Douglas C. Burton

Radiographical spinopelvic parameters and disability in the setting of adult spinal deformity: a prospective multicenter analysis.

Study Design. Prospective multicenter study evaluating operative (OP) versus nonoperative (NONOP) treatment for adult spinal deformity (ASD). Objective. Evaluate correlations between spinopelvic parameters and health-related quality of life (HRQOL) scores in patients with ASD. Summary of Background Data. Sagittal spinal deformity is commonly defined by an increased sagittal vertical axis (SVA); however, SVA alone may underestimate the severity of the deformity. Spinopelvic parameters provide a more complete assessment of the sagittal plane but only limited data are available that correlate spinopelvic parameters with disability. Methods. Baseline demographic, radiographical, and HRQOL data were obtained for all patients enrolled in a multicenter consecutive database. Inclusion criteria were: age more than 18 years and radiographical diagnosis of ASD. Radiographical evaluation was conducted on the frontal and lateral planes and HRQOL questionnaires (Oswestry Disability Index [ODI], Scoliosis Research Society-22r and Short Form [SF]-12) were completed. Radiographical parameters demonstrating highest correlation with HRQOL values were evaluated to determine thresholds predictive of ODI more than 40. Results. Four hundred ninety-two consecutive patients with ASD (mean age, 51.9 yr) were enrolled. Patients from the OP group (n = 178) were older (55 vs. 50.1 yr, P < 0.05), had greater SVA (5.5 vs. 1.7 cm, P < 0.05), greater pelvic tilt (PT; 22° vs. 11°, P < 0.05), and greater pelvic incidence/lumbar lordosis PI/LL mismatch (PI-LL; 12.2 vs. 4.3; P < 0.05) than NONOP group (n = 314). OP group demonstrated greater disability on all HRQOL measures compared with NONOP group (ODI = 41.4 vs. 23.9, P < 0.05; Scoliosis Research Society score total = 2.9 vs. 3.5, P < 0.05). Pearson analysis demonstrated that among all parameters, PT, SVA, and PI-LL correlated most strongly with disability for both OP and NONOP groups (P < 0.001). Linear regression models demonstrated threshold radiographical spinopelvic parameters for ODI more than 40 to be: PT 22° or more (r = 0.38), SVA 47 mm or more (r = 0.47), PI − LL 11° or more (r = 0.45). Conclusion. ASD is a disabling condition. Prospective analysis of consecutively enrolled patients with ASD demonstrated that PT and PI-LL combined with SVA can predict patient disability and provide a guide for patient assessment for appropriate therapeutic decision making. Threshold values for severe disability (ODI > 40) included: PT 22° or more, SVA 47 mm or more, and PI − LL 11° or more.

Adolescent idiopathic scoliosis: natural history and long term treatment effects

Adolescent idiopathic scoliosis is a lifetime, probably systemic condition of unknown cause, resulting in a spinal curve or curves of ten degrees or more in about 2.5% of most populations. However, in only about 0.25% does the curve progress to the point that treatment is warranted.Untreated, adolescent idiopathic scoliosis does not increase mortality rate, even though on rare occasions it can progress to the >100° range and cause premature death. The rate of shortness of breath is not increased, although patients with 50° curves at maturity or 80° curves during adulthood are at increased risk of developing shortness of breath. Compared to non-scoliotic controls, most patients with untreated adolescent idiopathic scoliosis function at or near normal levels. They do have increased pain prevalence and may or may not have increased pain severity. Self-image is often decreased. Mental health is usually not affected. Social function, including marriage and childbearing may be affected, but only at the threshold of relatively larger curves.Non-operative treatment consists of bracing for curves of 25° to 35° or 40° in patients with one to two years or more of growth remaining. Curve progression of ≥ 6° is 20 to 40% more likely with observation than with bracing. Operative treatment consists of instrumentation and arthrodesis to realign and stabilize the most affected portion of the spine. Lasting curve improvement of approximately 40% is usually achieved.In the most completely studied series to date, at 20 to 28 years follow-up both braced and operated patients had similar, significant, and clinically meaningful reduced function and increased pain compared to non-scoliotic controls. However, their function and pain scores were much closer to normal than patient groups with other, more serious conditions.Risks associated with treatment include temporary decrease in self-image in braced patients. Operated patients face the usual risks of major surgery, a 6 to 29% chance of requiring re-operation, and the remote possibility of developing a pain management problem.Knowledge of adolescent idiopathic scoliosis natural history and long-term treatment effects is and will always remain somewhat incomplete. However, enough is know to provide patients and parents the information needed to make informed decisions about management options.

Further development and validation of the Scoliosis Research Society (SRS) Outcomes Instrument

Study Design. Outcome study to determine response distribution, internal consistency, and validity of a Modified SRS Outcomes Instrument (MSRSI). Objectives. Refinement and validation of the SRS Outcomes Instrument for idiopathic scoliosis. Summary of Background Data. Experience with the SRS Outcomes Instrument suggested several refinements and the need for validation. Methods. Following experience-based modification, the Modified SRS Outcomes Instrument and Short Form 36 (SF-36) questionnaires were administered to 35 previously surveyed postoperative idiopathic scoliosis patients. Results. Thirty (86%) patients with an average age of 25 years returned the questionnaires at an average of 10 years postoperative. Distribution of scores was acceptable. Internal consistency utilizing Cronbach’s &agr; was 0.80, 0.81, 0.77, 0.89, and 0.88 for pain, self-image/appearance, function/activity, mental health, and satisfaction with surgery, respectively. Validity, determined by Pearson correlation coefficients with comparable SF-36 domains, was 0.70 or greater for 13 of the 14 relevant domains between SF-36 and MSRSI (P < 0.001). Conclusion. The SRS Outcomes Instrument is simple and internally consistent. Based on experience, a number of modifications have been made that improve the instruments scope and internal consistency. Finally, the instrument is valid in comparison to SF-36.

Refinement of the SRS-22 health-related quality of life questionnaire function domain

Study Design. Prospective observational case series. Objectives. To improve the Scoliosis Research Society-22 (SRS-22) Health-Related Quality of Life (HRQL) questionnaire Function domain internal consistency for patients younger than 18 years. Summary of Background Data. During English validation as well as Spanish and Turkish transcultural adaptation studies, low internal consistency of the Function domain was discovered for patients younger than 18 years. The problem was traced to questions 15 (relating to financial considerations) and 18 (relating to going out with friends). Otherwise, the SRS-22 HRQL questionnaire has been shown to be valid and has been successfully translated into Spanish and Turkish. Methods. Based on existing data, question 18s stem and responses were revised without changing its content and added to the SRS-22 questionnaire. Question 15 remained unchanged, and the effect of inclusion or exclusion on domain score was determined. During a 3-month period, the questionnaire was completed by 111 outpatients, including four groups: idiopathic scoliosis age <18 years (n = 37), idiopathic scoliosis age ≥18 years (n = 32), other spinal disorders age <18 years (n = 17), and other spinal disorders age ≥18 years (n = 25). Results. As a result of the revision of question 18, the Function domain internal consistency, Cronbachs alpha, for patients age <18 years was increased from 0.67 to 0.78 for patients with idiopathic scoliosis and from 0.60 to 0.80 for patients with other spinal disorders. Domain internal consistency remained high, 0.77 to 0.96 for all the other domain-patient groupings. Removal of question 15 slightly improved Function domain internal consistency for idiopathic scoliosis patients <18 years old and slightly decreased it for patients <18 years old with other spinal conditions. Conclusion. With a minor revision of question 18 (related to going out) the internal consistency of the SRS-22 Function domain has been improved in idiopathic scoliosis patients <18 years of age. Deletion of question 15 (related to financial considerations) has a variable, small effect depending on patient group. Retention of question 15 is recommended unless a cultural variable, such as differences in healthcare payment schemes, substantially lowers domain psychometric properties.

The SRS-Schwab Adult Spinal Deformity Classification: Assessment and Clinical Correlations Based on a Prospective Operative and Nonoperative Cohort

BACKGROUND The SRS-Schwab classification of adult spinal deformity (ASD) is a validated system that provides a common language for the complex pathology of ASD. Classification reliability has been reported; however, correlation with treatment has not been assessed. OBJECTIVE To assess the clinical relevance of the SRS-Schwab classification based on correlations with health-related quality of life (HRQOL) measures and the decision to pursue operative vs nonoperative treatment. METHODS Prospective analysis of consecutive ASD patients (18 years of age and older) collected through a multicenter group. The SRS-Schwab classification includes a curve type descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis, pelvic tilt, pelvic incidence/lumbar lordosis mismatch). Differences in demographics, HRQOL (Oswestry Disability Index, SRS-22, Short Form-36), and classification between operative and nonoperative patients were evaluated. RESULTS A total of 527 patients (mean age, 52.9 years; range, 18.4-85.1 years) met inclusion criteria. Significant differences in HRQOL were identified based on SRS-Schwab curve type, with thoracolumbar and primary sagittal deformities associated with greater disability and poorer health status than thoracic or double curve deformities. Operative patients had significantly poorer grades for each of the sagittal spinopelvic modifiers, and progressively higher grades were associated with significantly poorer HRQOL (P < .05). Patients with worse sagittal spinopelvic modifier grades were significantly more likely to require major osteotomies, iliac fixation, and decompression (P ≤ .009). CONCLUSION The SRS-Schwab classification provides a validated language to describe and categorize ASD. This study demonstrates that the SRS-Schwab classification reflects severity of disease state based on multiple measures of HRQOL and significantly correlates with the important decision of whether to pursue operative or nonoperative treatment.

Change in classification grade by the SRS-Schwab Adult Spinal Deformity Classification predicts impact on health-related quality of life measures: prospective analysis of operative and nonoperative treatment.

Study Design. Multicenter, prospective, consecutive series. Objective. To evaluate responsiveness of the Scoliosis Research Society (SRS)-Schwab adult spinal deformity (ASD) classification to changes in health-related quality of life (HRQOL) after treatment for ASD. Summary of Background Data. Ideally, a classification system should describe and be responsive to changes in a disease state. We hypothesized that the SRS-Schwab classification is responsive to changes in HRQOL measures after treatment for ASD. Methods. A multicenter, prospective, consecutive series from the International Spine Study Group. Inclusion criteria: ASD, age more than 18, operative or nonoperative treatment, baseline and 1-year radiographs, and HRQOL measures (Oswestry Disability Index [ODI], SRS-22, Short Form [SF]-36). The SRS-Schwab classification includes a curve descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis [SVA], pelvic tilt, pelvic incidence/lumbar lordosis [PI-LL] mismatch). Changes in modifiers at 1 year were assessed for impact on HRQOL from pretreatment values based on minimal clinically important differences. Results. Three hundred forty-one patients met criteria (mean age = 54; 85% females; 177 operative and 164 nonoperative). Change in pelvic tilt modifier at 1-year follow-up was associated with changes in ODI and SRS-22 (total and appearance scores) (P ⩽ 0.034). Change in SVA modifier at 1 year was associated with changes in ODI, SF-36 physical component score, and SRS-22 (total, activity, and appearance scores) (P ⩽ 0.037). Change in PI-LL modifier at 1 year was associated with changes in SF-36 physical component score and SRS-22 (total, activity, and appearance scores) (P ⩽ 0.03). Patients with improvement of pelvic tilt, SVA, or PI-LL modifiers were significantly more likely to achieve minimal clinically important difference for ODI, SF-36 physical component score (SVA and PI-LL only), SRS activity, and SRS pain (PI-LL only). Conclusion. The SRS-Schwab classification provides a validated system to evaluate ASD, and the classification components correlate with HRQOL measures. This study demonstrates that the classification modifiers are responsive to changes in disease state and reflect significant changes in patient-reported outcomes. Level of Evidence: 3

Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery

OBJECTIVE Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. METHODS As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. RESULTS Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury). CONCLUSIONS This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

Safety and efficacy of Isola instrumentation and arthrodesis for adolescent idiopathic scoliosis: two- to 12-year follow-up.

Study Design. Retrospective case series including patient outcome assessment. Objective. To study the safety and efficacy of Isola instrumentation in comparison with similar series. Summary of Background Data. Both the technique and technology used in the surgical treatment of adolescent idiopathic scoliosis continue to evolve, the common theme since the 1980s being provision of instrumentation stable and strong enough to eliminate the need for postoperative immobilization. The purpose of this study is to determine the safety and efficacy of a system deliberately integrating hook, wire, and screw anchors to deliver torsional and countertorsional corrective loads. Methods. A total of 185 consecutive patients, index patient included, were treated by posterior instrumentation and arthrodesis from January 1989 through December 2000. Safety was studied by complications, and reoperation type and occurrence. Effectiveness was studied by deformity correction and health-related quality of life questionnaire response. Variables affecting effectiveness were sought. A total of 179 patients (97%) had outcome assessment at an average of 6 years postoperative, and 176 had radiographic evaluation at an average of 5 years postoperative. Results. There were no deaths, spinal cord or nerve root problems, or acute posterior wound infections. Proven pseudarthrosis occurred in 4 patients (2.2%) and delayed deep wound infection in 2 patients (1.1%). The implant-related reoperation rate was 8% and was necessary more often in the first quarter of the series (17% vs. 4.6%, P = 0.0062). The largest Cobb angle averaged 62° preoperative and 23° at latest follow-up, 63% correction. The largest angle of trunk inclination averaged 16.7° before surgery and 9.9° at latest follow-up, a 39% correction (P < 0.0001). Eighty-eight percent of patients were satisfied or very satisfied with the outcome. The principal problems identified were the need for a stronger transverse connector, stable end-instrumented vertebrae foundations, and convex thoracic anchorage. Conclusions. Isola instrumentation seems to be at least as safe and effective as other instrumentations being used for the surgical treatment of adolescent idiopathic scoliosis.

Changes in thoracic kyphosis negatively impact sagittal alignment after lumbar pedicle subtraction osteotomy: a comprehensive radiographic analysis.

Study Design. Consecutive, multicenter retrospective review. Objective. To evaluate if change in thoracic kyphosis (TK) has a positive or negative impact on spinopelvic alignment after lumbar pedicle subtraction osteotomy (PSO) with short fusions. Summary of Background Data. In the setting of sagittal malalignment, the effect of large vertebral resections can now be anticipated in long fusions, but their impact on unfused segments (reciprocal changes [RC]) remains poorly understood. Methods. A total of 34 adult patients (mean age = 54 years; SD = 12) who underwent lumbar PSO with upper instrumented vertebra below T10 were included. Radiographic analysis included pre- and postassessment of TK, lumbar lordosis (LL), sagittal vertical axis (SVA), T1 spinopelvic inclination (T1SPI), pelvic tilt (PT), and pelvic incidence (PI). Final SVA and PT were analyzed to determine successful realignment. RC in the thoracic spine was designated favorable or unfavorable on the basis of impact on final SVA and PT. Results. Mean PSO resection was 26°. LL increased from 20° to 49° (P < 0.001). SVA improved from 14 to 4 cm (P < 0.001), and PT improved from 33° to 25° (P < 0.001). Mean increase in TK was 13° (P = 0.002) but was unchanged in 11 patients. Five patients had a favorable RC, and 18 patients had an unfavorable RC. Unfavorable RC was attributed to junctional failure in 6 of 18 patients. Significant differences in the unfavorable RC group included age and greater preoperative PT, PI, SVA, and T1SPI. Conclusion. Significant postoperative alignment changes can occur through unfused thoracic spinal segments after lumbar PSO. Unfavorable RC may limit optimal correction and lead to clinical failures. Risk factors for unfavorable thoracic RC include older patients, larger preoperative PI and PT, and worse preoperative T1SPI and are not simply due to junctional failure. Care should be taken with selective lumbar fusion and PSO in older patients and in those with severe preoperative spinopelvic parameters.

The T1 Pelvic Angle, a Novel Radiographic Measure of Global Sagittal Deformity, Accounts for Both Spinal Inclination and Pelvic Tilt and Correlates with Health-Related Quality of Life

BACKGROUND Adult spinal deformity is a prevalent cause of pain and disability. Established measures of sagittal spinopelvic alignment such as sagittal vertical axis and pelvic tilt can be modified by postural compensation, including pelvic retroversion, knee flexion, and the use of assistive devices for standing. We introduce the T1 pelvic angle, a novel measure of sagittal alignment that simultaneously accounts for both spinal inclination and pelvic retroversion. The purpose of this study was to investigate the relationship of the T1 pelvic angle and other established sagittal alignment measures and to correlate these parameters with health-related quality-of-life measures. METHODS This is a multicenter, prospective, cross-sectional analysis of consecutive patients with adult spinal deformity. Inclusion criteria were adult spinal deformity, an age of greater than eighteen years, and any of the following: scoliosis, a Cobb angle of ≥ 20°, sagittal vertical axis of ≥ 5 cm, thoracic kyphosis of ≥ 60°, and pelvic tilt of ≥ 25°. Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society (SRS)-22, and Short Form-36 (SF-36) questionnaires. RESULTS Five hundred and fifty-nine consecutive patients with adult spinal deformity (mean age, 52.5 years) were enrolled. The T1 pelvic angle correlated with the sagittal vertical axis (r = 0.837), pelvic incidence minus lumbar lordosis (r = 0.889), and pelvic tilt (0.933). Categorizing the patients by increasing T1 pelvic angle (<10°, 10° to 20°, 21° to 30°, and > 30°) revealed a significant and progressive worsening in health-related quality of life (p < 0.001 for all). The T1 pelvic angle and sagittal vertical axis correlated with the ODI (0.435 and 0.455), SF-36 Physical Component Summary (-0.445 and -0.458), and SRS (-0.358 and -0.383) (p < 0.001 for all). Utilizing a linear regression analysis, a T1 pelvic angle of 20° corresponded to a severe disability (an ODI of >40), and the meaningful change in T1 pelvic angle corresponding to one minimal clinically important difference was 4.1° on the ODI. CONCLUSIONS The T1 pelvic angle correlates with health-related quality of life in patients with adult spinal deformity. The T1 pelvic angle is related to both pelvic tilt and sagittal vertical axis; however, unlike sagittal vertical axis, it does not vary on the basis of the extent of pelvic retroversion or patient support in standing. Since the T1 pelvic angle is an angular and not a linear measure, it does not require calibration of the radiograph. Thus, the T1 pelvic angle measures sagittal deformity independent of many postural compensatory mechanisms, and it can be useful as a preoperative planning tool, with a target T1 pelvic angle of < 14°. LEVEL OF EVIDENCE Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.