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ObjectiveAlthough short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.MethodsThe ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.ResultsThe 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.ConclusionsThe significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

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 Design. Longitudinal observational cohort. Objectives. The purpose of this study was to evaluate the utility of Quantitative Romberg measurements as pre-op and post-op balance outcome measures. Summary of Background Data. Cervical spondylotic myelopathy (CSM) is characterized by balance deficiencies produced by impaired proprioception. Evaluation is subjective, and binary physical exam findings lack the precision to assess postoperative outcome improvement. Methods. CSM patients were prospectively enrolled to undergo preoperative and postoperative Quantitative Romberg tests on a force plate to record center of pressure (COP) motion for 30 seconds with eyes open followed by eyes closed. Revision cases were excluded. Kinematics of COP movement parameters were compared between preoperative and postoperative state for each patient. Results. Twenty-seven CSM patients were enrolled and completed both pre/post-testing. The mean age was 60.0 years, with 13 (48%) males and 9 (33%) smokers. Mean number of surgical levels was 2.48. The minimum mean follow-up was six months. There was a statistically significant improvement in eyes closed after surgery compared with preoperative for total COP motion (523.44 vs. 387.00 cm, P<0.001), average sway speed (17.41 vs. 13.00 cm/s, P< 0.001), and total lateral COP motion (253.44 vs. 186.70 cm, P<0.001). There was no statistically significant improvement in the modified Japanese Orthopaedic Association (13.29 vs. 14.29, P=0.28). Conclusions. CSM balance findings on Quantitative Romberg testing significantly improve postoperatively in patients with CSM. These findings support this testing as representative of proprioceptive balance deficiencies seen in CSM. Quantitative Romberg may be used as an objective measure of clinical outcome and assist in stratification of surgical interventions, surgery timing, and technique. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective cross-sectional. Objectives. To determine associations between Hounsfield units (HU) within a region of interest on computed tomography (CT) scans and dual energy X-ray absorptiometry (DEXA) measurements in children and adolescents. Summary of Background Data. HU on CT scans as a proxy for bone mineral density (BMD) is widely used in adults. However, the utility of CT as a proxy for BMD have not been evaluated in children and adolescents. Materials and Methods. Patients younger than 18 years with a lumbar spine CT scan and a DEXA within 6 months of each other were identified. A region of interest was used to measure the HU at each lumbar vertebral body on midaxial cuts. Charts were reviewed for demographics, medical comorbidities, and DEXA reports. Correlation coefficients were calculated between the mean DEXA Z-score and the HU value. Patients were also stratified by Z-score (= -1.0, between -1.0 and -2.0, and =-2.0) and matched by age, sex and body mass index (BMI) to a cohort of healthy children and compared. Results. A moderate correlation between mean DEXA Z-score and mean HU on CT was found (r2=0.42, P< 0.001). After matching for age, sex and BMI, 21 patients in each group between the ages of 4 and 17 years were analyzed. The mean HU value of the control group was 231.69. When stratified by Z-score (= -1.0, between -1.0 and -2.0, and =-2.0), the mean HU values were 244.59, 216.50, and 176.54, respectively. Patients with a Z-score of =-2.0 had a significantly lower mean HU than matched controls. Conclusions. HU on lumbar CT in children and adolescents with DEXA Z-scores <-2.0, were lower when compared with healthy matched controls. This study suggests that HU on opportunistic CT scans of the spine may be used as a reasonable proxy for BMD in the pediatric population. [ABSTRACT FROM AUTHOR]

Study designProspective, cross-sectional study.ObjectiveThe aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).Summary of background dataPrevious literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.MethodsProspective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.Inclusion criteria40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.ResultsMean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.ConclusionIn primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.Level of evidence2.