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Justin S. Smith, Thomas J. Buell, Christopher I. Shaffrey, Han Jo Kim, Eric Klineberg, Themistocles Protopsaltis, Peter Passias, Gregory M. Mundis Jr., Robert Eastlack, Vedat Deviren, Michael P. Kelly, Alan H. Daniels, Jeffrey L. Gum, Alex Soroceanu, Munish Gupta, Doug Burton, Richard Hostin, Robert Hart, Virginie Lafage, Renaud Lafage, Frank J. Schwab, Shay Bess and Christopher P. Ames

OBJECTIVE

Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically.

METHODS

A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30–90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2–7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°.

RESULTS

Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively).

CONCLUSIONS

This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

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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

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.

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Christopher P. Ames, Justin S. Smith, Robert Eastlack, Donald J. Blaskiewicz, Christopher I. Shaffrey, Frank Schwab, Shay Bess, Han Jo Kim, Gregory M. Mundis Jr., Eric Klineberg, Munish Gupta, Michael O’Brien, Richard Hostin, Justin K. Scheer, Themistocles S. Protopsaltis, Kai-Ming G. Fu, Robert Hart, Todd J. Albert, K. Daniel Riew, Michael G. Fehlings, Vedat Deviren, Virginie Lafage and International Spine Study Group

OBJECT

Despite the complexity of cervical spine deformity (CSD) and its significant impact on patient quality of life, there exists no comprehensive classification system. The objective of this study was to develop a novel classification system based on a modified Delphi approach and to characterize the intra- and interobserver reliability of this classification.

METHODS

Based on an extensive literature review and a modified Delphi approach with an expert panel, a CSD classification system was generated. The classification system included a deformity descriptor and 5 modifiers that incorporated sagittal, regional, and global spinopelvic alignment and neurological status. The descriptors included: “C,” “CT,” and “T” for primary cervical kyphotic deformities with an apex in the cervical spine, cervicothoracic junction, or thoracic spine, respectively; “S” for primary coronal deformity with a coronal Cobb angle ≥ 15°; and “CVJ” for primary craniovertebral junction deformity. The modifiers included C2–7 sagittal vertical axis (SVA), horizontal gaze (chin-brow to vertical angle [CBVA]), T1 slope (TS) minus C2–7 lordosis (TS–CL), myelopathy (modified Japanese Orthopaedic Association [mJOA] scale score), and the Scoliosis Research Society (SRS)-Schwab classification for thoracolumbar deformity. Application of the classification system requires the following: 1) full-length standing posteroanterior (PA) and lateral spine radiographs that include the cervical spine and femoral heads; 2) standing PA and lateral cervical spine radiographs; 3) completed and scored mJOA questionnaire; and 4) a clinical photograph or radiograph that includes the skull for measurement of the CBVA. A series of 10 CSD cases, broadly representative of the classification system, were selected and sufficient radiographic and clinical history to enable classification were assembled. A panel of spinal deformity surgeons was queried to classify each case twice, with a minimum of 1 intervening week. Inter- and intrarater reliability measures were based on calculations of Fleiss k coefficient values.

RESULTS

Twenty spinal deformity surgeons participated in this study. Interrater reliability (Fleiss k coefficients) for the deformity descriptor rounds 1 and 2 were 0.489 and 0.280, respectively, and mean intrarater reliability was 0.584. For the modifiers, including the SRS-Schwab components, the interrater (round 1/round 2) and intrarater reliabilities (Fleiss k coefficients) were: C2–7 SVA (0.338/0.412, 0.584), horizontal gaze (0.779/0.430, 0.768), TS-CL (0.721/0.567, 0.720), myelopathy (0.602/0.477, 0.746), SRS-Schwab curve type (0.590/0.433, 0.564), pelvic incidence-lumbar lordosis (0.554/0.386, 0.826), pelvic tilt (0.714/0.627, 0.633), and C7-S1 SVA (0.071/0.064, 0.233), respectively. The parameter with the poorest reliability was the C7–S1 SVA, which may have resulted from differences in interpretation of positive and negative measurements.

CONCLUSIONS

The proposed classification provides a mechanism to assess CSD within the framework of global spinopelvic malalignment and clinically relevant parameters. The intra- and interobserver reliabilities suggest moderate agreement and serve as the basis for subsequent improvement and study of the proposed classification.

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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

Object

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.

Methods

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°.

Results

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).

Conclusions

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.

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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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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.