Study design. Retrospective observational study of consecutive patients. Objective. The purpose of the study is to determine if a surgeon’s qualitative assessment of bone intraoperatively correlates with radiologic parameters of bone strength. Summary of Background Data. Preoperative radiologic assessment of bone can include modalities such as computed tomography (CT) Hounsfield units (HUs), dual-energy x-ray absorptiometry (DXA) bone mineral density with trabecular bone score (TBS) and magnetic resonance imaging vertebral bone quality (VBQ). Quantitative analysis of bone with screw insertional torque and pull-out strength measurement has been performed in cadaveric models and has been correlated to these radiologic parameters. However, these quantitative measurements are not routinely available for use in surgery. Surgeons anecdotally judge bone strength, but the fidelity of the intraoperative judgment has not been investigated. Methods. All adult patients undergoing instrumented posterior thoracolumbar spine fusion by one of seven surgeons at a single center over a 3-month period were included. Surgeons evaluated the strength of bone based on intraoperative feedback and graded each patient’s bone on a 5-point Likert scale. Two independent reviewers measured preoperative CT HUs and magnetic resonance imaging VBQ. Bone mineral density, lowest T-score, and TBS were extracted from DXA within 2 years of surgery. Results. Eighty-nine patients were enrolled and 16, 28, 31, 13, and 1 patients had Likert grade 1 (strongest bone), 2, 3, 4, and 5 (weakest bone), respectively. The surgeon assessment of bone correlated with VBQ (τ=0.15, P=0.07), CT HU (τ=−0.31, P<0.01), lowest DXA T-score (τ=−0.47, P<0.01), and TBS (τ=−0.23, P=0.06). Conclusion. Spine surgeons’ qualitative intraoperative assessment of bone correlates with preoperative radiologic parameters, particularly in posterior thoracolumbar surgeries. This information is valuable to surgeons as this supports the idea that decisions based on feel in surgery have a statistical foundation.
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.
Opportunistic CT-Based Hounsfield Units Strongly Correlate with Biomechanical CT Measurements in the Thoracolumbar Spine
Study Design. Retrospective cohort study. Objective. Hounsfield units (HUs) are known to correlate with clinical outcomes, but no study has evaluated how they correlate with biomechanical computed tomography (BCT) and dual-energy x-ray absorptiometry (DXA) measurements. Summary of Background. Low bone mineral density (BMD) represents a major risk factor for fracture and poor outcomes following spine surgery. DXA can provide regional BMD measurements but has limitations. Opportunistic HUs provide targeted BMD estimates; however, they are not formally accepted for diagnosing osteoporosis in current guidelines. More recently, BCT analysis has emerged as a new modality endorsed by the International Society for Clinical Densitometry for assessing bone strength. Methods. Consecutive cases from 2017 to 2022 at a single institution were reviewed for patients who underwent BCT in the thoracolumbar spine. BCT-measured vertebral strength, trabecular BMD, and the corresponding American College of Radiology Classification were recorded. DXA studies within three months of the BCT were reviewed. Pearson Correlation Coefficients were calculated, and receiver-operating characteristic curves were constructed to assess the predictive capacity of HUs. Threshold analysis was performed to identify optimal HU values for identifying osteoporosis and low BMD. Results. Correlation analysis of 114 cases revealed a strong relationship between HUs and BCT vertebral strength (r=0.69; P<0.0001; R 2=0.47) and trabecular BMD (r=0.76; P<0.0001; R 2=0.58). However, DXA poorly correlated with opportunistic HUs and BCT measurements. HUs accurately predicted osteoporosis and low BMD (Osteoporosis: C=0.95, 95% CI 0.89–1.00; Low BMD: C=0.87, 95% CI 0.79–0.96). Threshold analysis revealed that 106 and 122 HUs represent optimal thresholds for detecting osteoporosis and low BMD. Conclusion. Opportunistic HUs strongly correlated with BCT-based measures, while neither correlated strongly with DXA-based BMD measures in the thoracolumbar spine. HUs are easy to perform at no additional cost and provide accurate BMD estimates at noninstrumented vertebral levels across all American College of Radiology-designated BMD categories.
Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial
Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.
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
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.
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.
En bloc resection of a high cervical chordoma followed by reconstruction with a free vascularized fibular graft: illustrative case
BACKGROUND Wide excision of chordoma provides better local control than intralesional resection or definitive radiotherapy. The en bloc excision of high cervical chordomas is a challenging endeavor because of the complex anatomy of this region and limited reconstructive options. OBSERVATIONS This is the first case report to describe reconstruction with a free vascularized fibular graft following the en bloc excision of a chordoma involving C1–3. LESSONS This report demonstrates the durability of this construct at 10-year follow-up and is the first case report demonstrating satisfactory long-term oncological outcomes after a true margin-negative resection of a high cervical chordoma.
A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis
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.