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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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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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Christopher I. Shaffrey and Justin S. Smith

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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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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.

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Scott L. Parker, Stephen K. Mendenhall, David N. Shau, Owoicho Adogwa, William N. Anderson, Clinton J. Devin and Matthew J. McGirt

Object

Spine surgery outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect, but the extent of improvement in the numerical scores of these questionnaires lacks a direct clinical meaning. Because of this, the concept of a minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of same-level recurrent stenosis following index lumbar fusion, which commonly requires revision decompression and fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for this pathology.

Methods

In 53 consecutive patients undergoing revision surgery for same-level recurrent lumbar stenosis–associated back and leg pain, PRO measures of back and leg pain were assessed preoperatively and 2 years postoperatively, using the visual analog scale for back pain (VAS-BP) and leg pain (VAS-LP), Oswestry Disability Index (ODI), Physical and Mental Component Summary categories of the 12-Item Short Form Health Survey (SF-12 PCS and MCS) for quality of life, Zung Depression Scale (ZDS), and EuroQol-5D health survey (EQ-5D). Four established anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for 2 separate anchors (health transition index of the SF-36 and the satisfaction index).

Results

All patients were available for 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs assessed. The 4 MCID calculation methods generated a range of MCID values for each of the PROs (VAS-BP 2.2–6.0, VAS-LP 3.9–7.5, ODI 8.2–19.9, SF-12 PCS 2.5–12.1, SF-12 MCS 7.0–15.9, ZDS 3.0–18.6, and EQ-5D 0.29–0.52). Each patient answered synchronously for the 2 anchors, suggesting both of these anchors are equally appropriate and valid for this patient population.

Conclusions

The same-level recurrent stenosis surgery-specific MCID is highly variable based on calculation technique. The “minimum detectable change” approach is the most appropriate method for calculation of MCIDs in this population because it was the only method to reliably provide a threshold above the 95% confidence interval of the unimproved cohort (greater than the measurement error). Based on this method, the MCID thresholds following neural decompression and fusion for symptomatic same-level recurrent stenosis are 2.2 points for VAS-BP, 5.0 points for VAS-LP, 8.2 points for ODI, 2.5 points for SF-12 PCS, 10.1 points for SF-12 MCS, 4.9 points for ZDS, and 0.39 QALYs for EQ-5D.

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

OBJECTIVE

Geriatric patients undergoing lumbar spine surgery have unique needs due to the physiological changes of aging. They are at risk for adverse outcomes such as delirium, infection, and iatrogenic complications, and these complications, in turn, contribute to the risk of functional decline, nursing home admission, and death. Whether preoperative and perioperative comanagement by a geriatrician reduces the incidence of in-hospital complications and length of in-hospital stay after elective lumbar spine surgery remains unknown.

METHODS

A unique model of comanagement for elderly patients undergoing lumbar fusion surgery was implemented at a major academic medical center. The Perioperative Optimization of Senior Health (POSH) program was launched with the aim of improving outcomes in elderly patients (> 65 years old) undergoing complex lumbar spine surgery. In this model, a geriatrician evaluates elderly patients preoperatively, in addition to performing routine preoperative anesthesia surgical screening, and comanages them daily throughout the course of their hospital stay to manage medical comorbid conditions and coordinate multidisciplinary rehabilitation along with the neurosurgical team. The first 100 cases were retrospectively reviewed after initiation of the POSH protocol and compared with the immediately preceding 25 cases to assess the incidence of perioperative complications and clinical outcomes.

RESULTS

One hundred twenty-five patients undergoing lumbar decompression and fusion were enrolled in this pilot program. Baseline characteristics were similar between both cohorts. The mean length of in-hospital stay was 30% shorter in the POSH cohort (6.13 vs 8.72 days; p = 0.06). The mean duration of time between surgery and patient mobilization was significantly shorter in the POSH cohort compared with the non-POSH cohort (1.57 days vs 2.77 days; p = 0.02), and the number of steps ambulated on day of discharge was 2-fold higher in the POSH cohort (p = 0.04). Compared with the non-POSH cohort, the majority of patients in the POSH cohort were discharged to home (24% vs 54%; p = 0.01).

CONCLUSIONS

Geriatric comanagement reduces the incidence of postoperative complications, shortens the duration of in-hospital stay, and contributes to improved perioperative functional status in elderly patients undergoing elective spinal surgery for the correction of adult degenerative scoliosis.

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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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Owoicho Adogwa, Scott L. Parker, David Shau, Stephen K. Mendelhall, Joseph Cheng, Oran Aaronson, Clinton J. Devin and Matthew J. McGirt

Object

The number of low-back fusion procedures for the treatment of spine disorders has increased steadily over the past 10 years. Lumbar pseudarthrosis is a potential complication of lumbar arthrodesis and can be associated with significant pain and disability. The aim of this study was to assess, using validated patient-reported outcomes measures, the long-term effectiveness of revision arthrodesis in the treatment of symptomatic pseudarthrosis.

Methods

This is a retrospective study of 47 patients who underwent revision lumbar arthrodesis for pseudarthrosis-associated back pain. Baseline 2-year outcomes were assessed using the following: visual analog scale (VAS) for back pain, Oswestry Disability Index (ODI), Zung Self-Rating Depression Scale, time to narcotic independence, time to return to work, EuroQol health-state utility, and physical and mental quality of life (Short Form [SF]–12 Physical and Mental Component Summary scores).

Results

The mean duration of time between prior fusion and development of symptomatic pseudarthrosis was 2.69 years. Bone morphogenetic protein was used in 4 cases (8.5%) of revision arthrodesis. A significant improvement in VAS back pain (7.31 ± 0.81 vs 5.06 ± 2.64, p = 0.001), ODI (29.74 ± 5.35 vs 25.42 ± 6.0, p = 0.001), and physical health SF-12 (23.83 ± 6.89 vs 27.85 ± 8.90, p = 0.001) scores was observed when comparing baseline and 2-year post–revision arthrodesis scores, respectively, with a mean cumulative 2-year gain of 0.35 quality-adjusted life years. The median time to narcotics independence was 12.16 (interquartile range 1.5–24.0) months and the median time to return to work was 4 months (interquartile range 3–5 months). By 2 years after revision surgery, no patients had experienced pseudarthrosis. The SF-12 Mental Component Summary (44.72 ± 7.90 vs 43.46 ± 7.51, p = 0.43) and Zung Self-Rating Depression Scale scores (39.36 ± 7.48 vs 41.39 ± 10.72, p = 0.37) were not significantly improved by 2 years.

Conclusions

The authors' study suggests that revision lumbar arthrodesis for symptomatic pseudarthrosis provides improvement in low-back pain, disability, and quality of life. Revision lumbar arthrodesis should be considered a viable treatment option for patients with pseudarthrosis-related back pain. Mental health symptoms from pseudarthrosis-associated back pain may be more refractory to revision surgery.