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OBJECTIVE Traditional surgery for adult spinal deformity (ASD) is effective but may result in exposure-related morbidity. Minimally invasive surgery (MIS) can potentially minimize this morbidity; however, high-level evidence is lacking. This study presents the first prospective multicenter investigation of MIS approaches for ASD. METHODS A prospective multicenter study was conducted. Inclusion criteria were age ≥ 18 years, with at least one of the following radiographic criteria: coronal Cobb (CC) angle ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, and thoracic kyphosis > 60°. Additional inclusion criteria were circumferential MIS, including interbody fusion (transforaminal lumbar interbody fusion [TLIF], lateral lumbar interbody fusion [LLIF], or anterior lumbar interbody fusion [ALIF]) with percutaneous posterior fixation on a minimum of 4 intervertebral levels. Radiographic and clinical outcomes (visual analog scale [VAS], Oswestry Disability Index [ODI], and Scoliosis Research Society–22 [SRS-22]) were collected preoperatively and at 12 months postoperatively; preoperative and postoperative values were compared using paired Student t-tests. RESULTS Seventy-five patients with a minimum 1-year follow-up were identified (75 of 111; 67.6%). The mean ± SD age was 68.8 ± 9.0 years, and 48 patients (64%) were female. Patients underwent a mean of 6.7 ± 2.9 levels of fusion with LLIF (85%), ALIF (55%), and TLIF (9%); the mean estimated blood loss was 547.6 ± 567.2 mL, and the mean length of stay was 7.0 ± 3.7 days. Significant improvements were observed in ODI (−19 ± 12.9, p < 0.001), SRS-22 (0.8 ± 0.66, p < 0.001), VAS back (−4.3 ± 2.8, p < 0.001), and VAS leg (−3.0 ± 3.2, p < 0.001) scores. Significant decreases in SVA (−26.4 ± 53.6 mm; p < 0.001), pelvic incidence–lumbar lordosis (−11.3° ± 14.9°, p < 0.001), and CC angle (−12.1° ± 11.8°, p < 0.001) were also observed. Complications occurred in 39 patients (52%); 11 patients (15%) experienced major complications, and 16 patients (21%) required reoperation. CONCLUSIONS MIS approaches for ASD resulted in meaningful symptomatic improvement. The complication rates were similar to historic norms, with a fairly high reoperation rate at 1 year. Longer follow-up will be necessary to evaluate the durability of this approach in the treatment of ASD.

OBJECTIVE Previous studies have demonstrated the short-term radiographic and clinical benefits of circumferential minimally invasive surgery (cMIS) and hybrid (i.e., minimally invasive anterior or lateral interbody fusion with an open posterior approach) techniques to correct adult spinal deformity (ASD). However, it is not known if these benefits are maintained over longer periods of time. This study evaluated the 2- and 3-year outcomes of cMIS and hybrid correction of ASD. METHODS A multicenter database was retrospectively reviewed for patients undergoing cMIS or hybrid surgery for ASD. Patients were ≥ 18 years of age and had one of the following: maximum coronal Cobb angle (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic incidence–lumbar lordosis mismatch (PI-LL) ≥ 10°, or pelvic tilt (PT) > 20°. Radiographic parameters were evaluated at the latest follow-up. Clinical outcomes were compared at 2- and 3-year time points and adjusted for age, preoperative CC, levels operated, levels with interbody fusion, presence of L5–S1 anterior lumbar interbody fusion, and upper and lower instrumented vertebral level. RESULTS Overall, 197 (108 cMIS, 89 hybrid) patients were included with 187 (99 cMIS, 88 hybrid) and 111 (60 cMIS, 51 hybrid) patients evaluated at 2 and 3 years, respectively. The mean (± SD) follow-up duration for cMIS (39.0 ± 13.3 months, range 22–74 months) and hybrid correction (39.9 ± 16.8 months, range 22–94 months) were similar for both cohorts. Hybrid procedures corrected the CC greater than the cMIS technique (adjusted p = 0.022). There were no significant differences in postoperative SVA, PI-LL, PT, and sacral slope (SS). At 2 years, cMIS had lower Oswestry Disability Index (ODI) scores (adjusted p < 0.001), greater ODI change as a percentage of baseline (adjusted p = 0.006), less visual analog scale (VAS) back pain (adjusted p = 0.006), and greater VAS back pain change as a percentage of baseline (adjusted p = 0.001) compared to hybrid techniques. These differences were no longer significant at 3 years. At 3 years, but not 2 years, VAS leg pain was lower for cMIS compared to hybrid techniques (adjusted p = 0.032). Those undergoing cMIS had fewer overall complications compared to hybrid techniques (adjusted p = 0.006), but a higher odds of pseudarthrosis (adjusted p = 0.039). CONCLUSIONS In this review of a multicenter database for patients undergoing cMIS and hybrid surgery for ASD, hybrid procedures were associated with a greater CC improvement compared to cMIS techniques. cMIS was associated with superior ODI and back pain at 2 years, but this difference was no longer evident at 3 years. However, cMIS was associated with superior leg pain at 3 years. There were fewer complications following cMIS, with the exception of pseudarthrosis.

Spinopelvic parameters have hitherto dictated much of adult spinal deformity (ASD) correction. The Roussouly classification is used for the normal adult spine. We evaluated whether a correlation would be found between the Roussouly type and the rate of revision surgery in patients with ASD undergoing circumferential minimally invasive spinal (cMIS) correction.A multicenter retrospective review of patients who had undergone cMIS surgery for ASD was performed. The inclusion criteria were age ≥18 years and 1 of the following: coronal Cobb angle20°, sagittal vertical axis5 cm, pelvic tilt20°, pelvic incidence (PI) to lumbar lordosis (LL) mismatch10°, cMIS surgery, and a minimum of 2 years of follow-up data available. The patients were classified by Roussouly type, and the clinical and radiographic outcomes were evaluated.A total of 104 patients were included in the present analysis. Of the 104 patients, 41 had Roussouly type 1, 32 had type 2, 23 had type 3, and 8 had type 4. Preoperatively, the patients with type 4 had the highest PI (P = 0.002) and LL (P0.001). Postoperatively, the PI-LL mismatch, Cobb angle, and sagittal vertical axis were not different among the 4 groups. However, the patients with type 2 had had the highest rate of complications (type 1, 29.3%; type 2, 61.3%; type 3, 34.8%; type 4, 25.0%; P = 0.031). The reoperation rates were comparable (type 1, 19.5%; type 2, 38.7%; type 3, 13.0%; type 4, 12.5%; P = 0.097). The reoperation rates for adjacent segment degeneration or proximal junctional kyphosis were also comparable (P = 0.204 and P = 0.060, respectively).We did not find a clear correlation between Roussouly type and the rate of revision surgery for adjacent segment disease or proximal junctional kyphosis in patients who had undergone cMIS surgery for ASD.

Background The decision upper-most instrumented vertebrae (UIV) in a multi-level fusion procedure can dramatically influence outcomes of corrective spine surgery. We aimed to create an algorithm for selection of UIV based on surgeon selection/reasoning of sample cases. Methods The clinical/imaging data for 11 adult spinal deformity (ASD) patients were presented to 14 spine deformity surgeons who selected the UIV and provided reasons for avoidance of adjacent levels. The UIV chosen was grouped into either upper thoracic (UT, T1-T6), lower thoracic (LT, T7-T12), lumbar or cervical. Disagreement between surgeons was defined as ≥3 not agreeing. We performed a descriptive analysis of responses and created an algorithm for choosing UIV then applied this to a large database of ASD patients. Results Surgeons agreed in 8/11 cases on regional choice of UIV. T10 was the most common UIV in the LT region (58%) and T3 was the most common UIV in the UT region (44%). The most common determinant of UIV in the UT region was proximal thoracic kyphosis and presence of coronal deformity. The most common determinant of UIV in the LT region was small proximal thoracic kyphosis. Within the ASD database (236 patients), when the algorithm called for UT fusion, patients fused to TL region were more likely to develop proximal junctional kyphosis (PJK) at 1 year post-operatively (76.9% vs. 38.9%, P=0.025). Conclusions Our algorithm for selection of UIV emphasizes the role of proximal and regional thoracic kyphosis. Failure to follow this consensus for UT fusion was associated with twice the rate of PJK.

STUDY DESIGN A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study. OBJECTIVE Establish the short and long-term safety and effectiveness of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care. SUMMARY OF BACKGROUND DATA Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay. METHODS One hundred two subjects were enrolled across 10 sites. Ninety nine subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion. RESULTS Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up. Mean VAS-LBP change from baseline to 6-weeks post-op (-46 mm) continued to improve through 12 months (-51 mm). Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (-17) was almost doubled by 12 months (-32). Fusion rates at 12-months are high (98%). No device-related serious adverse events have occurred. CONCLUSION 12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.Level of Evidence: 3.

BACKGROUND: Adjacent segment pathology (ASP) following cervical disc arthroplasty (CDA) or anterior cervical discectomy and fusion (ACDF) is identified by imaging (RASP) or clinical symptoms (CASP). Clinical symptoms of CASP have been broadly defined, but subsequent adjacent-level surgeries are clear indicators of CASP. Current literature remains inconsistent in the incidence and potential predictors of CASP. Here, we will evaluate a robust data set for the incidence of CASP resulting in subsequent surgery, attempt to identify factors that might affect CASP, and analyze the association of CASP with patient-reported outcomes (PROS) and RASP. METHODS: Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C, Zimmer Biomet, Westminster, CO) with ACDF. CASP was defined as any adjacent-level subsequent surgical intervention. Post hoc analyses were conducted on the incidence, time to CASP diagnosis, and relationship of CASP with patient demographics. Longitudinal retrospective case-control analysis was used to assess the correlation of CASP to PROs and radiographic adjacent segment pathology (RASP). RESULTS: Kaplan-Meier estimates indicated significantly lower probability of CASP over time for 1-level (P = .002) and 2-level (P = .008) CDA patients. Treatment with ACDF and younger age were associated with higher CASP risk. CDA was more effective than ACDF (70.5%; 95% CI = 45.1, 84.2; P < .0001) at preventing CASP. Case-control analysis indicated increased probability of CASP for patients with grade 3/4 RASP, but the difference was not statistically significant. When we pooled CASP patients, the median grade of RASP at the visit prior to surgery was 1, with only 6 patients presenting with grade 3/4 RASP. CONCLUSIONS: Patients treated with CDA have a lower incidence of CASP than do patients treated with ACDF, although the mechanism remains unclear. CASP and RASP remain uncorrelated in this large data set, but other predictive variables such as treatment, age, and number of levels should be further investigated.

Background It is well known that clinical improvements following surgical intervention are variable. While all surgeons strive to maximize reliability and degree of improvement, certain patients will fail to achieve meaningful gains. We aim to analyze patients who failed to reach minimal clinically important difference (MCID) in an effort to improve outcomes for minimally invasive deformity surgery. Methods Data were collected on a multicenter registry of minimally invasive surgery adult spinal deformity surgeries. Patient inclusion criteria were age ≥18 years, coronal Cobb ≥20 degrees, pelvic incidence-lumbar lordosis ≥10 degrees, or a sagittal vertical axis >5 cm. All patients had minimum 2 years' follow-up (N = 222). MCID was defined as 12.8 or more points of improvement in the Oswestry Disability Index. Up to 2 different etiologies for failure were allowed per patient. Results We identified 78 cases (35%) where the patient failed to achieve MCID at long-term follow-up. A total of 82 identifiable causes were seen in these patients with 14 patients having multiple causes. In 6 patients, the etiology was unclear. The causes were subclassified as neurologic, medical, structural, under treatment, degenerative progression, traumatic, idiopathic, and floor effects. In 71% of cases, an identifiable cause was related to the spine, whereas in 35% the cause was not related to the spine. Conclusions Definable causes of failed MIS ASD surgery are often identifiable and similar to open surgery. In some cases the cause is treatable and structural. However, it is also common to see failure due to pathologies unrelated to the index surgery.

Little information exists regarding longer-term outcomes with minimally invasive spine surgery (MISS), particularly regarding long-segment and deformity procedures. We aimed to evaluate intermediate-term outcomes of MISS for adult spinal deformity (ASD). This retrospective review of a prospectively collected multicenter database examined outcomes at 4 or more years following circumferential MIS (cMIS) or hybrid (HYB) surgery for ASD. A total of 53 patients at 8 academic centers satisfied the following inclusion criteria: age > 18 years and coronal Cobb > 20°, pelvic incidence-lumbar lordosis (PI-LL) > 10°, or sagittal vertical axis (SVA) > 5 cm. Radiographic outcomes demonstrated improvements of PI-LL from 16.8° preoperatively to 10.8° and coronal Cobb angle from 38° preoperatively to 18.2° at 4 years. The incidence of complications over the follow-up period was 56.6%. A total of 21 (39.6%) patients underwent reoperation in the thoracolumbar spine, most commonly for adjacent level disease or proximal junctional kyphosis, which occurred in 11 (20.8%) patients. Mean Oswestry Disability Index (ODI) at baseline and years 1 through 4 were 49.9, 33.1, 30.2, 32.7, and 35.0, respectively. The percentage of patients meeting minimal clinically important difference (MCID) (defined as 12% or more from baseline) decreased over time, with leg pain reduction more durable than back pain reduction. Intermediate-term clinical and radiographic improvement following MISS for ASD is sustained, but extent of improvement lessens over time. Outcome variability exists within a subset of patients not meeting MCID, which increases over time after year two. Loss of improvement over time was more notable in back than leg pain. However, average ODI improvement meets MCID at 4 years after MIS ASD surgery.

OBJECTIVEMinimally invasive surgery (MIS) can be used as an alternative or adjunct to traditional open techniques for the treatment of patients with adult spinal deformity. Recent advances in MIS techniques, including advanced anterior approaches, have increased the range of candidates for MIS deformity surgery. The minimally invasive spinal deformity surgery (MISDEF2) algorithm was created to provide an updated framework for decision-making when considering MIS techniques in correction of adult spinal deformity.METHODSA modified algorithm was developed that incorporates a patient’s preoperative radiographic parameters and leads to one of 4 general plans ranging from basic to advanced MIS techniques to open deformity surgery with osteotomies. The authors surveyed 14 fellowship-trained spine surgeons experienced with spinal deformity surgery to validate the algorithm using a set of 24 cases to establish interobserver reliability. They then re-surveyed the same surgeons 2 months later with the same cases presented in a different sequence to establish intraobserver reliability. Responses were collected and analyzed. Correlation values were determined using SPSS software.RESULTSOver a 3-month period, 14 fellowship-trained deformity surgeons completed the surveys. Responses for MISDEF2 algorithm case review demonstrated an interobserver kappa of 0.85 for the first round of surveys and an interobserver kappa of 0.82 for the second round of surveys, consistent with substantial agreement. In at least 7 cases, there was perfect agreement between the reviewing surgeons. The mean intraobserver kappa for the 2 surveys was 0.8.CONCLUSIONSThe MISDEF2 algorithm was found to have substantial inter- and intraobserver agreement. The MISDEF2 algorithm incorporates recent advances in MIS surgery. The use of the MISDEF2 algorithm provides reliable guidance for surgeons who are considering either an MIS or an open approach for the treatment of patients with adult spinal deformity.

OBJECTIVEThe past decade has seen major advances in techniques for treating more complex spinal disorders using minimally invasive surgery (MIS). While appealing from the standpoint of patient perioperative outcomes, a major impediment to adoption has been the significant learning curve in utilizing MIS techniques.METHODSData were retrospectively analyzed from a multicenter series of adult spinal deformity surgeries treated at eight tertiary spine care centers in the period from 2008 to 2015. All patients had undergone a less invasive or hybrid approach for a deformity correction satisfying the following inclusion criteria at baseline: coronal Cobb angle ≥ 20°, sagittal vertical axis (SVA) > 5 cm, or pelvic tilt > 20°. Analyzed data included baseline demographic details, severity of deformity, surgical metrics, clinical outcomes (numeric rating scale [NRS] score and Oswestry Disability Index [ODI]), radiographic outcomes, and complications. A minimum follow-up of 2 years was required for study inclusion.RESULTSAcross the 8-year study period, among 222 patients, there was a trend toward treating increasingly morbid patients, with the mean age increasing from 50.7 to 62.4 years (p = 0.013) and the BMI increasing from 25.5 to 31.4 kg/m2 (p = 0.12). There was no statistical difference in the severity of coronal and sagittal deformity treated over the study period. With regard to radiographic changes following surgery, there was an increasing emphasis on sagittal correction and, conversely, less coronal correction. There was no statistically significant difference in clinical outcomes over the 8-year period, and meaningful improvements were seen in all years (ODI range of improvement: 15.0–26.9). Neither were there statistically significant differences in major complications; however, minor complications were seen less often as the surgeons gained experience (p = 0.064). Operative time was decreased on average by 47% over the 8-year period.Trends in surgical practice were seen as well. Total fusion construct length was unchanged until the last year when there was a marked decrease in conjunction with a decrease in interbody levels treated (p = 0.004) while obtaining a higher degree of sagittal correction, suggesting more selective but powerful interbody reduction methods as reflected by an increase in the lateral and anterior column resection techniques being utilized.CONCLUSIONSThe use of minimally invasive methods for adult spinal deformity surgery has evolved over the past decade. Experienced surgeons are treating older and more morbid patients with similar outcomes. A reliance on selective, more powerful interbody approaches is increasing as well.

Cervical total disc replacement devices have been marketed in the United States (US) since 2007, with abundant level 1 evidence published on the treatment. Adherence to the strict inclusion/exclusion criteria and the surgical technique training of the US clinical trials remains the consistent and conservative approach to patient selection and implantation technique. However, patient selection and surgical technique remain debated among US surgeons as the published data and available cervical total disc replacements continue to grow.

To compare circumferential minimally invasive (cMIS) versus open surgeries for mild-to-moderate adult spinal deformity (ASD) with regard to intensive care unit (ICU) and hospital lengths of stay (LOS).A retrospective review of 2 multicenter ASD databases with 426 ASD (sagittal vertical axis6 cm) surgery patients with 4 or more fusion levels and 2-year follow-up was conducted. ICU stay, LOS, and estimated blood loss (EBL) were compared between open and cMIS surgeries.Propensity matching resulted in 88 patients (44 cMIS, 44 open). cMIS were older (61 vs. 53 years, P = 0.005). Mean levels fused were 6.5 in cMIS and 7.1 in open (P = 0.368). Preoperative lordosis was higher in open than in cMIS (42.7° vs. 40.9°, P = 0.016), and preoperative visual analog score back pain was greater in open than in cMIS (7 vs. 6.2, P = 0.033). Preoperative and postoperative spinopelvic parameters and coronal Cobb angles were not different. EBL was 534 cc in cMIS and 1211 cc in open (P 0.001). Transfusions were less in cMIS (27.3% vs. 70.5%, P0.001). ICU stay was 0.6 days for cMIS and 1.2 days for open (P = 0.009). Hospital LOS was 7.9 days for cMIS versus 9.6 for open (P = 0.804).For patients with mild-to-moderate ASD, cMIS surgery had a significantly lower EBL and shorter ICU stay. Major and minor complication rates were lower in cMIS patients than open patients. Overall LOS was shorter in cMIS patients, but did not reach statistical significance.

BACKGROUND Proximal junctional kyphosis (PJK) is a common radiographic complication of adult spinal deformity (ASD) corrective surgery. Although previous literature has reported a 5 to 61% incidence of PJK, these studies are limited by small sample sizes and short-term follow-up. OBJECTIVE To assess the incidence of PJK utilizing a high-powered ASD database. METHODS Retrospective review of a prospective multicenter ASD database. Operative ASD patients > 18 yr old from 2009 to 2017 were included. PJK was defined as ≥ 10° for the sagittal Cobb angle between the inferior upper instrumented vertebra (UIV) endplate and the superior endplate of the UIV + 2. Chi-square analysis and post hoc testing assessed annual and overall incidence of acute (6-wk follow-up [f/u]), progressive (increase in degree of PJK from 6 wk to 1 yr), and delayed (1-yr, 2-yr, and 3-yr f/u) PJK development. RESULTS A total of 1005 patients were included (age: 59.3; 73.5% F; body mass index: 27.99). Overall PJK incidence was 69.4%. Overall incidence of acute PJK was 48.0%. Annual incidence of acute PJK has decreased from 53.7% in 2012 to 31.6% in 2017 (P = .038). Overall incidence of progressive PJK was 35.0%, with stable rates observed from 2009 to 2016 (P = .297). Overall incidence of 1-yr-delayed PJK was 9.3%. Annual incidence of 1-yr-delayed PJK has decreased from 9.2% in 2009 to 3.2% in 2016 (P

Cervical disc arthroplasty (CDA) has become an acceptable alternative for anterior cervical discectomy and fusion (ACDF) for a significant patient population with cervical radiculopathy and/or myelopathy secondary to degenerative changes in the cervical spine. There are sufficient mid- and long-term data supporting performance and safety of one-level CDA. With the success of single-level cervical CDA, considerable interest exists about CDA use for multilevel cervical degenerative disc disease (DDD). This review analyzes the safety and efficacy of two-level CDA for treatment of symptomatic cervical DDD with focus on the Mobi-C® Cervical Disc.This review summarizes previously published articles in a literature search using keywords: 'two-level-anterior cervical arthrodesis; two-level anterior cervical decompression and fusion (ACDF); two-level cervical disc arthroplasty (CDA); two-level cervical total disc replacement; two-level symptomatic degenerative disc disease (DDD); Mobi-C® disc'.Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.

BACKGROUND CONTEXT Concerns exist regarding disease transmission and cost associated with postoperative nonroutine discharge. Few data exist evaluating impact of nonroutine vs home discharge on readmissions, complications and patient reported outcome measures (PROMs) for adult spinal deformity (ASD) surgery. PURPOSE Evaluate 30-day readmissions, 90-day return to surgery, postoperative complications, and postoperative PROMs for matched ASD patients receiving nonroutine discharge vs home discharge following surgery. STUDY DESIGN/SETTING Propensity score matched (PSM) analysis of ASD patients prospectively enrolled into a multicenter study. PATIENT SAMPLE Surgically treated ASD patients prospectively enrolled into multicenter study. OUTCOME MEASURES 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), duration of hospital stay, 30-day readmission, 90-day return to surgery, postoperative complications. METHODS Surgically treated ASD patients prospectively enrolled in a multicenter ASD study were divided into two discharge disposition groups, nonroutine (NON) and home (HOME). NON was further divided into acute rehab (REHAB) or skilled nursing facility (SNF) discharge. Study inclusion criteria; (1) surgery ≥5 levels fused, (2) ≥2-year follow-up. PSM was used to match NON vs HOME for age, frailty and total levels fused. 30-day hospital readmission, 90-day return to surgery, postoperative complications, one and minimum 2 year PROM data was compared for NON vs HOME, and REHAB vs SNF vs HOME. RESULTS From 2015 to 2019, 241 of 374 eligible treated patients were evaluated and 158 included in this study after PSM (mean 2.7 year follow-up). NON (n=106) and HOME (n=52) had similar age (67.6 vs 67.6 years), ASD-frailty index (3.9 vs 3.9), levels fused at surgery (13.8 vs 13.7), and preop PROMs, respectively (p>0.05). Duration of hospital stay (9.7 vs 10.4 days), 30-day readmission (6.6% vs 6.6%), 90-day return to surgery (9.4% vs10.4%), total complications/patient (2.0 vs 1.5), major complications/patient (0.8 vs 0.5), were similar NON vs HOME, respectively (p>0.05). At last follow-up, HOME demonstrated better ODI (21.6 vs 28.2), SRS-total (3.8 vs 3.5), and SRS-activity (3.7 vs 3.3) than NON, respectively (p 0.05) and improved PROMs for HOME vs REHAB and SNF (p CONCLUSIONS Analysis of 158 operatively treated ASD patients prospectively enrolled into a multicenter study and matched for age, frailty, and surgery performed demonstrated that postoperative discharge to skilled nursing or acute rehab facilities did not reduce 30-day readmissions, 90-day return to surgery, or postoperative complications. At one and minimum two years postop, patients discharged home had better PROMs scores than nonroutine discharge. These data should be considered in conjunction with postoperative needs and the cost and disease transmission risks for nonroutine discharge. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Evidence suggests that increasing age raises the risk for higher complications with traditional open deformity surgery. The decreased exposure related morbidity associated with minimally invasive surgery (MIS) has the potential to lower the complication profile in older surgical patients. PURPOSE To evaluate the impact of age on complications and reoperations. STUDY DESIGN/SETTING Prospective outcomes registry. PATIENT SAMPLE A total of 142 patients. OUTCOME MEASURES Complications and reoperations. METHODS Inclusion criteria included age ≥ 18 years, and at least one of the following criteria: coronal curve (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. Complications (major/minor) and reoperations were collected. A total of 142 patients who underwent circumferential MIS surgery were divided into younger (≤65 yrs, N=45) and older (>65 yrs, N=97) groups. Chi-square and t-test analyses were performed. RESULTS Mean age was 57 years (SD±10) in the younger and 73.7yrs (SD±4.8) in the older groups (p CONCLUSIONS Despite significantly more comorbidities, total complications were not higher in elderly patients undergoing MIS surgery. However, elderly patients were found to have a higher reoperation rate, with PJK and instrumentation failure/mal-positioning being the most frequent reasons. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. PEEK is used increasingly for spinal implants due to its mechanical properties and lack of artifact on imaging. A cervical TDR was designed with commercially pure titanium-coated PEEK endplates and a biconvex zirconia toughened alumina ceramic core. PURPOSE The purpose of this study was to compare this PEEK-on-ceramic TDR to anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. STUDY DESIGN/SETTING This was a prospective, nonrandomized, multicenter Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial comparing the investigational group to a propensity-matched historic control group. PATIENT SAMPLE Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n=150 patients from 16 sites). The historic control group included 117 propensity-matched ACDF patients from an earlier cervical TDR IDE trial employing the same inclusion/exclusion criteria. All patients were treated for single-level symptomatic cervical disc degeneration. OUTCOME MEASURES The primary outcome was a composite 5-point success classification at 24-month follow-up requiring: >15 point (of 100) improvement in Neck Disability Index (NDI) score; 2) maintenance/improvement in neurologic status; 3) no device failure; 4) no reoperation/revision/removal and/or supplemental fixation at the index level, and 5) no major adverse events. Outcome measures included NDI, visual analog scale (VAS) assessing neck and arm pain, neurological status, adverse events and subsequent surgery. Radiographic assessment included flexion/extension range of motion. Facet joints were assessed at 24 months comparing pre- to postoperative MRI images using a published 4-point scale. METHODS Evaluations were performed preoperatively and postoperatively within 2 and 6 weeks, and 3, 6, 12 and 24 months. The control was propensity match with ACDF patients from an earlier TDR vs ACDF trial, which used the same inclusion criteria and primary outcome assessments. RESULTS The overall composite success rate was significantly greater in the TDR group vs ACDF (93.0% vs 73.6%; p CONCLUSIONS The results of this study found that the Simplify® Cervical Artificial Disc produced outcomes similar or superior on some measures, including superiority in the composite success classification, compared with ACDF, for the treatment of single-level symptomatic cervical disc degeneration. ROM at the treated level increased from the preoperative value and was maintained throughout follow-up. Safety of the PEEK-on-ceramic disc was established with no device failures in the series. These results support that the device is a viable alternative to ACDF. FDA DEVICE/DRUG STATUS Simplify Cervical Disc Replacement (Approved for this indication)

Background: Patient selection for cervical disc arthroplasty (CDA) in the United States remains a topic of debate among surgeons. Many surgeons base US patient selection for CDA implantation on the Food and Drug Administration (FDA) indications/contraindications. While off-label use does occur, the frequency and extent of off-label use in the US remains largely unknown. Outside the United States, patient selection is notably less stringent; however such data also remain largely unpublished or presented/published with a low level of evidence. Here, we will review the current approved US on-label patient selection criteria for CDA and discuss the rationale and supporting evidence to expand these criteria in the United States. Methods: A PubMed literature search was completed using the keywords “cervical disc arthroplasty” and “cervical disc replacement.” The articles were evaluated by the authors for patient selection criteria. Conclusions: The current published data do not conclusively prove that the patients excluded from CDA by strict adherence to FDA indications would benefit from CDA surgery over anterior cervical discectomy and fusion. As surgeons, it is a difficult decision regarding when to expand indications to include off-label use of CDA. In our practice, generally CDA patient selection agrees with the FDA indications and contraindications, as there is a lack of level 1 evidence to confirm effectiveness of CDA outside of the current FDA indications. We will likely need more well-constructed studies to include prospective and controlled trials that specifically evaluate the “off-label” applications before US surgeons are convinced to expand indications and insurance companies agree to reimburse.

OBJECTIVE Minimally invasive surgery (MIS) for spinal deformity uses interbody techniques for correction, indirect decompression, and arthrodesis. Selection criteria for choosing a particular interbody approach are lacking. The authors created the minimally invasive interbody selection algorithm (MIISA) to provide a framework for rational decision-making in MIS for deformity. METHODS A retrospective data set of circumferential MIS (cMIS) for adult spinal deformity (ASD) collected over a 5-year period was analyzed by level in the lumbar spine to identify surgeon preferences and evaluate segmental lordosis outcomes. These data were used to inform a Delphi session of minimally invasive deformity surgeons from which the algorithm was created. The algorithm leads to 1 of 4 interbody approaches: anterior lumbar interbody fusion (ALIF), anterior column release (ACR), lateral lumbar interbody fusion (LLIF), and transforaminal lumbar interbody fusion (TLIF). Preoperative and 2-year postoperative radiographic parameters and clinical outcomes were compared. RESULTS Eleven surgeons completed 100 cMISs for ASD with 338 interbody devices, with a minimum 2-year follow-up. The type of interbody approach used at each level from L1 to S1 was recorded. The MIISA was then created with substantial agreement. The surgeons generally preferred LLIF for L1–2 (91.7%), L2–3 (85.2%), and L3–4 (80.7%). ACR was most commonly performed at L3–4 (8.4%) and L2–3 (6.2%). At L4–5, LLIF (69.5%), TLIF (15.9%), and ALIF (9.8%) were most commonly utilized. TLIF and ALIF were the most selected approaches at L5–S1 (61.4% and 38.6%, respectively). Segmental lordosis at each level varied based on the approach, with greater increases reported using ALIF, especially at L4–5 (9.2°) and L5–S1 (5.3°). A substantial increase in lordosis was achieved with ACR at L2–3 (10.9°) and L3–4 (10.4°). Lateral interbody arthrodesis without the use of an ACR did not generally result in significant lordosis restoration. There were statistically significant improvements in lumbar lordosis (LL), pelvic incidence–LL mismatch, coronal Cobb angle, and Oswestry Disability Index at the 2-year follow-up. CONCLUSIONS The use of the MIISA provides consistent guidance for surgeons who plan to perform MIS for deformity. For L1–4, the surgeons preferred lateral approaches to TLIF and reserved ACR for patients who needed the greatest increase in segmental lordosis. For L4–5, the surgeons’ order of preference was LLIF, TLIF, and ALIF, but TLIF failed to demonstrate any significant lordosis restoration. At L5–S1, the surgical team typically preferred an ALIF when segmental lordosis was desired and preferred a TLIF if preoperative segmental lordosis was adequate.

OBJECTIVESurgical decision-making and planning is a key factor in optimizing outcomes in adult spinal deformity (ASD). Minimally invasive spinal (MIS) strategies for ASD have been increasingly used as an option to decrease postoperative morbidity. This study analyzes factors involved in the selection of either a traditional open approach or a minimally invasive approach to treat ASD in a prospective, nonrandomized multicenter trial. All centers had at least 5 years of experience in minimally invasive techniques for ASD.METHODSThe study enrolled 268 patients, of whom 120 underwent open surgery and 148 underwent MIS surgery. Inclusion criteria included age ≥ 18 years, and at least one of the following criteria: coronal curve (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. Surgical approach selection was made at the discretion of the operating surgeon. Preoperative significant differences were included in a multivariate logistic regression analysis to determine odds ratios (ORs) for approach selection.RESULTSSignificant preoperative differences (p < 0.05) between open and MIS groups were noted for age (61.9 vs 66.7 years), numerical rating scale (NRS) back pain score (7.8 vs 7), CC (36° vs 26.1°), PT (26.4° vs 23°), T1 pelvic angle (TPA; 25.8° vs 21.7°), and pelvic incidence–lumbar lordosis (PI-LL; 19.6° vs 14.9°). No significant differences in BMI (29 vs 28.5 kg/m2), NRS leg pain score (5.2 vs 5.7), Oswestry Disability Index (48.4 vs 47.2), Scoliosis Research Society 22-item questionnaire score (2.7 vs 2.8), PI (58.3° vs 57.1°), LL (38.9° vs 42.3°), or SVA (73.8 mm vs 60.3 mm) were found. Multivariate analysis found that age (OR 1.05, p = 0.002), VAS back pain score (OR 1.21, p = 0.016), CC (OR 1.03, p < 0.001), decompression (OR 4.35, p < 0.001), and TPA (OR 1.09, p = 0.023) were significant factors in approach selection.CONCLUSIONSIncreasing age was the primary driver for selecting MIS surgery. Conversely, increasingly severe deformities and the need for open decompression were the main factors influencing the selection of traditional open surgery. As experience with MIS surgery continues to accumulate, future longitudinal evaluation will reveal if more experience, use of specialized treatment algorithms, refinement of techniques, and technology will expand surgeon adoption of MIS techniques for adult spinal deformity.

Study Design: Retrospective, multicenter review of adult scoliosis patients with minimum 2-year follow-up. Objective: Because the fractional curve (FC) of adult scoliosis can cause radiculopathy, we evaluated patients treated with either circumferential minimally invasive surgery (cMIS) or open surgery. Methods: A multicenter retrospective adult deformity review was performed. Patients included: age >18 years with FC >10°, ≥3 levels of instrumentation, 2-year follow-up, and one of the following: coronal Cobb angle (CCA) > 20°, pelvic incidence and lumbar lordosis (PI-LL) > 10°, pelvic tilt (PT) > 20°, and sagittal vertical axis (SVA) > 5 cm. Results: The FC was treated in 118 patients, 79 open and 39 cMIS. The FCs had similar coronal Cobb angles preoperative (17° cMIS, 19.6° open) and postoperative (7° cMIS, 8.1° open), but open had more levels treated (12.1 vs 5.7). cMIS patients had greater reduction in VAS leg (6.4 to 1.8) than open (4.3 to 2.5). With propensity matching 40 patients for levels treated (cMIS: 6.6 levels, N = 20; open: 7.3 levels, N = 20), both groups had similar FC correction (18° in both preoperative, 6.9° in cMIS and 8.5° postoperative). Open had more posterior decompressions (80% vs 22.2%, P < .001). Both groups had similar preoperative (Visual Analogue Scale [VAS] leg 6.1 cMIS and 5.4 open) and postoperative (VAS leg 1.6 cMIS and 3.1 open) leg pain. All cMIS patients had interbody grafts; 35% of open did. There was no difference in change of primary CCA, PI-LL, LL, Oswestry Disability Index, or VAS Back. Conclusion: Patients’ FCs treated with cMIS had comparable reduction of leg pain compared with those treated with open surgery, despite significantly fewer cMIS patients undergoing direct decompression.

Study Design: A multicenter retrospective review of an adult spinal deformity database. Objective: We aimed to characterize reoperation rates and etiologies of adult spinal deformity surgery with circumferential minimally invasive surgery (cMIS) and hybrid (HYB) techniques. Methods: Inclusion criteria were age ≥18 years, and one of the following: coronal Cobb >20°, sagittal vertical axis >5 cm, pelvic tilt >20°, and pelvic incidence-lumbar lordosis >10°. Patients with either cMIS or HYB surgery, ≥3 spinal levels treated with 2-year minimum follow-up were included. Results: A total of 133 patients met inclusion for this study (65 HYB and 68 cMIS). Junctional failure (13.8%) was the most common reason for reoperation in the HYB group, while fixation failure was the most common reason in the cMIS group (14.7%). There was a higher incidence of proximal junctional failure (PJF) than distal junctional failure (DJF) within HYB (12.3% vs 3.1%), but no significant differences in PJF or DJF rates when compared to cMIS. Early (30 days) reoperations (cMIS = 26.5%; HYB = 27.7%), but early reoperations were more common in the HYB group after propensity matching, largely due to infection rates (10.8% vs 0%, P = .04). Conclusions: Adult spinal deformity correction with cMIS and HYB techniques result in overall reoperation rates of 27.9% and 33.8%, respectively, at minimum 2-year follow-up. Junctional failures are more common after HYB approaches, while pseudarthrosis/fixation failures happen more often with cMIS techniques. Early reoperations were less common than later returns to the operating room in both groups, but cMIS demonstrated less risk of infection and early reoperation when compared with the HYB group.

OBJECTIVESeven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up.METHODSAn FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR.RESULTSA total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring.CONCLUSIONSCervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy.Clinical trial registration no.: NCT00374413 (clinicaltrials.gov)

Cervical disc arthroplasty (CDA) was developed as an alternative for anterior cervical discectomy and fusion (ACDF) for nerve root decompression. The rationale behind CDA was to help prevent adjacent segment degeneration which potentially may lead to additional surgery. Multiple randomized controlled trials have evaluated a myriad of disc arthroplasty devices over the past 10 years and provided data regarding clinical benefits and safety. Their long-term data, reporting results at 5-10 years, presents the opportunity to comment on the overall efficacy, safety and reported complications of these devices. This report reviews results of the Prestige, proDisc-C, Mobi-C Disc and various other arthroplasty devices and provides an overall report of the longest term available data and comparisons between devices.This review summarizes previously published articles in a literature search using keywords: 'cervical disc arthroplasty', 'cervical total disc replacement', 'anterior cervical decompression and fusion', 'anterior cervical arthrodesis', 'symptomatic degenerative disc disease' and commercial names of devices.CDA, with the devices reviewed, resulted in favorable outcomes in comparison to ACDF for the treatment of symptomatic cervical degenerative disc disease (DDD) taking in to account the long-term functional recovery, adverse events, development of adjacent segment degeneration and subsequent surgical interventions.

Background Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. Objective To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. Methods This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. Results At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. Conclusion Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

BACKGROUND Pelvic tilt (PT) is a compensatory mechanism for adult spinal deformity patients to mitigate sagittal imbalance. The association between preop PT and postop clinical and radiographic outcomes has not been well studied in patients undergoing minimally invasive adult deformity surgery. OBJECTIVE To evaluate clinical and radiographic outcomes in adult spinal deformity patients with high and low preoperative PT treated surgically using less invasive techniques. METHODS Retrospective case-control, institutional review board-approved study. A multicenter, minimally invasive surgery spinal deformity patient database was queried for 2-yr follow-up with complete radiographic and health-related quality of life (HRQOL) data. Hybrid surgery patients were excluded. Inclusion criteria were as follows: age > 18 and either coronal Cobb angle > 20, sagittal vertical axis > 5 cm, pelvic incidence-lumbar lordosis (PI-LL) > 10 or PT > 20. Patients were stratified by preop PT as per Schwab classification: low (PT 30). Postoperative radiographic alignment parameters (PT, PI, LL, Cobb angle, sagittal vertical axis) and HRQOL data (Visual Analog Scale Back/Leg, Oswestry Disability Index) were evaluated and analyzed. RESULTS One hundred sixty-five patients had complete 2-yr outcomes data, and 64 patients met inclusion criteria (25 low, 21 mid, 18 high PT). High PT group had higher preop PI-LL mismatch (32.1 vs 4.7; P < .001). At last follow-up, 76.5% of patients in the high PT group had continued PI-LL mismatch compared to 34.8% in the low PT group (P < .006). There was a difference between groups in terms of postop changes of PT (-3.9 vs 1.9), LL (8.7 vs 0.5), and PI-LL (-9.5 vs 0.1). Postoperatively, HRQOL data (Oswestry Disability Index and Visual Analog Scale) were significantly improved in both groups (P < .001). CONCLUSION Adult deformity patients with high preoperative PT treated with minimally invasive surgical techniques had less radiographic success but equivalent clinical outcomes as patients with low PT.

Introduction Sagittal plane realignment is important to achieve desirable clinical outcomes after adult spinal deformity (ASD) surgery. This study evaluates the impact of minimally invasive (MIS) techniques on sagittal plane alignment and clinical outcomes in ASD patients. Methods A retrospective, multi-center review of ASD patients (age ≥18 years, and with one of the following: coronal Cobb ≥20°, sagittal vertical axis [SVA] >5 cm, and/or pelvic tilt >25°), MIS surgery, and four or more levels instrumented. Patients were stratified by baseline SRS-Schwab global alignment modifier (GAM) into three groups: 0 (SVA 9.5 cm). Radiographic and clinical outcomes measures were analyzed with a minimum of 2-year follow-up. Results A total of 96 ASD patients were identified, and 63 met the study's inclusion criteria of circumferential MIS or posterior MIS only, with four or more levels instrumented (n: Group 0 = 37, Group + = 15, and Group ++ = 11). Group 0 was younger than ++ (56.8 vs. 69.6 years), with a higher proportion of females than Group + or ++ (83.8% vs. 66.7% and 54.5%, respectively). Baseline HRQoL was similar. Postoperatively, Groups 0 and + had improved Oswestry Disability Index (ODI) and numeric rating scale (NRS) back and leg scores. Group ++ only had improvement in NRS scores. At the latest follow-up, Groups 0 and ++ had similar sagittal measurements except for PT (21.6 vs. 23.6, p = .009). The + group had improvement in PI–LL (24.2 to 17; p = .015) and LL (30.9 to 38.3; p = .013). Eight of 27 (21.6%) Group 0 patients deteriorated (4 to Group +, 4 to Group ++). Three of 15 (20.0%) Group + patients deteriorated to Group ++, and 3 improved to Group 0. Six of 11 (54.5%) Group ++ patients improved (3 to Group + and 3 to Group 0). Conclusions MIS techniques successfully stabilized ASD patients with Group 0 and + deformities and improved HRQoL. This study suggests that severe sagittal imbalance is not adequately treated with MIS approaches.

BACKGROUND CONTEXT Interbody fusions are widely accepted as a successful method to treat lumbar degenerative disc disease (DDD). Increasingly, surgeons are seeking interbody devices that are larger for stability and grafting purposes, but can still be inserted through less-invasive techniques. An investigational device exempt (IDE) trial of such a device is complete to 24 months. This novel, conformable mesh interbody fusion device when placed in the disc space through a small portal and filled with bone graft in situ may reduce the risk of trauma to surrounding structures while creating a large graft footprint that intimately contours to the patient's own anatomy. PURPOSE The purpose of this study is to evaluate the long-term results of a novel conformable mesh interbody fusion device. STUDY DESIGN/SETTING This investigation is a prospective, multi-center, single-arm, FDA and IRB approved IDE, performance goal trial. PATIENT SAMPLE A total of 102 adult subjects presenting with degenerative disc disease at a single level between L2 and S1 and unresponsive to six-months conservative care had instrumented lumbar interbody fusion. OUTCOME MEASURES Validated assessment tools include 100mm VAS for pain, Oswestry Disability Index (ODI) for function, single question survey for patient satisfaction, and computerized tomography (CT) scan for fusion. METHODS Subjects were enrolled across 10 geographically distributed sites. Pain/ODI surveys, physical evaluations, and imaging were performed serially through 24 months. Specifically, CT scans were done at 12 and, if not fused, 24 months. Independent radiologists assessed CTs for fusion. An independent committee adjudicated adverse events. Subjects with complete data at 24-months were included in the analysis. RESULTS Ninety-six (96, 94% follow up rate) subjects (57.0±12.0 y, 50.0% Female, Body Mass Index 30.6±4.9) reported average decreased low back pain (LBP) from baseline of 45.0± 26.6 at 6-weeks and 51.4±26.2 at 24-months. Right/left leg pain reduced by 28.9±36.7/37.8±32.4 at 6-weeks and 30.5±33.0/40.3±34.6 at 24-months. Mean ODI improved 17.1±18.7 from baseline to 6 weeks and 32.0±18.5 by 24-months. At 24 months, 91.7% of subjects rated their procedure as excellent/good. Fusion rates were 97.9% (94/96) at 12-months, and 99% (95/96) at 24 months. Mean operative time, estimated blood loss (EBL), length of stay (LOS) were 2.6±0.9 h, 137±217 mL, and 2.3±1.2 d, respectively. No device-related serious adverse events have occurred. CONCLUSIONS Clinically significant outcomes for pain, function, fusion and device safety are demonstrated in this population. Substantial clinical improvements occur by 6 weeks postop and continue to improve to 24-months. The successful outcomes observed in this trial support use of this novel device in an instrumented lumbar interbody fusion. FDA DEVICE/DRUG STATUS OptiMesh (Not approved for this indication)

BACKGROUND CONTEXT Numerous strategies are used to minimize PJK in (ASD). The use of PPS is one such strategy. Studying this topic is difficult as there is a lack of homogeneity in the patient population being studied. PURPOSE Investigate if PPS minimizes the risk of perioperative PJK compared to traditional open techniques. STUDY DESIGN/SETTING Retrospective review of prospective multicenter adult spinal deformity database PATIENT SAMPLE Inclusion criteria are age >18, and one of the following: PT>25, PI-LL>10, or SVA>5 cm. OUTCOME MEASURES NRS leg, ODI, SF-12, EQ5D, SRS-22. METHODS A prospective database was retrospectively reviewed. Inclusion criteria are age >18, and one of the following: PT>25, PI-LL>10, or SVA>5 cm. Patients were grouped as MIS (all PPS no open component) or OPEN. Propensity matching was used to create 2 equal groups controlling for: age, BMI, Preop (PI-LL, PI, TPA), and post op (PI-LL correction and posterior levels fused). PJK was evaluated in 2 groups: Mild (PJK10) 10° change from preop and severe (PJK20) a 20° change, as previously reported. RESULTS A total of 1,023 patients met criteria: 114 MIS and 909 OPEN. MIS were older with higher BMI. No significant difference was found between groups in preop alignment or SRS Schwab classification. OPEN had more levels fused (11.3 vs 5.5), change in PI-LL (14.9 vs 9.3) and LL (16.2 vs 9.7; all p 0.59). PJK20 was 2.6% in OPEN vs 3.9% in MIS at 1YR (p=1). The PJK angle was not different (4.3 v 4.2). MIS had less EBL (510 v 1574 cc; p=0.000) longer OR time (448 v 373 min; p=0.022) and more interbodies (3.4 vs 2.1; p=0.000). There was no difference in rate of revision surgery (14.3% OPEN vs 10.4%). Major complications occurred more frequently in OPEN (23.4% vs 9.1%). CONCLUSIONS While the use of percutaneous fixation intuitively seems protective for PJK, our study found that when controlling for radiographic deformity, deformity correction, demographics and the magnitude of surgical intervention that percutaneous fixation is equivalent to open techniques in rate of perioperative PJK. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Traditional iliac (IS) and S2-alar-iliac (S2AI) pelvic fixation methods have unique technical characteristics in their application, and result in varied biomechanical and anatomic impact. These differences may lead to variance in lumbopelvic fixation failure types and rates. PURPOSE We intended to evaluate the influence of type of iliac fixation utilized for adult spinal deformity (ASD) correction on the frequency and manner of lumbopelvic fixation failure. STUDY DESIGN/SETTING Retrospective review of prospective, multicenter ASD database. PATIENT SAMPLE This study included 410 patients. OUTCOME MEASURES HRQL (ODI, SF-36, NRS), rod fracture, screw fracture, screw loosening, revision surgery, pseudarthrosis METHODS Inclusion criteria included ASD (coronal Cobb≥20°, sagittal vertical axis (SVA) ≥5cm, pelvic tilt ≥25° and/or thoracic kyphosis >60°) ≥ 18 years old, 2yr follow-up, and >5 level fusion with pelvic fixation. Cohort subdivided by type of pelvic fixation (IS vs S2AI). Loosening was defined by lucency around the screw shank on radiographs. Univariate testing was performed using t-tests and chi-squared tests. Multivariate logistic regression, accounting for significant confounders, was used to examine differences between the two groups for screw loosening/fracture, rod fracture, and revision surgery. Level of significance = p RESULTS Of the total of 1422 patients, 410 met inclusion criteria (IS=287, S2AI=131). The two groups had similar age, BMI, baseline co-morbidities, and number of levels fused (p>0.05), as well as similar baseline HRQLs (SF-36, ODI, SRS-22, NRS leg and back, p>0.05) and deformity (PT, PI-LL, SVA, p>0.05). Patients in the IS group had a higher proportion of unilateral fixation compared to S2AI group (12.9% vs 5.6%; p=0.001). The overall pelvic fixation failure rate (screw loosening/screw fracture/rod fracture) was 29.4%. Loosening of pelvic fixation occurred in 13.4% of patients, and was more prevalent in the S2AI fixation group (OR 2.74, p=0.001). The rate of S1 screw loosening was 2.9%, and more likely to occur in the S2AI group (OR 4.17, p=0.045). The rate of pelvic fixation fracture in the overall cohort was 2.3%, with no difference between groups (p=0.37). Rod fracture occurred in 14.1% below L4, with a trend toward less occurrence in the S2AI group (OR 0.47, p=0.06). Revision surgery was required in 22.7% of our cohort, with no difference between groups (p=0.449). Patients with failure of the pelvic fixation had less improvement in their HRQL at 2years (PCS 7.69 vs 10.46 p=0.028; SRS 0.83 vs 1.03 p=0.019; ODI 12.91 vs 19.77 p=0.0016). CONCLUSIONS Pelvic fixation is commonly used in long segment adult spinal deformity surgery to improve the rate of L5-S1 fusion and protect from construct failure at the lumbosacral junction. Our results demonstrate a substantial rate of pelvic fixation hardware issues following ASD correction. Lumbopelvic fixation failure occurred at a rate of 29.4% following surgical correction of ASD that involved iliac fixation and was associated with diminished clinical outcomes. Additionally, S2AI screws were more likely to demonstrate loosening, but less commonly associated with rod fractures. Patients who experienced failure of their pelvic fixation had less improvement in their HRQL two years postoperatively. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Purpose To assess preliminary associations between fatty-infiltration (FI) of cervical spine extensor musculature, cervical sagittal balance, and clinical outcomes in cervical deformity (CD) patients. Methods Operative CD patients (C2-C7 Cobb > 10°, CL > 10°, cSVA > 4 cm, or CBVA > 25°) with pre-operative (BL) MRIs and 1-year (1Y) post-operative MRIs or CTs were assessed for fatty-infiltration of cervical extensor musculature, using dedicated imaging software at each C2-C7 intervertebral level and the apex of deformity (apex). FI was gauged as a ratio of fat-free-muscle-cross-sectional-area (FCSA) over total-muscle-CSA (TCSA), with lower ratio values indicating greater FI. BL-1Y associations between FI, sagittal alignment, and clinical outcomes were assessed using appropriate parametric and non-parametric tests. Results 22 patients were included (Age 59.22, 71.4%F, BMI 29.2, CCI:0.75, Frailty: 0.43). BL deformity presentation: TS-CL: 29.0°, C2-C7 Sagittal Cobb:-1.6°, cSVA:30.4 mm. No correlations were observed between BL fatty-infiltration, sagittal alignment, frailty, or clinical outcomes (p > 0.05). Following surgical correction, C2-C7 (BL: 0.59 vs 1Y:0.67, p = 0.005) and apex (BL: 0.59 vs. 1Y: 0.66, p = 0.33) fatty-infiltration decreased. Achievement of lordotic curvature correlated with C2-C7 fatty infiltration reduction (Rs: 0.495, p Conclusions Deformity correction and sagittal balance appear to influence the reestablishment of cervical muscle tone from C2-C7 and reduction of back pain for severely frail CD patients. This analysis helps to understand cervical extensor musculature’s role amongst CD patients.

Background Spinal deformity surgery is often invasive and lengthy. Staging surgery over separate operative days may reduce complications. Staging is often used in minimally invasive treatment of adult spinal deformity (ASD). Objective To investigate the impact of staging on complication rates between hybrid (HYB; minimally invasive interbody with open posterior screw and rod fixation) and circumferential minimally invasive surgery (cMIS; minimally invasive interbody and screw/rod placement) procedures in patients with ASD. Methods A multicenter database of patients with ASD was reviewed. Patients who underwent staging (at least 3 levels) and 2 years of follow-up were analyzed. A total of 99 patients underwent staging: 53 cMIS and 46 HYB surgeries. Propensity matching for levels fused resulted in 19 patients in each group. Intra- and perioperative complications were assessed. Results Three HYB but no cMIS intraoperative complications occurred. More HYB patients had perioperative complications than cMIS patients. Neurologic complications were more frequent in HYB versus cMIS. Other complications did not differ significantly. Thirty-day reoperations were higher with cMIS than HYB, but there was no difference in reoperation rate at long-term follow-up. cMIS patients had greater improvement in the Oswestry Disability Index. There was no difference in complications between staged versus unstaged cMIS surgeries. Conclusions cMIS staged surgeries appear safer than HYB staged surgeries, and equally safe to cMIS unstaged surgeries. Perioperative complications were significantly higher for HYB staged surgeries. HYB surgeries may have better results when performed in a single setting, whereas cMIS surgeries can be performed in 1 or 2 stages depending on surgeon preference.

Supplemental Digital Content is Available in the Text., BACKGROUND: The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion. OBJECTIVE: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years. METHODS: Data were derived from a randomized trial of 330 patients. Data from the 12-Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated quality-adjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate. RESULTS: The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was −$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (−$225 816 per QALY to $22 071 per QALY). CONCLUSION: This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality. ABBREVIATIONS: ACDF, anterior cervical discectomy and fusion AWP, average wholesale price CE, cost-effectiveness CEA, cost-effectiveness analysis CPT, Current Procedural Terminology cTDR, cervical total disc replacement CUA, cost-utility analysis DDD, degenerative disc disease DRG, diagnosis-related group FDA, US Food and Drug Administration ICER, incremental cost-effectiveness ratio IDE, Investigational Device Exemption NDI, neck disability index QALY, quality-adjusted life years RCT, randomized controlled trial RTW, return-to-work SF-12, 12-Item Short Form Health Survey VAS, visual analog scale WTP, willingness-to-pay

BACKGROUND CONTEXT Based on biomechanical studies, the use and type of interbody device at the lumbosacral junction creates variable stress/strain on the lumbopelvic fixation. This variability may lead to differential failure mechanisms and rates within following correction of adult spinal deformity (ASD). PURPOSE We aimed to evaluate the relationship of lumbosacral interbody presence and type with lumbopelvic fixation failure after ASD correction utilizing iliac (IS) or S2 alar iliac (S2AI) screws. STUDY DESIGN/SETTING Retrospective review of prospective, multicenter ASD database. PATIENT SAMPLE A total of 342 patients. OUTCOME MEASURES Pelvic fixation loosening, IS/S2AI screw fracture, S1 screw fracture, rod fracture (below L4), revision surgery, pseudarthrosis, HRQLs. METHODS Inclusion criteria consisted of patients with ASD (coronal Cobb ≥20°, sagittal vertical axis (SVA) ≥5cm, pelvic tilt ≥25° and/or thoracic kyphosis >60°) ≥18 years old and 2yr f/u who underwent >5 level fusion with pelvic fixation. Patients with prior L5-S1 fusion were excluded. Patients were divided into three groups based on the lumbosacral interbody fusion strategy (none, ALIF, TLIF/PLIF). Univariate testing via one-way ANOVA and chi-square tests, and multivariate logistic regression, accounting for significant confounders, were used to examine the difference between the three groups in regard to pseudarthosis, pelvic fixation loosening, rod fracture and revision surgery. Level of significance=p RESULTS A total of 342 patients met inclusion criteria (L5-S1 interbody groups: none=164, ALIF=87, TLIF=91). The three groups were similar in terms of baseline comorbidities, gender, BMI, pelvic fixation type (iliac screws vs S2AI), and use of BMP2 posteriorly. There were differences in rate of interbody BMP2 use (ALIF 22.9%, TLIF 48.35%, p=0.0001), use of unilateral pelvic fixation (none 7.36%, ALIF 19.8%, TLIF 3.29%, p=0.0001) and age (none 65.41, ALIF 60.47, TLIF 63.81, p=0.0005). Multivariate logistic regression revealed ALIF at L5-S1 was associated with lower odds of pseudarthrosis (OR 0.16, p-0.026) and rod fracture (OR 0.19, p=0.012) compared to no interbody fusion, while TLIF was no different than no interbody. There were no differences between groups in regard to pelvic fixation loosening or revision surgery. CONCLUSIONS The use of ALIF at L5-S1 during correction of ASD protects against fixation failure at the lumbopelvic junction compared to the use of TLIF or no interbody. This more protective effect of ALIF at the lumbosacral junction may allow for selective unilateral pelvic fixation for ASD surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

OBJECTIVEThe authors have provided a review of radiographic subsidence after lateral lumbar interbody fusion (LLIF) as a comparative analysis between titanium and polyetheretherketone (PEEK) cages. Many authors describe a reluctance to use titanium cages in spinal fusion secondary to subsidence concerns due to the increased modulus of elasticity of metal cages. The authors intend for this report to provide observational data regarding the juxtaposition of these two materials in the LLIF domain.METHODSA retrospective review of a prospectively maintained database identified 113 consecutive patients undergoing lateral fusion for degenerative indications from January to December 2017. The surgeons performing the cage implantations were two orthopedic spine surgeons and two neurosurgeons. Plain standing radiographs were obtained at 1–2 weeks, 8–12 weeks, and 12 months postoperatively. Using a validated grading system, interbody subsidence into the endplates was graded at these time points on a scale of 0 to III. The primary outcome measure was subsidence between the two groups. Secondary outcomes were analyzed as well.RESULTSOf the 113 patients in the sample, groups receiving PEEK and titanium implants were closely matched at 57 and 56 patients, respectively. Cumulatively, 156 cages were inserted and recombinant human bone morphogenetic protein–2 (rhBMP-2) was used in 38.1%. The average patient age was 60.4 years and average follow-up was 75.1 weeks. Subsidence in the titanium group in this study was less common than in the PEEK cage group. At early follow-up, groups had similar subsidence outcomes. Statistical significance was reached at the 8- to 12-week and 52-week follow-ups, demonstrating more subsidence in the PEEK cage group than the titanium cage group. rhBMP-2 usage was also highly correlated with higher subsidence rates at all 3 follow-up time points. Age was correlated with higher subsidence rates in univariate and multivariate analysis.CONCLUSIONSTitanium cages were associated with lower subsidence rates than PEEK cages in this investigation. Usage of rhBMP-2 was also robustly associated with higher endplate subsidence. Each additional year of age correlated with an increased subsidence risk. Subsidence in LLIF is likely a response to a myriad of factors that include but are certainly not limited to cage material. Hence, the avoidance of titanium interbody implants secondary solely to concerns over a modulus of elasticity likely overlooks other variables of equal or greater importance.

BACKGROUND CONTEXT Surgical intervention aimed at addressing adult spinal deformity (ASD) is an invasive and complex procedure that surgeons often elect to perform anterior/posterior (A/P) on different days. Literature on the effect of the interval between procedures on outcomes is limited. PURPOSE Identifying optimal interval of time between A/P staged surgeries during same hospitalization. STUDY DESIGN/SETTING Retrospective cohort study of a prospective multicenter database of ASD patients. PATIENT SAMPLE A total of 176 propensity score matched A/P ASD patients. OUTCOME MEASURES Health-related quality of life (HRQL) measures including Oswestry Disability Index (ODI), Scoliosis Research Society Questionnaire (SRS22); SF-36, EBL, LOS. METHODS Op patients who met ASD database criteria (>18yrs, scoliosis ≥20°, SVA ≥5cm, PT ≥25° and/or TK >60°), had a A/P fusion to the pelvis and had complete radiographic and HRQL data at baseline (BL) and 2Y were included. Propensity score match for levels fused, number of interbodies, interbody approach, number of osteotomies, baseline frailty, ODI, CCI, revisions, SVA, PI-LL, and UIV isolated a matched cohort of A/P same day and staged surgical patients. All patients underwent both A/P procedures during same admission. Posterior-only procedures were excluded. Patients that underwent a staged (not same day) corrective procedure were further stratified into percentiles of days between staging: (1) 25th percentile (2 days); (2) 50th percentile (3 days); (3) 75th percentile (5 days). Means comparison tests assessed differences in baseline demographic, clinical data, and intervals of staging. RESULTS A total of 176 propensity score matched patients (63.0yrs, 80% F, 29.2 kg/m2) were isolated. Radiographically at baseline, patients presented with: PT (26.8±10.0), PI-LL (24.5±18.7), SVA (96.1±78.7). The median interval between A/P staged procedures was 3.0 days±2.6. Staged patients had significantly greater overall operative time (628 min vs 501 min) and lower ICU stays postoperatively (p CONCLUSIONS In the closest matched cohort known to date of A/P staged and same day surgery patients, staged procedures were shown to result in significant improvement radiographically, reduced ICU stays, and superior patient reported outcomes. An interval of three days between A/P staged procedures was associated with increased improvement in GAP proportionality even after adjusting for institution and surgeon. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

OBJECTIVEIt is now well accepted that spinopelvic parameters are correlated with clinical outcomes in adult spinal deformity (ASD). The purpose of this study was to determine whether obtaining optimal spinopelvic alignment was absolutely necessary to achieve a minimum clinically important difference (MCID) or substantial clinical benefit (SCB).METHODSA multicenter retrospective review of patients who underwent less-invasive surgery for ASD was conducted. Inclusion criteria were age ≥ 18 years and one of the following: coronal Cobb angle > 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 20°, or pelvic incidence to lumbar lordosis (PI-LL) mismatch > 10°. A total of 223 patients who were treated with circumferential minimally invasive surgery or hybrid surgery and had a minimum 2-year follow-up were identified. Based on optimal spinopelvic parameters (PI-LL mismatch ± 10° and SVA < 5 cm), patients were divided into aligned (AL) or malaligned (MAL) groups. The primary clinical outcome studied was the Oswestry Disability Index (ODI) score.RESULTSThere were 74 patients in the AL group and 149 patients in the MAL group. Age and body mass index were similar between groups. Although the baseline SVA was similar, PI-LL mismatch (9.9° vs 17.7°, p = 0.002) and PT (19° vs 24.7°, p = 0.001) significantly differed between AL and MAL groups, respectively. As expected postoperatively, the AL and MAL groups differed significantly in PI-LL mismatch (−0.9° vs 13.1°, p < 0.001), PT (14° vs 25.5°, p = 0.001), and SVA (11.8 mm vs 48.3 mm, p < 0.001), respectively. Notably, there was no difference in the proportion of AL or MAL patients in whom an MCID (52.75% vs 61.1%, p > 0.05) or SCB (40.5% vs 46.3%, p > 0.05) was achieved for ODI score, respectively. Similarly, no differences in percentage of patients obtaining an MCID or SCB for visual analog scale back and leg pain score were observed. On multivariate analysis controlling for surgical and preoperative demographic differences, achieving optimal spinopelvic parameters was not associated with achieving an MCID (OR 0.645, 95% CI 0.31–1.33) or an SCB (OR 0.644, 95% CI 0.31–1.35) for ODI score.CONCLUSIONSAchieving optimal spinopelvic parameters was not a predictor for achieving an MCID or SCB. Since spinopelvic parameters are correlated with clinical outcomes, the authors’ findings suggest that the presently accepted optimal spinopelvic parameters may require modification. Other factors, such as improvement in neurological symptoms and/or segmental instability, also likely impacted the clinical outcomes.

Background: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics. Methods: Posthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures. Results: At 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P = .04) and Visual Analog Scale (VAS) neck pain (P = .02). When analyzed at each time point NDI was significant at 48–84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain. Conclusions: This is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.

Adult degenerative scoliosis treatment is complicated by its predilection for an elderly patient population that often exhibits multiple unrelated medical comorbidities. As spine surgeons attempt to treat this disease process with less invasive solutions, the fractional curve at L4, L5, and S1 is often overlooked or undertreated secondary to required increased perioperative morbidity associated with its treatment. A treatment strategy to identify, address, and treat the fractional curve with either open or minimally invasive techniques can lead to improved patient outcomes and decreased revision rates in this complicated pathologic process.

OBJECTIVECervical deformity (CD) correction is clinically challenging. There is a high risk of developing complications with these highly complex procedures. The aim of this study was to use baseline demographic, clinical, and surgical factors to predict a poor outcome following CD surgery.METHODSThe authors performed a retrospective review of a multicenter prospective CD database. CD was defined as at least one of the following: cervical kyphosis (C2–7 Cobb angle > 10°), cervical scoliosis (coronal Cobb angle > 10°), C2–7 sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle (CBVA) > 25°. Patients were categorized based on having an overall poor outcome or not. Health-related quality of life measures consisted of Neck Disability Index (NDI), EQ-5D, and modified Japanese Orthopaedic Association (mJOA) scale scores. A poor outcome was defined as having all 3 of the following categories met: 1) radiographic poor outcome: deterioration or severe radiographic malalignment 1 year postoperatively for cSVA or T1 slope–cervical lordosis mismatch (TS-CL); 2) clinical poor outcome: failing to meet the minimum clinically important difference (MCID) for NDI or having a severe mJOA Ames modifier; and 3) complications/reoperation poor outcome: major complication, death, or reoperation for a complication other than infection. Univariate logistic regression followed by multivariate regression models was performed, and internal validation was performed by calculating the area under the curve (AUC).RESULTSIn total, 89 patients with CD were included (mean age 61.9 years, female sex 65.2%, BMI 29.2 kg/m2). By 1 year postoperatively, 18 (20.2%) patients were characterized as having an overall poor outcome. For radiographic poor outcomes, patients’ conditions either deteriorated or remained severe for TS-CL (73% of patients), cSVA (8%), horizontal gaze (34%), and global SVA (28%). For clinical poor outcomes, 80% and 60% of patients did not reach MCID for EQ-5D and NDI, respectively, and 24% of patients had severe symptoms (mJOA score 0–11). For the complications/reoperation poor outcome, 28 patients experienced a major complication, 11 underwent a reoperation, and 1 had a complication-related death. Of patients with a poor clinical outcome, 75% had a poor radiographic outcome; 35% of poor radiographic and 37% of poor clinical outcome patients had a major complication. A poor outcome was predicted by the following combination of factors: osteoporosis, baseline neurological status, use of a transition rod, number of posterior decompressions, baseline pelvic tilt, T2–12 kyphosis, TS-CL, C2–T3 SVA, C2–T1 pelvic angle (C2 slope), global SVA, and number of levels in maximum thoracic kyphosis. The final model predicting a poor outcome (AUC 86%) included the following: osteoporosis (OR 5.9, 95% CI 0.9–39), worse baseline neurological status (OR 11.4, 95% CI 1.8–70.8), baseline pelvic tilt > 20° (OR 0.92, 95% CI 0.85–0.98), > 9 levels in maximum thoracic kyphosis (OR 2.01, 95% CI 1.1–4.1), preoperative C2–T3 SVA > 5.4 cm (OR 1.01, 95% CI 0.9–1.1), and global SVA > 4 cm (OR 3.2, 95% CI 0.09–10.3).CONCLUSIONSOf all CD patients in this study, 20.2% had a poor overall outcome, defined by deterioration in radiographic and clinical outcomes, and a major complication. Additionally, 75% of patients with a poor clinical outcome also had a poor radiographic outcome. A poor overall outcome was most strongly predicted by severe baseline neurological deficit, global SVA > 4 cm, and including more of the thoracic maximal kyphosis in the construct.

Minimally invasive surgery (MIS) correction for adult spinal deformity (ASD) may reduce the need the need for postoperative skilled nursing facility (SNF) or inpatient rehabilitation (IR) placement following surgery. The likelihood of requiring placement in a facility rather than home disposition may be influenced by various factors. In addition, the associations between discharge location and outcomes and complication rates have not been elucidated in these patients. In this study, we aimed to define factors predicting disposition to an SNF/IR and to elucidate the rates of complications occurring in patients sent to home versus to a facility.A retrospective review of a multicenter ASD database, which included patients who underwent surgery between 2009 and 2014. Inclusion criteria were age18 years, MIS as part of index surgery, location of discharge, and at least 1 of the following: pelvic tilt20°, sagittal vertical axis5 cm, pelvic incidence-lumbar lordosis mismatch10, or lumbar scoliosis20°. Patients with a 2-year follow-up were included. Preoperative demographic and radiographic data, postoperative (30 day) complications, and health-related quality of life were analyzed.A total of 182 patients met our inclusion criteria, including 113 who were discharged to home and 69 who were discharged to an SNF/IR. Older patients (50 years) were more likely to be discharged to an SNF/IR (P = 0.043). Those aged70 years were 6-fold more likely to go to an SNF/IR. No association was identified between discharge to an SNF/IR and any radiographic parameters except preoperative pelvic tilt (odds ratio [OR], 1.11; P = 0.009). Staged cases were more likely to be discharged to an SNF/IR (OR, 3.24; 95% confidence interval, 1.11-9.46; P = 0.032); otherwise, there was no difference in levels treated, operating time, estimated blood loss, osteotomy, or length of hospital stay. Patients requiring discharge to an SNF/IR had a higher rate of complications (58% vs. 39.8%; P = 0.017), including major complications (19.5% vs. 42%; P = 0.001), perioperative complications (14.2% vs. 31.9%; P = 0.004) and infections (3.5% vs. 13%; P = 0.016). Patients discharged to an SNF/IR had a higher rate of revision (19.5% vs. 33%; P = 0.035). Health-related quality of life measures were similar regardless of disposition.Older patients and those undergoing staged MIS deformity correction have a higher likelihood of postoperative disposition to an SNF/IR. Complications occurred more commonly in those patients requiring transfer to an SNF/IR after hospitalization.

Background Cervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one- and two-level disc disease. Methods This study was a continuation of a prospective, multicenter, randomized, US FDA IDE clinical trial comparing cervical TDR with the Mobi-C© Cervical Disc versus ACDF through 7 years follow-up. Inclusion criteria included a diagnosis of symptomatic cervical degenerative disc disease at one or two cervical levels. TDR patients were treated using a Mobi-C© artificial disc (Zimmer Biomet, Austin TX, USA). ACDF with allograft and anterior plate was used as a control treatment. Outcome measures were collected preoperatively and postoperatively at 6 weeks, at 3, 6, 12, 18 months, annually through 60 months, and at 84 months. Measured outcomes included Overall success, Neck Disability Index (NDI), VAS neck and arm pain, segmental range of motion (ROM), patient satisfaction, SF-12 MCS/PCS, major complications, and subsequent surgery rate. The primary endpoint was an FDA composite definition of success comprising clinical improvement and an absence of major complications and secondary surgery events. Results A total of 599 patients were enrolled and treated, with 164 treated with one-level TDR, 225 treated with two-level TDR, 81 treated with one-level ACDF, and 105 treated with two-level ACDF. At seven years, follow-up rates ranged from 73.5% to 84.4% (overall 80.2%). The overall success rates of two level TDR and ACDF patients were 60.8% and 34.2%, respectively (p 0.05). Both the single and two level TDR and ACDF groups showed significant improvement from baseline NDI scores, VAS neck and arm pain scores, and SF-12 MCS/PCS scores (p In the two level TDR group, the NDI success rate was significantly greater in the TDR group (TDR: 79.0% vs. ACDF: 58.0%; p=0.001). There was significantly more improvement in NDI change score at 7 years in the TDR patients versus ACDF. The TDR group had a significantly higher rate of patients who were “very satisfied” with their treatment compared to the ACDF group (TDR: 85.9% vs. ACDF: 73.9%). The rate of subsequent surgery at the index level was significantly lower in the TDR group compared to the ACDF group (TDR: 4.4% vs. ACDF: 16.2%; p=0.001). The rate of adjacent level secondary surgery was significantly lower in the two level TDR (4.4%) patients compared to the ACDF (11.3%; p=0.03) patients. In both single and two level cohorts, the percentage of patients with worse NDI (2.5%-3.8% of two level surgeries and 1.2%-2.5% of single level surgeries) or worse neck pain (5%-6.8% of the two level surgeries and 1.3% - 3.8% of the single level surgeries) was strikingly low in both groups but trended lower in the TDR patients. Conclusions At seven years, the composite success analysis demonstrated clinical superiority of two level TDR over ACDF and non-inferiority of single level TDR versus ACDF. There were lower rates of secondary surgery and higher adjacent level disc survivorship in both groups. Both surgeries were remarkably effective in alleviating pain relative to baseline and the rate of patients with worse disability or neck pain was surprisingly low. Overall, greater than 95% of patients (from both groups) who underwent TDR and 88% of patients who underwent ACDF were “very satisfied” at seven years. The differences in clinical effectiveness of TDR versus ACDF becomes more apparent as treatment increases from one to two levels, indicating a significant benefit for TDR over ACDF for two-level procedures. Ethical Standards The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. Level of Evidence 1.

OBJECTIVERecently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4–5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4–5 level.METHODSThe authors conducted a retrospective evaluation of 18 consecutive patients with Grade 1 or 2 spondylolisthesis from a prospectively maintained database. All patients underwent a transpsoas approach, followed by posterior percutaneous instrumentation without decompression. The Oswestry Disability Index (ODI) and SF-12 were administered during the clinical evaluations. Radiographic evaluation was also performed. The mean follow-up was 6.2 months.RESULTSFifteen patients with Grade 1 and 3 patients with Grade 2 spondylolisthesis were identified and underwent fusion at a total of 20 levels. The mean operative time was 165 minutes for the combined anterior and posterior phases of the operation. The estimated blood loss was 113 ml. The most common cage width in the anteroposterior dimension was 22 mm (78%). Anterior thigh dysesthesia was identified on detailed sensory evaluation in 6 of 18 patients (33%); all patients experienced resolution within 6 months postoperatively. No patient had lasting sensory loss or motor deficit. The average ODI score improved 26 points by the 6-month follow-up. At the 6-month follow-up, the SF-12 mean Physical and Mental Component Summary scores improved by 11.9% and 9.6%, respectively. No patient required additional decompression postoperatively.CONCLUSIONSThis study offers clinical results to establish lateral lumbar interbody fusion as an effective technique for the treatment of Grade 1 or 2 degenerative spondylolisthesis at L4–5. The use of this surgical approach provides a minimally invasive solution that offers excellent arthrodesis rates as well as favorable clinical and radiological outcomes, with low rates of postoperative complications. However, adhering to the techniques of transpsoas lateral surgery, such as minimal table break, an initial look-and-see approach to the psoas, clear identification of the plexus, minimal cranial caudal expansion of the retractor, mobilization of any traversing sensory nerves, and total psoas dilation times less than 20 minutes, ensures the lowest possible complication profile for both visceral and neural injuries even in the narrow safe zones when accessing the L4–5 disc space in patients with degenerative spondylolisthesis.

BACKGROUND CONTEXT Previous research has demonstrated short term benefit in radiographic and clinical outcomes using minimally invasive (cMIS) and Hybrid techniques to correct adult spinal deformity (ASD). However, it is not known if these benefits are maintained over longer periods of time. PURPOSE Evaluate the durability of radiologic and clinical outcomes in cMIS and Hybrid correction of ASD. STUDY DESIGN/SETTING Multicenter retrospective review of ASD database PATIENT SAMPLE A total of 197 (99%) patients were evaluated at 2 years and 96 (49%) patients had 3 year data available. Inclusion criteria were age ≥18 years, and one of the following: coronal cobb>20°, SVA>5cm, PT>20°, PI-LL >10°. OUTCOME MEASURES Adjusting for age and preoperative Cobb angle, radiographic, clinical outcomes and complications were assessed at 2 and 3 years postoperatively. METHODS A retrospective data base was analyzed using paired t-test and Mann-Whitney U analysis for continuous variables and Chi-Square analysis for categorical variables RESULTS A total of 197 (99%) patients were evaluated at 2 years and 96 (49%) patients had 3-year data available. When analyzing the latest data available, cMIS corrected the Cobb angle greater than Hybrid technique (18.3 vs 15.2, p CONCLUSIONS In this retrospective review of a large database of patients undergoing minimally invasive and Hybrid surgery for ASD, both techniques significantly improved radiographic parameters, and this was maintained through 2 and 3 years. When controlling for age and pre-operative Cobb angle, cMIS improved Cobb angle slightly more than Hybrid technique. Although back pain and ODI were significantly more improved using cMIS technique at 2 years, this difference was no longer significant by 3 years. Complications were significantly less frequent using cMIS than Hybrid technique. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Lumbar spinal stenosis has been shown to negatively impact health-related quality of life. Interspinous process decompression (IPD) is a minimally invasive procedure that utilizes a stand-alone spacer to serve as a joint extension blocker to relieve neural compression in patients with spinal stenosis. Using the 5-year results from an FDA randomized controlled trial of IPD, the quality of life in 189 patients treated with the Superion® spacer was evaluated with the SF-12. Physical and mental component summary (PCS, MCS) scores were computed preoperatively and at annual intervals. For the PCS, mean scores improved from 29.4 ± 8.1 preoperatively to 41.2 ± 12.4 at 2 years (40%) and to 43.8 ± 11.6 at 5 years (49%) (p0.10 for both comparisons). These results demonstrate that the significant impairment in physical well-being found in patients with lumbar spinal stenosis can be ameliorated, in large part, by IPD treatment.