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Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Christopher I. Shaffrey, Justin S. Smith and Shay Bess

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Michael P. Kelly, Michael A. Kallen, Christopher I. Shaffrey, Justin S. Smith, Douglas C. Burton, Christopher P. Ames, Virginie Lafage, Frank J. Schwab, Han Jo Kim, Eric O. Klineberg, Shay Bess and the International Spine Study Group

OBJECTIVE

After using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society–22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).

METHODS

PROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.

RESULTS

In total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).

CONCLUSIONS

The authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS–computer adaptive test instruments in ASD.

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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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Dominic Maggio, Tamir T. Ailon, Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Frank Schwab, Regis W. Haid Jr., Themistocles Protopsaltis, Eric Klineberg, Justin K. Scheer, Shay Bess, Paul M. Arnold, Jens Chapman, Michael G. Fehlings, Christopher Ames, AOSpine North America and International Spine Study Group

OBJECT

The associations among global spinal alignment, patient-reported disability, and surgical outcomes have increasingly gained attention. The assessment of global spinal alignment requires standing long-cassette anteroposterior and lateral radiographs; however, spine surgeons routinely rely only on short-segment imaging when evaluating seemingly isolated lumbar pathology. This may prohibit adequate surgical planning and may predispose surgeons to not recognize associated pathology in the thoracic spine and sagittal spinopelvic malalignment. The authors used a case-based survey questionnaire to evaluate if including long-cassette radiographs led to changes to respondents' operative plans as compared with their chosen plan when cases contained standard imaging of the involved lumbar spine only.

METHODS

A case-based survey was distributed to AOSpine International members that consisted of 15 cases of lumbar spine pathology and lumbar imaging only. The same 15 cases were then shuffled and presented a second time with additional long-cassette radiographs. Each case required participants to select a single operative plan with 5 choices ranging from least to most extensive. The cases included 5 “control” cases with normal global spinal alignment and 10 “test” cases with significant sagittal and/or coronal malalignment. Mean scores were determined for each question with higher scores representing more invasive and/or extensive operative plans.

RESULTS

Of 712 spine surgeons who started the survey, 316 (44%) completed the entire series, including 68% of surgeons with spine fellowship training and representation from more than 40 countries. For test cases, but not for control cases, there were significantly higher average surgical invasiveness scores for cases presented with long-cassette radiographs (4.2) as compared with those cases with lumbar imaging only (3.4; p = 0.002). The addition of long-cassette radiographs resulted in 82.1% of respondents recommending instrumentation up to the thoracic spine, a 23.2% increase as compared with the same cases presented with lumbar imaging only (p = 0.008).

CONCLUSIONS

This study demonstrates the importance of maintaining a low threshold for performing standing long-cassette imaging when assessing seemingly isolated lumbar pathology. Such imaging is necessary for the assessment of spinopelvic and global spinal alignment, which can be important in operative planning. Deformity, particularly positive sagittal malalignment, may go undetected unless one maintains a high index of suspicion and obtains long-cassette radiographs. It is recommended that spine surgeons recognize the prevalence and importance of such deformity when contemplating operative intervention.

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Michael P. Kelly, Lukas P. Zebala, Han Jo Kim, Daniel M. Sciubba, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Eric Klineberg, Gregory Mundis Jr., Douglas Burton, Robert Hart, Alex Soroceanu, Frank Schwab, Virginie Lafage and International Spine Study Group

OBJECT

The goal of this study was to examine the effectiveness of preoperative autologous blood donation (PABD) in adult spinal deformity (ASD) surgery.

METHODS

Patients undergoing single-stay ASD reconstructions were identified in a multicenter database. Patients were divided into groups according to PABD (either PABD or NoPABD). Propensity weighting was used to create matched cohorts of PABD and NoPABD patients. Allogeneic (ALLO) exposure, autologous (AUTO) wastage (unused AUTO), and complication rates were compared between groups.

RESULTS

Four hundred twenty-eight patients were identified as meeting eligibility criteria. Sixty patients were treated with PABD, of whom 50 were matched to 50 patients who were not treated with PABD (NoPABD). Nearly one-third of patients in the PABD group (18/60, 30%) did not receive any autologous transfusion and donated blood was wasted. In 6 of these cases (6/60, 10%), patients received ALLO blood transfusions without AUTO. In 9 cases (9/60, 15%), patients received ALLO and AUTO blood transfusions. Overall rates of transfusion of any type were similar between groups (PABD 70% [42/60], NoPABD 75% [275/368], p = 0.438). Major and minor in-hospital complications were similar between groups (Major PABD 10% [6/60], NoPABD 12% [43/368], p = 0.537; Minor PABD 30% [18/60], NoPABD 24% [87/368], p = 0.499). When controlling for potential confounders, PABD patients were more likely to receive some transfusion (OR 15.1, 95% CI 2.1-106.7). No relationship between PABD and ALLO blood exposure was observed, however, refuting the concept that PABD is protective against ALLO blood exposure. In the matched cohorts, PABD patients were more likely to sustain a major perioperative cardiac complication (PABD 8/50 [16%], NoPABD 1/50 [2%], p = 0.046). No differences in rates of infection or wound-healing complications were observed between cohorts.

CONCLUSIONS

Preoperative autologous blood donation was associated with a higher probability of perioperative transfusions of any type in patients with ASD. No protective effect of PABD against ALLO blood exposure was observed, and no risk of perioperative infectious complications was observed in patients exposed to ALLO blood only. The benefit of PABD in patients with ASD remains undefined.

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David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

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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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Ferran Pellisé, Miquel Serra-Burriel, Justin S. Smith, Sleiman Haddad, Michael P. Kelly, Alba Vila-Casademunt, Francisco Javier Sánchez Pérez-Grueso, Shay Bess, Jeffrey L. Gum, Douglas C. Burton, Emre Acaroğlu, Frank Kleinstück, Virginie Lafage, Ibrahim Obeid, Frank Schwab, Christopher I. Shaffrey, Ahmet Alanay, Christopher Ames, the International Spine Study Group and the European Spine Study Group

OBJECTIVE

Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO).

METHODS

Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis.

RESULTS

The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%–75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs.

CONCLUSIONS

The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.

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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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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.