Publications by authors named "Regis W Haid"

62 Publications

Neurosurgery Research and Education Foundation funding conversion to National Institutes of Health funding.

J Neurosurg 2021 Jun 11:1-8. Epub 2021 Jun 11.

1Department of Neurological Surgery, Ohio State University Wexner Medical Center, Columbus, Ohio.

Objective: The Neurosurgery Research and Education Foundation (NREF) provides research support for in-training and early career neurosurgeon-scientists. To define the impact of this funding, the authors assessed the success of NREF awardees in obtaining subsequent National Institutes of Health (NIH) funding.

Methods: NREF in-training (Research Fellowship [RF] for residents) and early career awards/awardees (Van Wagenen Fellowship [VW] and Young Clinician Investigator [YCI] award for neurosurgery faculty) were analyzed. NIH funding was defined by individual awardees using the NIH Research Portfolio Online Reporting tool (1985-2014).

Results: Between 1985 and 2014, 207 unique awardees were supported by 218 NREF awards ($9.84 million [M] in funding), including 117 RF ($6.02 M), 32 VW ($1.68 M), and 69 YCI ($2.65 M) awards. Subspecialty funding included neuro-oncology (79 awards; 36% of RF, VW, and YCI awards), functional (53 awards; 24%), vascular (37 awards; 17%), spine (22 awards; 10%), pediatrics (18 awards; 8%), trauma/critical care (5 awards; 2%), and peripheral nerve (4 awards; 2%). These awardees went on to receive $353.90 M in NIH funding that resulted in an overall NREF/NIH funding ratio of 36.0:1 (in dollars). YCI awardees most frequently obtained later NIH funding (65%; $287.27 M), followed by VW (56%; $41.10 M) and RF (31%; $106.59 M) awardees. YCI awardees had the highest NREF/NIH funding ratio (108.6:1), followed by VW (24.4:1) and RF (17.7:1) awardees. Subspecialty awardees who went on to obtain NIH funding included vascular (19 awardees; 51% of vascular NREF awards), neuro-oncology (40 awardees; 51%), pediatrics (9 awardees; 50%), functional (25 awardees; 47%), peripheral nerve (1 awardees; 25%), trauma/critical care (2 awardees; 20%), and spine (2 awardees; 9%) awardees. Subspecialty NREF/NIH funding ratios were 56.2:1 for vascular, 53.0:1 for neuro-oncology, 47.6:1 for pediatrics, 34.1:1 for functional, 22.2:1 for trauma/critical care, 9.5:1 for peripheral nerve, and 0.4:1 for spine. Individuals with 2 NREF awards achieved a higher NREF/NIH funding ratio (83.3:1) compared to those with 1 award (29.1:1).

Conclusions: In-training and early career NREF grant awardees are an excellent investment, as a significant portion of these awardees go on to obtain NIH funding. Moreover, there is a potent multiplicative impact of NREF funding converted to NIH funding that is related to award type and subspecialty.
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http://dx.doi.org/10.3171/2020.11.JNS203871DOI Listing
June 2021

Introduction. Biologics in spine surgery.

Neurosurg Focus 2021 Jun;50(6):E1

6Department of Neurosurgery, University of Utah, Salt Lake City, Utah.

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http://dx.doi.org/10.3171/2021.3.FOCUS21171DOI Listing
June 2021

Patient-reported outcome improvements at 24-month follow-up after fusion added to decompression for grade I degenerative lumbar spondylolisthesis: a multicenter study using the Quality Outcomes Database.

J Neurosurg Spine 2021 Apr 16:1-10. Epub 2021 Apr 16.

16Department of Neurological Surgery, University of California, San Francisco, California.

Objective: The ideal surgical management of grade I lumbar spondylolisthesis has not been determined despite extensive prior investigations. In this cohort study, the authors used data from the large, multicenter, prospectively collected Quality Outcomes Database to bridge the gap between the findings in previous randomized trials and those in a more heterogeneous population treated in a typical practice. The objective was to assess the difference in patient-reported outcomes among patients undergoing decompression alone or decompression plus fusion.

Methods: The primary outcome measure was change in 24-month Oswestry Disability Index (ODI) scores. The minimal clinically important difference (MCID) in ODI score change and 30% change in ODI score at 24 months were also evaluated. After adjusting for patient-specific and clinical factors, multivariable linear and logistic regressions were employed to evaluate the impact of fusion on outcomes. To account for differences in age, sex, body mass index, and baseline listhesis, a sensitivity analysis was performed using propensity score analysis to match patients undergoing decompression only with those undergoing decompression and fusion.

Results: In total, 608 patients who had grade I lumbar spondylolisthesis were identified (85.5% with at least 24 months of follow-up); 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-month change in ODI score was significantly greater in the fusion plus decompression group than in the decompression-only group (-25.8 ± 20.0 vs -15.2 ± 19.8, p < 0.001). Fusion remained independently associated with 24-month ODI score change (B = -7.05, 95% CI -10.70 to -3.39, p ≤ 0.001) in multivariable regression analysis, as well as with achieving the MCID for the ODI score (OR 1.767, 95% CI 1.058-2.944, p = 0.029) and 30% change in ODI score (OR 2.371, 95% CI 1.286-4.371, p = 0.005). Propensity score analysis resulted in 94 patients in the decompression-only group matched 1 to 1 with 94 patients in the fusion group. The addition of fusion to decompression remained a significant predictor of 24-month change in the ODI score (B = 2.796, 95% CI 2.228-13.275, p = 0.006) and of achieving the 24-month MCID ODI score (OR 2.898, 95% CI 1.214-6.914, p = 0.016) and 24-month 30% change in ODI score (OR 2.300, 95% CI 1.014-5.216, p = 0.046).

Conclusions: These results suggest that decompression plus fusion in patients with grade I lumbar spondylolisthesis may be associated with superior outcomes at 24 months compared with decompression alone, both in reduction of disability and in achieving clinically meaningful improvement. Longer-term follow-up is warranted to assess whether this effect is sustained.
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http://dx.doi.org/10.3171/2020.9.SPINE201082DOI Listing
April 2021

"July Effect" Revisited: July Surgeries at Residency Training Programs are Associated with Equivalent Long-term Clinical Outcomes Following Lumbar Spondylolisthesis Surgery.

Spine (Phila Pa 1976) 2021 Jun;46(12):836-843

Department of Neurological Surgery, University of California, San Francisco, Ca.

Study Design: Retrospective analysis of a prospective registry.

Objective: We utilized the Quality Outcomes Database (QOD) registry to investigate the "July Effect" at QOD spondylolisthesis module sites with residency trainees.

Summary Of Background Data: There is a paucity of investigation on the long-term outcomes following surgeries involving new trainees utilizing high-quality, prospectively collected data.

Methods: This was an analysis of 608 patients who underwent single-segment surgery for grade 1 degenerative lumbar spondylolisthesis at 12 high-enrolling sites. Surgeries were classified as occurring in July or not in July (non-July). Outcomes collected included estimated blood loss, length of stay, operative time, discharge disposition, complications, reoperation and readmission rates, and patient-reported outcomes (Oswestry Disability Index [ODI], Numeric Rating Scale [NRS] Back Pain, NRS Leg Pain, EuroQol-5D [EQ-5D] and the North American Spine Society [NASS] Satisfaction Questionnaire). Propensity score-matched analyses were utilized to compare postoperative outcomes and complication rates between the July and non-July groups.

Results: Three hundred seventy-one surgeries occurred at centers with a residency training program with 21 (5.7%) taking place in July. In propensity score-matched analyses, July surgeries were associated with longer operative times ( average treatment effect = 22.4 minutes longer, 95% confidence interval 0.9-449.0, P = 0.041). Otherwise, July surgeries were not associated with significantly different outcomes for the remaining perioperative parameters (estimated blood loss, length of stay, discharge disposition, postoperative complications), overall reoperation rates, 3-month readmission rates, and 24-month ODI, NRS back pain, NRS leg pain, EQ-5D, and NASS satisfaction score (P > 0.05, all comparisons).

Conclusion: Although July surgeries were associated with longer operative times, there were no associations with other clinical outcomes compared to non-July surgeries following lumbar spondylolisthesis surgery. These findings may be due to the increased attending supervision and intraoperative education during the beginning of the academic year. There is no evidence that the influx of new trainees in July significantly affects long-term patient-centered outcomes.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003903DOI Listing
June 2021

Chronicling the philanthropic arm of neurological surgery: a review of the growth and development of the Neurosurgery Research & Education Foundation.

J Neurosurg 2020 Aug 7:1-8. Epub 2020 Aug 7.

8Atlanta Brain and Spine Care, Atlanta, Georgia.

Objective: The Neurosurgery Research & Education Foundation (NREF), previously known as the Research Foundation of the American Association of Neurological Surgeons (AANS), was established in 1980 to encourage and facilitate innovation through financial support to young neurosurgeons in the process of honing their competencies in neurosciences and neurological surgery. This article provides a historical overview of NREF, its mission, and charitable contributions and the ever-expanding avenues for neurosurgeons, neurosurgical residents and fellows, and medical students to supplement clinical training and to further neurosurgical research advances.

Methods: Data were collected from the historical archives of the AANS and NREF website. Available data included tabulated revenue, geographic and institutional records of funding, changes in funding for fellowships and awards, advertising methods, and sources of funding.

Results: Since 1984, NREF has invested more than $23 million into the future of neurosurgery. To date, NREF has provided more than 500 fellowship opportunities which have funded neurosurgeons' education and research efforts at all stages of training and practice.

Conclusions: NREF is designed to serve as the vehicle through which the neurosurgical community fosters the continued excellence in the care of patients with neurosurgical diseases.
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http://dx.doi.org/10.3171/2020.5.JNS201474DOI Listing
August 2020

Patients with a depressive and/or anxiety disorder can achieve optimum Long term outcomes after surgery for grade 1 spondylolisthesis: Analysis from the quality outcomes database (QOD).

Clin Neurol Neurosurg 2020 10 17;197:106098. Epub 2020 Jul 17.

Department of Neurologic Surgery, University of Michigan, Ann Arbor, Michigan, United States.

Introduction: In the current study, we sought to compare baseline demographic, clinical, and operative characteristics, as well as baseline and follow-up patient reported outcomes (PROs) of patients with any depressive and/or anxiety disorder undergoing surgery for low-grade spondylolisthesis using a national spine registry.

Patients And Methods: The Quality Outcomes Database (QOD) was queried for patients undergoing surgery for Meyerding grade 1 lumbar spondylolisthesis undergoing 1-2 level decompression or 1 level fusion at 12 sites with the highest number of patients enrolled in QOD with 2-year follow-up data.

Results: Of the 608 patients identified, 25.6 % (n = 156) had any depressive and/or anxiety disorder. Patients with a depressive/anxiety disorder were less likely to be discharged home (p < 0.001). At 3=months, patients with a depressive/anxiety disorder had higher back pain (p < 0.001), lower quality of life (p < 0.001) and higher disability (p = 0.013); at 2 year patients with depression and/or anxiety had lower quality of life compared to those without (p < 0.001). On multivariable regression, depression was associated with significantly lower odds of achieving 20 % or less ODI (OR 0.44, 95 % CI 0.21-0.94,p = 0.03). Presence of an anxiety disorder was not associated with decreased odds of achieving that milestone at 3 months. The presence of depressive-disorder, anxiety-disorder or both did not have an impact on ODI at 2 years. Finally, patient satisfaction at 2-years did not differ between the two groups (79.8 % vs 82.7 %,p = 0.503).

Conclusion: We found that presence of a depressive-disorder may impact short-term outcomes among patients undergoing surgery for low grade spondylolisthesis but longer term outcomes are not affected by either a depressive or anxiety disorder.
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http://dx.doi.org/10.1016/j.clineuro.2020.106098DOI Listing
October 2020

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 Jun 4. Epub 2020 Jun 4.

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated.

Objective: To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis.

Methods: A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change.

Results: The mean age was 64.2 ± 11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [-12.9 to -2.6]; P = .003), NRS back pain change (β -1.2; 95% CI [-2.1 to -0.4]; P = .004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 3.7; 95% CI [1.7-8.3]; P < .001). Increasing age was associated with superior NRS leg pain change (β -0.1; 95% CI [-0.1 to -0.01]; P = .03) and NASS satisfaction (OR = 1.05; 95% CI [1.01-1.09]; P = .02). Fusion surgeries were associated with superior ODI change (β -6.7; 95% CI [-12.7 to -0.7]; P = .03), NRS back pain change (β -1.1; 95% CI [-2.1 to -0.2]; P = .02), and NASS satisfaction (OR = 3.6; 95% CI [1.6-8.3]; P = .002).

Conclusion: Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.
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http://dx.doi.org/10.1093/neuros/nyaa206DOI Listing
June 2020

A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database.

Neurosurgery 2020 09;87(3):555-562

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness.

Objective: To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size.

Methods: We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively.

Results: A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P < .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P < .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P < .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P > .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = -4.7; 95% CI = -9.3 to -0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance.

Conclusion: For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.
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http://dx.doi.org/10.1093/neuros/nyaa097DOI Listing
September 2020

Open versus minimally invasive decompression for low-grade spondylolisthesis: analysis from the Quality Outcomes Database.

J Neurosurg Spine 2020 May 8:1-11. Epub 2020 May 8.

5Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

Objective: Lumbar decompression without arthrodesis remains a potential treatment option for cases of low-grade spondylolisthesis (i.e., Meyerding grade I). Minimally invasive surgery (MIS) techniques have recently been increasingly used because of their touted benefits including lower operating time, blood loss, and length of stay. Herein, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics and postoperative clinical and patient-reported outcomes (PROs) between patients undergoing open versus MIS lumbar decompression.

Methods: The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Among more than 200 participating sites, the 12 with the highest enrollment of patients into the lumbar spine module came together to initiate a focused project to assess the impact of fusion on PROs in patients undergoing surgery for grade I lumbar spondylolisthesis. For the current study, only patients in this cohort from the 12 highest-enrolling sites who underwent a decompression alone were evaluated and classified as open or MIS (tubular decompression). Outcomes of interest included PROs at 2 years; perioperative outcomes such as blood loss and complications; and postoperative outcomes such as length of stay, discharge disposition, and reoperations.

Results: A total of 140 patients undergoing decompression were selected, of whom 71 (50.7%) underwent MIS and 69 (49.3%) underwent an open decompression. On univariate analysis, the authors observed no significant differences between the 2 groups in terms of PROs at 2-year follow-up, including back pain, leg pain, Oswestry Disability Index score, EQ-5D score, and patient satisfaction. On multivariable analysis, compared to MIS, open decompression was associated with higher satisfaction (OR 7.5, 95% CI 2.41-23.2, p = 0.0005). Patients undergoing MIS decompression had a significantly shorter length of stay compared to the open group (0.68 days [SD 1.18] vs 1.83 days [SD 1.618], p < 0.001).

Conclusions: In this multiinstitutional prospective study, the authors found comparable PROs as well as clinical outcomes at 2 years between groups of patients undergoing open or MIS decompression for low-grade spondylolisthesis.
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http://dx.doi.org/10.3171/2020.3.SPINE191239DOI Listing
May 2020

Correlation of return to work with patient satisfaction after surgery for lumbar spondylolisthesis: an analysis of the Quality Outcomes Database.

Neurosurg Focus 2020 05;48(5):E5

17Geisinger Health, Danville, Pennsylvania.

Objective: Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction.

Methods: The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW.

Results: Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1-2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3-4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]).

Conclusions: There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.
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http://dx.doi.org/10.3171/2020.2.FOCUS191022DOI Listing
May 2020

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

Neurosurg Focus 2020 05;48(5):E2

4Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: "1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated 'risk models' to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies." The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).
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http://dx.doi.org/10.3171/2020.2.FOCUS207DOI Listing
May 2020

Assessing the differences in characteristics of patients lost to follow-up at 2 years: results from the Quality Outcomes Database study on outcomes of surgery for grade I spondylolisthesis.

J Neurosurg Spine 2020 Feb 28:1-9. Epub 2020 Feb 28.

4Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

Objective: Loss to follow-up has been shown to bias outcomes assessment among studies utilizing clinical registries. Here, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics of patients captured with those lost to follow-up at 2 years.

Methods: The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes (PROs) among patients with grade I spondylolisthesis were evaluated.

Results: Of the 608 patients enrolled in the study undergoing 1- or 2-level decompression (23.0%, n = 140) or 1-level fusion (77.0%, n = 468), 14.5% (n = 88) were lost to follow-up at 2 years. Patients who were lost to follow-up were more likely to be younger (59.6 ± 13.5 vs 62.6 ± 11.7 years, p = 0.031), be employed (unemployment rate: 53.3% [n = 277] for successful follow-up vs 40.9% [n = 36] for those lost to follow-up, p = 0.017), have anxiety (26.1% [n = 23] vs 16.3% [n = 85], p = 0.026), have higher back pain scores (7.4 ± 2.9 vs 6.6 ± 2.8, p = 0.010), have higher leg pain scores (7.4 ± 2.5 vs 6.4 ± 2.9, p = 0.003), have higher Oswestry Disability Index scores (50.8 ± 18.7 vs 46 ± 16.8, p = 0.018), and have lower EQ-5D scores (0.481 ± 0.2 vs 0.547 ± 0.2, p = 0.012) at baseline.

Conclusions: To execute future, high-quality studies, it is important to identify patients undergoing surgery for spondylolisthesis who might be lost to follow-up. In a large, prospective registry, the authors found that those lost to follow-up were more likely to be younger, be employed, have anxiety disorder, and have worse PRO scores.
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http://dx.doi.org/10.3171/2019.12.SPINE191155DOI Listing
February 2020

Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database.

Spine (Phila Pa 1976) 2020 Jul;45(14):1000-1008

Department of Neurological Surgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, UT.

Study Design: Prospective database analysis.

Objective: To assess the effect of age on patient-reported outcomes (PROs) and complication rates after surgical treatment for spondylolisthesis SUMMARY OF BACKGROUND DATA.: Degenerative lumbar spondylolisthesis affects 3% to 20% of the population and up to 30% of the elderly. There is not yet consensus on whether age is a contraindication for surgical treatment of elderly patients.

Methods: The Quality Outcomes Database lumbar registry was used to evaluate patients from 12 US academic and private centers who underwent surgical treatment for grade 1 lumbar spondylolisthesis between July 2014 and June 2016.

Results: A total of 608 patients who fit the inclusion criteria were categorized by age into the following groups: less than 60 (n = 239), 60 to 70 (n = 209), 71 to 80 (n = 128), and more than 80 (n = 32) years. Older patients showed lower mean body mass index (P < 0.001) and higher rates of diabetes (P = 0.007), coronary artery disease (P = 0.0001), and osteoporosis (P = 0.005). A lower likelihood for home disposition was seen with higher age (89.1% in <60-year-old vs. 75% in >80-year-old patients; P = 0.002). There were no baseline differences in PROs (Oswestry Disability Index, EuroQol health survey [EQ-5D], Numeric Rating Scale for leg pain and back pain) among age categories. A significant improvement for all PROs was seen regardless of age (P < 0.05), and most patients met minimal clinically important differences (MCIDs) for improvement in postoperative PROs. No differences in hospital readmissions or reoperations were seen among age groups (P < 0.05). Multivariate analysis demonstrated that, after controlling other variables, a higher age did not decrease the odds of achieving MCID at 12 months for the PROs.

Conclusion: Our results indicate that well-selected elderly patients undergoing surgical treatment of grade 1 spondylolisthesis can achieve meaningful outcomes. This modern, multicenter US study reflects the current use and limitations of spondylolisthesis treatment in the elderly, which may be informative to patients and providers.

Level Of Evidence: 4.
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http://dx.doi.org/10.1097/BRS.0000000000003441DOI Listing
July 2020

Deformity Correction Through the Use of Reduction Towers: 2-Dimensional Operative Video.

Oper Neurosurg (Hagerstown) 2020 08;19(2):E157-E158

Duke Medical Center, Department: Duke Spine Center, Durham, North Carolina.

Spinal deformity management can be difficult. The decision for surgery, approach, number of levels, and surgical technique all present challenges. Even when other issues are managed appropriately the process of how to correct the deformity needs special consideration. Numerous techniques have been studied including vertebra-to-rod, rod de-rotation, 3-rod-techniques, and cantilever maneuvers. While cantilever is the preferred technique when treating sagittal plane deformity, scoliosis often requires a combination of techniques due to the complexity of deformity in coronal and transverse planes. This video illustrates an adult scoliosis correction using sequential reduction towers and de-rotation techniques. Using this method the step of hook holders is eliminated and tension is distributed evenly across the rod using sequential reduction of the reduction towers across the length of the rod. This has led to a very efficient correction of our deformity as well as a powerful de-rotation tool. We routinely use this technique for flexible and rigid deformities, which is assessed pre-op with a computed tomography. The patient is a 67-yr-old female with prior lumbar decompressions and worsening back pain with radiculopathy. No significant sagittal malalignment is present but pelvic tilt is elevated and a coronal deformity exists. pelvic incidence measures 59°, LL50°, PT28° and lumbar scoliosis shows a coronal Cobb angle of 50.8°. Briefly, surgery involved transpedicular instrumentation from T10-S1 with bilateral iliac screw fixation. To achieve mobility posterior column osteotomies were performed at T12-L1, L1-2, L2-3, L3-4, L4-5, and L5-S1 levels. TLIF was performed at L4-5, L5-S1 for fusion. Postoperative scoliosis X-rays demonstrated improved sagittal and coronal alignment with PI59°, LL59°, PT22°, and coronal Cobb angle of 12°.
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http://dx.doi.org/10.1093/ons/opz356DOI Listing
August 2020

Predictors of nonroutine discharge among patients undergoing surgery for grade I spondylolisthesis: insights from the Quality Outcomes Database.

J Neurosurg Spine 2019 Dec 6:1-10. Epub 2019 Dec 6.

4Department of Neurological Surgery, University of Utah, Salt Lake City, Utah.

Objective: Discharge to an inpatient rehabilitation facility or another acute-care facility not only constitutes a postoperative challenge for patients and their care team but also contributes significantly to healthcare costs. In this era of changing dynamics of healthcare payment models in which cost overruns are being increasingly shifted to surgeons and hospitals, it is important to better understand outcomes such as discharge disposition. In the current article, the authors sought to develop a predictive model for factors associated with nonroutine discharge after surgery for grade I spondylolisthesis.

Methods: The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis who underwent a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes among patients with grade I spondylolisthesis were evaluated. Nonroutine discharge was defined as those who were discharged to a postacute or nonacute-care setting in the same hospital or transferred to another acute-care facility.

Results: Of the 608 patients eligible for inclusion, 9.4% (n = 57) had a nonroutine discharge (8.7%, n = 53 discharged to inpatient postacute or nonacute care in the same hospital and 0.7%, n = 4 transferred to another acute-care facility). Compared to patients who were discharged to home, patients who had a nonroutine discharge were more likely to have diabetes (26.3%, n = 15 vs 15.7%, n = 86, p = 0.039); impaired ambulation (26.3%, n = 15 vs 10.2%, n = 56, p < 0.001); higher Oswestry Disability Index at baseline (51 [IQR 42-62.12] vs 46 [IQR 34.4-58], p = 0.014); lower EuroQol-5D scores (0.437 [IQR 0.308-0.708] vs 0.597 [IQR 0.358-0.708], p = 0.010); higher American Society of Anesthesiologists score (3 or 4: 63.2%, n = 36 vs 36.7%, n = 201, p = 0.002); and longer length of stay (4 days [IQR 3-5] vs 2 days [IQR 1-3], p < 0.001); and were more likely to suffer a complication (14%, n = 8 vs 5.6%, n = 31, p = 0.014). On multivariable logistic regression, factors found to be independently associated with higher odds of nonroutine discharge included older age (interquartile OR 9.14, 95% CI 3.79-22.1, p < 0.001), higher body mass index (interquartile OR 2.04, 95% CI 1.31-3.25, p < 0.001), presence of depression (OR 4.28, 95% CI 1.96-9.35, p < 0.001), fusion surgery compared with decompression alone (OR 1.3, 95% CI 1.1-1.6, p < 0.001), and any complication (OR 3.9, 95% CI 1.4-10.9, p < 0.001).

Conclusions: In this multisite study of a defined cohort of patients undergoing surgery for grade I spondylolisthesis, factors associated with higher odds of nonroutine discharge included older age, higher body mass index, presence of depression, and occurrence of any complication.
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http://dx.doi.org/10.3171/2019.9.SPINE19644DOI Listing
December 2019

Sexual Dysfunction: Prevalence and Prognosis in Patients Operated for Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 08;87(2):200-210

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: There is a paucity of investigation on the impact of spondylolisthesis surgery on back pain-related sexual inactivity.

Objective: To investigate predictors of improved sex life postoperatively by utilizing the prospective Quality Outcomes Database (QOD) registry.

Methods: A total of 218 patients who underwent surgery for grade 1 degenerative lumbar spondylolisthesis were included who were sexually active. Sex life was assessed by Oswestry Disability Index item 8 at baseline and 24-mo follow-up.

Results: Mean age was 58.0 ± 11.0 yr, and 108 (49.5%) patients were women. At baseline, 178 patients (81.7%) had sex life impairment. At 24 mo, 130 patients (73.0% of the 178 impaired) had an improved sex life. Those with improved sex lives noted higher satisfaction with surgery (84.5% vs 64.6% would undergo surgery again, P = .002). In multivariate analyses, lower body mass index (BMI) was associated with improved sex life (OR = 1.14; 95% CI [1.05-1.20]; P < .001). In the younger patients (age < 57 yr), lower BMI remained the sole significant predictor of improvement (OR = 1.12; 95% CI [1.03-1.23]; P = .01). In the older patients (age ≥ 57 yr)-in addition to lower BMI (OR = 1.12; 95% CI [1.02-1.27]; P = .02)-lower American Society of Anesthesiologists (ASA) grades (1 or 2) (OR = 3.7; 95% CI [1.2-12.0]; P = .02) and ≥4 yr of college education (OR = 3.9; 95% CI [1.2-15.1]; P = .03) were predictive of improvement.

Conclusion: Over 80% of patients who present for surgery for degenerative lumbar spondylolisthesis report a negative effect of the disease on sex life. However, most patients (73%) report improvement postoperatively. Sex life improvement was associated with greater satisfaction with surgery. Lower BMI was predictive of improved sex life. In older patients-in addition to lower BMI-lower ASA grade and higher education were predictive of improvement.
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http://dx.doi.org/10.1093/neuros/nyz406DOI Listing
August 2020

A comparison of minimally invasive transforaminal lumbar interbody fusion and decompression alone for degenerative lumbar spondylolisthesis.

Neurosurg Focus 2019 05;46(5):E13

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVEThe optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.METHODSA total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.RESULTSThe mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF-as opposed to MIS decompression alone-was associated with superior ODI change (β = -7.59, 95% CI -14.96 to -0.23; p = 0.04), NRS back pain change (β = -1.54, 95% CI -2.78 to -0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12-0.82; p = 0.02).CONCLUSIONSFor symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.
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http://dx.doi.org/10.3171/2019.2.FOCUS18722DOI Listing
May 2019

Predictive model for long-term patient satisfaction after surgery for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

Neurosurg Focus 2019 05;46(5):E12

13Atlanta Brain and Spine Care, Atlanta, Georgia; and.

OBJECTIVESince the enactment of the Affordable Care Act in 2010, providers and hospitals have increasingly prioritized patient-centered outcomes such as patient satisfaction in an effort to adapt the "value"-based healthcare model. In the current study, the authors queried a prospectively maintained multiinstitutional spine registry to construct a predictive model for long-term patient satisfaction among patients undergoing surgery for Meyerding grade I lumbar spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients undergoing surgery for grade I lumbar spondylolisthesis between July 1, 2014, and June 30, 2016. The primary outcome of interest for the current study was patient satisfaction as measured by the North American Spine Surgery patient satisfaction index, which is measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. In order to identify predictors of higher satisfaction, the authors fitted a multivariable proportional odds logistic regression model for ≥ 2 years of patient satisfaction after adjusting for an array of clinical and patient-specific factors. The absolute importance of each covariate in the model was computed using an importance metric defined as Wald chi-square penalized by the predictor degrees of freedom.RESULTSA total of 502 patients, out of a cohort of 608 patients (82.5%) with grade I lumbar spondylolisthesis, undergoing either 1- or 2-level decompression (22.5%, n = 113) or 1-level decompression and fusion (77.5%, n = 389), met the inclusion criteria; of these, 82.1% (n = 412) were satisfied after 2 years. On univariate analysis, satisfied patients were more likely to be employed and working (41.7%, n = 172, vs 24.4%, n = 22; overall p = 0.001), more likely to present with predominant leg pain (23.1%, n = 95, vs 11.1%, n = 10; overall p = 0.02) but more likely to present with lower Numeric Rating Scale score for leg pain (median and IQR score: 7 [5-9] vs 8 [6-9]; p = 0.05). Multivariable proportional odds logistic regression revealed that older age (OR 1.57, 95% CI 1.09-2.76; p = 0.009), preoperative active employment (OR 2.06, 95% CI 1.27-3.67; p = 0.015), and fusion surgery (OR 2.3, 95% CI 1.30-4.06; p = 0.002) were the most important predictors of achieving satisfaction with surgical outcome.CONCLUSIONSCurrent findings from a large multiinstitutional study indicate that most patients undergoing surgery for grade I lumbar spondylolisthesis achieved long-term satisfaction. Moreover, the authors found that older age, preoperative active employment, and fusion surgery are associated with higher odds of achieving satisfaction.
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http://dx.doi.org/10.3171/2019.2.FOCUS18734DOI Listing
May 2019

Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.

J Neurosurg Spine 2018 11;30(2):234-241

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVEThe AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.
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http://dx.doi.org/10.3171/2018.8.SPINE17913DOI Listing
November 2018

Obese Patients Benefit, but do not Fare as Well as Nonobese Patients, Following Lumbar Spondylolisthesis Surgery: An Analysis of the Quality Outcomes Database.

Neurosurgery 2020 01;86(1):80-87

Department of Neurological Surgery, University of California, San Francisco, California.

Background: Given recent differing findings following 2 randomized clinical trials on degenerative lumbar spondylolisthesis (DLS) surgery, there is a need to better define how subsets of patients fare following surgery.

Objective: To investigate the impact of obesity on patient-reported outcomes (PROs) following DLS surgery.

Methods: A total of 12 high-enrolling sites were queried, and we found 797 patients undergoing surgery for grade 1 DLS. For univariate comparisons, patients were stratified by BMI ≥ 30 kg/m2 (obese) and < 30 kg/m2 (nonobese). Baseline, 3-mo, and 12-mo follow-up parameters were collected. PROs included the North American Spine Society satisfaction questionnaire, numeric rating scale (NRS) back pain, NRS leg pain, Oswestry Disability Index (ODI), and EuroQoL-5D (EQ-5D) Questionnaire.

Results: We identified 382 obese (47.9%) and 415 nonobese patients (52.1%). At baseline, obese patients had worse NRS back pain, NRS leg pain, ODI, and EQ-5D scores (P < .001, P = .01, P < .001, and P = .02, respectively). Both cohorts improved significantly for back and leg pain, ODI, and EQ-5D at 12 mo (P < .001). At 12 mo, similar proportions of obese and nonobese patients responded that surgery met their expectations (62.6% vs 67.4%, P = .24). In multivariate analyses, BMI was independently associated with worse NRS leg pain and EQ-5D at 12 mo (P = .01 and P < .01, respectively) despite adjusting for baseline differences.

Conclusion: Obesity is associated with inferior leg pain and quality of life-but similar back pain, disability, and satisfaction-12 mo postoperatively. However, obese patients achieve significant improvements in all PRO metrics at 12 mo.
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http://dx.doi.org/10.1093/neuros/nyy589DOI Listing
January 2020

Women fare best following surgery for degenerative lumbar spondylolisthesis: a comparison of the most and least satisfied patients utilizing data from the Quality Outcomes Database.

Neurosurg Focus 2018 01;44(1):E3

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVE The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis. METHODS This was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of "1" and "4," respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment. RESULTS Four hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all). CONCLUSIONS This study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.
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http://dx.doi.org/10.3171/2017.10.FOCUS17553DOI Listing
January 2018

The effect of posterior polyester tethers on the biomechanics of proximal junctional kyphosis: a finite element analysis.

J Neurosurg Spine 2017 Jan 9;26(1):125-133. Epub 2016 Sep 9.

Atlanta Brain and Spine Care, Atlanta, Georgia.

OBJECTIVE Proximal junctional kyphosis (PJK) remains problematic following multilevel instrumented spine surgery. Previous biomechanical studies indicate that providing less rigid fixation at the cranial aspect of a long posterior instrumented construct, via transition rods or hooks at the upper instrumented vertebra (UIV), may provide a gradual transition to normal motion and prevent PJK. The purpose of this study was to evaluate the ability of posterior anchored polyethylene tethers to distribute proximal motion segment stiffness in long instrumented spine constructs. METHODS A finite element model of a T7-L5 spine segment was created to evaluate range of motion (ROM), intradiscal pressure, pedicle screw loads, and forces in the posterior ligament complex within and adjacent to the proximal terminus of an instrumented spine construct. Six models were tested: 1) intact spine; 2) bilateral, segmental pedicle screws (PS) at all levels from T-11 through L-5; 3) bilateral pedicle screws from T-12 to L-5 and transverse process hooks (TPH) at T-11 (the UIV); 4) pedicle screws from T-11 to L5 and 1-level tethers from T-10 to T-11 (TE-UIV+1); 5) pedicle screws from T-11 to L-5 and 2-level tethers from T-9 to T-11 (TE-UIV+2); and 6) pedicle screws and 3-level tethers from T-8 to T-11 (TE-UIV+3). RESULTS Proximal-segment range of motion (ROM) for the PS construct increased from 16% at UIV-1 to 91% at UIV. Proximal-segment ROM for the TPH construct increased from 27% at UIV-1 to 92% at UIV. Posterior tether constructs distributed ROM at the UIV and cranial adjacent segments most effectively; ROM for TE-UIV+1 was 14% of the intact model at UIV-1, 76% at UIV, and 98% at UIV+1. ROM for TE-UIV+2 was 10% at UIV-1, 51% at UIV, 69% at UIV+1, and 97% at UIV+2. ROM for TE-UIV+3 was 7% at UIV-1, 33% at UIV, 45% at UIV+1, and 64% at UIV+2. Proximal segment intradiscal pressures, pedicle screw loads, and ligament forces in the posterior ligament complex were progressively reduced with increasing number of posterior tethers used. CONCLUSIONS Finite element analysis of long instrumented spine constructs demonstrated that posterior tethers created a more gradual transition in ROM and adjacent-segment stress from the instrumented to the noninstrumented spine compared with all PS and TPH constructs. Posterior tethers may limit the biomechanical risk factor for PJK; however, further clinical research is needed to evaluate clinical efficacy.
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http://dx.doi.org/10.3171/2016.6.SPINE151477DOI Listing
January 2017

Assessment of Impact of Long-Cassette Standing X-Rays on Surgical Planning for Cervical Pathology: An International Survey of Spine Surgeons.

Neurosurgery 2016 May;78(5):717-24

*Department of Neurosurgery, University of Virginia Medical Center, Charlottesville, Virginia;‡Department of Orthopaedic Surgery, University of California Davis Sacramento, California;§Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, New York;¶Department of Orthopaedic Surgery, Rocky Mountain Hospital for Children, Denver, Colorado;‖Department of Orthopaedic Surgery, Warren Alpert School of Medicine, Brown University, Providence, Rhode Island;#Department of Neurosurgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois;**Department of Neurosurgery, University of Kansas Medical Center, Kansas City, Kansas;‡‡Department of Neurosurgery, Atlanta Brain and Spine Care, Atlanta, Georgia;§§Department of Orthopaedic Surgery, Swedish Neuroscience Institute, Seattle, Washington;¶¶Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada;‖‖Department of Neurosurgery, University of California San Francisco, San Francisco, California.

Background: Understanding the role of regional segments of the spine in maintaining global balance has garnered significant attention recently. Long-cassette radiographs (LCR) are necessary to evaluate global spinopelvic alignment. However, it is unclear how LCRs impact operative decision-making for cervical spine pathology.

Objective: To evaluate whether the addition of LCRs results in changes to respondents' operative plans compared to standard imaging of the involved cervical spine in an international survey of spine surgeons.

Methods: Fifteen cases (5 control cases with normal and 10 test cases with abnormal global alignment) of cervical pathology were presented online with a vignette and cervical imaging. Surgeons were asked to select a surgical plan from 6 options, ranging from the least (1 point) to most (6 points) extensive. Cases were then reordered and presented again with LCRs and the same surgical plan question.

Results: One hundred fifty-seven surgeons completed the survey, of which 79% were spine fellowship trained. The mean response scores for surgical plan increased from 3.28 to 4.0 (P = .003) for test cases with the addition of LCRs. However, no significant changes (P = .10) were identified for the control cases. In 4 of the test cases with significant mid thoracic kyphosis, 29% of participants opted for the more extensive surgical options of extension to the mid and lower thoracic spine when they were provided with cervical imaging only, which significantly increased to 58.3% upon addition of LCRs.

Conclusion: In planning for cervical spine surgery, surgeons should maintain a low threshold for obtaining LCRs to assess global spinopelvic alignment.
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http://dx.doi.org/10.1227/NEU.0000000000001128DOI Listing
May 2016

Assessment of impact of standing long-cassette radiographs on surgical planning for lumbar pathology: an international survey of spine surgeons.

J Neurosurg Spine 2015 Nov 31;23(5):581-588. Epub 2015 Jul 31.

Department of Neurosurgery, University of California, San Francisco, California.

OBJECT The associations among global spinal alignment, patient-reported disability, and surgical outcomes have increasingly gained attention. The assessment of global spinal alignment requires standing long-cassette anteroposterior and lateral radiographs; however, spine surgeons routinely rely only on short-segment imaging when evaluating seemingly isolated lumbar pathology. This may prohibit adequate surgical planning and may predispose surgeons to not recognize associated pathology in the thoracic spine and sagittal spinopelvic malalignment. The authors used a case-based survey questionnaire to evaluate if including long-cassette radiographs led to changes to respondents' operative plans as compared with their chosen plan when cases contained standard imaging of the involved lumbar spine only. METHODS A case-based survey was distributed to AOSpine International members that consisted of 15 cases of lumbar spine pathology and lumbar imaging only. The same 15 cases were then shuffled and presented a second time with additional long-cassette radiographs. Each case required participants to select a single operative plan with 5 choices ranging from least to most extensive. The cases included 5 "control" cases with normal global spinal alignment and 10 "test" cases with significant sagittal and/or coronal malalignment. Mean scores were determined for each question with higher scores representing more invasive and/or extensive operative plans. RESULTS Of 712 spine surgeons who started the survey, 316 (44%) completed the entire series, including 68% of surgeons with spine fellowship training and representation from more than 40 countries. For test cases, but not for control cases, there were significantly higher average surgical invasiveness scores for cases presented with long-cassette radiographs (4.2) as compared with those cases with lumbar imaging only (3.4; p = 0.002). The addition of long-cassette radiographs resulted in 82.1% of respondents recommending instrumentation up to the thoracic spine, a 23.2% increase as compared with the same cases presented with lumbar imaging only (p = 0.008). CONCLUSIONS This study demonstrates the importance of maintaining a low threshold for performing standing long-cassette imaging when assessing seemingly isolated lumbar pathology. Such imaging is necessary for the assessment of spinopelvic and global spinal alignment, which can be important in operative planning. Deformity, particularly positive sagittal malalignment, may go undetected unless one maintains a high index of suspicion and obtains long-cassette radiographs. It is recommended that spine surgeons recognize the prevalence and importance of such deformity when contemplating operative intervention.
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http://dx.doi.org/10.3171/2015.1.SPINE14833DOI Listing
November 2015

Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article.

J Neurosurg Spine 2014 Oct 18;21(4):516-28. Epub 2014 Jul 18.

Staff Physician, Spine Service, Wilderness Spine Services, Columbus;

Object: The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up.

Methods: At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months.

Results: Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p < 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs. 24 [11.9%] of 265, respectively).

Conclusions: Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 ( ClinicalTrials.gov ).
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http://dx.doi.org/10.3171/2014.6.SPINE13996DOI Listing
October 2014

Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials.

J Neurosurg Spine 2012 Mar 23;16(3):216-28. Epub 2011 Dec 23.

Department of Neurological Surgery, University of California, San Francisco, California, USA.

Object: There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.

Methods: A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.

Results: The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I(2) = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I(2) = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I(2) = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.

Conclusions: Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.
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http://dx.doi.org/10.3171/2011.6.SPINE10623DOI Listing
March 2012

Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion.

J Neurosurg Spine 2011 May;14(5):619-25

Department of Neurosurgery, Emory University, Atlanta, Georgia, USA.

Object: Cervical stenotic myelopathy due to spondylosis or ossification of the posterior longitudinal ligament is often treated with laminoplasty or cervical laminectomy (with fusion). The goal of this study was to compare outcomes, radiographic results, complications, and implant costs associated with these 2 treatments.

Methods: The authors analyzed the records of 56 patients (age range 42–81 years) who were surgically treated for cervical stenosis. Of this group, 30 underwent laminoplasty and 26 underwent laminectomy with fusion. Patients who had cervical kyphosis or spondylolisthesis were excluded. An average of 4 levels were instrumented in the laminoplasty group and 5 levels in the fusion group (p < 0.01). Forty-two percent of the fusions crossed the cervicothoracic junction, but no laminoplasty instrumentation crossed the cervicothoracic junction, and it only reached C-7 in one-third of the cases. Preoperative and postoperative Nurick grades and modified Japanese Orthopaedic Association (mJOA) scores were obtained. Outcomes were also assessed with neck pain visual analog scale (VAS) scores and the Odom outcome criteria. Postoperative length of stay, complications, and implant costs were calculated.

Results: The mean duration of follow-up, average patient age, and length of hospital stay were similar for both groups. The mean Nurick scores were also similar in the 2 groups and improved an average of 1.4 points in both (p < 0.01 for preoperative-postoperative comparison in each group). The mean mJOA scores improved 2.7 points in laminoplasty patients and 2.8 points in fusion patients (p < 0.01 for each group). The mean VAS scores for neck pain did not change significantly in the laminoplasty cohort (3.2 ± 2.8 [SD] preoperatively vs 3.4 ± 2.6 postoperatively, p = 0.50). In the fusion cohort, the mean VAS scores improved from 5.8 ± 3.2 to 3.0 ± 2.3 (p < 0.01). Excellent or good Odom outcomes were observed in 76.7% of the patients in the laminoplasty cohort and 80.8% of those in the fusion cohort (p = 0.71). In the fusion group, complications were twice as common and implant costs were nearly 3 times as high as in the laminoplasty group. When cases involving fusions crossing the cervicothoracic junction were excluded, analysis showed similar complication rates in the 2 groups.

Conclusions: Patients treated with laminoplasty and patients treated with laminectomy and fusion had similar improvements in Nurick scores, mJOA scores, and Odom outcomes. Patients who underwent fusion typically had higher preoperative neck pain scores, but their neck pain improved significantly after surgery. There was no significant change in the neck pain scores of patients treated with laminoplasty. Our series suggests cervical fusion significantly reduces neck pain in patients with stenotic myelopathy, but that the cost of the implant and rate of reoperation are greater than in laminoplasty.
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http://dx.doi.org/10.3171/2011.1.SPINE10206DOI Listing
May 2011

Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial.

J Neurosurg Spine 2010 Sep;13(3):308-18

Spine Service, Wilderness Spine Services, The Hughston Clinic, Columbus, Georgia, USA.

Object: The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease.

Methods: In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients).

Results: Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3 degrees at 36 months and 6.5 degrees at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels.

Conclusions: The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.
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http://dx.doi.org/10.3171/2010.3.SPINE09513DOI Listing
September 2010

Circumferential fusion for cervical kyphotic deformity.

J Neurosurg Spine 2008 Dec;9(6):515-21

Department of Neurosurgery, University of California, San Francisco, San Francisco, California 94143, USA.

Object: The treatment of cervical kyphotic deformity is challenging. Few prior reports have examined combined anterior/posterior correction methods, and fusion rates and standardized outcomes are rarely cited in literature examining these techniques. The authors present their midterm results with cervical kyphosis correction.

Methods: The authors retrospectively reviewed the charts of 30 patients with cervical kyphotic deformity who underwent circumferential spine surgery between 2001 and 2007. The causes of the deformity included chronic fracture in 17 patients, degenerative disease in 10, and tumor in 3. Anterior procedures included discectomies and corpectomies/osteotomies at 1 or more levels with fusion. Posterior operations included decompression and/or osteotomies with lateral mass or pedicle fixation. Preoperative and postoperative Ishihara kyphosis indices, modified Japanese Orthopaedic Association (mJOA) scores, and Nurick grades were analyzed. Arthrodesis was assessed via dynamic radiographs, and CT scans were used to assess fusion in questionable cases.

Results: One patient was lost to follow-up. Two patients died within 1 month of surgery. The follow-up period in the remaining 27 patients ranged from 1 to 6.4 years (mean 2.6 years). Ishihara indices improved from a preoperative mean of -17.7 to a postoperative mean of +11.4. The mean Nurick grades improved from 3.2 preoperatively to 1.3 postoperatively. The mJOA scores improved from a preoperative mean of 10 to 15 postoperatively. All surviving patients who underwent follow-up showed postoperative fusion except 1 patient with renal failure and osteoporosis (95% fusion rate). The overall rate of complications (major and minor) was 33.3%.

Conclusions: In cases of cervical kyphosis, management with decompression, osteotomy, and stabilization from both anterior and posterior approaches can restore cervical lordosis. Furthermore, such surgical techniques can produce measurable improvements in neurological function (as measured with Nurick grades and mJOA scores) and achieve high fusion rates. However, there is a significant rate of complications.
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http://dx.doi.org/10.3171/SPI.2008.10.08226DOI Listing
December 2008

Cervical arthroplasty with the PRESTIGE LP cervical disc.

Neurosurgery 2007 Apr;60(4 Suppl 2):310-4; discussion 314-5

Department of Neurosurgery, University of California at San Francisco, San Francisco, California 94143, USA.

The technique for anterior cervical arthroplasty using the PRESTIGE LP (Medtronic Sofamor Danek, Memphis, TN) cervical disc is illustrated. Surgical positioning and the operative approach are demonstrated. Our methods of retractor placement and surgical exposure are discussed. The technique used for decompression and endplate preparation is presented in detail. Optimal arthroplasty device positioning is demonstrated. The surgical pearls and pitfalls of anterior cervical arthroplasty are highlighted.
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http://dx.doi.org/10.1227/01.NEU.0000255376.42099.13DOI Listing
April 2007