37, PROMIS PF: -0.28 - -0.39, SRS Acti.: -0.20 - -0.33). When controlling for deformity severity and PI, most associations between lower limbs compensation and PROMS were lost. However, P.Shift and SFA remained weakly correlated with physical scores (ODI and PROMIS PF). The recruitment of LE compensation is overall proportional to the severity of adult spinal deformity, with different patterns observed between men and women. Patients achieved similar PT by recruiting different patterns of LE compensation. Hip extension and posterior pelvic translation are independently associated with impairment in patient-reported outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Background Context: Recombinant human bone morphogenetic protein 2 (rhBMP-2) plays a pivotal role in complex spine surgery. Despite its limited approval, the off-label use of rhBMP-2 is prevalent, particularly in transforaminal lumbar interbody fusions (TLIFs).Purpose: To determine the effectiveness and safety of rhBMP-2 use in TLIF procedures versus autograft.Study Design: Retrospective cohort study.Patient Sample: Patients older than 18 years undergoing spine surgery for lumbar degenerative spine disease at a single academic institution.Outcome Measures: Clinical outcome was determined according to patient records. Radiographic outcome was determined according to plain X-rays and computed tomography (CT).Methods: A retrospective study from 1997 to 2014 was conducted on 191 adults undergoing anterior-posterior instrumented spinal fusion with TLIF at a single academic institution. Patient data were gathered from operative notes, follow-up clinic notes, and imaging studies to determine complications and fusion rates. One hundred eighty-seven patients fit the criteria, which included patients with a minimum of one TLIF, and had a minimum 2-year radiographic and clinical follow-up. Patients were further classified into a BMP group (n=83) or non-BMP group (n=104). Three logistic regression models were run using rhBMP-2 exposure as the independent variable. The respective outcome variables were TLIF-related complications (radiculitis, seroma, osteolysis, and ectopic bone), surgical complications, and all complications.Results: Bone morphogenetic protein (n=83) and non-BMP (n=104) groups had similar baseline demographics (sex, diabetes, pre-existing cancer). On average, the BMP and non-BMP groups were similarly aged (51.9 vs. 47.9 years, p>.05), but the BMP group had a shorter follow-up time (3.03 vs. 4.06 years; p<.001) and fewer smokers (8 vs. 21 patients; p<.048). The fusion rate for the BMP and non-BMP groups was 92.7% and 92.3%, respectively. The pseudoarthrosis rate was 7.5% (14 of 187 patients). Radiculitis was observed in seven patients in the BMP group (8.4%) and two patients in the non-BMP group (1.9%). Seroma was observed in two patients in the BMP group (2.4%) and none in the non-BMP group. No deep infections were observed in the BMP group, and in one patient in the non-BMP group (0.96%). Although patients exposed to BMP were at a significantlygreater risk of developing radiculitis and seroma (odds ratio [OR]=4.53, confidence interval [CI]=1.42-14.5), BMP exposure was not a significant predictor of surgical complications (OR=0.32, CI=0.10-1.00) or overall complications (OR=1.11, CI=0.53-2.34). The outcome of TLIF-related complications was too rare and the confidence interval too wide for practical significance of the first model.Conclusion: Evidence supports the hypothesis that off-label use of rhBMP-2 in TLIF procedures is relatively effective for achieving bone fusion at rates similar to patients receiving autograft. Patients exhibited similar complication rates between the two groups, with the BMP group exhibiting slightly higher rates of radiculitis and seroma. [ABSTRACT FROM AUTHOR]

Tranexamic acid (TXA) is commonly used to lower blood loss in ASD surgery. Despite widespread use of TXA in ASD surgery, there is a lack of consensus regarding the optimal dosing intraoperatively. This study aims to assess differences in blood loss and complications between high-dose, medium-dose, and low-dose TXA regimens. Complex ASD patients who receive high-dose TXA will have decreased blood loss compared to those who receive low-dose TXA. Retrospective Review. A total of 265 ASD patients in a multi-center prospective study were retrospectively analyzed. Blood loss (ml), Major Blood Loss (>90th percentile ml), units transfused intraoperatively, units transfused perioperatively. Patients were separated into three cohorts by TXA regimen: 1) low-dose patients had =20mg/kg loading dose with =2mg/kg/hr maintenance dose 2) medium-dose patients had 20-50 mg/kg loading dose with 2-5 mg/kg/hr maintenance dose. 3) high-dose patients had =50mg/kg loading dose with =5mg/kg/hr maintenance dose. Major or minor blood loss was defined as above or below the 90th percentile of our cohort respectively. Multivariable analysis controlled for levels fused, BMI, platelets, Hgb, OR time, 3CO, and radiographic alignment. Fifty-four (20%) patients received low-dose regimen, 133 (50%) received medium-dose and 80 (30%) received high dose. Mean blood loss was 1,551±1,295 ml, intraoperative units RBCs 1.52±2, and perioperative units RBCs 2.3±2.3. Mean major blood loss was 4,566±1,516ml and minor blood loss 1,236±755ml. Compared to the low-dose group, patients in the high-dose group had 77.8% decreased odds of major blood loss (OR 0.222; P=0.007), decreased blood loss (Coef. -540.92ml; P=0.019), units transfused intraoperatively (Coef. -.739 units; P < 0.001), and units transfused perioperatively (Coef. -0.328 units; P=0.025). Compared to medium-dose group, the high-dose group had less units transfused intraoperatively (Coef. -.59 units; P < 0.001) and perioperatively (Coef. -.42 units; P < 0.001) with no difference in blood loss. There was no difference between the medium and low dose groups in blood loss or units transfused. There was no association between high-dose TXA regimen and increased rates of DVT, PE, or any medical complication before six weeks. No patients had a seizure. In this multicenter prospectively collected database, ASD patients receiving high-dose intraoperative TXA have decreased odds of major blood loss, less RBC transfusions intraoperatively and 540ml less blood loss compared to low dose TXA, without additional risk of seizure or thromboembolic complications. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Adult spinal deformity (ASD) refers to multiple types of spinal deformity. This study used a prospective multicenter database of patients with "complex" surgical ASD to derive a data-driven classification of different deformity patterns, and assessed if such patterns have distinct clinical outcomes. Use an AI-based unsupervised approach to identify patterns of ASD. Retrospective analysis of a multi-center prospective database. A total of 286 patients with complex ASD who underwent surgical correction. Operative decision-making and 30-day adverse events. Complex surgical ASD included severe deformity, surgical complexity or advanced age with a multilevel fusion. An unsupervised cluster analysis that allowed for 10% outliers was used to identify different patterns of deformity. Perioperative outcomes of these clusters were then compared using ANOVA, Kustal-Wallis, and Chi-Squared analyses as indicated, with p-value < 0.05 considered significant. The Hyper-Kyphosis (Hyper TK, n = 31) group had a mean thoracic kyphosis of 82.6±17.6°, lumbar hyperextension (PI-LL: -20.4±14.7°) and relatively straight coronal curvatures. Hyper-Kyphosis patients were the youngest (mean age 48±20 years) and had the lowest disability (mean ODI 32.9±17.1) and pain scores (median NRS back 6 IQR 3 to 8, median NRS leg 1 IQR 0 to 4). The Severe Coronal (Coronal, n = 91) group had a mean thoracic Cobb of 44.7±17.8° and a mean thoraco-lumbar Cobb of 57.9±16.5° with preserved global sagittal alignment. Coronal patients had moderate disability (mean ODI 33.5±18.8), functional impairment (PCD: 34.4±12.3) and pain scores (median NRS back 7 IQR 5 to 8, median NRS leg 4 IQR 0 to 7). The Severe Sagittal (Sev. Sag. n=79) group had a severe spino-pelvic mismatch (42.9±12.9°) and global sagittal deformity (24.3±7.9°). Sev Sag had higher BMIs (28.9±5.9), high levels of disability (mean ODI 49.3±15.6) and low appearance scores (2.3±0.7). Finally, the Moderate Sagittal (Mod. Sag. n=85) group had moderate deformities without distinctive radiographic characteristics, a mean age of 68.8±7.8°, the highest PROMIS pain interference sub-scores (65.2±5.8), high levels of disability (mean ODI 47.6±15.3) and back pain (NRS back 7 IQR 6 to 9), and poor overall quality of life (mean SRS total 2.8±0.6). Thirty-day adverse events were equivalent. Hyper TK and Coronal patients had the longest constructs, but fusion to the pelvis was most common in Mod Sag (89.4%) and Sev Sag (97.5%) deformities. Coronal patients had more osteotomies per case (median 11 IQR 6.5 to 14), longer OR times, and more 30-day implant-related complications (5.5%). Sev Sag and Hyper TK patients were more likely to require a 3-column osteotomy (43% and 32.3%, respectively). Sev Sag deformities were more likely to require interbody implants (29.1%) and operative wound debridement (7.6%). Hyper TK patients had shorter hospital stays. AI methodologies identified 4 distinct patient clusters within a large population of surgically treated ASD patients. Each ASD cluster presented with 1) a unique spinal deformity pattern, 2) reported distinct pathognomonic health deficits, 3) received consistent surgical treatment across 11 centers, and 4) had characteristic perioperative complications and hospital stays. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]