Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group
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.
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.
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).
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.
Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up
Presented at the 2015 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves
Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Frank Schwab, Justin K. Scheer, Themistocles Protopsaltis, Eric Klineberg, Munish Gupta, Richard Hostin, Kai-Ming G. Fu, Gregory M. Mundis Jr., Han Jo Kim, Vedat Deviren, Alex Soroceanu, Robert A. Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group
Although recent studies suggest that average clinical outcomes are improved following surgery for selected adult spinal deformity (ASD) patients, these outcomes span a broad range. Few studies have specifically addressed factors that may predict favorable clinical outcomes. The objective of this study was to compare patients with ASD with best versus worst clinical outcomes following surgical treatment to identify distinguishing factors that may prove useful for patient counseling and optimization of clinical outcomes.
This is a retrospective review of a prospectively collected, multicenter, database of consecutively enrolled patients with ASD who were treated operatively. Inclusion criteria were age > 18 years and ASD. For patients with a minimum of 2-year follow-up, those with best versus worst outcomes were compared separately based on Scoliosis Research Society-22 (SRS-22) and Oswestry Disability Index (ODI) scores. Only patients with a baseline SRS-22 ≤ 3.5 or ODI ≥ 30 were included to minimize ceiling/floor effects. Best and worst outcomes were defined for SRS-22 (≥ 4.5 and ≤ 2.5, respectively) and ODI (≤ 15 and ≥ 50, respectively).
Of 257 patients who met the inclusion criteria, 227 (88%) had complete baseline and 2-year follow-up SRS-22 and ODI outcomes scores and radiographic imaging and were analyzed in the present study. Of these 227 patients, 187 had baseline SRS-22 scores ≤ 3.5, and 162 had baseline ODI scores ≥ 30. Forthe SRS-22, best and worst outcomes criteria were met at follow-up for 25 and 27 patients, respectively. For the ODI, best and worst outcomes criteria were met at follow-up for 43 and 51 patients, respectively. With respect to the SRS-22, compared with best outcome patients, those with worst outcomes had higher baseline SRS-22 scores (p < 0.0001), higher prevalence of baseline depression (p < 0.001), more comorbidities (p = 0.012), greater prevalence of prior surgery (p = 0.007), a higher complication rate (p = 0.012), and worse baseline deformity (sagittal vertical axis [SVA], p = 0.045; pelvic incidence [PI] and lumbar lordosis [LL] mismatch, p = 0.034). The best-fit multivariate model for SRS-22 included baseline SRS-22 (p = 0.033), baseline depression (p = 0.012), and complications (p = 0.030). With respect to the ODI, compared with best outcome patients, those with worst outcomes had greater baseline ODI scores (p < 0.001), greater baseline body mass index (BMI; p = 0.002), higher prevalence of baseline depression (p < 0.028), greater baseline SVA (p = 0.016), a higher complication rate (p = 0.02), and greater 2-year SVA (p < 0.001) and PI-LL mismatch (p = 0.042). The best-fit multivariate model for ODI included baseline ODI score (p < 0.001), 2-year SVA (p = 0.014) and baseline BMI (p = 0.037). Age did not distinguish best versus worst outcomes for SRS-22 or ODI (p > 0.1).
Few studies have specifically addressed factors that distinguish between the best versus worst clinical outcomes for ASD surgery. In this study, baseline and perioperative factors distinguishing between the best and worst outcomes for ASD surgery included several patient factors (baseline depression, BMI, comorbidities, and disability), as well as residual deformity (SVA), and occurrence of complications. These findings suggest factors that may warrant greater awareness among clinicians to achieve optimal surgical outcomes for patients with ASD.
Shayan Fakurnejad, Justin K. Scheer, Virginie Lafage, Justin S. Smith, Vedat Deviren, Richard Hostin, Gregory M. Mundis Jr., Douglas C. Burton, Eric Klineberg, Munish Gupta, Khaled Kebaish, Christopher I. Shaffrey, Shay Bess, Frank Schwab, Christopher P. Ames and The International Spine Study Group
Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined.
The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22°), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11°). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1–6) or thoracolumbar (T9–L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups.
Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 ± 12.4 years (range 20–82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL measures except the MCS score. For the entire patient cohort, the improvements ranged from 57.6% for the SRS-22 pain score MCID to 24.4% for the ODI score SCB. For patients undergoing PSO or VCR, the likelihood of their outcomes reaching MCID or SCB ranged from 24.3% to 62.3% and from 16.2% to 47.8%, respectively. The SRS-22 self-image score of patients who had a UIV in the upper thoracic region reached MCID significantly more than that of patients who had a UIV in the thoracolumbar region (70.6% vs 41.9%, p = 0.0281). All other outcomes were similar for UIVs of upper thoracic and thoracolumbar regions. Comparison of patients whose spines were above or below the radiographic thresholds associated with disability indicated similar rates of meeting MCID and SCB for HRQOL at the 2-year follow-up.
Outcomes for patients having UIVs in the upper thoracic region were no more likely to meet MCID or SCB than for those having UIVs in the thoracolumbar region, except for the MCID in the SRS-22 self-image measure. The HRQOL outcomes in patients who had optimal sagittal correction according to radiographic thresholds determined preoperatively were not significantly more likely to reach MCID or SCB at the 2-year follow-up. Future work needs to determine whether the Schwab preoperative radiographic thresholds for severe disability apply in postoperative settings.
Justin S. Smith, Ellen Shaffrey, Eric Klineberg, Christopher I. Shaffrey, Virginie Lafage, Frank J. Schwab, Themistocles Protopsaltis, Justin K. Scheer, Gregory M. Mundis Jr., Kai-Ming G. Fu, Munish C. Gupta, Richard Hostin, Vedat Deviren, Khaled Kebaish, Robert Hart, Douglas C. Burton, Breton Line, Shay Bess, Christopher P. Ames and The International Spine Study Group
Improved understanding of rod fracture (RF) following adult spinal deformity (ASD) surgery could prove valuable for surgical planning, patient counseling, and implant design. The objective of this study was to prospectively assess the rates of and risk factors for RF following surgery for ASD.
This was a prospective, multicenter, consecutive series. Inclusion criteria were ASD, age > 18 years, ≥5 levels posterior instrumented fusion, baseline full-length standing spine radiographs, and either development of RF or full-length standing spine radiographs obtained at least 1 year after surgery that demonstrated lack of RF. ASD was defined as presence of at least one of the following: coronal Cobb angle ≥20°, sagittal vertical axis (SVA) ≥5 cm, pelvic tilt (PT) ≥25°, and thoracic kyphosis ≥60°.
Of 287 patients who otherwise met inclusion criteria, 200 (70%) either demonstrated RF or had radiographic imaging obtained at a minimum of 1 year after surgery showing lack of RF. The patients' mean age was 54.8 ± 15.8 years; 81% were women; 10% were smokers; the mean body mass index (BMI) was 27.1 ± 6.5; the mean number of levels fused was 12.0 ± 3.8; and 50 patients (25%) had a pedicle subtraction osteotomy (PSO). The rod material was cobalt chromium (CC) in 53%, stainless steel (SS), in 26%, or titanium alloy (TA) in 21% of cases; the rod diameters were 5.5 mm (in 68% of cases), 6.0 mm (in 13%), or 6.35 mm (in 19%). RF occurred in 18 cases (9.0%) at a mean of 14.7 months (range 3–27 months); patients without RF had a mean follow-up of 19 months (range 12–24 months). Patients with RF were older (62.3 vs 54.1 years, p = 0.036), had greater BMI (30.6 vs 26.7, p = 0.019), had greater baseline sagittal malalignment (SVA 11.8 vs 5.0 cm, p = 0.001; PT 29.1° vs 21.9°, p = 0.016; and pelvic incidence [PI]–lumbar lordosis [LL] mismatch 29.6° vs 12.0°, p = 0.002), and had greater sagittal alignment correction following surgery (SVA reduction by 9.6 vs 2.8 cm, p < 0.001; and PI-LL mismatch reduction by 26.3° vs 10.9°, p = 0.003). RF occurred in 22.0% of patients with PSO (10 of the 11 fractures occurred adjacent to the PSO level), with rates ranging from 10.0% to 31.6% across centers. CC rods were used in 68% of PSO cases, including all with RF. Smoking, levels fused, and rod diameter did not differ significantly between patients with and without RF (p > 0.05). In cases including a PSO, the rate of RF was significantly higher with CC rods than with TA or SS rods (33% vs 0%, p = 0.010). On multivariate analysis, only PSO was associated with RF (p = 0.001, OR 5.76, 95% CI 2.01–15.8).
Rod fracture occurred in 9.0% of ASD patients and in 22.0% of PSO patients with a minimum of 1-year follow-up. With further follow-up these rates would likely be even higher. There was a substantial range in the rate of RF with PSO across centers, suggesting potential variations in technique that warrant future investigation. Due to higher rates of RF with PSO, alternative instrumentation strategies should be considered for these cases.
Justin S. Smith, Manish Singh, Eric Klineberg, Christopher I. Shaffrey, Virginie Lafage, Frank J. Schwab, Themistocles Protopsaltis, David Ibrahimi, Justin K. Scheer, Gregory Mundis Jr., Munish C. Gupta, Richard Hostin, Vedat Deviren, Khaled Kebaish, Robert Hart, Douglas C. Burton, Shay Bess and Christopher P. Ames
Increased sagittal vertical axis (SVA) correlates strongly with pain and disability for adults with spinal deformity. A subset of patients with sagittal spinopelvic malalignment (SSM) have flatback deformity (pelvic incidence–lumbar lordosis [PI-LL] mismatch > 10°) but remain sagittally compensated with normal SVA. Few data exist for SSM patients with flatback deformity and normal SVA. The authors' objective was to compare baseline disability and treatment outcomes for patients with compensated (SVA < 5 cm and PI-LL mismatch > 10°) and decompensated (SVA > 5 cm) SSM.
The study was a multicenter, prospective analysis of adults with spinal deformity who consecutively underwent surgical treatment for SSM. Inclusion criteria included age older than 18 years, presence of adult spinal deformity with SSM, plan for surgical treatment, and minimum 1-year follow-up data. Patients with SSM were divided into 2 groups: those with compensated SSM (SVA < 5 cm and PI-LL mismatch > 10°) and those with decompensated SSM (SVA ≥ 5 cm). Baseline and 1-year follow-up radiographic and health-related quality of life (HRQOL) outcomes included Oswestry Disability Index, Short Form–36 scores, and Scoliosis Research Society–22 scores. Percentages of patients achieving minimal clinically important difference (MCID) were also assessed.
A total of 125 patients (27 compensated and 98 decompensated) met inclusion criteria. Compared with patients in the compensated group, patients in the decompensated group were older (62.9 vs 55.1 years; p = 0.004) and had less scoliosis (43° vs 54°; p = 0.002), greater SVA (12.0 cm vs 1.7 cm; p < 0.001), greater PI-LL mismatch (26° vs 20°; p = 0.013), and poorer HRQOL scores (Oswestry Disability Index, Short Form-36 physical component score, Scoliosis Research Society-22 total; p ≤ 0.016). Although these baseline HRQOL differences between the groups reached statistical significance, only the mean difference in Short Form–36 physical component score reached threshold for MCID. Compared with baseline assessment, at 1 year after surgery improvement was noted for patients in both groups for mean SVA (compensated –1.1 cm, decompensated +4.8 cm; p ≤ 0.009), mean PI-LL mismatch (compensated 6°, decompensated 5°; p < 0.001), and all HRQOL measures assessed (p ≤ 0.005). No significant differences were found between the compensated and decompensated groups in the magnitude of HRQOL score improvement or in the percentages of patients achieving MCID for each of the outcome measures assessed.
Decompensated SSM patients with elevated SVA experience significant disability; however, the amount of disability in compensated SSM patients with flatback deformity caused by PI-LL mismatch but normal SVA is underappreciated. Surgical correction of SSM demonstrated similar radiographic and HRQOL score improvements for patients in both groups. Evaluation of SSM should extend beyond measuring SVA. Among patients with concordant pain and disability, PI-LL mismatch must be evaluated for SSM patients and can be considered a primary indication for surgery.
Justin K. Scheer, Virginie Lafage, Justin S. Smith, Vedat Deviren, Richard Hostin, Ian M. McCarthy, Gregory M. Mundis, Douglas C. Burton, Eric Klineberg, Munish C. Gupta, Khaled M. Kebaish, Christopher I. Shaffrey, Shay Bess, Frank Schwab, Christopher P. Ames and the International Spine Study Group (ISSG)
Spinal osteotomies for adult spinal deformity correction may include resection of all 3 spinal columns (pedicle subtraction osteotomy [PSO] and vertebral column resection [VCR]). The relationship between patient age and health-related quality of life (HRQOL) outcomes for patients undergoing major spinal deformity correction via PSO or VCR has not been well characterized. The goal of this study was to characterize that relationship.
This study was a retrospective review of 374 patients who had undergone a 3-column osteotomy (299 PSOs and 75 VCRs) and were part of a prospectively collected, multicenter adult spinal deformity database. The consecutively enrolled patients were drawn from 11 sites across the United States. Health-related QOL outcomes, according to the visual analog scale (VAS), Oswestry Disability Index (ODI), 36-Item Short-Form Health Survey (SF-36, physical component score [PCS] and mental component score), and Scoliosis Research Society-22 questionnaire (SRS), were evaluated preoperatively and 1 and 2 years postoperatively. Differences and correlations between patient age and HRQOL outcomes were investigated. Age groupings included young (age ≤ 45 years), middle aged (age 46–64 years), and elderly (age ≥ 65 years).
In patients who had undergone PSO, age significantly correlated (Spearman's correlation coefficient) with the 2-year ODI (ρ = 0.24, p = 0.0450), 2-year SRS function score (ρ = 0.30, p = 0.0123), and 2-year SRS total score (ρ = 0.30, p = 0.0133). Among all patients (PSO+VCR), the preoperative PCS and ODI in the young group were significantly higher and lower, respectively, than those in the elderly. Among the PSO patients, the elderly group had much greater improvement than the young group in the 1- and 2-year PCS, 2-year ODI, and 2-year SRS function and total scores. Among the VCR patients, the young age group had much greater improvement than the elderly in the 1-year SRS pain score, 1-year PCS, 2-year PCS, and 2-year ODI. There was no significant difference among all the age groups as regards the likelihood of reaching a minimum clinically important difference (MCID) within each of the HRQOL outcomes (p > 0.05 for all). Among the PSO patients, the elderly group was significantly more likely than the young to reach an MCID for the 1-year PCS (61% vs 21%, p = 0.0077) and the 2-year PCS (67% vs 17%, p = 0.0054), SRS pain score (57% vs 20%, p = 0.0457), and SRS function score (62% vs 20%, p = 0.0250). Among the VCR patients, the young group was significantly more likely than the elderly patients to reach an MCID for the 1-year (100% vs 20%, p = 0.0036) and 2-year (100% vs 0%, p = 0.0027) PCS scores and 1-year (60% vs 0%, p = 0.0173) and 2-year (70% vs 0%, p = 0.0433) SRS pain scores.
The PSO and VCR are not equivalent surgeries in terms of HRQOL outcomes and patient age. Among patients who underwent PSO, the elderly group started with more preoperative disability than the younger patients but had greater improvements in HRQOL outcomes and was more likely to reach an MCID at 1 and 2 years after treatment. Among those who underwent VCR, all had similar preoperative disabilities, but the younger patients had greater improvements in HRQOL outcomes and were more likely to reach an MCID at 1 and 2 years after treatment.
Justin K. Scheer, Jessica A. Tang, Justin S. Smith, Eric Klineberg, Robert A. Hart, Gregory M. Mundis Jr., Douglas C. Burton, Richard Hostin, Michael F. O'Brien, Shay Bess, Khaled M. Kebaish, Vedat Deviren, Virginie Lafage, Frank Schwab, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group
Complications and reoperation for surgery to correct adult spinal deformity are not infrequent, and many studies have analyzed the rates and factors that influence the likelihood of reoperation. However, there is a need for more comprehensive analyses of reoperation in adult spinal deformity surgery from a global standpoint, particularly focusing on the 1st year following operation and considering radiographic parameters and the effects of reoperation on health-related quality of life (HRQOL). This study attempts to determine the prevalence of reoperation following surgery for adult spinal deformity, assess the indications for these reoperations, evaluate for a relation between specific radiographic parameters and the need for reoperation, and determine the potential impact of reoperation on HRQOL measures.
A retrospective review was conducted of a prospective, multicenter, adult spinal deformity database collected through the International Spine Study Group. Data collected included age, body mass index, sex, date of surgery, information regarding complications, reoperation dates, length of stay, and operation time. The radiographic parameters assessed were total number of levels instrumented, total number of interbody fusions, C-7 sagittal vertical axis, uppermost instrumented vertebra (UIV) location, and presence of 3-column osteotomies. The HRQOL assessment included Oswestry Disability Index (ODI), 36-Item Short Form Health Survey physical component and mental component summary, and SRS-22 scores. Smoking history, Charlson Comorbidity Index scores, and American Society of Anesthesiologists Physical Status classification grades were also collected and assessed for correlation with risk of early reoperation. Various statistical tests were performed for evaluation of specific factors listed above, and the level of significance was set at p < 0.05.
Fifty-nine (17%) of a total of 352 patients required reoperation. Forty-four (12.5%) of the reoperations occurred within 1 year after the initial surgery, including 17 reoperations (5%) within 30 days.
Two hundred sixty-eight patients had a minimum of 1 year of follow-up. Fifty-three (20%) of these patients had a 3-column osteotomy, and 10 (19%) of these 53 required reoperation within 1 year of the initial procedure. However, 3-column osteotomy was not predictive of reoperation within 1 year, p = 0.5476). There were no significant differences between groups with regard to the distribution of UIV, and UIV did not have a significant effect on reoperation rates. Patients needing reoperation within 1 year had worse ODI and SRS-22 scores measured at 1-year follow-up than patients not requiring operation.
Analysis of data from a large multicenter adult spinal deformity database shows an overall 17% reoperation rate, with a 19% reoperation rate for patients treated with 3-column osteotomy and a 16% reoperation rate for patients not treated with 3-column osteotomy. The most common indications for reoperation included instrumentation complications and radiographic failure. Reoperation significantly affected HRQOL outcomes at 1-year follow-up. The need for reoperation may be minimized by carefully considering spinal alignment, termination of fixation, and type of surgical procedure (presence of osteotomy). Precautions should be taken to avoid malposition or instrumentation (rod) failure.