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Michael M. Safaee, Cecilia L. Dalle Ore, Corinna C. Zygourakis, Vedat Deviren and Christopher P. Ames

OBJECTIVE

Proximal junctional kyphosis (PJK) is a well-recognized complication of surgery for adult spinal deformity and is characterized by increased kyphosis at the upper instrumented vertebra (UIV). PJK prevention strategies have the potential to decrease morbidity and cost by reducing rates of proximal junctional failure (PJF), which the authors define as radiographic PJK plus clinical sequelae requiring revision surgery.

METHODS

The authors performed an analysis of 195 consecutive patients with adult spinal deformity. Age, sex, levels fused, upper instrumented vertebra (UIV), use of 3-column osteotomy, pelvic fixation, and mean time to follow-up were collected. The authors also reviewed operative reports to assess for the use of surgical adjuncts targeted toward PJK prevention, including ligament augmentation, hook fixation, and vertebroplasty. The cost of surgery, including direct and total costs, was also assessed at index surgery and revision surgery. Only revision surgery for PJF was included.

RESULTS

The mean age of the cohort was 64 years (range 25–84 years); 135 (69%) patients were female. The mean number of levels fused was 10 (range 2–18) with the UIV as follows: 2 cervical (1%), 73 upper thoracic (37%), 108 lower thoracic (55%), and 12 lumbar (6%). Ligament augmentation was used in 99 cases (51%), hook fixation in 60 cases (31%), and vertebroplasty in 71 cases (36%). PJF occurred in 18 cases (9%). Univariate analysis found that ligament augmentation and hook fixation were associated with decreased rates of PJF. However, in a multivariate model that also incorporated age, sex, and UIV, only ligament augmentation maintained a significant association with PJF reduction (OR 0.196, 95% CI 0.050–0.774; p = 0.020). Patients with ligament augmentation, compared with those without, had a higher cost of index surgery, but ligament augmentation was overall cost effective and produced significant cost savings. In sensitivity analyses in which we independently varied the reduction in PJF, cost of ligament augmentation, and cost of reoperation by ± 50%, ligament augmentation remained a cost-effective strategy for PJF prevention.

CONCLUSIONS

Prevention strategies for PJK/PJF are limited, and their cost-effectiveness has yet to be established. The authors present the results of 195 patients with adult spinal deformity and show that ligament augmentation is associated with significant reductions in PJF in both univariate and multivariate analyses, and that this intervention is cost-effective. Future studies will need to determine if these clinical results are reproducible, but for high-risk cases, these data suggest an important role of ligament augmentation for PJF prevention and cost savings.

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Aaron J. Clark, Jessica A. Tang, Jeremi M. Leasure, Michael E. Ivan, Dimitriy Kondrashov, Jenni M. Buckley, Vedat Deviren and Christopher P. Ames

Object

Reconstruction after total sacrectomy is a critical component of malignant sacral tumor resection, permitting early mobilization and maintenance of spinal pelvic alignment. However, implant loosening, graft migration, and instrumentation breakage remain major problems. Traditional techniques have used interiliac femoral allograft, but more modern methods have used fibular or cage struts from the ilium to the L-5 endplate or sacral body replacement with transiliac bars anchored to cages to the L-5 endplate. This study compares the biomechanical stability under gait-simulating fatigue loading of the 3 current methods.

Methods

Total sacrectomy was performed and reconstruction was completed using 3 different constructs in conjunction with posterior spinal screw rod instrumentation from L-3 to pelvis: interiliac femur strut allograft (FSA); L5–iliac cage struts (CSs); and S-1 body replacement expandable cage (EC). Intact lumbar specimens (L3–sacrum) were tested for flexion-extension range of motion (FE-ROM), axial rotation ROM (AX-ROM), and lateral bending ROM (LB-ROM). Each instrumented specimen was compared with its matched intact specimen to generate an ROM ratio. Fatigue testing in compression and flexion was performed using a custom-designed long fusion gait model.

Results

Compared with intact specimen, the FSA FE-ROM ratio was 1.22 ± 0.60, the CS FE-ROM ratio was significantly lower (0.37 ± 0.12, p < 0.001), and EC was lower still (0.29 ± 0.14, p < 0.001; values are expressed as the mean ± SD). The difference between CS and EC in FE-ROM ratio was not significant (p = 0.83). There were no differences in AX-ROM or LB-ROM ratios (p = 0.77 and 0.44, respectively). No failures were noted on fatigue testing of any EC construct (250,000 cycles). This was significantly improved compared with FSA (856 cycles, p < 0.001) and CS (794 cycles, p < 0.001).

Conclusions

The CS and EC appear to be significantly more stable constructs compared with FSA with FE-ROM. The 3 constructs appear to be equal with AX-ROM and LB-ROM. Most importantly, EC appears to be significantly more resistant to fatigue compared with FSA and CS. Reconstruction of the load transfer mechanism to the pelvis via the L-5 endplate appears to be important in maintenance of alignment after total sacrectomy reconstruction.

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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

Object

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.

Methods

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.

Results

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.

Conclusions

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.

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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.

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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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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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Khoi D. Than, Paul Park, Kai-Ming Fu, Stacie Nguyen, Michael Y. Wang, Dean Chou, Pierce D. Nunley, Neel Anand, Richard G. Fessler, Christopher I. Shaffrey, Shay Bess, Behrooz A. Akbarnia, Vedat Deviren, Juan S. Uribe, Frank La Marca, Adam S. Kanter, David O. Okonkwo, Gregory M. Mundis Jr., Praveen V. Mummaneni and the International Spine Study Group

OBJECTIVE

Minimally invasive surgery (MIS) techniques are increasingly used to treat adult spinal deformity. However, standard minimally invasive spinal deformity techniques have a more limited ability to restore sagittal balance and match the pelvic incidence–lumbar lordosis (PI-LL) than traditional open surgery. This study sought to compare “best” versus “worst” outcomes of MIS to identify variables that may predispose patients to postoperative success.

METHODS

A retrospective review of minimally invasive spinal deformity surgery cases was performed to identify parameters in the 20% of patients who had the greatest improvement in Oswestry Disability Index (ODI) scores versus those in the 20% of patients who had the least improvement in ODI scores at 2 years' follow-up.

RESULTS

One hundred four patients met the inclusion criteria, and the top 20% of patients in terms of ODI improvement at 2 years (best group, 22 patients) were compared with the bottom 20% (worst group, 21 patients). There were no statistically significant differences in age, body mass index, pre- and postoperative Cobb angles, pelvic tilt, pelvic incidence, levels fused, operating room time, and blood loss between the best and worst groups. However, the mean preoperative ODI score was significantly higher (worse disability) at baseline in the group that had the greatest improvement in ODI score (58.2 vs 39.7, p < 0.001). There was no difference in preoperative PI-LL mismatch (12.8° best vs 19.5° worst, p = 0.298). The best group had significantly less postoperative sagittal vertical axis (SVA; 3.4 vs 6.9 cm, p = 0.043) and postoperative PI-LL mismatch (10.4° vs 19.4°, p = 0.027) than the worst group. The best group also had better postoperative visual analog scale back and leg pain scores (p = 0.001 and p = 0.046, respectively).

CONCLUSIONS

The authors recommend that spinal deformity surgeons using MIS techniques focus on correcting a patient's PI-LL mismatch to within 10° and restoring SVA to < 5 cm. Restoration of these parameters seems to impact which patients will attain the greatest degree of improvement in ODI outcomes, while the spines of patients who do the worst are not appropriately corrected and may be fused into a fixed sagittal plane deformity.

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Paul Park, Michael Y. Wang, Virginie Lafage, Stacie Nguyen, John Ziewacz, David O. Okonkwo, Juan S. Uribe, Robert K. Eastlack, Neel Anand, Raqeeb Haque, Richard G. Fessler, Adam S. Kanter, Vedat Deviren, Frank La Marca, Justin S. Smith, Christopher I. Shaffrey, Gregory M. Mundis Jr. and Praveen V. Mummaneni

OBJECT

Minimally invasive surgery (MIS) techniques are becoming a more common means of treating adult spinal deformity (ASD). The aim of this study was to compare the hybrid (HYB) surgical approach, involving minimally invasive lateral interbody fusion with open posterior instrumented fusion, to the circumferential MIS (cMIS) approach to treat ASD.

METHODS

The authors performed a retrospective, multicenter study utilizing data collected in 105 patients with ASD who were treated via MIS techniques. Criteria for inclusion were age older than 45 years, coronal Cobb angle greater than 20°, and a minimum of 1 year of follow-up. Patients were stratified into 2 groups: HYB (n = 62) and cMIS (n = 43).

RESULTS

The mean age was 60.7 years in the HYB group and 61.0 years in the cMIS group (p = 0.910). A mean of 3.6 interbody fusions were performed in the HYB group compared with a mean of 4.0 interbody fusions in the cMIS group (p = 0.086). Posterior fusion involved a mean of 6.9 levels in the HYB group and a mean of 5.1 levels in the cMIS group (p = 0.003). The mean follow-up was 31.3 months for the HYB group and 38.3 months for the cMIS group. The mean Oswestry Disability Index (ODI) score improved by 30.6 and 25.7, and the mean visual analog scale (VAS) scores for back/leg pain improved by 2.4/2.5 and 3.8/4.2 for the HYB and cMIS groups, respectively. There was no significant difference between groups with regard to ODI or VAS scores. For the HYB group, the lumbar coronal Cobb angle decreased by 13.5°, lumbar lordosis (LL) increased by 8.2°, sagittal vertical axis (SVA) decreased by 2.2 mm, and LL–pelvic incidence (LL-PI) mismatch decreased by 8.6°. For the cMIS group, the lumbar coronal Cobb angle decreased by 10.3°, LL improved by 3.0°, SVA increased by 2.1 mm, and LL-PI decreased by 2.2°. There were no significant differences in these radiographic parameters between groups. The complication rate, however, was higher in the HYB group (55%) than in the cMIS group (33%) (p = 0.024).

CONCLUSIONS

Both HYB and cMIS approaches resulted in clinical improvement, as evidenced by decreased ODI and VAS pain scores. While there was no significant difference in degree of radiographic correction between groups, the HYB group had greater absolute improvement in degree of lumbar coronal Cobb angle correction, increased LL, decreased SVA, and decreased LL-PI. The complication rate, however, was higher with the HYB approach than with the cMIS approach.

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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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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.