Publications by authors named "Christopher I Shaffrey"

445 Publications

Patient-related and radiographic predictors of inferior health-related quality-of-life measures in adult patients with nonoperative spinal deformity.

J Neurosurg Spine 2021 Apr 2:1-7. Epub 2021 Apr 2.

3Department of Orthopedics, Hospital for Special Surgery, New York, New York.

Objective: Patients with nonoperative (N-Op) adult spinal deformity (ASD) have inferior long-term spinopelvic alignment and clinical outcomes. Predictors of lower quality-of-life measures in N-Op populations have yet to be sufficiently investigated. The aim of this study was to identify patient-related factors and radiographic parameters associated with inferior health-related quality-of-life (HRQOL) scores in N-Op ASD patients.

Methods: N-Op ASD patients with complete radiographic and outcome data at baseline and 2 years were included. N-Op patients and operative (Op) patients were propensity score matched for baseline disability and deformity. Patient-related factors and radiographic alignment parameters (pelvic tilt [PT], sagittal vertical axis [SVA], pelvic incidence [PI]-lumbar lordosis [LL] mismatch, mismatch between cervical lordosis and T1 segment slope [TS-CL], cervical-thoracic pelvic angle [PA], and others) at baseline and 2 years were analyzed as predictors for moderate to severe 2-year Oswestry Disability Index (ODI > 20) and failing to meet the minimal clinically importance difference (MCID) for 2-year Scoliosis Research Society Outcomes Questionnaire (SRS) scores (< 0.4 increase from baseline). Conditional inference decision trees identified predictors of each HRQOL measure and established cutoffs at which factors have a global effect. Random forest analysis (RFA) generated 5000 conditional inference trees to compute a variable importance table for top predictors of inferior HRQOL. Statistical significance was set at p < 0.05.

Results: Six hundred sixty-two patients with ASD (331 Op patients and 331 N-Op patients) with complete radiographic and HRQOL data at their 2-year follow-up were included. There were no differences in demographics, ODI, and Schwab deformity modifiers between groups at baseline (all p > 0.05). N-Op patients had higher 2-year ODI scores (27.9 vs 20.3, p < 0.001), higher rates of moderate to severe disability (29.3% vs 22.4%, p = 0.05), lower SRS total scores (3.47 vs 3.91, p < 0.001), and higher rates of failure to reach SRS MCID (35.3% vs 15.7%, p < 0.001) than Op patients at 2 years. RFA ranked the top overall predictors for moderate to severe ODI at 2 years for N-Op patients as follows: 1) frailty index > 2.8, 2) BMI > 35 kg/m2, T4PA > 28°, and 4) Charlson Comorbidity Index > 1. Top radiographic predictors were T4PA > 28° and C2-S1 SVA > 93 mm. RFA also ranked the top overall predictors for failure to reach 2-year SRS MCID for N-Op patients, as follows: 1) T12-S1 lordosis > 53°, 2) cervical SVA (cSVA) > 28 mm, 3) C2-S1 angle > 14.5°, 4) TS-CL > 12°, and 5) PT > 23°. The top radiographic predictors were T12-S1 Cobb angle, cSVA, C2-S1 angle, and TS-CL.

Conclusions: When controlling for baseline deformity in N-Op versus Op patients, subsequent deterioration in frailty, BMI, and radiographic progression over a 2-year follow-up were found to drive suboptimal patient-reported outcome measures in N-Op cohorts as measured by validated ODI and SRS clinical instruments.
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http://dx.doi.org/10.3171/2020.9.SPINE20519DOI Listing
April 2021

Timing of conversion to cervical malalignment and proximal junctional kyphosis following surgical correction of adult spinal deformity: a 3-year radiographic analysis.

J Neurosurg Spine 2021 Mar 19:1-9. Epub 2021 Mar 19.

2Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York.

Objective: The goal of this study was to assess the conversion rate from baseline cervical alignment to postoperative cervical deformity (CD) and the corresponding proximal junctional kyphosis (PJK) rate in patients undergoing thoracolumbar adult spinal deformity (ASD) surgery.

Methods: The operative records of patients with ASD with complete radiographic data beginning at baseline up to 3 years were included. Patients with no baseline CD were postoperatively stratified by Ames CD criteria (T1 slope-cervical lordosis mismatch [TS-CL] > 20°, cervical sagittal vertical axis [cSVA] > 40 mm), where CD was defined as fulfilling one or more of the Ames criteria. Severe CD was defined as TS-CL > 30° or cSVA > 60 mm. Follow-up intervals were established after ASD surgery, with 6 weeks postoperatively defined as early; 6 weeks-1 year as intermediate; 1-2 years as late; and 2-3 years as long-term. Descriptive analyses and McNemar tests identified the CD conversion rate, PJK rate (< -10° change in uppermost instrumented vertebra and the superior endplate of the vertebra 2 levels superior to the uppermost instrumented vertebra), and specific alignment parameters that converted.

Results: Two hundred sixty-six patients who underwent ASD surgery (mean age 59.7 years, 77.4% female) met the inclusion criteria; 103 of these converted postoperatively, and the remaining 163 did not meet conversion criteria. Thirty-eight patients converted to CD early, 26 converted at the intermediate time point, 29 converted late, and 10 converted in the long-term. At conversion, the early group had the highest mean TS-CL at 25.4° ± 8.5° and the highest mean cSVA at 33.6 mm-both higher than any other conversion group. The long-term group had the highest mean C2-7 angle at 19.7° and the highest rate of PJK compared to other groups (p = 0.180). The early group had the highest rate of conversion to severe CD, with 9 of 38 patients having severe TS-CL and only 1 patient per group converting to severe cSVA. Seven patients progressed from having only malaligned TS-CL at baseline (with normal cSVA) to CD with both malaligned TS-CL and cSVA by 6 weeks. Conversely, only 2 patients progressed from malaligned cSVA to both malaligned cSVA and TS-CL. By 1 year, the former number increased from 7 to 26 patients, and the latter increased from 2 to 20 patients. The revision rate was highest in the intermediate group at 48.0%, versus the early group at 19.2%, late group at 27.3%, and long-term group at 20% (p = 0.128). A higher pelvic incidence-lumbar lordosis mismatch, lower thoracic kyphosis, and a higher thoracic kyphosis apex immediately postoperatively significantly predicted earlier rather than later conversion (all p < 0.05). Baseline lumbar lordosis, pelvic tilt, and sacral slope were not significant predictors.

Conclusions: Patients with ASD with normative cervical alignment who converted to CD after thoracolumbar surgery had varying radiographic findings based on timing of conversion. Although the highest number of patients converted within 6 weeks postoperatively, patients who converted in the late or long-term follow-up intervals had higher rates of concurrent PJK and greater radiographic progression.
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http://dx.doi.org/10.3171/2020.8.SPINE20320DOI Listing
March 2021

The minimally invasive interbody selection algorithm for spinal deformity.

J Neurosurg Spine 2021 Mar 12:1-8. Epub 2021 Mar 12.

13Department of Neurological Surgery, Weill Cornell Medical College, New York, New York.

Objective: Minimally invasive surgery (MIS) for spinal deformity uses interbody techniques for correction, indirect decompression, and arthrodesis. Selection criteria for choosing a particular interbody approach are lacking. The authors created the minimally invasive interbody selection algorithm (MIISA) to provide a framework for rational decision-making in MIS for deformity.

Methods: A retrospective data set of circumferential MIS (cMIS) for adult spinal deformity (ASD) collected over a 5-year period was analyzed by level in the lumbar spine to identify surgeon preferences and evaluate segmental lordosis outcomes. These data were used to inform a Delphi session of minimally invasive deformity surgeons from which the algorithm was created. The algorithm leads to 1 of 4 interbody approaches: anterior lumbar interbody fusion (ALIF), anterior column release (ACR), lateral lumbar interbody fusion (LLIF), and transforaminal lumbar interbody fusion (TLIF). Preoperative and 2-year postoperative radiographic parameters and clinical outcomes were compared.

Results: Eleven surgeons completed 100 cMISs for ASD with 338 interbody devices, with a minimum 2-year follow-up. The type of interbody approach used at each level from L1 to S1 was recorded. The MIISA was then created with substantial agreement. The surgeons generally preferred LLIF for L1-2 (91.7%), L2-3 (85.2%), and L3-4 (80.7%). ACR was most commonly performed at L3-4 (8.4%) and L2-3 (6.2%). At L4-5, LLIF (69.5%), TLIF (15.9%), and ALIF (9.8%) were most commonly utilized. TLIF and ALIF were the most selected approaches at L5-S1 (61.4% and 38.6%, respectively). Segmental lordosis at each level varied based on the approach, with greater increases reported using ALIF, especially at L4-5 (9.2°) and L5-S1 (5.3°). A substantial increase in lordosis was achieved with ACR at L2-3 (10.9°) and L3-4 (10.4°). Lateral interbody arthrodesis without the use of an ACR did not generally result in significant lordosis restoration. There were statistically significant improvements in lumbar lordosis (LL), pelvic incidence-LL mismatch, coronal Cobb angle, and Oswestry Disability Index at the 2-year follow-up.

Conclusions: The use of the MIISA provides consistent guidance for surgeons who plan to perform MIS for deformity. For L1-4, the surgeons preferred lateral approaches to TLIF and reserved ACR for patients who needed the greatest increase in segmental lordosis. For L4-5, the surgeons' order of preference was LLIF, TLIF, and ALIF, but TLIF failed to demonstrate any significant lordosis restoration. At L5-S1, the surgical team typically preferred an ALIF when segmental lordosis was desired and preferred a TLIF if preoperative segmental lordosis was adequate.
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http://dx.doi.org/10.3171/2020.9.SPINE20230DOI Listing
March 2021

Appropriate Risk Stratification and Accounting for Age-Adjusted Reciprocal Changes in the Thoracolumbar Spine Reduces the Incidence and Magnitude of Distal Junctional Kyphosis in Cervical Deformity Surgery.

Spine (Phila Pa 1976) 2021 Mar 11. Epub 2021 Mar 11.

Department of Orthopedics, NYU Langone Orthopedic Hospital, New York, NY, USA Department of Orthopedics, Hospital for Special Surgery, New York, NY, USA Department of Orthopedic Surgery, SUNY Downstate Medical Center, Brooklyn, NY, USA Department of Orthopaedic Surgery, Rocky Mountain Scoliosis and Spine, Denver, CO Department of Orthopedic Surgery, University of Kansas Medical Center, Kansas City, KS, USA Department of Orthopedic Surgery, University of California, Davis, Davis, CA, USA Department of Orthopaedic Surgery, Warren Alpert School of Medicine, Brown University, Providence, RI, USA San Diego Center for Spinal Disorders, La Jolla, CA, USA Division of Orthopaedic Surgery, Scripps Clinic, La Jolla, CA, USA Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA Department of Neurosurgery, University of Virginia, Charlottesville, VA, USA Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.

Study Design: Retrospective cohort study of a prospective cervical deformity (CD) database.

Objective: Identify factors associated with Distal Junctional Kyphosis (DJK); assess differences across DJK types.

Summary Of Background Data: DJK may develop as compensation for mal-correction of sagittal deformity in the thoracic curve. There is limited understanding of DJK drivers, especially for different DJK types.

Methods: Included: patients with pre- and postoperative clinical/radiographic data. Excluded: patients with previous fusion to L5 or below. DJK was defined per surgeon note or DJK angle (kyphosis from LIV to LIV-2)<-10°, and pre- to postoperative change in DJK angle by<-10°. Age-specific target LL-TK alignment was calculated as published. Offset from target LL-TK was correlated to DJK magnitude and inclination. DJK types: severe (DJK<-20°), progressive (DJK increase>4.4°), symptomatic (reoperation or published disability thresholds of NDI ≥ 24 or mJOA≤14). Random forest identified factors associated with DJK. Means comparison tests assessed differences.

Results: Included: 136 CD patients (61 ± 10yrs, 61%F). DJK rate was 30%. Postop offset from ideal LL-TK correlated with greater DJK angle (r = 0.428) and inclination of the distal end of the fusion construct (r = 0.244, both p < 0.02). Seven of the top 15 factors associated with DJK were radiographic, four surgical, and four clinical. Breakdown by type: severe (22%), progressive (24%), symptomatic (61%). Symptomatic had more posterior osteotomies than asymptomatic (p = 0.018). Severe had worse NDI and upper-cervical deformity (CL, C2 slope, C0-C2), as well as more posterior osteotomies than non-severe (all p < 0.01). Progressive had greater malalignment both globally and in the cervical spine (all p < 0.03) than static. Each type had varying associated factors.

Conclusion: Offset from age-specific alignment is associated with greater DJK and more anterior distal construct inclination, suggesting DJK may develop due to inappropriate realignment. Preoperative clinical and radiographic factors are associated with symptomatic and progressive DJK, suggesting the need for preoperative risk stratification.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000004033DOI Listing
March 2021

Surgical outcomes in rigid versus flexible cervical deformities.

J Neurosurg Spine 2021 Feb 12:1-9. Epub 2021 Feb 12.

13Department of Neurological Surgery, University of California, San Francisco, California.

Objective: Cervical deformity (CD) patients have severe disability and poor health status. However, little is known about how patients with rigid CD compare with those with flexible CD. The main objectives of this study were to 1) assess whether patients with rigid CD have worse baseline alignment and therefore require more aggressive surgical corrections and 2) determine whether patients with rigid CD have similar postoperative outcomes as those with flexible CD.

Methods: This is a retrospective review of a prospective, multicenter CD database. Rigid CD was defined as cervical lordosis (CL) change < 10° between flexion and extension radiographs, and flexible CD was defined as a CL change ≥ 10°. Patients with rigid CD were compared with those with flexible CD in terms of cervical alignment and health-related quality of life (HRQOL) at baseline and at multiple postoperative time points. The patients were also compared in terms of surgical and intraoperative factors such as operative time, blood loss, and number of levels fused.

Results: A total of 127 patients met inclusion criteria (32 with rigid and 95 with flexible CD, 63.4% of whom were females; mean age 60.8 years; mean BMI 27.4); 47.2% of cases were revisions. Rigid CD was associated with worse preoperative alignment in terms of T1 slope minus CL, T1 slope, C2-7 sagittal vertical axis (cSVA), and C2 slope (C2S; all p < 0.05). Postoperatively, patients with rigid CD had an increased mean C2S (29.1° vs 22.2°) at 3 months and increased cSVA (47.1 mm vs 37.5 mm) at 1 year (p < 0.05) compared with those with flexible CD. Patients with rigid CD had more posterior levels fused (9.5 vs 6.3), fewer anterior levels fused (1 vs 2.0), greater blood loss (1036.7 mL vs 698.5 mL), more 3-column osteotomies (40.6% vs 12.6%), greater total osteotomy grade (6.5 vs 4.5), and mean osteotomy grade per level (3.3 vs 2.1) (p < 0.05 for all). There were no significant differences in baseline HRQOL scores, the rate of distal junctional kyphosis, or major/minor complications between patients with rigid and flexible CD. Both rigid and flexible CD patients reported significant improvements from baseline to 1 year according to the numeric rating scale for the neck (-2.4 and -2.7, respectively), Neck Disability Index (-8.4 and -13.3, respectively), modified Japanese Orthopaedic Association score (0.1 and 0.6), and EQ-5D (0.01 and 0.05) (p < 0.05). However, HRQOL changes from baseline to 1 year did not differ between rigid and flexible CD patients.

Conclusions: Patients with rigid CD have worse baseline cervical malalignment compared with those with flexible CD but do not significantly differ in terms of baseline disability. Rigid CD was associated with more invasive surgery and more aggressive corrections, resulting in increased operative time and blood loss. Despite more extensive surgeries, rigid CD patients had equivalent improvements in HRQOL compared with flexible CD patients. This study quantifies the importance of analyzing flexion-extension images, creating a prognostic tool for surgeons planning CD correction, and counseling patients who are considering CD surgery.
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http://dx.doi.org/10.3171/2020.8.SPINE191185DOI Listing
February 2021

Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study.

Global Spine J 2021 Feb 9:2192568220988276. Epub 2021 Feb 9.

University of Virginia, Charlottesville, VA, USA.

Study Design: Prospective cohort.

Objective: To prospectively evaluate PROs up to 5-years after complex ASD surgery.

Methods: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.

Results: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, < 0.001), SF36-PCS (31.5 vs. 38.8, < 0.001), SF36-MCS (44.9 vs. 49.1, = 0.009), SRS-22-total (2.78 vs. 3.61, < 0.001), NRS-back pain (5.70 vs. 2.95, < 0.001) and NRS leg pain (3.64 vs. 2.62, = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values ( > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.

Conclusions: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.
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http://dx.doi.org/10.1177/2192568220988276DOI Listing
February 2021

Preoperative optimization for patients undergoing elective spine surgery.

Clin Neurol Neurosurg 2021 Mar 14;202:106445. Epub 2021 Jan 14.

Department of Neurosurgery, Division of Spine, Duke University Medical Center, Durham, NC, USA. Electronic address:

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http://dx.doi.org/10.1016/j.clineuro.2020.106445DOI Listing
March 2021

Postoperative Low-Dose Tranexamic Acid After Major Spine Surgery: A Matched Cohort Analysis.

Neurospine 2020 Dec 31;17(4):888-895. Epub 2020 Dec 31.

Department of Anesthesiology, University of Virginia Health Science Center, Charlottesville, VA, USA.

Objective: This was a retrospective, cohort study investigating the efficacy and safety of continuous low-dose postoperative tranexamic acid (PTXA) on drain output and transfusion requirements following adult spinal deformity surgery.

Methods: One hundred forty-seven patients undergoing posterior instrumented thoracolumbar fusion of ≥ 3 vertebral levels at a single institution who received low-dose PTXA infusion (0.5-1 mg/kg/hr) for 24 hours were compared to 292 control patients who did not receive PTXA. The cohorts were propensity matched based on age, sex, American Society of Anesthesiologist physical status classification, body mass index, number of surgical levels, revision surgery, operative duration, and total intraoperative TXA dose (n = 106 in each group). Primary outcome was 72-hour postoperative drain output. Secondary outcomes were number of allogeneic blood transfusions.

Results: There was no significant difference in postoperative drain output in the PTXA group compared to control (660 ± 420 mL vs. 710 ± 490 mL, p = 0.46). The PTXA group received significantly more crystalloid (6,100 ± 3,100 mL vs. 4,600 ± 2,400 mL, p < 0.001) and red blood cell transfusions postoperatively (median [interquartile range]: 1 [0-2] units vs. 0 [0-1] units; incidence rate ratio [95% confidence interval], 1.6 [1.2-2.2]; p = 0.001). Rates of adverse events were comparable between groups.

Conclusion: Continuous low-dose PTXA infusion was not associated with reduced drain output after spinal deformity surgery. No difference in thromboembolic incidence was observed. A prospective dose escalation study is warranted to investigate the efficacy of higher dose PTXA.
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http://dx.doi.org/10.14245/ns.2040114.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788407PMC
December 2020

"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) 2020 Dec 24;Publish Ahead of Print. Epub 2020 Dec 24.

Department of Neurological Surgery, University of California, San Francisco, California Department of Neurological Surgery, University of Utah, Salt Lake City, Utah Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota Norton Leatherman Spine Center, Louisville, Kentucky Department of Neurological Surgery, University of Tennessee Health Science Center, Semmes Murphey Neurologic and Spine Institute, Memphis, Tennessee Division of Neurosurgery, Duke University Medical Center, Durham, North Carolina Goodman Campbell Brain and Spine, Indianapolis, Indiana Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia Neuroscience Institute, Carolinas HealthCare System and Carolina NeuroSurgery and Spine Associates, Charlotte, North Carolina Atlantic Neurosurgical Specialists, Morristown, New Jersey Department of Neurological Surgery, University of Michigan, Ann Arbor, Michigan Departments of Neurological Surgery and Rehab Medicine, University of Miami, Florida Department of Neurological Surgery, Weill Cornell Medical Center, New York, New York Geisinger Health, Danville, Pennsylvania Atlanta Brain and Spine Care, Atlanta, Georgia.

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 twelve 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 analysis was utilized to compare postoperative outcomes and complication rates between the July and non-July groups.

Results: 371 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 (ATE = 22.4 minutes longer, 95%CI 0.9 to 449, 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).

Conclusions: Though 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.
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http://dx.doi.org/10.1097/BRS.0000000000003903DOI Listing
December 2020

Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.

Lancet Neurol 2021 02 22;20(2):98-106. Epub 2020 Dec 22.

Department of Health Services, University of Washington, Seattle, WA, USA.

Background: Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.

Methods: This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828.

Findings: From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications.

Interpretation: In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study.

Funding: AOSpine North America.
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http://dx.doi.org/10.1016/S1474-4422(20)30407-5DOI Listing
February 2021

Improvement in SRS-22R Self-Image Correlate Most with Patient Satisfaction after 3-Column Osteotomy.

Spine (Phila Pa 1976) 2020 Dec 17;Publish Ahead of Print. Epub 2020 Dec 17.

Norton Leatherman Spine Center, 210 East Gray Street, Louisville, KY 40202 Inova Loudoun Hospital, Lansdowne, VA 2017 Sarah Cannon Research Institute, Nashville, TN 37203 Department of Orthopaedic Surgery, Baylor Scoliosis Center, Plano, Texas Department of Orthopaedic Surgery, Washington University, St Louis, Missouri Department of Orthopaedic Surgery, Hospital for Special Surgery, New York City, New York Department of Neurosurgery, University of Virginia, Charlottesville, Virginia Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, New York Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland Department of Orthopaedic Surgery, Spine Division, Duke University Medical Center Department of Orthopaedic Surgery, University of Kansas Medical Center, Kansas City, Kansas Department of Neurological Surgery, University of California, San Francisco, San Francisco, California Presbyterian/St. Luke's Medical Center, Rocky Mountain Hospital for Children, Denver, Colorado International Spine Study Group Foundation, Brighton, Colorado.

Study Design: Longitudinal Cohort.

Objectives: To examine the relationship between patient satisfaction, Patient Reported Outcome Measures (PROMs) and radiographic parameters in Adult Spine Deformity (ASD) patients undergoing 3 Column Osteotomies (3CO).

Summary Of Background Data: Identifying factors that influence patient satisfaction in ASD is important. Evidence suggests SRS22R Self-Image domain correlates with patient satisfaction in patients with ASD.

Methods: This is a retrospective review of ASD patients enrolled in a prospective, multicenter database undergoing a 3CO with complete SRS22R pre-op and minimum 2-years postop. Spearman correlations were used to evaluate associations between the 2-yr SRS Satisfaction score and changes in SRS22R domain scores, Oswestry Disability Index (ODI), and radiographic parameters.

Results: Of 135 patients eligible for 2-year follow-up, 98 patients (73%) had complete pre- and 2-yr postop data. The cohort was mostly female (69%) with mean BMI of 29.7 kg/m2 and age of 61.0 yrs. Mean levels fused was 12.9 with EBL of 2695cc and OR time of 407 minutes; 27% were revision surgeries. There was a statistically significant improvement between pre- and 2-year post-op PROMs and all radiographic parameters except Coronal Vertical Axis. The majority of patients had an SRS Satisfaction score of ≥ 3.0 (90%) or ≥ 4.0 (68%), consistent with a moderate ceiling effect. Correlations of patient satisfaction was significant for Pain (0.43, p < 0.001), Activity (0.39, p < 0.001), Mental (0.38, p = 0.001) Self-Image (0.52, p < 0.001). ODI and SF-36 PCS had a moderate correlation as well, with MCS being weak. There was no statistically significant correlations between any radiographic or operative parameters and patient satisfaction.

Conclusion: There was statistically significant improvement in all PROMs and radiographic parameters, except CVA at 2-years in ASD patients undergoing 3CO. Improvement in SRS Self-Image domain has the strongest correlation with patient satisfaction.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003897DOI Listing
December 2020

Impact of New Motor Deficit on HRQOL After Adult Spinal Deformity Surgery: Subanalysis From Scoli Risk 1 Prospective Study.

Spine (Phila Pa 1976) 2021 Apr;46(7):E450-E457

Department of Neurosurgery and Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA.

Study Design: International, multicenter, prospective, longitudinal observational cohort.

Objective: To assess how new motor deficits affect patient reported quality of life scores after adult deformity surgery.

Summary Of Background Data: Adult spinal deformity surgery is associated with high morbidity, including risk of new postoperative motor deficit. It is unclear what effect new motor deficit has on Health-related Quality of Life scores (HRQOL) scores.

Methods: Adult spinal deformity patients were enrolled prospectively at 15 sites worldwide. Other inclusion criteria included major Cobb more than 80°, C7-L2 curve apex, and any patient undergoing three column osteotomy. American Spinal Injury Association (ASIA) scores and standard HRQOL scores were recorded pre-op, 6 weeks, 6 months, and 2 years.

Results: Two hundred seventy two complex adult spinal deformity (ASD) patients enrolled. HRQOL scores were worse for patients with lower extremity motor score (LEMS). Mean HRQOL changes at 6 weeks and 2 years compared with pre-op for patients with motor worsening were: ODI (+12.4 at 6 weeks and -4.7 at 2 years), SF-36v2 physical (-4.5 at 6 weeks and +2.3 at 2 years), SRS-22r (0.0 at 6 weeks and +0.4 at 2 years). Mean HRQOL changes for motor-neutral patients were: ODI (+0.6 at 6 weeks and -12.1 at 2 years), SF-36v2 physical (-1.6 at 6 weeks and +5.9 at 2 years), and SRS-22r (+0.4 at 6 weeks and +0.7 at 2 years). For patients with LEMS improvement, mean HRQOL changes were: ODI (-0.6 at 6 weeks and -16.3 at 2 years), SF-36v2 physical (+1.0 at 6 weeks and +7.0 at 2 years), and SRS-22r (+0.5 at 6 weeks and +0.9 at 2 years).

Conclusion: In the subgroup of deformity patients who developed a new motor deficit, total HRQOLs and HRQOL changes were negatively impacted. Patients with more than 2 points of LEMS worsening had the worst changes, but still showed overall HRQOL improvement at 6 months and 2 years compared with pre-op baseline.Level of Evidence: 3.
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April 2021

A Comparison of Three Different Positioning Techniques on Surgical Corrections and Postoperative Alignment in Cervical Spinal Deformity (CD) Surgery.

Spine (Phila Pa 1976) 2021 May;46(9):567-570

Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.

Study Design: Retrospective review of a prospective multicenter cervical deformity database.

Objective: To examine the differences in sagittal alignment correction between three positioning methods in cervical spinal deformity surgery (CD).

Summary Of Background Data: Surgical correction for CD is technically demanding and various techniques are utilized to achieve sagittal alignment objectives. The effect of different patient positioning techniques on sagittal alignment correction following CD remains unknown.

Methods: Patients with sagittal deformity who underwent a posterior approach (with and without anterior approach) with an upper instrumented vertebra of C6 or above. Patients with Grade 5, 6, or 7 osteotomies were excluded. Positioning groups were Mayfield skull clamp, bivector traction, and halo ring. Preoperative lower surgical sagittal curve (C2-C7), C2-C7 sagittal vertical axis (cSVA), cervical scoliosis, T1 slope minus cervical lordosis (TS-CL), T1 slope (T1S), chin-brow vertebral angle (CBVA), C2-T3 curve, and C2-T3 SVA was assessed and compared with postoperative radiographs. Segmental changes were analyzed using the Fergusson method.

Results: Eighty patients (58% female) with a mean age of 60.6 ± 10.5 years (range, 31-83) were included. The mean postoperative C2-C7 lordosis was 7.8° ± 14 and C2-C7 SVA was 34.1 mm ± 15. There were overall significant changes in cervical alignment across the entire cohort, with improvements in T1 slope (P < 0.001), C2-C7 (P < 0.001), TS-CL (P < 0.001), and cSVA (P = 0.006). There were no differences postoperatively of any radiographic parameter between positioning groups (P > 0.05). The majority of segmental lordotic correction was achieved at C4-5-6 (mean 6.9° ± 11). Additionally, patients who had bivector traction applied had had significantly more segmental correction at C7-T1-T2 compared with Mayfield and halo traction (4.2° vs. 0.3° vs. -1.7° respectively, P < 0.027).

Conclusion: Postoperative cervical sagittal correction or alignment was not affected by patient position. The majority of segmental correction occurred at C4-5-6 across all positioning methods, while bivector traction had the largest corrective ability at the cervicothoracic junction.Level of Evidence: 4.
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May 2021

Biomechanics, evaluation, and management of subaxial cervical spine injuries: A comprehensive review of the literature.

J Clin Neurosci 2021 Jan 3;83:131-139. Epub 2020 Dec 3.

Departments of Neurosurgery, Duke University Medical Center, Durham, NC, USA. Electronic address:

Study Design: Literature review.

Objectives: It has been reported that 2.4-3.7% of all blunt trauma victims suffer some element of cervical spine fracture, with the majority of these patients suffering from C3-7 (subaxial) involvement. With the improvement of first-response to trauma in the community, there are an increasing number of patients who survive their initial trauma and thus arrive at the hospital in need of further evaluation, stabilization, and management of these injuries.

Methods: A comprehensive literature review compiled all relevant data on the biomechanics, imaging, evaluation, and medical and surgical management strategies for subaxial cervical spine fractures.

Results: After review of the current literature on subaxial cervical spine biomechanics, imaging characteristics, evaluation strategies and surgical and orthopedic management techniques, the authors created a comprehensive review and protocol for management of subaxial cervical spine fractures.

Conclusions: The subaxial cervical spine is biomechanically and anatomically unique from the remainder of the spinal axis. Evaluation of subaxial cervical spine injuries is nuanced, and improper management of these injuries can lead to significant patient morbidity and even death. This provides a comprehensive review combining anatomy, imaging characteristics, evaluation strategies, and surgical and orthopedic management principles for subaxial cervical spine fractures.
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http://dx.doi.org/10.1016/j.jocn.2020.11.004DOI Listing
January 2021

Multicenter assessment of surgical outcomes in adult spinal deformity patients with severe global coronal malalignment: determination of target coronal realignment threshold.

J Neurosurg Spine 2020 Dec 4:1-14. Epub 2020 Dec 4.

18Department of Neurological Surgery, University of California, San Francisco, California.

Objective: The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes.

Methods: This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed.

Results: Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK).

Conclusions: Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.
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December 2020

Neurological Complications and Recovery Rates of Patients With Adult Cervical Deformity Surgeries.

Global Spine J 2020 Nov 23:2192568220975735. Epub 2020 Nov 23.

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

Study Design: Retrospective cohort study.

Objective: This study aims to report the incidence, risk factors, and recovery rate of neurological complications (NC) in patients with adult cervical deformity (ACD) who underwent corrective surgery.

Methods: ACD patients undergoing surgery from 2013 to 2015 were enrolled in a prospective, multicenter database. Patients were separated into 2 groups according to the presence of neurological complications (NC vs no-NC groups). The types, timing, recovery patterns, and interventions for NC were recorded. Patients' demographics, surgical details, radiographic parameters, and health-related quality of life (HRQOL) scores were compared.

Results: 106 patients were prospectively included. Average age was 60.8 years with a mean of 18.2 months follow-up. The overall incidence of NC was 18.9%; of these, 68.1% were major complications. Nerve root motor deficit was the most common complication, followed by radiculopathy, sensory deficit, and spinal cord injury. The proportion of complications occurring within 30 days of surgery was 54.5%. The recovery rate from neurological complication was high (90.9%), with most of the recoveries occurring within 6 months and continuing even after 12 months. Only 2 patients (1.9%) had continuous neurological complication. No demographic or preoperative radiographic risk factors could be identified, and anterior corpectomy and posterior foraminotomy were found to be performed less in the NC group. The final HRQOL outcome was not significantly different between the 2 groups.

Conclusions: Our data is valuable to surgeons and patients to better understand the neurological complications before performing or undergoing complex cervical deformity surgery.
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November 2020

The medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the United States.

Neurosurg Focus 2020 11;49(5):E20

1Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and.

Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem.This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). Litigation resulted in average payouts of $1,204,422 ± $753,832 between 1995 and 2019, when adjusted for inflation. The median time to case closure was 56.3 (35.2-67.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.4-77.2) months for defendant (surgeon) verdicts (p = 0.117).
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November 2020

Hematocrit as a predictor of preoperative transfusion-associated complications in spine surgery: A NSQIP study.

Clin Neurol Neurosurg 2021 Jan 23;200:106322. Epub 2020 Oct 23.

Division of Spine, Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA.

Background Context: Preoperative optimization of medical comorbidities prior to spinal surgery is becoming an increasingly important intervention in decreasing postoperative complications and ensuring a satisfactory postoperative course. The treatment of preoperative anemia is based on guidelines made by the American College of Cardiology (ACC), which recommends packed red blood cell transfusion when hematocrit is less than 21% in patients without cardiovascular disease and 24% in patients with cardiovascular disease. The literature has yet to quantify the risk profile associated with preoperative pRBC transfusion.

Purpose: To determine the incidence of complications following preoperative pRBC transfusion in a cohort of patients undergoing spine surgery.

Study Design: Retrospective review of a national surgical database.

Patient Sample: The national surgical quality improvement program database OUTCOME NEASURES: Postoperative physiologic complications after a preoperative transfusion. Complications were defined as the occurrence of any DVT, PE, stroke, cardiac arrest, myocardial infarction, longer length of stay, need for mechanical ventilation greater than 48 h, surgical site infections, sepsis, urinary tract infections, pneumonia, or higher 30-day mortality.

Methods: The national surgical quality improvement program database was queried, and patients were included if they had any type of spine surgery and had a preoperative transfusion.

Results: Preoperative pRBC transfusion was found to be protective against complications when the hematocrit was less than 20% and associated with more complications when the hematocrit was higher than 20%. In patients with a hematocrit higher than 20%, pRBC transfusion was associated with longer lengths of stay, and higher rates of ventilator dependency greater than 48 h, pneumonia, and 30-day mortality.

Conclusion: This is the first study to identify an inflection point in determining when a preoperative pRBC transfusion may be protective or may contribute to complications. Further studies are needed to be conducted to stratify by the prevalence of cardiovascular disease.
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January 2021

Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.

Clin Orthop Relat Res 2021 02;479(2):312-320

K. Y. H. Kwan, The University of Hong Kong, Pokfulam, Hong Kong.

Background: The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset.

Questions/purposes: After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires?

Methods: A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test.

Results: At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category.

Conclusion: Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications.

Level Of Evidence: Level III, diagnostic study.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899533PMC
February 2021

Practical answers to frequently asked questions for shared decision-making in adult spinal deformity surgery.

J Neurosurg Spine 2020 Oct 16:1-10. Epub 2020 Oct 16.

1Norton Leatherman Spine Center, Louisville, Kentucky.

Objective: The shared decision-making (SDM) process provides an opportunity to answer frequently asked questions (FAQs). The authors aimed to present a concise list of answers to FAQs to aid in SDM for adult spinal deformity (ASD) surgery.

Methods: From a prospective, multicenter ASD database, patients enrolled between 2008 and 2016 who underwent fusions of 5 or more levels with a minimum 2-year follow-up were included. All deformity types were included to provide general applicability. The authors compiled a list of FAQs from patients undergoing ASD surgery and used a retrospective analysis to provide answers. All responses are reported as either the means or the proportions reaching the minimal clinically important difference at the 2-year follow-up interval.

Results: Of 689 patients with ASD who were eligible for 2-year follow-up, 521 (76%) had health-related quality-of-life scores available at the time of that follow-up. The mean age at the initial surgery was 58.2 years, and 78% of patients were female. The majority (73%) underwent surgery with a posterior-only approach. The mean number of fused levels was 12.2. Revision surgery accounted for 48% of patients. The authors answered 12 FAQs as follows:1. Will my pain improve? Back and leg pain will both be reduced by approximately 50%.2. Will my activity level improve? Approximately 65% of patients feel improvement in their activity level.3. Will I feel better about myself? More than 70% of patients feel improvement in their appearance.4. Is there a chance I will get worse? 4.1% feel worse at 2 years postoperatively.5. What is the likelihood I will have a complication? 67.8% will have a major or minor complication, with 47.8% having a major complication.6. Will I need another surgery? 25.0% will have a reoperation within 2 years.7. Will I regret having surgery? 6.5% would not choose the same treatment.8. Will I get a blood transfusion? 73.7% require a blood transfusion.9. How long will I stay in the hospital? You need to stay 8.1 days on average.10. Will I have to go to the ICU? 76.0% will have to go to the ICU.11. Will I be able to return to work? More than 70% will be working at 1 year postoperatively.12. Will I be taller after surgery? You will be 1.1 cm taller on average.

Conclusions: The above list provides concise, practical answers to FAQs encountered in the SDM process while counseling patients for ASD surgery.
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October 2020

A single-center retrospective analysis of 3- or 4-level anterior cervical discectomy and fusion: surgical outcomes in 66 patients.

J Neurosurg Spine 2020 Oct 9:1-7. Epub 2020 Oct 9.

1Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia; and.

Objective: Anterior cervical discectomy and fusion (ACDF) is a safe and effective intervention to treat cervical spine pathology. Although these were originally performed as single-level procedures, multilevel ACDF has been performed for patients with extensive degenerative disc disease. To date, there is a paucity of data regarding outcomes related to ACDFs of 3 or more levels. The purpose of this study was to compare surgical outcomes of 3- and 4-level ACDF procedures.

Methods: The authors performed a retrospective chart review of patients who underwent 3- and 4-level ACDF at the University of Virginia Health System between January 2010 and December 2017. In patients meeting the inclusion/exclusion criteria, demographics, fusion rates, time to fusion, and reoperation rates were evaluated. Fusion was determined by < 1 mm of change in interspinous distance between individual fused vertebrae on lateral flexion/extension radiographs and lack of radiolucency between the grafts and vertebral bodies. Any procedure requiring a surgical revision was considered a failure.

Results: Sixty-six patients (47 with 3-level and 19 with 4-level ACDFs) met the inclusion/exclusion criteria of having at least one lateral flexion/extension radiograph series ≥ 12 months after surgery. Seventy percent of 3-level patients and 68% of 4-level patients had ≥ 24 months of follow-up. Ninety-four percent of 3-level patients and 100% of 4-level patients achieved radiographic fusion for at least 1 surgical level. Eighty-eight percent and 82% of 3- and 4-level patients achieved fusion at C3-4; 85% and 89% of 3- and 4-level patients achieved fusion at C4-5; 68% and 89% of 3- and 4-level patients achieved fusion at C5-6; 44% and 42% of 3- and 4-level patients achieved fusion at C6-7; and no patients achieved fusion at C7-T1. Time to fusion was not significantly different between levels. Revision was required in 6.4% of patients with 3-level and in 16% of patients with 4-level ACDF. The mean time to revision was 46.2 and 45.4 months for 3- and 4-level ACDF, respectively. The most common reason for revision was worsening of initial symptoms.

Conclusions: The authors' experience with long-segment anterior cervical fusions shows their fusion rates exceeding most of the reported fusion rates for similar procedures in the literature, with rates similar to those reported for short-segment ACDFs. Three-level and 4-level ACDF procedures are viable options for cervical spine pathology, and the authors' analysis demonstrates an equivalent rate of fusion and time to fusion between 3- and 4-level surgeries.
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October 2020

Long-term impact of obesity on patient-reported outcomes and patient satisfaction after lumbar spine surgery: an observational study.

J Neurosurg Spine 2020 Sep 25:1-10. Epub 2020 Sep 25.

1Department of Neurosurgery, Duke University Medical Center; and.

Objective: Obese body habitus is a challenging issue to address in lumbar spine surgery. There is a lack of consensus on the long-term influence of BMI on patient-reported outcomes and satisfaction. This study aimed to examine the differences in patient-reported outcomes over the course of 12 and 24 months among BMI classifications of patients who underwent lumbar surgery.

Methods: A search was performed using the Quality Outcomes Database (QOD) Spine Registry from 2012 to 2018 to identify patients who underwent lumbar surgery and had either a 12- or 24-month follow-up. Patients were categorized based on their BMI as normal weight (≤ 25 kg/m2), overweight (25-30 kg/m2), obese (30-40 kg/m2), and morbidly obese (> 40 kg/m2). Outcomes included the Oswestry Disability Index (ODI) and the visual analog scale (VAS) for back pain (BP) and leg pain (LP), and patient satisfaction was measured at 12 and 24 months postoperatively.

Results: A total of 31,765 patients were included. At both the 12- and 24-month follow-ups, those who were obese and morbidly obese had worse ODI, VAS-BP, and VAS-LP scores (all p < 0.01) and more frequently rated their satisfaction as "I am the same or worse than before treatment" (all p < 0.01) compared with those who were normal weight. Receiver operating characteristic curve analysis revealed that the BMI cutoffs for predicting worsening disability and surgery dissatisfaction were 30.1 kg/m2 and 29.9 kg/m2 for the 12- and 24-month follow-ups, respectively.

Conclusions: Higher BMI was associated with poorer patient-reported outcomes and satisfaction at both the 12- and 24-month follow-ups. BMI of 30 kg/m2 is the cutoff for predicting worse patient outcomes after lumbar surgery.
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September 2020

Radiographic benefit of incorporating the inflection between the cervical and thoracic curves in fusion constructs for surgical cervical deformity patients.

J Craniovertebr Junction Spine 2020 Apr-Jun;11(2):131-138. Epub 2020 Jun 5.

Department of Orthopedics, Hospital for Special Surgery New York, NY, USA.

Purpose: The aim is to assess the relationship between cervicothoracic inflection point and baseline disability, as well as the relationship between clinical outcomes and pre- to postoperative changes in inflection point.

Methods: Cervical deformity (CD) patients with baseline and 3-month (3M) postoperative radiographic, clinical, and inflection data were grouped by region of inflection point: C6 or above, C6-C7 to C7-T1, T1, or below. Inflection was defined as: Distal-most level where cervical lordosis (CL) changes to thoracic kyphosis (TK). Differences in alignment and patient factors across pre- and postoperative inflection point groups were assessed, as were outcomes by the inclusion of inflection in the CD-corrective fusion construct.

Results: A total of 108 patients were included. Preoperative inflection breakdown: C6 or above (42%), C6-C7 to C7-T1 (44%), T1 or below (15%). Surgery was associated with a caudal migration of inflection by 3M: C6 or above (8%), C6-C7 to C7-T1 (58%), T1 or below (33%). For patients with preoperative inflection T1 or below, the inclusion of inflection in the fusion construct was associated with improvements in horizontal gaze (McGregor's Slope included: -11.3° vs. not included: 1.6°, = 0.038). The inclusion of preoperative inflection in fusion was associated with the superior cervical sagittal vertical axis (cSVA) changes for C6-C7 to C7-T1 patients (-5.2 mm vs. 3.2 mm, = 0.018). The location of postoperative inflection was associated with variation in 3M alignment: Inflection C6 or above was associated with less Pelvic Tilt (PT), PT and a trend of larger cSVA. Location of inflection or inclusion in fusion was not associated with reoperation or distal junctional kyphosis.

Conclusions: Incorporating the inflection point between CL and TK in the fusion construct was associated with superior restoration of cervical alignment and horizontal gaze for surgical CD patients.
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http://dx.doi.org/10.4103/jcvjs.JCVJS_57_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462144PMC
June 2020

Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy.

Spine (Phila Pa 1976) 2020 Nov;45(22):1541-1552

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University School of Medicine, Nashville, Tennessee.

Study Design: Retrospective analysis of prospectively collected registry data.

Objective: To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery.

Summary Of Background Data: Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care.

Methods: This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients.

Results: Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725.

Conclusions: These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling.

Level Of Evidence: 2.
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November 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 Oct 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

Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.

Spine Deform 2020 12 6;8(6):1333-1339. Epub 2020 Jul 6.

Duke University Duke Spine Center-Clinic 1B/1C, 40 Duke Medicine Circle, Durham, NC, 27710-400, USA.

Study Design: Longitudinal comparative cohort.

Objective: The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.

Methods: Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.

Results: Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.

Conclusion: This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.

Level Of Evidence: II.
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http://dx.doi.org/10.1007/s43390-020-00154-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708503PMC
December 2020

Prospective multicenter assessment of complication rates associated with adult cervical deformity surgery in 133 patients with minimum 1-year follow-up.

J Neurosurg Spine 2020 Jun 19:1-13. Epub 2020 Jun 19.

17Department of Neurological Surgery, University of California, San Francisco, California.

Objective: Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically.

Methods: A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30-90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°.

Results: Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively).

Conclusions: This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.
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http://dx.doi.org/10.3171/2020.4.SPINE20213DOI Listing
June 2020

Factors affecting approach selection for minimally invasive versus open surgery in the treatment of adult spinal deformity: analysis of a prospective, nonrandomized multicenter study.

J Neurosurg Spine 2020 Jun 19:1-6. Epub 2020 Jun 19.

5Department of Orthopaedic Surgery, Scripps Clinic, La Jolla, California.

Objective: Surgical decision-making and planning is a key factor in optimizing outcomes in adult spinal deformity (ASD). Minimally invasive spinal (MIS) strategies for ASD have been increasingly used as an option to decrease postoperative morbidity. This study analyzes factors involved in the selection of either a traditional open approach or a minimally invasive approach to treat ASD in a prospective, nonrandomized multicenter trial. All centers had at least 5 years of experience in minimally invasive techniques for ASD.

Methods: The study enrolled 268 patients, of whom 120 underwent open surgery and 148 underwent MIS surgery. Inclusion criteria included age ≥ 18 years, and at least one of the following criteria: coronal curve (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. Surgical approach selection was made at the discretion of the operating surgeon. Preoperative significant differences were included in a multivariate logistic regression analysis to determine odds ratios (ORs) for approach selection.

Results: Significant preoperative differences (p < 0.05) between open and MIS groups were noted for age (61.9 vs 66.7 years), numerical rating scale (NRS) back pain score (7.8 vs 7), CC (36° vs 26.1°), PT (26.4° vs 23°), T1 pelvic angle (TPA; 25.8° vs 21.7°), and pelvic incidence-lumbar lordosis (PI-LL; 19.6° vs 14.9°). No significant differences in BMI (29 vs 28.5 kg/m2), NRS leg pain score (5.2 vs 5.7), Oswestry Disability Index (48.4 vs 47.2), Scoliosis Research Society 22-item questionnaire score (2.7 vs 2.8), PI (58.3° vs 57.1°), LL (38.9° vs 42.3°), or SVA (73.8 mm vs 60.3 mm) were found. Multivariate analysis found that age (OR 1.05, p = 0.002), VAS back pain score (OR 1.21, p = 0.016), CC (OR 1.03, p < 0.001), decompression (OR 4.35, p < 0.001), and TPA (OR 1.09, p = 0.023) were significant factors in approach selection.

Conclusions: Increasing age was the primary driver for selecting MIS surgery. Conversely, increasingly severe deformities and the need for open decompression were the main factors influencing the selection of traditional open surgery. As experience with MIS surgery continues to accumulate, future longitudinal evaluation will reveal if more experience, use of specialized treatment algorithms, refinement of techniques, and technology will expand surgeon adoption of MIS techniques for adult spinal deformity.
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http://dx.doi.org/10.3171/2020.4.SPINE20169DOI Listing
June 2020