Search

Study designSecondary analysis of prospective multicenter cohort.ObjectiveTo assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).Summary of background dataOperative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.MethodsThe ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.ResultsTwo hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P

Study designProspective cohort study.ObjectivesMost studies of dysphagia in the cervical spine have focused on a degenerative patient population; the rate of dysphagia following surgery for cervical deformity (CD) is unknown. This study aims to investigate if surgery for cervical deformity results in postoperative dysphagia.MethodsPatients with CD undergoing surgery from 2013 to 2015 were prospectively enrolled to evaluate dysphagia. Demographic, operative, and radiographic variables were analyzed. The Quality of Life in Swallowing Disorders (SWAL-QoL) was used to measure dysphagia. Paired t test, independent t tests, and bivariate Pearson correlations were performed.ResultsA total of 88 CD patients, aged 61.52 ± 10.52 years, were enrolled. All patients (100%) had 3-month SWAL-QoL for analysis. The baseline preoperative SWAL-QoL was 78.35. This is roughly the same level of dysphagia as an anterior cervical discectomy patient that is 3 weeks removed from surgery. Increasing body mass index (BMI) was correlated with decreased SWAL-QoL score (r = -0.30, P = .001). Age, gender, smoking, and Charlson Comorbidity Index (CCI) showed no significant correlations with preoperative SWAL-QoL. Patients with prior cervical surgery had a lower preoperative SWAL-QoL (P = .04). While 11 patients had acute postoperative dysphagia, CD surgery did not result in lower SWAL-QoL at 3 months (77.26 vs 78.35, P = .53). Surgical variables, including estimated blood loss (EBL), anterior or posterior fusion levels, steroid use, preoperative traction, staged surgery, surgical approach, anterior corpectomy, posterior osteotomy, and UIV (upper instrumented vertebrae) location, showed no impact on postoperative SWAL-QoL. Correction of cervical kyphosis was not correlated to 3-month SWAL-QoL scores or the change in SWAL-QoL scores.ConclusionsWhile patients undergoing surgery for cervical deformity had swallowing dysfunction at baseline, we did not observe a significant decline in SWAL-QoL scores at 3 months. Patients with prior cervical surgery and higher BMI had a lower baseline SWAL-QoL. There were no surgical or radiographic variables correlated to a change in SWAL-QOL score.

Study designRetrospective cohort study.ObjectiveFactors that predict outcomes for adult cervical spine deformity (ACSD) have not been well defined. To compare ACSD patients with best versus worst outcomes.MethodsThis study was based on a prospective, multicenter observational ACSD cohort. Best versus worst outcomes were compared based on Neck Disability Index (NDI), Neck Pain Numeric Rating Scale (NP-NRS), and modified Japanese Orthopaedic Association (mJOA) scores.ResultsOf 111 patients, 80 (72%) had minimum 1-year follow-up. For NDI, compared with best outcome patients (n = 28), worst outcome patients (n = 32) were more likely to have had a major complication (P = .004) and to have undergone a posterior-only procedure (P = .039), had greater Charlson Comorbidity Index (P = .009), and had worse postoperative C7-S1 sagittal vertical axis (SVA; P = .027). For NP-NRS, compared with best outcome patients (n = 26), worst outcome patients (n = 18) were younger (P = .045), had worse baseline NP-NRS (P = .034), and were more likely to have had a minor complication (P = .030). For the mJOA, compared with best outcome patients (n = 16), worst outcome patients (n = 18) were more likely to have had a major complication (P = .007) and to have a better baseline mJOA (P = .030). Multivariate models for NDI included posterior-only surgery (P = .006), major complication (P = .002), and postoperative C7-S1 SVA (P = .012); models for NP-NRS included baseline NP-NRS (P = .009), age (P = .017), and posterior-only surgery (P = .038); and models for mJOA included major complication (P = .008).ConclusionsFactors distinguishing best and worst ACSD surgery outcomes included patient, surgical, and radiographic factors. These findings suggest areas that may warrant greater awareness to optimize patient counseling and outcomes.

Study designRetrospective cohort study.ObjectiveDetermine the indications, complications, and clinical outcomes in patients requiring fusions from the cervical spine to the pelvis. Several investigators have examined fusions from the thoracic spine to the sacrum, but no similar study has been performed for cervical-to-pelvis fusions.MethodsPatients from 2003 to 2014 with an upper instrumented vertebrae (UIV) in the cervical spine (any level) and a lower instrumented vertebrae (LIV) in the sacrum or pelvis were included in the study. Those with infectious or acute trauma-related deformities were excluded. Patient demographics, medical history, diagnosis, operative procedure, and health-related quality of life measures were analyzed. Student's t test, Kruskal-Wallis test, and χ2 test were used as appropriate; significance was set at P < .05 for all tests.ResultsFifty-five patients met inclusion criteria for the study. Average follow-up was 2.8 years. Proximal junctional kyphosis was the most common indication for cervical-to-pelvis fusions (36%). The most common UIV was C2 (29%) followed by C7 (24%). There was an average 31° correction in maximum kyphosis and a 3.3 cm improvement in sagittal vertical axis. In adults, the rate of complication was 71.4%, with a major complication rate of 39.3% and reoperation rate of 53.6%. There was significant improvement in the Scoliosis Research Society (SRS-22r) score (3.0 to 3.5; P < .01).ConclusionProximal junctional kyphosis is the most common indication for patients requiring fusion to the cervical spine. Adult patients incur a significant risk of major complications and reoperations. However, significant improvement in SRS-22r outcomes are noted in these patients.

PurposeEvaluate the presence of new-onset cervical deformity (CD) in nonoperative adult spinal deformity (ASD) patients with extended follow-up, with consideration for predictors, prevalence, and impact on patient-reported outcomes.MethodsRetrospective review of a prospective nonoperative ASD cohort. New onset CD patients at 1- (CD-1Y) and 2-year (CD-2Y) follow-up were defined as displaying baseline cervical alignment. Univariate analyses determined differences in radiographic parameters and outcome scores of CD and maintained-cervical-alignment patients. Multivariate binary logistic regression models determined new-onset CD predictors.ResultsA total of 143 patients were included (mean age 54 years, mean body mass index 25.6 kg/m2, 86% female). Cervical deformity rate was 38.5% at baseline. New-onset CD incidence at 1- and 2-year follow-up was 30.0% and 41.7%, respectively. Global sagittal profile comparison of CD-1Y/CD-2Y versus maintained cervical alignment cases revealed no differences (P > .05) at any interval. Baseline C2-C7 sagittal vertical axis (SVA) was associated with increased new-onset CD risk at 1 (odds ratio [OR] 1.14, P = .025) and 2 years (OR 1.04, P = .032); prior spine surgical history was associated with CD risk at 1-year follow-up (OR 6.75, P = .047); baseline C2 slope was associated with increased CD risk at 2-year follow-up (OR 1.12, P = .041). CD development did not significantly impact health-related quality of life (P > .05).ConclusionsCervical deformity can manifest in nonoperative ASD patients: 30.0% at 1-year follow-up, and 41.7% at 2-year follow-up. Progressive CD manifested independently of thoracolumbar profile changes. Increased baseline C2-C7 SVA, C2 slope, and prior surgical history increased new-onset CD odds at 1 and 2 years.

Study Design: Multicenter, prospective cohort Objectives: Malalignment following adult spine deformity (ASD) surgery can impact outcomes and increase mechanical complications. We assess whether preoperative goals for sagittal alignment following ASD surgery are achieved. Methods: ASD patients were prospectively enrolled based on 3 criteria: deformity severity (PI-LL ≥25°, TPA ≥30°, SVA ≥15 cm, TCobb≥70° or TLCobb≥50°), procedure complexity (≥12 levels fused, 3-CO or ACR) and/or age (>65 and ≥7 levels fused). The surgeon documented sagittal alignment goals prior to surgery. Goals were compared with achieved alignment on first follow-up standing radiographs. Results: The 266 enrolled patients had a mean age of 61.0 years (SD = 14.6) and 68% were women. Mean instrumented levels was 13.6 (SD = 3.8), and 23.2% had a 3-CO. Mean (SD) offsets (achieved-goal) were: SVA = −8.5 mm (45.6 mm), PI-LL = −4.6° (14.6°), TK = 7.2° (14.7°), reflecting tendencies to undercorrect SVA and PI-LL and increase TK. Goals were achieved for SVA, PI-LL, and TK in 74.4%, 71.4%, and 68.8% of patients, respectively, and was achieved for all 3 parameters in 37.2% of patients. Three factors were independently associated with achievement of all 3 alignment goals: use of PACs/equivalent for surgical planning (P <.001), lower baseline GCA (P =.009), and surgery not including a 3-CO (P =.037). Conclusions: Surgeons failed to achieve goal alignment of each sagittal parameter in ∼25-30% of ASD patients. Goal alignment for all 3 parameters was only achieved in 37.2% of patients. Those at greatest risk were patients with more severe deformity. Advancements are needed to enable more consistent translation of preoperative alignment goals to the operating room. [ABSTRACT FROM AUTHOR]

Study designProspective cohort study.ObjectivesTo describe the rate of short-term complications following the posterior use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in cervical deformity (CD) surgery.MethodsCD patients from 2013 to 2015 were enrolled in a prospective, multicenter database. Patients were divided into those receiving rhBMP-2 (BMP) and no rhBMP-2 (NOBMP). The relationship between BMP use, demographic variables surgical variables, radiographic parameters and complications was evaluated.ResultsA total of 100 patients (47 BMP, 53 NOBMP) were included. Follow-up time averaged 7.6 months (range 3-12 months). An average of 13.6mg of BMP was used per person with 1.49 mg per level. Compared with the NOBMP group, patients in the BMP group were older (P = .03). BMP was more commonly used in patients that and had longer prior fusions (6.0 vs 2.5, P < .01). There were no differences between groups with regards to a history of surgery, Charlson Comorbidity Index, estimated blood loss, operation time, fusion levels, and surgical approach. The maintenance of radiographic parameters at 6-month follow-up was similar. There were no differences in terms of total complication incidence, total complications per person, major complications per person or any specific complication. Linear regression and Pearson correlation analysis did not reveal any strong r2 values (r2 = 0.09, 0.08, 0.06) between the use of BMP and complications (major or operative).ConclusionsBMP use was not directly associated with an increased incidence of early complications in this prospective cohort of operative adult CD patients. Its use was associated with increased number of levels instrumented and fused.

BackgroundCurrent health-related quality of life (HRQL) metrics used to assess patient outcomes following surgical correction of cervical deformity (CD) are not deformity-specific and thus cannot capture all aspects of a patient's deformity and outcomes. The purpose of this study is to evaluate the sensitivity of different HRQL outcome measures in assessing CD patients' outcomes 1-year post-operatively.MethodsRetrospective review of prospective multi-center database. Inclusion criteria: CD patients ≥18 yrs with pre- and 1-year post-operative radiographs and HRQLs [modified Japanese Orthopaedic Association (mJOA), EuroQol five-dimensions (EQ-5D), neck disability index (NDI)]. Associations between changes in EQ5D and NDI with improvement at 1-year in mJOA scores were assessed by whether or not the patient met the minimum clinically important difference (MCID) as well as whether or not they improved by one or more categories (i.e., change from moderate to mild). Odds ratios reported with 95% confidence intervals.ResultsSixty-three CD patients were included (mean 62 y, 55.6% F). Average baseline NDI scores were 46.75, mJOA was 13.68, and EQ-5D 0.74. Overall baseline myelopathy breakdown: none-9.5%, mild-30.2%, moderate-42.9%, high-17.5%. At 1-year, 46% of patients improved in mJOA, 71.4% NDI, and 65.1% EQ-5D. 19% of patients met mJOA MCID, 44.4% NDI MCID, 19% EQ-5D MCID. One-point improvement in NDI increased the odds of mJOA improvement and reaching mJOA MCID (improvement: OR, 1.06, CI: 1.01-1.10, P=0.01; MCID: OR, 1.06, CI: 1.02-1.11, P=0.006). Improvement in EQ-5D by 0.1 increased the odds of improving in mJOA and reaching mJOA MCID at 1-year (improvement: OR, 3.85, CI: 1.51-9.76, P=0.005; MCID: OR, 3.88, CI: 1.52-9.88, P=0.005). While correlations exist between outcome measures, when modeling these outcomes while controlling for confounders including cSVA change, surgical invasiveness, age and CCI, these HRQLs were not strongly correlated.ConclusionsImprovements in functional outcomes, as defined by mJOA score, were correlated with changes in neck based disability and general health state, defined by NDI and EQ-5D respectively. In an adjusted model, however, these direct relationships were not maintained. A CD-specific HRQL might be more useful for surgeons in assessing patient outcomes using a single metric.

BackgroundCervical kyphosis and C2-C7 plumb line (CPL) are established descriptors of cervical sagittal deformity (CSD). Reciprocal changes in these parameters have been demonstrated in thoracolumbar deformity correction. The purpose of this study was to investigate the development of CSD, using T1 slope minus cervical lordosis (TS-CL) to define CSD and to correlate TS-CL and a novel global sagittal parameter, cervical-thoracic pelvic angle (CTPA), with CPL.MethodsA multicenter, retrospective analysis of patients with thoracolumbar deformity undergoing three-column osteotomy was performed. Preoperative and postoperative cervical parameters were investigated. Linear regression for postoperative values resulted in a CPL of 4 cm corresponding to a TS-CL threshold of 17°. Patients were classified based on postoperative TS-CL into uncompensated (TS-CL > 17°) or compensated cohorts (TS-CL < 17°); the two were compared using an unpaired t test. Logistic regression modeling was used to determine predictors of postoperative CSD.ResultsA total of 223 patients with thoracolumbar deformity (mean age, 57.56 years) were identified. CTPA correlated with CPL (preoperative r = .85, postoperative r = .69). TS-CL correlated with CTPA (preoperative r = .52, postoperative r = .37) and CPL (preoperative r = .52; postoperative r = .37). CSD had greater preoperative CPL (P < .001) and CTPA (P < .001). The compensated cohort had a decrease in TS-CL (from 10.2 to 8.0) with sagittal vertical axis (SVA) correction, whereas the uncompensated had an increase in TS-CL (from 22.3 to 26.8) with all P < .001. Reciprocal change was demonstrated in the compensated group given that CL decreased with SVA correction (r = .39), but there was no such correlation in the uncompensated. Positive predictors of postoperative CSD included baseline TS-CL > 17° (P = .007), longer fusion (P = .033), and baseline CTPA (P = .029).ConclusionsTS-CL and CTPA correlated significantly with established sagittal balance measures. Whereas reciprocal change in cervical and thoracolumbar alignment was demonstrated in the compensated cohort, the uncompensated population had progression of their cervical deformities after three-column osteotomy.Clinical relevanceThe balance between TS-CL mirrors the relationship between pelvic incidence minus lumbar lordosis in defining deformities of their respective spinal regions.

Study Design:Retrospective cohort study. Objectives:Describe the rate and risk factors for venous thromboembolic events (VTEs; defined as deep venous thrombosis [DVT] and/or pulmonary embolism [PE]) in adult spinal deformity (ASD) surgery. Methods:ASD patients with VTE were identified in a prospective, multicenter database. Complications, revision, and mortality rate were examined. Patient demographics, operative details, and radiographic and clinical outcomes were compared with a non-VTE group. Multivariate binary regression model was used to identify predictors of VTE. Results:A total of 737 patients were identified, 32 (4.3%) had VTE (DVT = 14; PE = 18). At baseline, VTE patients were less likely to be employed in jobs requiring physical labor (59.4% vs 79.7%, P < .01) and more likely to have osteoporosis (29% vs 15.1%, P = .037) and liver disease (6.5% vs 1.4%, P = .027). Patients with VTE had a larger preoperative sagittal vertical axis (SVA; 93 mm vs 55 mm, P < .01) and underwent larger SVA corrections. VTE was associated with a combined anterior/posterior approach (45% vs 25%, P = .028). VTE patients had a longer hospital stay (10 vs 7 days, P < .05) and higher mortality rate (6.3% vs 0.7%, P < .01). Multivariate analysis demonstrated osteoporosis, lack of physical labor, and increased SVA correction were independent predictors of VTE (r2 = .11, area under the curve = 0.74, P < .05). Conclusions:The incidence of VTE in ASD is 4.3% with a DVT rate of 1.9% and PE rate of 2.4%. Osteoporosis, lack of physical labor, and increased SVA correction were independent predictors of VTE. Patients with VTE had a higher mortality rate compared with non-VTE patients.

Study designRetrospective cohort study.ObjectivesDescribe the rate of dural tears (DTs) in adult spinal deformity (ASD) surgery. Describe the risk factors for DT and the impact of this complication on clinical outcomes.MethodsPatients with ASD undergoing surgery between 2008 and 2014 were separated into DT and non-DT cohorts; demographics, operative details, radiographic, and clinical outcomes were compared. Statistical analysis included t tests or χ2 tests as appropriate and a multivariate analysis.ResultsA total of 564 patients were identified. The rate of DT was 10.8% (n = 61). Patients with DT were older (61.1 vs 56.5 years, P = .005) and were more likely to have had prior spine surgery (odds ratio [OR] = 2.0, 95% confidence interval [CI] = 1.2-3.3, P = .007). DT patients had higher pelvic tilt, lower lumbar lordosis, and greater pelvic-incidence lumbar lordosis mismatch than non-DT patients (P < .05). DT patients had longer operative times (424 vs 375 minutes, P = .008), were more likely to undergo interbody fusions (OR = 2.0, 95% CI = 1.1-3.6, P = .021), osteotomies (OR = 2.2, 95% CI = 1.1-4.0, P = .012), and decompressions (OR = 2.3, 95% CI = 1.3-4.3, P = .003). In our multivariate analysis, only decompressions were associated with an increased risk of DT (OR = 3.2, 95% CI = 1.4-7.6, P = .006). There were no significant differences in patient outcomes at 2 years.ConclusionsThe rate of DT was 10.8% in an ASD cohort. This is similar to rates of DT reported following surgery for degenerative pathology. A history of prior spine surgery, decompression, interbody fusion, and osteotomies are all associated with an increased risk of DT, but decompression is the only independent risk factor for DT.

Study Design: Retrospective review of prospective database. Objectives: Vertebral pelvic angles (VPAs) account for complexity in spine shape by assessing the relative position of each vertebra with regard to the pelvis. This study uses VPAs to investigate the shape of the fused spine after T10-pelvis fusion, in patients with adult spinal deformity (ASD), and then explores its association with proximal junctional kyphosis (PJK). Methods: Included patients had radiographic evidence of ASD and underwent T10-pelvis realignment. VPAs were used to construct a virtual shape of the post-operative spine. VPA-predicted and actual shapes were then compared between patients with and without PJK. Logistic regression was used to identify components of the VPA-based model that were independent predictors of PJK occurrence and post-operative shape. Results: 287 patients were included. VPA-predicted shape was representative of the true post-operative contour, with a mean point-to-point error of 1.6-2.9% of the T10-S1 spine length. At 6-weeks follow-up, 102 patients (35.5%) developed PJK. Comparison of the true post-operative shapes demonstrated that PJK patients had more posteriorly translated vertebrae from L3 to T7 (P <.001). Logistic regression demonstrated that L3PA (P =.047) and T11PA (P <.001) were the best independent predictors of PJK and were, in conjunction with pelvic incidence, sufficient to reproduce the actual spinal contour (error <3%). Conclusions: VPAs are reliable in reproducing the true, post-operative spine shape in patients undergoing T10-pelvis fusion for ASD. Because VPAs are independent of patient position, L3PA, T11PA, and PI measurements can be used for both pre- and intra-operative planning to ensure optimal alignment. [ABSTRACT FROM AUTHOR]