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Cervical arthroplasty: what does the labeling say?

Mazda K. Turel, Mena G. Kerolus, Owoicho Adogwa, and Vincent C. Traynelis

OBJECTIVE

The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published.

METHODS

The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed.

RESULTS

In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success.

CONCLUSIONS

This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

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Ossified ligamentum flavum of the thoracic spine presenting as spontaneous intracranial hypotension: case report

Mazda K. Turel, Mena G. Kerolus, and John E. O’Toole

Ossification of the ligament flavum in the thoracic spine is an uncommon radiological finding in the Western population but can present with back pain, varying degrees of myelopathy, and even paraplegia on occasion. The authors here present the case of a 50-year-old woman with a history of progressive back pain and symptoms of spontaneous intracranial hypotension who was found to have an ossified ligamentum flavum of the thoracic spine resulting in a dural erosion cerebrospinal fluid leak. Surgery involved removal of the ossified ligament flavum at T10–11, facetectomy, ligation of the nerve root, and primary closure of the dura, which resulted in complete resolution of the patient’s symptoms. Radiological, clinical, and intraoperative findings are discussed to assist surgeons with an accurate diagnosis and treatment in the setting of this unusual presentation.

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Comparison of minimally invasive decompression alone versus minimally invasive short-segment fusion in the setting of adult degenerative lumbar scoliosis: a propensity score–matched analysis

Murray Echt, Adewale A. Bakare, Jesus R. Varela, Andrew Platt, Mohammed Abdul Sami, Joseph Molenda, Mena Kerolus, and Richard G. Fessler

OBJECTIVE

Patients with degenerative lumbar scoliosis (DLS) and neurogenic pain may be candidates for decompression alone or short-segment fusion. In this study, minimally invasive surgery (MIS) decompression (MIS-D) and MIS short-segment fusion (MIS-SF) in patients with DLS were compared in a propensity score–matched analysis.

METHODS

The propensity score was calculated using 13 variables: sex, age, BMI, Charlson Comorbidity Index, smoking status, leg pain, back pain, grade 1 spondylolisthesis, lateral spondylolisthesis, multilevel spondylolisthesis, lumbar Cobb angle, pelvic incidence minus lumbar lordosis, and pelvic tilt in a logistic regression model. One-to-one matching was performed to compare perioperative morbidity and patient-reported outcome measures (PROMs). The minimal clinically important difference (MCID) for patients was calculated based on cutoffs of percentage change from baseline: 42.4% for Oswestry Disability Index (ODI), 25.0% for visual analog scale (VAS) low-back pain, and 55.6% for VAS leg pain.

RESULTS

A total of 113 patients were included in the propensity score calculation, resulting in 31 matched pairs. Perioperative morbidity was significantly reduced for the MIS-D group, including shorter operative duration (91 vs 204 minutes, p < 0.0001), decreased blood loss (22 vs 116 mL, p = 0.0005), and reduced length of stay (2.6 vs 5.1 days, p = 0.0004). Discharge status (home vs rehabilitation), complications, and reoperation rates were similar. Preoperative PROMs were similar, but after 3 months, improvement was significantly higher for the MIS-SF group in the VAS back pain score (−3.4 vs −1.2, p = 0.044) and Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) score (+10.3 vs +1.9, p = 0.009), and after 1 year the MIS-SF group continued to have significantly greater improvement in the VAS back pain score (−3.9 vs −1.2, p = 0.026), ODI score (−23.1 vs −7.4, p = 0.037), 12-Item Short-Form Health Survey MCS score (+6.5 vs −6.5, p = 0.0374), and VR-12 MCS score (+7.6 vs −5.1, p = 0.047). MCID did not differ significantly between the matched groups for VAS back pain, VAS leg pain, or ODI scores (p = 0.38, 0.055, and 0.072, respectively).

CONCLUSIONS

Patients with DLS undergoing surgery had similar rates of significant improvement after both MIS-D and MIS-SF. For matched patients, tradeoffs were seen for reduced perioperative morbidity for MIS-D versus greater magnitudes of improvement in back pain, disability, and mental health for patients 1 year after MIS-SF. However, rates of MCID were similar, and the small sample size among the matched patients may be subject to patient outliers, limiting generalizability of these results.

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Transforaminal lumbar interbody fusion using a novel minimally invasive expandable interbody cage: patient-reported outcomes and radiographic parameters

Josha Woodward, Hani Malone, Christopher D. Witiw, John Paul G. Kolcun, Lacin Koro, Kevin C. Keegan, Shahjehan Ahmad, Mena G. Kerolus, Brian T. David, R. David Fessler, and Richard G. Fessler

OBJECTIVE

The goal of this study was to evaluate the clinical and radiographic outcomes of a novel multidirectional in situ expandable minimally invasive surgery (MIS) transforaminal lumbar interbody fusion (TLIF) cage.

METHODS

A retrospective analysis of 69 consecutive patients undergoing a 1- or 2-level MIS TLIF using an expandable cage was performed over a 2-year period. Standard MIS techniques with pedicle screw fixation were used in all cases. Upright lateral dynamic flexion/extension radiographs were reviewed prior to and at 1 year after surgery. Clinical metrics included numeric rating scale for back and leg pain, Oswestry Disability Index, and the SF-12 and VR-12 physical and mental health surveys. Radiographic parameters included anterior and posterior disc height, neuroforaminal height, spondylolisthesis, segmental lordosis, lumbar lordosis, and fusion rate.

RESULTS

A total of 69 patients representing 75 operative levels met study inclusion criteria. The mean patient age at surgery was 63.4 ± 1.2 years, with a female predominance of 51%. The average radiographic and clinical follow-ups were 372 and 368 days, respectively. A total of 63 patients (91%) underwent 1-level surgery and 6 patients (9%) underwent 2-level surgery. Significant reductions of numeric rating scale scores for back and leg pain were observed—from 6.1 ± 0.7 to 2.5 ± 0.3 (p < 0.0001) and 4.9 ± 0.6 to 1.9 ± 0.2 (p < 0.0001), respectively. A similar reduction in Oswestry Disability Index from 38.0 ± 4.6 to 20.0 ± 2.3 (p < 0.0001) was noted. Likewise, SF-12 and VR-12 scores all showed statistically significant improvement from baseline (p < 0.001). The mean anterior and posterior disc heights improved from 8.7 ± 1.0 mm to 13.4 ± 1.5 mm (p = 0.0001) and 6.5 ± 0.8 mm to 9.6 ± 1.1 mm (p = 0.0001), respectively. Neuroforaminal height improved from 17.6 ± 2.0 mm to 21.9 ± 2.5 mm (p = 0.0001). When present, spondylolisthesis was, on average, reduced from 4.3 ± 0.5 mm to 1.9 ± 0.2 mm (p = 0.0001). Lumbar lordosis improved from 47.8° ± 5.5° to 58.5° ± 6.8° (p = 0.2687), and no significant change in segmental lordosis was observed. The overall rate of radiographic fusion was 93.3% at 1 year. No perioperative complications requiring operative revision were encountered.

CONCLUSIONS

In this series of MIS TLIFs, use of this novel interbody cage was shown to be safe and effective. Significant improvements in pain and disability were observed. Effective and durable restoration of disc height and neuroforaminal height and reduction of spondylolisthesis were obtained, with concurrent gains in lumbar lordosis. Taken together, this device offers excellent clinical and radiographic outcomes via an MIS approach.

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Understanding the role of pelvic obliquity and leg length discrepancy in adult spinal deformity patients with coronal malalignment: unlocking the black box

Scott L. Zuckerman, Christopher S. Lai, Yong Shen, Meghan Cerpa, Nathan J. Lee, Mena G. Kerolus, Alex S. Ha, Ian A. Buchanan, Eric Leung, Ronald A. Lehman, and Lawrence G. Lenke

OBJECTIVE

This study had 3 objectives: 1) to describe pelvic obliquity (PO) and leg-length discrepancy (LLD) and their relationship with coronal malalignment (CM); 2) to report rates of isolated PO and PO secondary to LLD; and 3) to assess the importance of preoperative PO and LLD in postoperative complications, readmission, reoperation, and patient-reported outcomes.

METHODS

Patients undergoing surgery (≥ 6-level fusions) for adult spinal deformity at a single institution were reviewed. Variables evaluated were as follows: 1) PO, angle between the horizontal plane and a line touching bilateral iliac crests; and 2) LLD, distance from the head to the tibial plafond. Coronal vertical axis (CVA) and sagittal vertical axis measurements were collected, both from C7. The cutoff for CM was CVA > 3 cm. The Oswestry Disability Index (ODI) was collected preoperatively and at 2 years.

RESULTS

Of 242 patients undergoing surgery for adult spinal deformity, 90 (37.0%) had preoperative CM. Patients with preoperative CM had a higher PO (2.8° ± 3.2° vs 2.0° ± 1.7°, p = 0.013), a higher percentage of patients with PO > 3° (35.6% vs 23.5%, p = 0.044), and higher a percentage of patients with LLD > 1 cm (21.1% vs 9.8%, p = 0.014). Whereas preoperative PO was significantly positively correlated with CVA (r = 0.26, p < 0.001) and maximum Cobb angle (r = 0.30, p < 0.001), preoperative LLD was only significantly correlated with CVA (r = 0.14, p = 0.035). A total of 12.2% of patients with CM had significant PO and LLD, defined as follows: PO ≥ 3°; LLD ≥ 1 cm. Postoperatively, preoperative PO was significantly associated with both postoperative CM (OR 1.22, 95% CI 1.05–1.40, p = 0.008) and postoperative CVA (β = 0.14, 95% CI 0.06–0.22, p < 0.001). A higher preoperative PO was independently associated with postoperative complications after multivariate logistic regression (OR 1.24, 95% CI 1.05–1.45, p = 0.010); however, 2-year ODI scores were not. Preoperative LLD had no significant relationship with postoperative CM, CVA, ODI, or complications.

CONCLUSIONS

A PO ≥ 3° or LLD ≥ 1 cm was seen in 44.1% of patients with preoperative CM and in 23.5% of patients with normal coronal alignment. Preoperative PO was significantly associated with preoperative CVA and maximum Cobb angle, whereas preoperative LLD was only associated with preoperative CVA. The direction of PO and LLD showed no consistent pattern with CVA. Preoperative PO was independently associated with complications but not with 2-year ODI scores.

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Incidence and risk factors of iatrogenic coronal malalignment after adult spinal deformity surgery: a single-center experience

Scott L. Zuckerman, Christopher S. Lai, Yong Shen, Nathan J. Lee, Mena G. Kerolus, Alex S. Ha, Ian A. Buchanan, Eric Leung, Meghan Cerpa, Ronald A. Lehman, and Lawrence G. Lenke

OBJECTIVE

The authors’ objectives were: 1) to evaluate the incidence and risk factors of iatrogenic coronal malalignment (CM), and 2) to assess the outcomes of patients with all three types of postoperative CM (iatrogenic vs unchanged/worsened vs improved but persistent).

METHODS

A single-institution, retrospective cohort study was performed on adult spinal deformity (ASD) patients who underwent > 6-level fusion from 2015 to 2019. Iatrogenic CM was defined as immediate postoperative C7 coronal vertical axis (CVA) ≥ 3 cm in patients with preoperative CVA < 3 cm. Additional subcategories of postoperative CM were unchanged/worsened CM, which was defined as immediate postoperative CVA within 0.5 cm of or worse than preoperative CVA, and improved but persistent CM, which was defined as immediate postoperative CVA that was at least 0.5 cm better than preoperative CVA but still ≥ 3 cm; both groups included only patients with preoperative CM. Immediate postoperative radiographs were obtained when the patient was discharged from the hospital after surgery. Demographic, radiographic, and operative variables were collected. Outcomes included major complications, readmissions, reoperations, and patient-reported outcomes (PROs). The t-test, Kruskal-Wallis test, and univariate logistic regression were performed for statistical analysis.

RESULTS

In this study, 243 patients were included, and the mean ± SD age was 49.3 ± 18.3 years and the mean number of instrumented levels was 13.5 ± 3.9. The mean preoperative CVA was 2.9 ± 2.7 cm. Of 153/243 patients without preoperative CM (CVA < 3 cm), 13/153 (8.5%) had postoperative iatrogenic CM. In total, 43/243 patients (17.7%) had postoperative CM: iatrogenic CM (13/43 [30.2%]), unchanged/worsened CM (19/43 [44.2%]), and improved but persistent CM (11/43 [25.6%]). Significant risk factors associated with iatrogenic CM were anxiety/depression (OR 3.54, p = 0.04), greater preoperative sagittal vertical axis (SVA) (OR 1.13, p = 0.007), greater preoperative pelvic obliquity (OR 1.41, p = 0.019), lumbosacral fractional (LSF) curve concavity to the same side of the CVA (OR 11.67, p = 0.020), maximum Cobb concavity opposite the CVA (OR 3.85, p = 0.048), and three-column osteotomy (OR 4.34, p = 0.028). In total, 12/13 (92%) iatrogenic CM patients had an LSF curve concavity to the same side as the CVA. Among iatrogenic CM patients, mean pelvic obliquity was 3.1°, 4 (31%) patients had pelvic obliquity > 3°, mean preoperative absolute SVA was 8.0 cm, and 7 (54%) patients had preoperative sagittal malalignment. Patients with iatrogenic CM were more likely to sustain a major complication during the 2-year postoperative period than patients without iatrogenic CM (12% vs 33%, p = 0.046), yet readmission, reoperation, and PROs were similar.

CONCLUSIONS

Postoperative iatrogenic CM occurred in 9% of ASD patients with preoperative normal coronal alignment (CVA < 3 cm). ASD patients who were most at risk for iatrogenic CM included those with preoperative sagittal malalignment, increased pelvic obliquity, LSF curve concavity to the same side as the CVA, and maximum Cobb angle concavity opposite the CVA, as well as those who underwent a three-column osteotomy. Despite sustaining more major complications, iatrogenic CM patients did not have increased risk of readmission, reoperation, or worse PROs.

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Evaluation of coronal alignment from the skull using the novel orbital–coronal vertical axis line

Scott L. Zuckerman, Hani Chanbour, Fthimnir M. Hassan, Christopher S. Lai, Yong Shen, Nathan J. Lee, Mena G. Kerolus, Alex S. Ha, Ian A. Buchanan, Eric Leung, Meghan Cerpa, Ronald A. Lehman Jr., and Lawrence G. Lenke

OBJECTIVE

When treating patients with adult spinal deformity (ASD), radiographic measurements evaluating coronal alignment above C7 are lacking. The current objectives were to: 1) describe the new orbital–coronal vertical axis (ORB-CVA) line that evaluates coronal alignment from cranium to sacrum, 2) assess correlation with other radiographic variables, 3) evaluate correlations with patient-reported outcomes (PROs), and 4) compare the ORB-CVA with the standard C7-CVA.

METHODS

A retrospective cohort study of patients with ASD from a single institution was undertaken. Traditional C7-CVA measurements were obtained. The ORB-CVA was defined as the distance between the central sacral vertical line and the vertical line from the midpoint between the medial orbital walls. The ORB-CVA was correlated using traditional coronal measurements, including C7-CVA, maximum coronal Cobb angle, pelvic obliquity, leg length discrepancy (LLD), and coronal malalignment (CM), defined as a C7-CVA > 3 cm. Clinical improvement was analyzed as: 1) group means, 2) minimal clinically important difference (MCID), and 3) minimal symptom scale (MSS) (Oswestry Disability Index < 20 or Scoliosis Research Society–22r Instrument [SRS-22r] pain + function domains > 8).

RESULTS

A total of 243 patients underwent ASD surgery, and 175 had a 2-year follow-up. Of the 243 patients, 90 (37%) had preoperative CM. The mean (range) ORB-CVA at each time point was as follows: preoperatively, 2.9 ± 3.1 cm (−14.2 to 25.6 cm); 1 year postoperatively, 2.0 ± 1.6 cm (−12.4 to 6.7 cm); and 2 years postoperatively, 1.8 ± 1.7 cm (−6.0 to 11.1 cm) (p < 0.001 from preoperatively to 1 and 2 years). Preoperative ORB-CVA correlated best with C7-CVA (r = 0.842, p < 0.001), maximum coronal Cobb angle (r = 0.166, p = 0.010), pelvic obliquity (r = 0.293, p < 0.001), and LLD (r = 0.158, p = 0.006). Postoperatively, the ORB-CVA correlated only with C7-CVA (r = 0.629, p < 0.001) and LLD (r = 0.153, p = 0.017). Overall, 155 patients (63.8%) had an ORB-CVA that was ≥ 5 mm different from C7-CVA. The ORB-CVA correlated as well and sometimes better than C7-CVA with SRS-22r subdomains. After multivariate logistic regression, a greater ORB-CVA was associated with increased odds of complication, whereas C7-CVA was not associated with any of the three clinical outcomes (complication, readmission, reoperation). A larger difference between the ORB-CVA and C7-CVA was significantly associated with readmission and reoperation after univariate and multivariate logistic regression analyses. A threshold of ≥ 1.5-cm difference between the preoperative ORB-CVA and C7-CVA was found to be predictive of poorer outcomes.

CONCLUSIONS

The ORB-CVA correlated well with known coronal measurements and PROs. ORB-CVA was independently associated with increased odds of complication, whereas C7-CVA was not associated with any outcomes. A ≥ 1.5-cm difference between the preoperative ORB-CVA and C7-CVA was found to be predictive of poorer outcomes.