Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Bone morphogenetic protein in subaxial cervical arthrodesis: a meta-analysis of 5828 patients.

OBJECTIVE: Use of bone morphogenetic protein (BMP)-an osteoinductive agent commonly used in lumbar arthrodesis-is off-label for cervical arthrodesis. This study aimed to identify the effect of BMP use on clinical and radiological outcomes in instrumented cervical arthrodesis. METHODS: A comprehensive systematic review of the literature was performed to identify studies directly comparing outcomes between cervical arthrodeses with and without using BMP. Outcomes were analyzed separately for cases of anterior cervical discectomy and fusion (ACDF) and posterior cervical fusion (PCF). RESULTS: A total of 20 studies with 5828 patients (1948 with BMP and 3880 without BMP) were included. In the ACDF cases, BMP use was associated with higher fusion rates (98.9% vs 93.6%, risk difference [RD] 8%; risk ratio [RR] 1.12, p = 0.02), lower reoperation rates (2.2% vs 3.1%, RD 3%; RR 0.48, p = 0.04), and higher risk of dysphagia (24.7% vs 8.1%, RD 11%; RR 1.93, p = 0.02). No significant differences in the Neck Disability Index, neck pain, or arm pain scores were associated with the use of BMP. On subgroup meta-analysis of ACDF cases, older age (≥ 50 years) and higher BMP dose (≥ 0.9 mg/level) were associated with significantly higher fusion rates and relatively lower risk for dysphagia, whereas arthrodesis of fewer segments (< 2 levels) showed significantly higher dysphagia rates without a significant increase in fusion rates. In the PCF cases, the use of BMP was not associated with significant differences in fusion (p = 0.38) or reoperation (p = 0.61) rates but was associated with significantly higher blood loss during surgery (mean difference 146.7 ml, p ≤ 0.01). CONCLUSIONS: Use of BMP in ACDF offers higher rates of augmented fusion and lower rates of all-cause reoperation but with an increased risk of dysphagia. The benefit of fusion outweighs the risk of dysphagia with a higher BMP dose in older patients being operated on for < 2 levels. The use of BMP in PCF seems to have a less important effect on clinical and radiological outcomes.

MRI Vertebral Bone Quality Correlates With Interbody Cage Subsidence After Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Retrospective observational study of consecutive patients. OBJECTIVE: The purpose of the study was to evaluate VBQ as a predictor of interbody subsidence and to determine threshold values that portend increased risk of subsidence. SUMMARY OF BACKGROUND DATA: Many risk factors have been reported for the subsidence of interbody cages in anterior cervical discectomy and fusion (ACDF). MRI Vertebral Bone Quality (VQB) is a relatively new radiographic parameter that can be easily obtained from preoperative MRI and has been shown to correlate with measurements of bone density such as DXA and CT Hounsfield Units. METHODS: All patients who underwent 1- to 3-level ACDF using titanium interbodies with anterior plating between the years 2018 and 2020 at our tertiary referral center were included. Subsidence measurements were performed by 2 independent reviewers on CT scans obtained 6 months postoperatively. VBQ was measured on pre-operative sagittal T1 MRI by 2 independent reviewers, and values were averaged. RESULTS: Eight-five fusion levels in 44 patients were included in the study. There were 32 levels (38%) with moderate subsidence and 12 levels with severe subsidence (14%). The average VBQ score in those patients with severe subsidence was significantly higher than those without subsidence (3.80 vs. 2.40, P<0.01). A threshold value of 3.2 was determined to be optimal for predicting subsidence (AUC=0.99) and had a sensitivity of 100% and a specificity of 94.1% in predicting subsidence. CONCLUSIONS: VBQ strongly correlates with the subsidence of interbody grafts after ACDF. A threshold VBQ score value of 3.2 has excellent sensitivity and specificity for predicting subsidence. Spine surgeons can use VBQ as a readily available screening tool to identify patients at higher risk for subsidence. LEVEL OF EVIDENCE: Level-IV.

Interbody cages versus structural bone grafts in lumbar arthrodesis: a systematic review and meta-analysis.

OBJECTIVE: The role of interbodies in lumbar arthrodesis has been insufficiently supported by evidence, impacting clinical decision-making and occasionally insurance coverage. This study aimed to compare clinical and radiological outcomes between lumbar arthrodesis with a synthetic interbody spacer (cage) versus structural bone graft alone (autograft or allograft) in patients with degenerative spine disease. METHODS: A systematic review of the literature was performed to identify studies directly comparing outcomes of lumbar interbody arthrodesis with and without interbody cage use. The outcomes of individual studies were synthesized in meta-analyses using random-effects models. RESULTS: Twenty studies with 1508 patients (769 with an interbody cage and 739 without an interbody cage) were included. Interbody cage placement was associated with a significantly greater increase in disc height after surgery (4.0 mm vs 3.4 mm, p < 0.01). There was a significantly greater reduction of back pain (visual analog scale [VAS] score) in cases in which an interbody cage was used (5.4 vs 4.7, p = 0.03). Fusion rates were 5.5% higher in the cage group (96.3% vs 90.8%) and reached statistical significance (p = 0.03). No statistically significant differences were identified between the two groups regarding all-cause reoperation rates, complication rates, or improvement in Oswestry Disability Index score or leg pain (VAS score). CONCLUSIONS: These results suggest that implantation of an interbody cage is associated with higher rates of fusion, more effective maintenance of disc height, and greater improvement of back pain. This study underlines the clinical value of interbody cages in lumbar arthrodesis for patients with degenerative spine disease.

The effect of C2 screw type on perioperative outcomes and long-term stability after C2-T2 posterior cervical decompression and fusion.

PURPOSE: To determine if C2 pedicle versus pars screw type predicts change in fusion status, C2 screw loosening, cervical alignment, and patient-reported outcomes measures (PROMs) after C2-T2 posterior cervical decompression and fusion (PDCF). METHODS: All adult patients who underwent C2-T2 PCDF for myelopathy or myeloradiculopathy between 2013-2020 were retrospectively identified. Patients were dichotomized by C2 screw type into bilateral C2 pedicle and bilateral C2 pars screw groups. Preoperative and short- and long-term postoperative radiographic outcomes and PROMs were collected. Univariate and multivariate analysis compared patient factors, fusion status, radiographic measures, and PROMs across groups. RESULTS: A total of 159 patients met the inclusion/exclusion criteria (76 bilateral pedicle screws, 83 bilateral pars screws). Patients in the C2 pars relative to C2 pedicle screw group were on average more likely to have bone morphogenic protein (p = 0.001) and four-millimeter diameter rods utilized intraoperatively (p = 0.033). There were no significant differences in total construct and C2-3 fusion rate, C2 screw loosening, or complication and revision rates between C2 screw groups in univariate and regression analysis. Changes in C2 tilt, C2-3 segmental lordosis, C0-2 Cobb angle, proximal junctional kyphosis, atlanto-dens interval, C1 lamina-occiput distance, C2 sagittal vertical axis, C2-7 lordosis, and PROMs at all follow-up intervals did not vary significantly by C2 screw type. CONCLUSION: There were no significant differences in fusion status, hardware complications, and radiographic and clinical outcomes based on C2 screw type following C2-T2 PCDF. Accordingly, intraoperative usage criteria can be flexible based on patient vertebral artery positioning and surgeon comfort level.

Bone Quality as Measured by Hounsfield Units More Accurately Predicts Proximal Junctional Kyphosis than Vertebral Bone Quality Following Long-Segment Thoracolumbar Fusion.

OBJECTIVE: To compare the prognostic power of Hounsfield units (HU) and Vertebral Bone Quality (VBQ) score for predicting proximal junctional kyphosis (PJK) following long-segment thoracolumbar fusion to the upper thoracic spine (T1-T6). METHODS: Vertebral bone quality around the upper instrumented vertebrae (UIV) was measured using HU on preoperative CT and VBQ on preoperative MRI. Spinopelvic parameters were also categorized according to the Scoliosis Research Society-Schwab classification. Univariable analysis to identify predictors of the occurrence of PJK and survival analyses with Kaplan-Meier method and Cox regression were performed to identify predictors of time to PJK (defined as ≥10° change in Cobb angle of UIV+2 and UIV). Sensitivity analyses showed thresholds of HU < 164 and VBQ > 2.7 to be most predictive for PJK. RESULTS: Seventy-six patients (mean age 66.0 ± 7.0 years; 27.6% male) were identified, of whom 15 suffered PJK. Significant predictors of PJK were high postoperative pelvic tilt (P = 0.038), high postoperative T1-pelvic angle (P = 0.041), and high postoperative PI-LL mismatch (P = 0.028). On survival analyses, bone quality, as assessed by the average HU of the UIV and UIV+1 was the only significant predictor of time to PJK (odds ratio [OR] 3.053; 95% CI 1.032-9.032; P = 0.044). VBQ measured using the UIV, UIV+1, UIV+2, and UIV-1 vertebrae approached, but did not reach significance (OR 2.913; 95% CI 0.797-10.646; P = 0.106). CONCLUSIONS: In larger cohorts, VBQ may prove to be a significant predictor of PJK following long-segment thoracolumbar fusion. However, Hounsfield units on CT have greater predictive power, suggesting preoperative workup for long-segment thoracolumbar fusion benefits from computed tomography versus magnetic resonance imaging alone to identify those at increased risk of PJK.

Significant Reduction in Bone Density as Measured by Hounsfield Units in Patients with Ankylosing Spondylitis or Diffuse Idiopathic Skeletal Hyperostosis.

Background: Multisegmental pathologic autofusion occurs in patients with ankylosing spondylitis (AS) and diffuse idiopathic skeletal hyperostosis (DISH). It may lead to reduced vertebral bone density due to stress shielding. Methods: This study aimed to determine the effects of autofusion on bone density by measuring Hounsfield units (HU) in the mobile and immobile spinal segments of patients with AS and DISH treated at a tertiary care center. The mean HU was calculated for five distinct regions-cranial adjacent mobile segment, cranial fused segment, mid-construct fused segment, caudal fused segment, and caudal adjacent mobile segment. Means for each region were compared using paired-sample t-tests. Multivariable regression was used to determine independent predictors of mid-fused segment HUs. Results: One hundred patients were included (mean age 76 ± 11 years, 74% male). The mean HU for the mid-construct fused segment (100, 95% CI [86, 113]) was significantly lower than both cranial and caudal fused segments (174 and 108, respectively; both p < 0.001), and cranial and caudal adjacent mobile segments (195 and 115, respectively; both p < 0.001). Multivariable regression showed the mid-construct HUs were predicted by history of smoking (-30 HU, p = 0.009). Conclusions: HUs were significantly reduced in the middle of long-segment autofusion, which was consistent with stress shielding. Such shielding may contribute to the diminution of vertebral bone integrity in AS/DISH patients and potentially increased fracture risk.

The Effect of C2 Muscular Exposure Technique on Radiographic and Clinical Outcomes After C2-T2 Posterior Cervical Fusion.

STUDY DESIGN: Retrospective cohort analysis. OBJECTIVE: To determine whether the C2 exposure technique was a predictor of change in cervical alignment and patient-reported outcomes measures (PROMs) after posterior cervical decompression and fusion (PCDF) for degenerative indications. BACKGROUND: In PCDF handling of the C2 posterior paraspinal musculature during the operative approach varies by surgeon technique. To date, no studies have investigated whether maintenance of the upper cervical semispinalis cervicis attachments as compared with complete reflection of upper cervical paraspinal musculature from the posterior bony elements is associated with superior radiographic and clinical outcomes after PCDF. PATIENTS AND METHODS: All adult patients who underwent C2-T2 PCDF for myelopathy or myeloradiculopathy at multi-institutional academic centers between 2013 and 2020 were retrospectively identified. Patients were dichotomized by the C2 exposure technique into semispinalis preservation or midline muscular reflection groups. Preoperative and short and long-term postoperative radiographic outcomes (upper cervical alignment, global alignment, and fusion status) and PROMs (Visual Analog Scale-Neck, Neck Disability Index, and Short Form-12) were collected. Univariate analysis compared patient factors, radiographic measures, and PROMs across C2 exposure groups. RESULTS: A total of 129 patients met the inclusion/exclusion criteria (73 muscle preservation and 56 muscle reflection). Patients in the muscular preservation group were on average younger (P= 0.005) and more likely to have bone morphogenic protein (P< 0.001) and C2 pars screws (P= 0.006) used during surgery. Preoperative to postoperative changes in C2 slope, C2 tilt, C2-C3 segmental lordosis, C2-C3 listhesis, C0-C2 Cobb angle, proximal junctional kyphosis, ADI, C1 lamina-occiput distance, C2 sagittal vertical axis, C2-C7 lordosis, and PROMs at all follow-up intervals did not vary significantly by C2 exposure technique. Likewise, there were no significant differences in fusion status, C2-C3 pseudoarthrosis, C2 screw loosening, and complication and revision rates between C2 exposure groups. CONCLUSIONS: Preservation of C2 semispinalis attachments versus muscular reflection did not significantly impact cervical alignment, clinical outcomes, or proximal junction complications in long-segment PCDF. LEVEL OF EVIDENCE: Level III.

Optimal Implant Sizing Using Machine Learning Is Associated With Increased Range of Motion After Cervical Disk Arthroplasty.

BACKGROUND AND OBJECTIVES: Cervical disk arthroplasty (CDA) offers the advantage of motion preservation in the treatment of focal cervical pathology. At present, implant sizing is performed using subjective tactile feedback and imaging of trial cages. This study aims to construct interpretable machine learning (IML) models to accurately predict postoperative range of motion (ROM) and identify the optimal implant sizes that maximize ROM in patients undergoing CDA. METHODS: Adult patients who underwent CDA for single-level disease from 2012 to 2020 were identified. Patient demographics, comorbidities, and outcomes were collected, including symptoms, examination findings, subsidence, and reoperation. Affected disk height, healthy rostral disk height, and implant height were collected at sequential time points. Linear regression and IML models, including bagged regression tree, bagged multivariate adaptive regression spline, and k-nearest neighbors, were used to predict ROM change. Model performance was assessed by calculating the root mean square error (RMSE) between predicted and actual changes in ROM in the validation cohort. Variable importance was assessed using RMSE loss. Area under the curve analyses were performed to identify the ideal implant size cutoffs in predicting improved ROM. RESULTS: Forty-seven patients were included. The average RMSE between predicted and actual ROM was 7.6° (range: 5.8-10.1) in the k-nearest neighbors model, 7.8° (range: 6.5-10.0) in the bagged regression tree model, 7.8° (range: 6.2-10.0) in the bagged multivariate adaptive regression spline model, and 15.8° (range: 14.3-17.5°) in a linear regression model. In the highest-performing IML model, graft size was the most important predictor with RMSE loss of 6.2, followed by age (RMSE loss = 5.9) and preoperative caudal disk height (RMSE loss = 5.8). Implant size at 110% of the normal adjacent disk height was the optimal cutoff associated with improved ROM. CONCLUSION: IML models can reliably predict change in ROM after CDA within an average of 7.6 degrees of error. Implants sized comparably with the healthy adjacent disk may maximize ROM.

Reduced Bone Density Based on Hounsfield Units After Long-Segment Spinal Fusion with Harrington Rods.

BACKGROUND: Long-segment instrumentation, such as Harrington rods, offloads vertebrae within the construct, which may result in significant stress shielding of the fused segments. The present study aimed to determine the effects of spinal fusion on bone density by measuring Hounsfield units (HUs) throughout the spine in patients with a history of Harrington rod fusion. METHODS: Patients with a history of Harrington rod fusion treated at a single academic institution were identified. Mean HUs were calculated at 5 spinal segments for each patient: cranial adjacent mobile segment, cranial fused segment, midconstruct fused segment, caudal fused segment, and caudal adjacent mobile segment. Mean HUs for each level were compared using a paired-sample t test, with statistical significance defined by P < 0.05. Hierarchic multiple regression, including age, gender, body mass index, and time since original fusion, was used to determine predictors of midfused segment HUs. RESULTS: One hundred patients were included (mean age, 55 ± 12 years; 62% female). Mean HUs for the midconstruct fused segment (110; 95% confidence interval [CI], 100-121) were significantly lower than both the cranial and caudal fused segments (150 and 118, respectively; both P < 0.05), as well as both the cranial and caudal adjacent mobile segments (210 and 130, respectively; both P < 0.001). Multivariable regression showed midconstruct HUs were predicted only by patient age (-2.6 HU/year; 95% CI, -3.4 to -1.9; P < 0.001) and time since original surgery (-1.4 HU/year; 95% CI, -2.6 to -0.2; P = 0.02). CONCLUSIONS: HUs were significantly decreased in the middle of previous long-segment fusion constructs, suggesting that multilevel fusion constructs lead to vertebral bone density loss within the construct, potentially from stress shielding.

Transforming Outcomes of Spine Surgery-Exploring the Power of Enhanced Recovery After Surgery Protocol: A Systematic Review and Meta-Analyses of 15 198 Patients.

BACKGROUND AND OBJECTIVES: Enhanced recovery after surgery (ERAS) protocols aim to optimize patient outcomes by reducing the surgical stress response, expediting recovery, and reducing care costs. We aimed to evaluate the impact of implementing ERAS protocols on the perioperative surgical outcomes and financial implications associated with spine surgeries. METHODS: A systematic review and meta-analysis of peer-reviewed studies directly comparing outcome differences between spine surgeries performed with and without utilization of ERAS pathways was conducted along Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Of 676 unique articles identified, 59 with 15 198 aggregate patients (7748 ERAS; 7450 non-ERAS) were included. ERAS-treated patients had shorter operative times (mean difference [MD]: 10.2 mins; P < .01), shorter hospitalizations (MD: 1.41 days, P < .01), fewer perioperative complications (relative risk [RR] = 0.64, P < .01), lower postoperative opioid use (MD of morphine equivalent dose: 164.36 mg; P < .01), and more rapid mobilization/time to first out-of-bed ambulation (MD: 0.92 days; P < .01). Spine surgeries employing ERAS were also associated with lower total costs (MD: $1140.26/patient; P < .01), especially in the United States (MD: $2869.11/patient, P < .01) and lower postoperative visual analog pain scores (MD = 0.56, P < .01), without any change in odds of 30-day readmission (RR: 0.80, P = .13) or reoperation (RR: 0.88, P = .60). Subanalyses based on the region of spine showed significantly lower length of stay in both cervical and lumbar surgeries implementing ERAS. Type of procedure showed a significantly lesser time-to-initiate mobilization in fusion surgeries using ERAS protocols compared with decompression. CONCLUSION: The present meta-analysis indicates that current literature supports ERAS implementation as a means of reducing care costs and safely accelerating hospital discharge for patients undergoing spine surgery.

The Predictors of Incidental Durotomy in Patients Undergoing Pedicle Subtraction Osteotomy for the Correction of Adult Spinal Deformity.

Background: Pedicle subtraction osteotomy (PSO) is a powerful tool for sagittal plane correction in patients with rigid adult spinal deformity (ASD); however, it is associated with high intraoperative blood loss and the increased risk of durotomy. The objective of the present study was to identify intraoperative techniques and baseline patient factors capable of predicting intraoperative durotomy. Methods: A tri-institutional database was retrospectively queried for all patients who underwent PSO for ASD. Data on baseline comorbidities, surgical history, surgeon characteristics and intraoperative maneuvers were gathered. PSO aggressiveness was defined as conventional (Schwab 3 PSO) or an extended PSO (Schwab type 4). The primary outcome of the study was the occurrence of durotomy intraoperatively. Univariable analyses were performed with Mann-Whitney U tests, Chi-squared analyses, and Fisher's exact tests. Statistical significance was defined by p < 0.05. Results: One hundred and sixteen patients were identified (mean age 61.9 ± 12.6 yr; 44.8% male), of whom 51 (44.0%) experienced intraoperative durotomy. There were no significant differences in baseline comorbidities between those who did and did not experience durotomy, with the exception that baseline weight and body mass index were higher in patients who did not suffer durotomy. Prior surgery (OR 2.73; 95% CI [1.13, 6.58]; p = 0.03) and, more specifically, prior decompression at the PSO level (OR 4.23; 95% CI [1.92, 9.34]; p < 0.001) was predictive of durotomy. A comparison of surgeon training showed no statistically significant difference in durotomy rate between fellowship and non-fellowship trained surgeons, or between orthopedic surgeons and neurosurgeons. The PSO level, PSO aggressiveness, the presence of stenosis at the PSO level, nor the surgical instrument used predicted the odds of durotomy occurrence. Those experiencing durotomy had similar hospitalization durations, rates of reoperation and rates of nonroutine discharge. Conclusions: In this large multisite series, a history of prior decompression at the PSO level was associated with a four-fold increase in intraoperative durotomy risk. Notably the use of extended (versus) standard PSO, surgical technique, nor baseline patient characteristics predicted durotomy. Durotomies occurred in 44% of patients and may prolong operative times. Additional prospective investigations are merited.

A Standardized Curriculum Improves Trainee Rod Bending Proficiency in Spinal Deformity Surgery. Results of a Prospective Randomized Controlled Educational Study.

INTRODUCTION: Surgical simulation is increasingly being accepted as a training platform to promote skill development and a safe surgical technique. Preliminary investigations in spine surgery show that simulation paired with educational intervention can markedly improve trainee performance. This study used a newly developed thoracolumbar fusion rod bending model to assess the effect of a novel educational curriculum and simulator training on surgical trainee rod bending speed and proficiency. METHODS: Junior (PGY1 to 2) and senior (PGY3-fellow) surgical trainees at a single academic institution were prospectively enrolled in a rod bending simulation using a T7-pelvis spinal fusion model. Participants completed two simulations, with 1 month between first and second attempts. Fifty percent of surgeons in each training level were randomized to receive an educational curriculum (rod bending technique videos and unlimited simulator practice) between simulation attempts. Rod bending simulation proficiency was determined by the percentage of participants who completed the task (conclusion at 20 minutes), time to task completion or conclusion, and number of incomplete set screws at task conclusion. Participants completed a preparticipation and postparticipation survey. Univariate analysis compared rod bending proficiency and survey results between education and control cohorts. RESULTS: Forty trainees (20 junior and 20 senior) were enrolled, with 20 participants randomized to the education and control cohorts. No notable differences were observed in the first simulation rod bending proficiency or preparticipation survey results between the education and control cohorts. In the second simulation, the education versus the control cohort demonstrated a significantly higher completion rate ( P = 0.01), shorter task time ( P = 0.009), fewer incomplete screws ( P = 0.003), and greater experience level ( P = 0.008) and comfort level ( P = 0.002) on postparticipation survey. DISCUSSION: Trainees who participated in a novel educational curriculum and simulator training relative to the control cohort improved markedly in rod bending proficiency and comfort level. Rod bending simulation could be incorporated in existing residency and fellowship surgical skills curricula. LEVEL OF EVIDENCE: I.

Comparison of Hounsfield units and vertebral bone quality score for the prediction of time to pathologic fracture in mobile spine metastases treated with radiotherapy.

OBJECTIVE: Spine metastases are commonly treated with radiotherapy for local tumor control; pathologic fracture is a potential complication of spinal radiotherapy. Both Hounsfield units (HUs) on CT and vertebral bone quality (VBQ) on MRI have been argued to predict stability as measured by odds of pathologic fracture, although it is unclear if there is a difference in the predictive power between the two methodologies. The objective of the present study was to examine whether one methodology is a better predictor of pathologic fracture following radiotherapy for mobile spine metastases. METHODS: Patients who underwent radiotherapy (conventional external-beam radiation therapy, stereotactic body radiation therapy, or intensity-modulated radiation therapy) for mobile spine (C1-L5) metastases at a tertiary care center were retrospectively identified. Details regarding underlying pathology, patient demographics, and tumor morphology were collected. Vertebral involvement was assessed using the Weinstein-Boriani-Biagini (WBB) system. Bone quality of the non-tumor-involved bone was assessed on both pretreatment CT and MRI. Univariable analyses were conducted to identify independent predictors of fracture, and Kaplan-Meier analyses were used to identify significant predictors of time to pathologic fracture. Stepwise Cox regression analysis was used to determine independent predictors of time to fracture. RESULTS: One hundred patients were included (mean age 62.7 ± 11.9 years; 61% male), of whom 35 experienced postradiotherapy pathologic fractures. The most common histologies were lung (22%), prostate (21%), breast (14%), and renal cell (13%). On univariable analysis, the mean HUs of the vertebrae adjacent to the fractured vertebra were significantly lower among those experiencing fracture; VBQ was not significantly associated with fracture odds. Survival analysis showed that average HUs ≤ 132, nonprostate pathology, involvement of ≥ 3 vertebral body segments on the WBB system, Spine Instability Neoplastic Score (SINS) ≥ 7, and the presence of axial pain all predicted increased odds of fracture (all p < 0.001). Cox regression found that HUs ≤ 132 (OR 2.533, 95% CI 1.257-5.103; p = 0.009), ≥ 3 WBB vertebral body segments involved (OR 2.376, 95% CI 1.132-4.987; p = 0.022), and axial pain (OR 2.036, 95% CI 0.916-4.526; p = 0.081) predicted increased fracture odds, while prostate pathology predicted decreased odds (OR 0.076, 95% CI 0.009-0.613; p = 0.016). Sensitivity analysis suggested that an HU threshold of ≤ 132 and a SINS of ≥ 7 identified patients at increased risk of fracture. CONCLUSIONS: The present results suggest that bone density surrogates as measured on CT, but not MRI, can be used to predict the risk of pathologic fracture following radiotherapy for mobile spine metastases. More extensive vertebral body involvement and the presence of mechanical axial pain additionally predict increased fracture odds.

Fractures in the ankylosed spine are associated with poor bone quality and lower hounsfield units.

STUDY DESIGN: Retrospective study INTRODUCTION: Patients with ankylosing spinal disorders have a higher risk of fractures, highlighting the need for bone health surveillance. Bone assessment by dual energy x-ray absorptiometry (DXA) is challenging due to abnormal bone formation but measurements by quantitative computed tomography (qCT) have demonstrated higher sensitivity and specificity. However, no studies have analyzed bone quality using qCT in the ankylosed spine population to assess three-column fracture characteristics and subsequent outcomes. METHODS: 106 patients with 115 three-column fractures were identified from 1999 to 2020. Patient demographics, Charlson comorbidity index, and injury severity score were extracted. Bone quality measured in Hounsfield units (HU), fracture characteristics, neurologic injury, and mortality were obtained. RESULTS: Most injuries occurred in the thoracic spine (70.4%) following a ground level fall (60.5%). HU adjacent to the fracture (127 HU) was significantly lower than the mobile segments (173 HU) (p < 0.001). Fracture adjacent HU was significantly lower in AS patients compared to DISH (109 vs 150 HU, p = 0.02, respectively) and were lower in fractures that resulted in a non-union or revision surgery (88 vs 137 HU, p = 0.04). Patients with longer fused segments were associated with multilevel and displaced fractures. CONCLUSIONS: Fracture adjacent HUs within the autofused segments were significantly lower than in the mobile segments, and longer fusion segments were associated with displaced, multilevel fractures. This study reinforces the importance of assessing patients for decreased HUs as well as better understand how the length of fused segments is associated with displaced, multilevel fractures. LEVEL OF EVIDENCE: Level III.

Paraspinal Sarcopenia is Associated With Worse Patient-Reported Outcomes Following Laminoplasty for Degenerative Cervical Myelopathy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The present study is the first to assess the impact of paraspinal sarcopenia on patient-reported outcome measures (PROMs) following cervical laminoplasty. BACKGROUND: While the impact of sarcopenia on PROMs following lumbar spine surgery is well-established, the impact of sarcopenia on PROMs following laminoplasty has not been investigated. METHODS: We performed a retrospective review of patients undergoing laminoplasty from C4-6 at a single institution between 2010 and 2021. Two independent reviewers utilized axial cuts of T2-weighted magnetic resonance imaging sequences to assess fatty infiltration of the bilateral transversospinales muscle group at the C5-6 level and classify patients according to the Fuchs Modification of the Goutalier grading system. PROMs were then compared between subgroups. RESULTS: We identified 114 patients for inclusion in this study, including 35 patients with mild sarcopenia, 49 patients with moderate sarcopenia, and 30 patients with severe sarcopenia. There were no differences in preoperative PROMs between subgroups. Mean postoperative neck disability index scores were lower in the mild and moderate sarcopenia subgroups (6.2 and 9.1, respectively) than in the severe sarcopenia subgroup (12.9, P =0.01). Patients with mild sarcopenia were nearly twice as likely to achieve minimal clinically important difference (88.6 vs. 53.5%; P <0.001) and six times as likely to achieve SCB (82.9 vs. 13.3%; P =0.006) compared with patients with severe sarcopenia. A higher percentage of patients with severe sarcopenia reported postoperative worsening of their neck disability index (13 patients, 43.3%; P =0.002) and Visual Analog Scale Arm scores (10 patients, 33.3%; P =0.03). CONCLUSION: Patients with severe paraspinal sarcopenia demonstrate less improvement in neck disability and pain postoperatively and are more likely to report worsening PROMs following laminoplasty. LEVEL OF EVIDENCE: 3.

Is Severe Neck Pain a Contraindication to Performing Laminoplasty in Patients With Cervical Spondylotic Myelopathy?

STUDY DESIGN: Retrospective review. OBJECTIVE: The purpose of this study was to investigate the surgical outcomes in a cohort of patients with severe preoperative axial neck pain undergoing laminoplasty for cervical spondylotic myelopathy (CSM). SUMMARY OF BACKGROUND DATA: No study has investigated whether patients with severe axial symptoms may achieve satisfactory neck pain and disability outcomes after laminoplasty. METHODS: We performed a retrospective review of 91 patients undergoing C4-6 laminoplasty for CSM at a single academic institution between 2010 and 2021. Patient-reported outcome measures (PROMs), including Neck Disability Index (NDI), visual analog scale (VAS) Neck, and VAS Arm, were recorded preoperatively and at 6 months and 1 year postoperatively. Patients were stratified as having mild pain if VAS neck was 0-3, moderate pain if 4-6, and severe pain if 7-10. PROMs were then compared between subgroups at all the perioperative time points. RESULTS: Both the moderate and severe neck pain subgroups demonstrated a substantial improvement in VAS neck from preoperative to 6 months postoperatively (-3.1±2.2 vs. -5.6±2.8, respectively; P <0.001), and these improvements were maintained at 1 year postoperatively. There was no difference in VAS neck between subgroups at either the 6-month or 1-year postoperative time points. Despite the substantially higher mean NDI in the moderate and severe neck pain subgroups preoperatively, there was no difference in NDI at 6 months or 1 year postoperatively ( P =0.99). There were no differences between subgroups in the degree of cord compression, severity of multifidus sarcopenia, sagittal alignment, or complications. CONCLUSIONS: Patients with moderate and severe preoperative neck pain undergoing laminoplasty achieved equivalent PROMs at 6 months and 1 year as patients with mild preoperative neck pain. The results of this study highlight the multifactorial nature of neck pain in these patients and indicate that severe axial symptoms are not an absolute contraindication to performing laminoplasty in well-aligned patients with CSM.

Characterizing the Current Clinical Trial Landscape in Spinal Deformity: A Retrospective Analysis of Trends in the ClinicalTrials.gov Registry.

BACKGROUND: The management of adult spinal deformity (ASD) relies upon retrospective data, but there have been calls for prospective trials to improve the evidentiary base. This study sought to define the state of the spinal deformity clinical trials and highlight trends to guide future research. METHODS: The ClinicalTrials.gov database was queried for all ASD trials initiated since 2008. ASD was defined as adults (>18 years) and defined by the trial. All identified trials were categorized by enrollment status, study design, funding source, start and completion dates, country, outcomes examined, among many other study characteristics. RESULTS: Sixty trials were included, of which 33(55.0%) started within the past 5 years of the query date. Most trials were sponsored by academic centers (60.0%) followed by industry (48.3%). Notably, 16 (27%) trials had multiple funding sources, all included collaboration with an industry entity. Only one trial had funding from a government agency. There were 30 (50%) interventional and 30 (50%) observational studies. The average time to completion was 50.8 ± 49.1 months. A total of 23 (38.3%) studies investigated a new procedural innovation, while 17 (28.3%) studies examined the safety or efficacy of a device. Study publications were associated with 17 (28.3%) trials in the registry. CONCLUSIONS: The number of trials has increased significantly over the past 5 years, with the bulk of trials being funded by academic centers and industry and a notably lack by government agencies. Most trials focused on device or procedural investigation. Despite growing interest in ASD clinical trials, there remain many points for improvement in the current evidentiary base.

Lower Hounsfield Units and Severe Multifidus Sarcopenia Are Independent Predictors of Increased Risk for Proximal Junctional Kyphosis and Failure Following Thoracolumbar Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose of the present study was to assess the impact of sarcopenia on the development of proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) following thoracolumbar spine fusion surgery using opportunistic evaluation of paraspinal fatty degeneration on preoperative magnetic resonance imaging. SUMMARY OF BACKGROUND DATA: While paraspinal sarcopenia has been shown to have detrimental consequences following posterior cervicothoracic fusions, the impact of paraspinal sarcopenia on PJK and PJF following thoracolumbar spine fusion surgery remains unknown. MATERIALS AND METHODS: We performed a retrospective review of patients who underwent posterior spine fusion surgery that extended caudally to the pelvis and terminated cranially between T10 and L2 between 2010 and 2017. The cohort was divided into three groups: (1) patients without PJK or PJF, (2) patients with PJK but no PJF, and (3) patients with PJF. Univariate and multivariate analyses were performed to determine risk factors for the development of proximal junctional complications. RESULTS: We identified 150 patients for inclusion in this study. Mean Hounsfield Units at the upper instrumented vertebra (UIV) was 148.3±34.5 in the cohort of patients without PJK or PJF, which was substantially higher than values recorded in the PJK (117.8±41.9) and PJF (118.8±41.8) subgroups (P<0.001). Severe multifidus sarcopenia was identified at a much higher rate in the subgroups of patients who developed PJK (76.0%) and PJF (78.9%) than in the subgroup of patients who developed neither PJK nor PJF (34.0%; P<0.001). Multivariate analysis demonstrated both low HU at the UIV and moderate-severe multifidus sarcopenia to be risk factors for the development of PJK and PJF. CONCLUSION: The results of this study suggest severe paraspinal sarcopenia and diminished bone density at the UIV impart an increased risk of developing PJK and PJF, while markers of systemic frailty such as modified Frailty Index and Charlson Comorbidity Index are not associated with an increased risk of these complications. LEVEL OF EVIDENCE: III.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.