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Erratum: Cost-effectiveness of transforaminal lumbar interbody fusion for Grade I degenerative spondylolisthesis 

Clinical article 

Owoicho Adogwa

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Radiculopathy in the setting of lumbar nerve root compression due to an extradural intraforaminal lipoma: a report of 3 cases

Daniel B. Loriaux, Owoicho Adogwa, and Oren N. Gottfried

A true adult spinal lipoma is an exceedingly rare cause of lumbar compression neuropathy. Only 5 cases of true extradural intraforaminal lipomas have been documented in the medical literature. The diagnostic criteria and treatment guidelines for this specific lipoma have yet to be established. This report features 3 histologically confirmed cases of extradural intraforaminal spinal lipomas that recently presented to the authors’ practice. In addition, the literature was surveyed to include the 5 previously reported cases of true adult extradural intraforaminal spinal lipomas. The consistency in presentation, response to surgical intervention, and postoperative recovery in these 8 cases supports surgical intervention at the time of diagnosis. The authors’ findings support elevated clinical suspicion, efficient diagnosis based on MRI, and early surgical intervention for this rare pathological entity. All cases presented in this report were symptomatic and occurred in the absence of other significant pathologies such as general spinal epidural lipomatosis, intradural lesions, tethering, or severe degenerative stenosis or herniated discs. The clinical, neuroradiological, and histological findings characteristic of a true adult extradural intraforaminal lipoma are emphasized to differentiate this lesion from the more common etiologies for lumbar compression neuropathy. Heightened awareness and clinical suspicion for the focal, foraminal spinal lipoma as a cause of radiculopathy symptoms will enable more efficient diagnosis and treatment.

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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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Editorial: Depression and outcome

Christopher I. Shaffrey and Justin S. Smith

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Correlation of 2-year SRS-22r and ODI patient-reported outcomes with 5-year patient-reported outcomes after complex spinal fusion: a 5-year single-institution study of 118 patients

Owoicho Adogwa, Isaac O. Karikari, Aladine A. Elsamadicy, Amanda R. Sergesketter, Diego Galan, and Keith H. Bridwell

OBJECTIVE

Patient-reported outcomes (PROs) are often measured up to 2 years after surgery; however, prospective collection of longitudinal outcomes for 5 years postoperatively can be challenging due to lack of patient follow-up. The aim of this study was to determine whether PROs collected at 2-year follow-up accurately predict long-term PROs 5 years after complex spinal fusion (≥ 5 levels).

METHODS

This was an ambispective study of 118 adult patients (≥ 18 years old) undergoing ≥ 5-level spinal arthrodesis to the sacrum with iliac fixation from January 2002 to December 2011. Patient demographics and radiographic parameters as well as intraoperative variables were collected. PRO instruments (Scoliosis Research Society [SRS]-22r function, self-image, mental health, pain, and Oswestry Disability Index [ODI]) were completed before surgery then at 2 and 5 years after surgery. Primary outcome investigated in this study was the correlation between SRS-22r domains and ODI collected at 2- and 5-year follow-up.

RESULTS

Of the 118 patients, 111 patients had baseline PROs, 105 patients had 2-year follow-up data, and 91 patients had 5-year follow-up PRO data with 72% undergoing revision surgery. The average pre- and postoperative major coronal curve Cobb angles for the cohort were 32.1° ± 23.7° and 19.8° ± 19.3°, respectively. There was a strong correlation between 2- and 5-year ODI (r2 = 0.80, p < 0.001) and between 2- and 5-year SRS-22r domains, including function (r2 = 0.79, p < 0.001), self-image (r2 = 0.82, p < 0.001), mental health (r2 = 0.77, p < 0.001), and pain (r2 = 0.79, p < 0.001). Of the PROs, ODI showed the greatest absolute change from baseline to 2- and 5-year follow-up (2-year Δ 17.6 ± 15.9; 5-year Δ 16.5 ± 19.9) followed by SRS-22r self-image (2-year Δ 1.4 ± 0.96; 5-year Δ 1.3 ± 1.0), pain (2-year Δ 0.94 ± 0.97; 5-year Δ 0.80 ± 1.0), function (2-year Δ 0.60 ± 0.62; 5-year Δ 0.49 ± 0.79), and mental health (2-year Δ 0.49 ± 0.77; 5-year Δ 0.38 ± 0.84).

CONCLUSIONS

Patient-reported outcomes collected at 2-year follow-up may accurately predict long-term PROs (5-year follow-up).

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A comparison of readmission and complication rates and charges of inpatient and outpatient multiple-level anterior cervical discectomy and fusion surgeries in the Medicare population

Syed I. Khalid, Ryan Kelly, Rita Wu, Akhil Peta, Adam Carlton, and Owoicho Adogwa

OBJECTIVE

This study aims to assess the relationship of comorbidities and postoperative complications to rates of readmission for geriatric patients undergoing anterior cervical discectomy and fusion (ACDF) involving more than 2 levels on an inpatient or outpatient basis. With the rising costs of healthcare in the United States, understanding the safety and efficacy of performing common surgical interventions (including ACDF) as outpatient procedures could prove to be of great economic impact.Objective This study aims to assess the effect of comorbidities and postoperative complications on the rates of readmission of geriatric patients undergoing multilevel anterior cervical discectomy and fusion (ACDF) procedures (i.e., ACDF involving 3 or more levels) on an inpatient or outpatient basis. Same-day surgery has been demonstrated to be a safe and cost-effective alternative to the traditional inpatient option for many surgical interventions. With the rising costs of healthcare, understanding the safety and efficacy of performing common surgical interventions as outpatient procedures could prove to be of great economic impact.

METHODS

The study population included total of 2492 patients: 2348 inpatients and 144 outpatients having ACDF procedures involving 3 or more levels in the Medicare Standard Analytical Files database. Age, sex, comorbidities, postoperative complications, readmission rates, and surgical procedure charges were compared between both cohorts. For selected variables, logistic regression was used to model odds ratios for various comorbidities against readmission rates for both inpatient and outpatient cohorts. Chi-square tests were also calculated to compare these comorbidities with readmission in each cohort.

RESULTS

Overall complication rates within 30 postoperative days were greater for inpatients than for outpatients (44.2% vs 12.5%, p < 0.001). More inpatients developed postoperative urinary tract infection (7.9% vs 0%, p < 0.001), and the inpatient cohort had increased risk of readmission with comorbidities of anemia (OR 1.52, p < 0.001), smoking (OR 2.12, p < 0.001), and BMI ≥ 30 (OR 1.43, p < 0.001). Outpatients had increased risk of readmission with comorbidities of anemia (OR 2.78, p = 0.047), diabetes mellitus type 1 or 2 (OR 3.25, p = 0.033), and BMI ≥ 30 (OR 3.95, p = 0.008). Inpatients also had increased readmission risk with a postoperative complication of surgical site infection (OR 2.38, p < 0.001). The average charges for inpatient multilevel ACDF were significantly higher than for multilevel ACDF performed on an outpatient basis ($12,734.27 vs $12,152.18, p = 0.0019).

CONCLUSIONS

This study suggests that ACDF surgery involving 3 or more levels performed as an outpatient procedure in the geriatric population may be associated with lower rates of readmissions, complications, and surgical charges.

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Correlation of preoperative depression and somatic perception scales with postoperative disability and quality of life after lumbar discectomy

Clinical article

Kaisorn L. Chaichana, Debraj Mukherjee, Owoicho Adogwa, Joseph S. Cheng, and Matthew J. McGirt

Object

Lumbar discectomy is the most common surgical procedure performed in the US for patients experiencing back and leg pain from herniated lumbar discs. However, not all patients will benefit from lumbar discectomy. Patients with certain psychological predispositions may be especially vulnerable to poor clinical outcomes.

The goal of this study was therefore to determine the role that preoperative depression and somatic anxiety have on long-term back and leg pain, disability, and quality of life (QOL) for patients undergoing single-level lumbar discectomy.

Methods

In 67 adults undergoing discectomy for a single-level herniated lumbar disc, the authors determined quantitative measurements of leg and back pain (visual analog scale [VAS]), quality of life (36-Item Short Form Health Survey [SF-36]), and disease-specific disability (Oswestry Disability Index) preoperatively and at 6 weeks, 3, 6, and 12 months after surgery. The degree of preoperative depression and somatization was assessed using the Zung Self-Rating Depression Scale and a modified somatic perception questionnaire (MSPQ). Multivariate regression analyses were performed to assess associations between Zung Scale and MSPQ scores with achievement of a minimum clinical important difference (MCID) in each outcome measure by 12 months postoperatively.

Results

All patients completed 12 months of follow-up. Overall, a significant improvement in VAS leg pain, VAS back pain, Oswestry Disability Index, and SF-36 Physical Component Summary scores was observed by 6 weeks after surgery. Improvements in all outcomes were maintained throughout the 12-month follow-up period. Increasing preoperative depression (measured using the Zung Scale) was associated with a decreased likelihood of achieving an MCID in disability (p = 0.006) and QOL (p = 0.04) but was not associated with VAS leg pain (p = 0.96) or back pain (p = 0.85) by 12 months. Increasing preoperative somatic anxiety (measured using the MSPQ) was associated with decreased likelihood of achieving an MCID in disability (p = 0.002) and QOL (p = 0.03) but was not associated with leg pain (p = 0.64) or back pain (p = 0.77) by 12 months.

Conclusions

The Zung Scale and MSPQ are valuable tools for stratifying risk in patients who may not experience clinically relevant improvement in disability and QOL after discectomy. Efforts to address these confounding and underlying contributors of depression and heightened somatic anxiety may improve overall outcomes after lumbar discectomy.

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Cost-effectiveness of transforaminal lumbar interbody fusion for Grade I degenerative spondylolisthesis

Clinical article

Owoicho Adogwa, Scott L. Parker, Brandon J. Davis, Oran Aaronson, Clinton Devin, Joseph S. Cheng, and Matthew J. McGirt

Object

Transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis-associated back and leg pain is associated with improvement in pain, disability, and quality of life. However, given the rising health care costs associated with spinal fusion procedures and varying results of recent cost-utility studies, the cost-effectiveness of TLIF remains unclear. The authors set out to assess the comprehensive costs of TLIF at their institution and to determine its cost-effectiveness in the treatment of degenerative spondylolisthesis.

Methods

Forty-five patients undergoing TLIF for Grade I degenerative spondylolisthesis–associated back and leg pain after 6–12 months of conservative therapy were included. The authors assessed the 2-year back pain visual analog scale (VAS) score, leg pain VAS score, Oswestry Disability Index, and total back-related medical resource utilization, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with US valuation). Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after TLIF was assessed.

Results

Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in back pain VAS score, leg pain VAS score, and Oswestry Disability Index was observed 2 years after TLIF, with a mean 2-year gain of 0.86 QALYs. The mean ± SD total 2-year cost of TLIF was $36,836 ± $11,800 (surgery cost, $21,311 ± $2800; outpatient resource utilization cost, $3940 ± $2720; indirect cost, $11,584 ± $11,363). Transforaminal lumbar interbody fusion was associated with a mean 2-year cost per QALY gained of $42,854.

Conclusions

Transforaminal lumbar interbody fusion improved pain, disability, and quality of life in patients with degenerative spondylolisthesis–associated back and leg pain. The total cost per QALY gained for TLIF was $42,854 when evaluated 2 years after surgery with Medicare fees, suggesting that TLIF is a cost-effective treatment of lumbar spondylolisthesis.

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Association between baseline cognitive impairment and postoperative delirium in elderly patients undergoing surgery for adult spinal deformity

Owoicho Adogwa, Aladine A. Elsamadicy, Victoria D. Vuong, Jared Fialkoff, Joseph Cheng, Isaac O. Karikari, and Carlos A. Bagley

OBJECTIVE

Postoperative delirium is common in elderly patients undergoing spine surgery and is associated with a longer and more costly hospital course, functional decline, postoperative institutionalization, and higher likelihood of death within 6 months of discharge. Preoperative cognitive impairment may be a risk factor for the development of postoperative delirium. The aim of this study was to investigate the relationship between baseline cognitive impairment and postoperative delirium in geriatric patients undergoing surgery for degenerative scoliosis.

METHODS

Elderly patients 65 years and older undergoing a planned elective spinal surgery for correction of adult degenerative scoliosis were enrolled in this study. Preoperative cognition was assessed using the validated Saint Louis University Mental Status (SLUMS) examination. SLUMS comprises 11 questions, with a maximum score of 30 points. Mild cognitive impairment was defined as a SLUMS score between 21 and 26 points, while severe cognitive impairment was defined as a SLUMS score of ≤ 20 points. Normal cognition was defined as a SLUMS score of ≥ 27 points. Delirium was assessed daily using the Confusion Assessment Method (CAM) and rated as absent or present on the basis of CAM. The incidence of delirium was compared in patients with and without baseline cognitive impairment.

RESULTS

Twenty-two patients (18%) developed delirium postoperatively. Baseline demographics, including age, sex, comorbidities, and perioperative variables, were similar in patients with and without delirium. The length of in-hospital stay (mean 5.33 days vs 5.48 days) and 30-day hospital readmission rates (12.28% vs 12%) were similar between patients with and without delirium, respectively. Patients with preoperative cognitive impairment (i.e., a lower SLUMS score) had a higher incidence of postoperative delirium. One- and 2-year patient reported outcomes scores were similar in patients with and without delirium.

CONCLUSIONS

Cognitive impairment is a risk factor for the development of postoperative delirium. Postoperative delirium may be associated with decreased preoperative cognitive reserve. Cognitive impairment assessments should be considered in the preoperative evaluations of elderly patients prior to surgery.

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Do measures of surgical effectiveness at 1 year after lumbar spine surgery accurately predict 2-year outcomes?

Owoicho Adogwa, Aladine A. Elsamadicy, Jing L. Han, Joseph Cheng, Isaac Karikari, and Carlos A. Bagley

OBJECTIVE

With the recent passage of the Patient Protection and Affordable Care Act, there has been a dramatic shift toward critical analyses of quality and longitudinal assessment of subjective and objective outcomes after lumbar spine surgery. Accordingly, the emergence and routine use of real-world institutional registries have been vital to the longitudinal assessment of quality. However, prospectively obtaining longitudinal outcomes for patients at 24 months after spine surgery remains a challenge. The aim of this study was to assess if 12-month measures of treatment effectiveness accurately predict long-term outcomes (24 months).

METHODS

A nationwide, multiinstitutional, prospective spine outcomes registry was used for this study. Enrollment criteria included available demographic, surgical, and clinical outcomes data. All patients had prospectively collected outcomes measures and a minimum 2-year follow-up. Patient-reported outcomes instruments (Oswestry Disability Index [ODI], SF-36, and visual analog scale [VAS]-back pain/leg pain) were completed before surgery and then at 3, 6, 12, and 24 months after surgery. The Health Transition Index of the SF-36 was used to determine the 1- and 2-year minimum clinically important difference (MCID), and logistic regression modeling was performed to determine if achieving MCID at 1 year adequately predicted improvement and achievement of MCID at 24 months.

RESULTS

The study group included 969 patients: 300 patients underwent anterior lumbar interbody fusion (ALIF), 606 patients underwent transforaminal lumbar interbody fusion (TLIF), and 63 patients underwent lateral interbody fusion (LLIF). There was a significant correlation between the 12- and 24-month ODI (r = 0.82; p < 0.0001), SF-36 Physical Component Summary score (r = 0.89; p < 0.0001), VAS-back pain (r = 0.90; p < 0.0001), and VAS-leg pain (r = 0.85; p < 0.0001). For the ALIF cohort, patients achieving MCID thresholds for ODI at 12 months were 13-fold (p < 0.0001) more likely to achieve MCID at 24 months. Similarly, for the TLIF and LLIF cohorts, patients achieving MCID thresholds for ODI at 12 months were 13-fold and 14-fold (p < 0.0001) more likely to achieve MCID at 24 months. Outcome measures obtained at 12 months postoperatively are highly predictive of 24-month outcomes, independent of the surgical procedure.

CONCLUSIONS

In a multiinstitutional prospective study, patient-centered measures of surgical effectiveness obtained at 12 months adequately predict long-term (24-month) outcomes after lumbar spine surgery. Patients achieving MCID at 1 year were more likely to report meaningful and durable improvement at 24 months, suggesting that the 12-month time point is sufficient to identify effective versus ineffective patient care.