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Christopher I. Shaffrey and Justin S. Smith

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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

Object

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.

Methods

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.

Results

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.

Conclusions

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.

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Praveen V. Mummaneni, Robert G. Whitmore, Jill N. Curran, John E. Ziewacz, Rishi Wadhwa, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Joseph S. Cheng, R. John Hurlbert, Andrea F. Douglas, Justin S. Smith, Neil R. Malhotra, Stephen J. Dante, Subu N. Magge, Michael G. Kaiser, Khalid M. Abbed, Daniel K. Resnick and Zoher Ghogawala

Object

There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes.

Methods

An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis.

Results

There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained).

Conclusions

This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

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Raqeeb M. Haque, Gregory M. Mundis Jr., Yousef Ahmed, Tarek Y. El Ahmadieh, Michael Y. Wang, Praveen V. Mummaneni, Juan S. Uribe, David O. Okonkwo, Robert K. Eastlack, Neel Anand, Adam S. Kanter, Frank La Marca, Behrooz A. Akbarnia, Paul Park, Virginie Lafage, Jamie S. Terran, Christopher I. Shaffrey, Eric Klineberg, Vedat Deviren and Richard G. Fessler

Object

Various surgical approaches, including open, minimally invasive, and hybrid techniques, have gained momentum in the management of adult spinal deformity. However, few data exist on the radiographic outcomes of different surgical techniques. The objective of this study was to compare the radiographic and clinical outcomes of the surgical techniques used in the treatment of adult spinal deformity.

Methods

The authors conducted a retrospective review of two adult spinal deformity patient databases, a prospective open surgery database and a retrospective minimally invasive surgery (MIS) and hybrid surgery database. The time frame of enrollment in this study was from 2007 to 2012. Spinal deformity patients were stratified into 3 surgery groups: MIS, hybrid surgery, and open surgery. The following pre- and postoperative radiographic parameters were assessed: lumbar major Cobb angle, lumbar lordosis, pelvic incidence minus lumbar lordosis (PI−LL), sagittal vertical axis, and pelvic tilt. Scores on the Oswestry Disability Index (ODI) and a visual analog scale (VAS) for both back and leg pain were also obtained from each patient.

Results

Of the 234 patients with adult spinal deformity, 184 patients had pre- and postoperative radiographs and were thus included in the study (MIS, n = 42; hybrid, n = 33; open, n = 109). Patients were a mean of 61.7 years old and had a mean body mass index of 26.9 kg/m2. Regarding radiographic outcomes, the MIS group maintained a significantly smaller mean lumbar Cobb angle (13.1°) after surgery compared with the open group (20.4°, p = 0.002), while the hybrid group had a significantly larger lumbar curve correction (26.6°) compared with the MIS group (18.8°, p = 0.045). The mean change in the PI−LL was larger for the hybrid group (20.6°) compared with the open (10.2°, p = 0.023) and MIS groups (5.5°, p = 0.003). The mean sagittal vertical axis correction was greater for the open group (25 mm) compared with the MIS group (≤ 1 mm, p = 0.008). Patients in the open group had a significantly larger postoperative thoracic kyphosis (41.45°) compared with the MIS patients (33.5°, p = 0.005). There were no significant differences between groups in terms of pre- and postoperative mean ODI and VAS scores at the 1-year follow-up. However, patients in the MIS group had much lower estimated blood loss and transfusion rates compared with patients in the hybrid or open groups (p < 0.001). Operating room time was significantly longer with the hybrid group compared with the MIS and open groups (p < 0.001). Major complications occurred in 14% of patients in the MIS group, 14% in the hybrid group, and 45% in the open group (p = 0.032).

Conclusions

This study provides valuable baseline characteristics of radiographic parameters among 3 different surgical techniques used in the treatment of adult spinal deformity. Each technique has advantages, but much like any surgical technique, the positive and negative elements must be considered when tailoring a treatment to a patient. Minimally invasive surgical techniques can result in clinical outcomes at 1 year comparable to those obtained from hybrid and open surgical techniques.

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Kristina Bianco, Robert Norton, Frank Schwab, Justin S. Smith, Eric Klineberg, Ibrahim Obeid, Gregory Mundis Jr., Christopher I. Shaffrey, Khaled Kebaish, Richard Hostin, Robert Hart, Munish C. Gupta, Douglas Burton, Christopher Ames, Oheneba Boachie-Adjei, Themistocles S. Protopsaltis and Virginie Lafage

Object

Three-column resection osteotomies (3COs) are commonly performed for sagittal deformity but have high rates of reported complications. Authors of this study aimed to examine the incidence of and intercenter variability in major intraoperative complications (IOCs), major postoperative complications (POCs) up to 6 weeks postsurgery, and overall complications (that is, both IOCs and POCs). They also aimed to investigate the incidence of and intercenter variability in blood loss during 3CO procedures.

Methods

The incidence of IOCs, POCs, and overall complications associated with 3COs were retrospectively determined for the study population and for each of 8 participating surgical centers. The incidence of major blood loss (MBL) over 4 L and the percentage of total blood volume lost were also determined for the study population and each surgical center. Complication rates and blood loss were compared between patients with one and those with two osteotomies, as well as between patients with one thoracic osteotomy (ThO) and those with one lumbar or sacral osteotomy (LSO). Risk factors for developing complications were determined.

Results

Retrospective review of prospectively acquired data for 423 consecutive patients who had undergone 3CO at 8 surgical centers was performed. The incidence of major IOCs, POCs, and overall complications was 7%, 39%, and 42%, respectively, for the study population overall. The most common IOC was spinal cord deficit (2.6%) and the most common POC was unplanned return to the operating room (19.4%). Patients with two osteotomies had more POCs (56% vs 38%, p = 0.04) than the patients with one osteotomy. Those with ThO had more IOCs (16% vs 6%, p = 0.03), POCs (58% vs 34%, p < 0.01), and overall complications (67% vs 37%, p < 0.01) than the patients with LSO. There was significant variation in the incidence of IOCs, POCs, and overall complications among the 8 sites (p < 0.01). The incidence of MBL was 24% for the study population, which varied significantly between sites (p < 0.01). Patients with MBL had a higher risk of IOCs, POCs, and overall complications (OR 2.15, 1.76, and 2.01, respectively). The average percentage of total blood volume lost was 55% for the study population, which also varied among sites (p < 0.01).

Conclusions

Given the complexity of 3COs for spinal deformity, it is important for spine surgeons to understand the risk factors and complication rates associated with these procedures. In this study, the overall incidence of major complications following 3CO procedures was 42%. Risks for developing complications included an older age (> 60 years), two osteotomies, ThO, and MBL.

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Juan S. Uribe, Armen R. Deukmedjian, Praveen V. Mummaneni, Kai-Ming G. Fu, Gregory M. Mundis Jr., David O. Okonkwo, Adam S. Kanter, Robert Eastlack, Michael Y. Wang, Neel Anand, Richard G. Fessler, Frank La Marca, Paul Park, Virginie Lafage, Vedat Deviren, Shay Bess and Christopher I. Shaffrey

Object

It is hypothesized that minimally invasive surgical techniques lead to fewer complications than open surgery for adult spinal deformity (ASD). The goal of this study was to analyze matched patient cohorts in an attempt to isolate the impact of approach on adverse events.

Methods

Two multicenter databases queried for patients with ASD treated via surgery and at least 1 year of follow-up revealed 280 patients who had undergone minimally invasive surgery (MIS) or a hybrid procedure (HYB; n = 85) or open surgery (OPEN; n = 195). These patients were divided into 3 separate groups based on the approach performed and were propensity matched for age, preoperative sagittal vertebral axis (SVA), number of levels fused posteriorly, and lumbar coronal Cobb angle (CCA) in an attempt to neutralize these patient variables and to make conclusions based on approach only. Inclusion criteria for both databases were similar, and inclusion criteria specific to this study consisted of an age > 45 years, CCA > 20°, 3 or more levels of fusion, and minimum of 1 year of follow-up. Patients in the OPEN group with a thoracic CCA > 75° were excluded to further ensure a more homogeneous patient population.

Results

In all, 60 matched patients were available for analysis (MIS = 20, HYB = 20, OPEN = 20). Blood loss was less in the MIS group than in the HYB and OPEN groups, but a significant difference was only found between the MIS and the OPEN group (669 vs 2322 ml, p = 0.001). The MIS and HYB groups had more fused interbody levels (4.5 and 4.1, respectively) than the OPEN group (1.6, p < 0.001). The OPEN group had less operative time than either the MIS or HYB group, but it was only statistically different from the HYB group (367 vs 665 minutes, p < 0.001). There was no significant difference in the duration of hospital stay among the groups. In patients with complete data, the overall complication rate was 45.5% (25 of 55). There was no significant difference in the total complication rate among the MIS, HYB, and OPEN groups (30%, 47%, and 63%, respectively; p = 0.147). No intraoperative complications were reported for the MIS group, 5.3% for the HYB group, and 25% for the OPEN group (p < 0.03). At least one postoperative complication occurred in 30%, 47%, and 50% (p = 0.40) of the MIS, HYB, and OPEN groups, respectively. One major complication occurred in 30%, 47%, and 63% (p = 0.147) of the MIS, HYB, and OPEN groups, respectively. All patients had significant improvement in both the Oswestry Disability Index (ODI) and visual analog scale scores after surgery (p < 0.001), although the MIS group did not have significant improvement in leg pain. The occurrence of complications had no impact on the ODI.

Conclusions

Results in this study suggest that the surgical approach may impact complications. The MIS group had significantly fewer intraoperative complications than did either the HYB or OPEN groups. If the goals of ASD surgery can be achieved, consideration should be given to less invasive techniques.

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Christopher I. Shaffrey and Justin S. Smith

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Michael P. Kelly, Lawrence G. Lenke, Christopher I. Shaffrey, Christopher P. Ames, Leah Y. Carreon, Virginie Lafage, Justin S. Smith and Adam L. Shimer

Object

The goal in this study was to evaluate the risk factors for complications, including new neurological deficits, in the largest cohort of patients with adult spinal deformity to date.

Methods

The Scoli-RISK-1 inclusion criteria were used to identify eligible patients from 5 centers who were treated between June 1, 2009, and June 1, 2011. Records were reviewed for patient demographic information, surgical data, and reports of perioperative complications. Neurological deficits were recorded as preexisting or as new deficits. Patients who underwent 3-column osteotomies (3COs) were compared with those who did not (posterior spinal fusion [PSF]). Between-group comparisons were performed using independent samples t-tests and chi-square analyses.

Results

Two hundred seven patients were identified—75 who underwent PSF and 132 treated with 3CO. In the latter group, patients were older (58.9 vs 49.4 years, p < 0.001), had a higher body mass index (29.0 vs 25.8, p = 0.029), smaller preoperative coronal Cobb measurements (33.8° vs 56.4°, p < 0.001), more preoperative sagittal malalignment (11.7 cm vs 5.4 cm, p < 0.001), and similar sagittal Cobb measurements (45.8° vs 57.7°, p = 0.113). Operating times were similar (393 vs 423 minutes, p = 0.130), although patients in the 3CO group sustained higher estimated blood loss (2120 vs 1700 ml, p = 0.066). Rates of new neurological deficits were similar (PSF: 6.7% vs 3CO: 9.9%, p = 0.389), and rates of any perioperative medical complication were similar (PSF: 46.7% vs 3CO: 50.8%, p = 0.571). Patients who underwent vertebral column resection (VCR) were more likely to sustain medical complications than those treated with pedicle subtraction osteotomy (73.7% vs 46.9%, p = 0.031), although new neurological deficits were similar (15.8% vs 8.8%, p = 0.348). Regression analysis did not reveal significant predictors of neurological injury or complication from collected data.

Conclusions

Despite higher estimated blood loss, rates of all complications (49.3%) and new neurological deficits (8.7%) did not vary for patients who underwent complex reconstruction, whether or not a 3CO was performed. Patients who underwent VCR sustained more medical complications without an increase in new neurological deficits. Prospective studies of patient factors, provider factors, and refined surgical data are needed to define and optimize risk factors for complication and neurological deficits.

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Adam S. Kanter, Christopher I. Shaffrey, Praveen Mummaneni, Michael Y. Wang and Juan S. Uribe

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Michael Y. Wang, Praveen V. Mummaneni, Kai-Ming G. Fu, Neel Anand, David O. Okonkwo, Adam S. Kanter, Frank La Marca, Richard Fessler, Juan Uribe, Christopher I. Shaffrey, Virginie Lafage, Raqeeb M. Haque, Vedat Deviren and Gregory M. Mundis Jr.

Object

Minimally invasive surgery (MIS) options for the treatment of adult spinal deformity (ASD) have advanced significantly over the past decade. However, a wide array of options have been described as being MIS or less invasive. In this study the authors investigated a multiinstitutional cohort of patients with ASD who were treated with less invasive methods to determine the extent of deformity correction achieved.

Methods

This study was a retrospective review of multicenter prospectively collected data in 85 consecutive patients with ASD undergoing MIS surgery. Inclusion criteria were as follows: age older than 45 years; minimum 20° coronal lumbar Cobb angle; and 1 year of follow-up. Procedures were classified as follows: 1) stand-alone (n = 7); 2) circumferential MIS (n = 43); or 3) hybrid (n = 35).

Results

An average of 4.2 discs (range 3–7) were fused, with a mean follow-up duration of 26.1 months in this study. For the stand-alone group the preoperative Cobb range was 22°–51°, with 57% greater than 30° and 28.6% greater than 50°. The mean Cobb angle improved from 35.7° to 30°. A ceiling effect of 23° for curve correction was observed, regardless of preoperative curve severity. For the circumferential MIS group the preoperative Cobb range was 19°–62°, with 44% greater than 30° and 5% greater than 50°. The mean Cobb angle improved from 32° to 12°. A ceiling effect of 34° for curve correction was observed. For the hybrid group the preoperative Cobb range was 23°–82°, with 74% greater than 30° and 23% greater than 50°. The mean Cobb angle improved from 43° to 15°. A ceiling effect of 55° for curve correction was observed.

Conclusions

Specific procedures for treating ASD have particular limitations for scoliotic curve correction. Less invasive techniques were associated with a reduced ability to straighten the spine, particularly with advanced curves. These data can guide preoperative technique selection when treating patients with ASD.