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Editorial. Integrating frailty assessment tools into patient-specific alignment target planning in adult spinal deformity: minimizing risk and optimizing outcomes

Elie Massaad, Ali Kiapour, and John H. Shin

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Does the presence of cervical deformity in patients with baseline mild myelopathy increase operative urgency in adult cervical spinal surgery? A retrospective analysis

Peter S. Tretiakov, Emmanuel Budis, Pooja Dave, Jamshaid Mir, Matthew Galetta, Nathan Lorentz, M. Burhan Janjua, Pawel P. Jankowski, and Peter G. Passias

OBJECTIVE

The objective of this study was to assess whether delaying surgical management of cervical deformity (CD) in patients with concomitant mild myelopathy increases the risk of suboptimal outcomes.

METHODS

Patients aged ≥ 18 years who had a baseline diagnosis of mild myelopathy with baseline and up to 2 years of postoperative data were assessed. Patients were categorized as having CD (CD+) or not (CD−) at baseline. Patients with symptoms of myelopathy for more than 1 year after the initial visit prior to surgery were considered delayed. Clinical and radiographic data were assessed using means comparison analyses. Multivariate regression analysis assessed correlations between increasing time to surgery and peri- and postoperative outcomes adjusted for baseline age and frailty score. Backstep logistic regression analysis assessed the risk of complications or reoperation, while controlling for baseline T1 slope minus cervical lordosis (TS-CL).

RESULTS

One hundred six patients were included (mean age 58.11 ± 11.97 years, 48% female, mean BMI 29.13 ± 6.89). Of the patients with baseline mild myelopathy, 22 (20.8%) were CD− while 84 (79.2%) were CD+. Overall, 9.5% of patients were considered to have delayed surgery. Linear regression revealed that both CD− and CD+ patients were more likely to require reoperation when there was more time between the initial visit and surgical admission (p < 0.001). Additionally, an adjusted logistic regression indicated that CD+ patients who had a greater length of time to surgery had a higher likelihood for major complications (p < 0.001). Conversely, CD+ patients who were operated on within 30 days of the initial visit had a significantly lower risk for a major complication (OR 0.901, 95% CI 0.889–1.105, p = 0.043), and a lower risk for reoperation (OR 0.954, 95% CI 0.877–1.090, p = 0.043), while controlling for the severity of deformity based on baseline TS-CL.

CONCLUSIONS

The findings of this study demonstrate that a delay in surgery after the initial visit significantly increases the risk for major complications and reoperation in patients with CD with associated mild baseline myelopathy. Early operative treatment in this patient population may lower the risk of postoperative complications.

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Should realignment goals vary based on patient frailty status in adult spinal deformity?

Presented at the 2023 AANS/CNS Joint Section on the Disorders of the Spine and Peripheral Nerves

Peter G. Passias, Jamshaid M. Mir, Tyler K. Williamson, Peter S. Tretiakov, Pooja Dave, Virginie Lafage, Renaud Lafage, and Andrew J. Schoenfeld

OBJECTIVE

The objective of this study was to adjust the sagittal age-adjusted score (SAAS) to accommodate frailty in alignment considerations and thereby increase the predictability of clinical outcomes and junctional failure.

METHODS

Surgical adult spinal deformity (ASD) patients with 2-year data were included. Frailty was assessed with the continuous ASD modified frailty index (ASD-mFI). Two-year outcomes were proximal junctional kyphosis (PJK), proximal junctional failure (PJF), major mechanical complications, and best clinical outcome (BCO), defined as Oswestry Disability Index (ODI) score < 15 and Scoliosis Research Society outcomes questionnaire total score > 4.5 by 2 years. Linear regression analysis established a 6-week score based on the component scores of SAAS, frailty, and US normal values for ODI score. Logistic regression analysis followed by conditional inference tree run forest analysis generated categorical thresholds. Multivariate analysis, controlling for age, baseline deformity, and history of revision, was used to compare outcome rates, and logistic regression generated odds ratios for the continuous score. Thirty percent of the cohort was used as a random sample for internal validation.

RESULTS

In total, 412 patients were included (mean ± SD age 60.1 ± 14.2 years, 80% female, BMI 26.9 ± 5.4 kg/m2). Baseline frailty categories were as follows: 57% not frail, 30% frail, and 14% severely frail. Overall, by 2 years, 39% of patients had developed PJK, 8% PJF, and 21% mechanical complications; 22% had undergone a reoperation; and 15% met BCO. When the cohort as a whole was assessed, the 6-week SAAS had a correlation with the development of PJK and PJF, but not mechanical complications, reoperation, or BCO. Development of mechanical complications, PJF, reoperation, and BCO demonstrated correlations with ASD-mFI (all p < 0.05). Regression analysis modifying SAAS on the basis of ODI norms and frailty generated the following equation: frailty-adjusted SAAS (FAS) = 0.108 × T1 pelvic angle + 0.162 × pelvic tilt − 0.39 × pelvic incidence − lumbar lordosis − 0.03 × ASD-mFI − 1.6771. With conditional inference tree analysis, thresholds were derived for FAS: aligned < 1.7, offset 1.7–2.2, and severely offset > 2.2. Significance between FAS categories was found for PJK, PJF, mechanical complications, reoperation, and BCO by 2 years. Binary logistic regression, controlling for baseline deformity and revision status, demonstrated significance between FAS and all 5 outcome variables (all p < 0.01). Internal validation saw each outcome variable maintain significance between categories, with even greater odds for PJF (OR 13.4, 95% CI 4.7–38.3, p < 0.001).

CONCLUSIONS

Consideration of physiological age, in addition to chronological age, may be beneficial in the management of operative goals to maximize clinical outcomes while minimizing junctional failure. This combination enables the spine surgeon to fortify a surgical plan for even the most challenging patients undergoing ASD corrective surgery.

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Comparison of multilevel low-grade techniques versus three-column osteotomies in adult spinal deformity surgery: does harmonious correction matter?

Peter G. Passias, Tyler K. Williamson, Jamshaid M. Mir, Jordan A. Lebovic, Pooja Dave, Peter S. Tretiakov, Rachel Joujon-Roche, Bailey Imbo, Oscar Krol, Stephane Owusu-Sarpong, Shaleen Vira, Andrew J. Schoenfeld, Alan H. Daniels, Bassel G. Diebo, Renaud Lafage, and Virginie Lafage

OBJECTIVE

Recent debate has arisen between whether to use a three-column osteotomy (3CO) or multilevel low-grade (MLG) techniques to treat severe sagittal malalignment in adult spinal deformity (ASD) surgery. The goal of this study was to compare the outcomes of 3CO and MLG techniques performed in corrective surgeries for ASD.

METHODS

ASD patients who had a baseline PI-LL > 30° and 2-year follow-up data were included. Patients underwent either 3CO or MLG (thoracolumbar posterior column osteotomies at ≥ 3 levels or anterior lumbar interbody fusion at ≥ 3 levels with no 3CO). The segmental utility ratio was used to assess relative segmental correction (segmental correction divided by overall correction in lordosis divided by the number of thoracolumbar interventions [interbody fusion, thoracolumbar posterior column osteotomies, and 3CO]). The paired t-test was used to assess lordotic distribution by differences in lordosis between adjacent lumbar disc spaces (e.g., L1–2 to L2–3). Multivariate analysis, controlling for age, sex, BMI, osteoporosis, baseline pelvic incidence, and T1 pelvic angle, was used to evaluate the complication rates and radiographic and patient-reported outcomes between the groups.

RESULTS

A total of 93 patients were included, 53% of whom underwent MLG and 47% of whom underwent 3CO. The MLG group had a lower BMI (p < 0.05). MLG patients received fewer previous fusions than 3CO patients (31% vs 80%, p < 0.001). MLG patients had 24% less blood loss but a 22% longer operative time (565 vs 419 minutes, p = 0.008). Using adjusted analysis, the 3CO group had greater segmental and relative correction at each level (segmental utility ratio mean 69% for 3CO vs 23% for MLG, p < 0.001). However, the 3CO group had lordotic differences between two adjacent lumbar disc pairs (range −0.5° to 9.0°, p = 0.009), while MLG was more harmonious (range 2.2°–6.5°, p > 0.4). MLG patients were more likely to undergo realignment to age-adjusted standards (OR 5.6, 95% CI 1.2–46.4; p = 0.033). MLG patients were less likely to develop neurological complications or undergo reoperation (OR 0.4, 95% CI 0.1–0.9; p = 0.041). Adjusted analysis revealed that MLG patients more often met a substantial clinical benefit in the Oswestry Disability Index score (OR 5.3, 95% CI 1.1–26.8; p = 0.043).

CONCLUSIONS

MLG techniques showed better utility in lumbar distribution and age-adjusted global correction while minimizing neurological complications and reoperation rates by 2 years postoperatively. In selected instances, these techniques may offer the spine deformity surgeon a safer alternative when correcting severe adult spinal deformity.

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Are we improving in the optimization of surgery for high-risk adult cervical spine deformity patients over time?

Presented at the 2023 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Peter G. Passias, Peter S. Tretiakov, Justin S. Smith, Renaud Lafage, Bassel Diebo, Justin K. Scheer, Robert K. Eastlack, Alan H. Daniels, Eric O. Klineberg, Khaled M. Khabeish, Gregory M. Mundis Jr., Jay D. Turner, Munish C. Gupta, Han Jo Kim, Frank Schwab, Shay Bess, Virginie Lafage, Christopher P. Ames, and Christopher I. Shaffrey

OBJECTIVE

The aim of this study was to investigate whether surgery for high-risk patients is being optimized over time and if poor outcomes are being minimized.

METHODS

Patients who underwent surgery for cervical deformity (CD) and were ≥ 18 years with baseline and 2-year data were stratified by year of surgery from 2013 to 2018. The cohort was divided into two groups based on when the surgery was performed. Patients in the early cohort underwent surgery between 2013 and 2015 and those in the recent cohort underwent surgery between 2016 and 2018. High-risk patients met at least 2 of the following criteria: 1) baseline C2–7 Cobb angle > 15°, mismatch between T1 slope and cervical lordosis ≥ 35°, C2–7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°; 2) age ≥ 70 years; 3) severe baseline frailty (Miller index); 4) Charlson Comorbidity Index (CCI) ≥ 1 SD above the mean; 5) three-column osteotomy as treatment; and 6) fusion > 10 levels or > 7 levels for elderly patients. The mean comparison analysis assessed differences between groups. Stepwise multivariable linear regression described associations between increasing year of surgery and complications.

RESULTS

Eighty-two CD patients met high-risk criteria (mean age 62.11 ± 10.87 years, 63.7% female, mean BMI 29.70 ± 8.16 kg/m2, and mean CCI 1.07 ± 1.45). The proportion of high-risk patients increased with time, with 41.8% of patients in the early cohort classified as high risk compared with 47.6% of patients in the recent cohort (p > 0.05). Recent high-risk patients were more likely to be female (p = 0.008), have a lower BMI (p = 0.038), and have a higher baseline CCI (p = 0.013). Surgically, high-risk patients in the recent cohort were more likely to undergo low-grade osteotomy (p = 0.003). By postoperative complications, recent high-risk patients were less likely to experience any postoperative adverse events overall (p = 0.020) or complications such as dysphagia (p = 0.045) at 2 years. Regression analysis revealed increasing year of surgery to be correlated with decreasing minor complication rates (p = 0.030), as well as lowered rates of distal junctional kyphosis by 2 years (p = 0.048).

CONCLUSIONS

Over time, high-risk CD patients have an increase in frequency and comorbidity rates but have demonstrated improved postoperative outcomes. These findings suggest that spine surgeons have improved over time in optimizing selection and reducing potential adverse events in high-risk patients.

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Natural history of adult spinal deformity: how do patients with suboptimal surgical outcomes fare relative to nonoperative counterparts?

Peter G. Passias, Rachel Joujon-Roche, Jamshaid M. Mir, Tyler K. Williamson, Peter S. Tretiakov, Bailey Imbo, Oscar Krol, Lara Passfall, Salman Ahmad, Jordan Lebovic, Stephane Owusu-Sarpong, Tomi Lanre-Amos, Themistocles Protopsaltis, Renaud Lafage, Virginie Lafage, Paul Park, Dean Chou, Praveen V. Mummaneni, Kai-Ming G. Fu, Khoi D. Than, Justin S. Smith, M. Burhan Janjua, Andrew J. Schoenfeld, Bassel G. Diebo, and Shaleen Vira

OBJECTIVE

Management of adult spinal deformity (ASD) has increasingly favored operative intervention; however, the incidence of complications and reoperations is high, and patients may fail to achieve idealized postsurgical results. This study compared health-related quality of life (HRQOL) metrics between patients with suboptimal surgical outcomes and those who underwent nonoperative management as a proxy for the natural history (NH) of ASD.

METHODS

ASD patients with 2-year data were included. Patients who were offered surgery but declined were considered nonoperative (i.e., NH) patients. Operative patients with suboptimal outcome (SOp)—defined as any reoperation, major complication, or ≥ 2 severe Scoliosis Research Society (SRS)–Schwab modifiers at follow-up—were selected for comparison. Propensity score matching (PSM) on the basis of baseline age, deformity, SRS-22 Total, and Charlson Comorbidity Index score was used to match the groups. ANCOVA and stepwise logistic regression analysis were used to assess outcomes between groups at 2 years.

RESULTS

In total, 441 patients were included (267 SOp and 174 NH patients). After PSM, 142 patients remained (71 SOp 71 and 71 NH patients). At baseline, the SOp and NH groups had similar demographic characteristics, HRQOL, and deformity (all p > 0.05). At 2 years, ANCOVA determined that NH patients had worse deformity as measured with sagittal vertical axis (36.7 mm vs 21.3 mm, p = 0.025), mismatch between pelvic incidence and lumbar lordosis (11.9° vs 2.9°, p < 0.001), and pelvic tilt (PT) (23.1° vs 20.7°, p = 0.019). The adjusted regression analysis found that SOp patients had higher odds of reaching the minimal clinically important differences in Oswestry Disability Index score (OR [95% CI] 4.5 [1.7–11.5], p = 0.002), SRS-22 Activity (OR [95% CI] 3.2 [1.5–6.8], p = 0.002), SRS-22 Pain (OR [95% CI] 2.8 [1.4–5.9], p = 0.005), and SRS-22 Total (OR [95% CI] 11.0 [3.5–34.4], p < 0.001).

CONCLUSIONS

Operative patients with SOp still experience greater improvements in deformity and HRQOL relative to the progressive radiographic and functional deterioration associated with the NH of ASD. The NH of nonoperative management should be accounted for when weighing the risks and benefits of operative intervention for ASD.

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Incremental benefits of circumferential minimally invasive surgery for increasingly frail patients with adult spinal deformity

Peter G. Passias, Peter S. Tretiakov, Pierce D. Nunley, Michael Y. Wang, Paul Park, Adam S. Kanter, David O. Okonkwo, Robert K. Eastlack, Gregory M. Mundis Jr., Dean Chou, Nitin Agarwal, Richard G. Fessler, Juan S. Uribe, Neel Anand, Khoi D. Than, Gregory Brusko, Kai-Ming Fu, Jay D. Turner, Vivian P. Le, Breton G. Line, Christopher P. Ames, Justin S. Smith, Christopher I. Shaffrey, Robert A. Hart, Douglas Burton, Renaud Lafage, Virginie Lafage, Frank Schwab, Shay Bess, and Praveen V. Mummaneni

OBJECTIVE

Circumferential minimally invasive surgery (cMIS) may provide incremental benefits compared with open surgery for patients with increasing frailty status by decreasing peri- and postoperative complications.

METHODS

Operative patients with adult spinal deformity (ASD) ≥ 18 years old with baseline and 2-year postoperative data were assessed. With propensity score matching, patients who underwent cMIS (cMIS group) were matched with similar patients who underwent open surgery (open group) based on baseline BMI, C7–S1 sagittal vertical axis, pelvic incidence to lumbar lordosis mismatch, and S1 pelvic tilt. The Passias modified ASD frailty index (mASD-FI) was used to determine patient frailty stratification as not frail, frail, or severely frail. Baseline and postoperative factors were assessed using two-way analysis of covariance (ANCOVA) and multivariate ANCOVA while controlling for baseline age, Charlson Comorbidity Index (CCI) score, and number of levels fused.

RESULTS

After propensity score matching, 170 ASD patients (mean age 62.71 ± 13.64 years, 75.0% female, mean BMI 29.25 ± 6.60 kg/m2) were included, split evenly between the cMIS and open groups. Surgically, patients in the open group had higher numbers of posterior levels fused (p = 0.021) and were more likely to undergo three-column osteotomies (p > 0.05). Perioperatively, cMIS patients had lower intraoperative blood loss and decreased use of cell saver across frailty groups (with adjustment for baseline age, CCI score, and levels fused), as well as fewer perioperative complications (p < 0.001). Adjusted analysis also revealed that compared to open patients, increasingly frail patients in the cMIS group were also more likely to demonstrate greater improvement in 1- and 2-year postoperative scores for the Oswestry Disability Index, SRS-36 (total), EQ-5D and SF-36 (all p < 0.05). With regard to postoperative complications, increasingly frail patients in the cMIS group were also noted to experience significantly fewer complications overall (p = 0.036) and fewer major intraoperative complications (p = 0.039). The cMIS patients were also less likely to need a reoperation than their open group counterparts (p = 0.043).

CONCLUSIONS

Surgery performed with a cMIS technique may offer acceptable outcomes, with diminishment of perioperative complications and mitigation of catastrophic outcomes, in increasingly frail patients who may not be candidates for surgery using traditional open techniques. However, further studies should be performed to investigate the long-term impact of less optimal alignment in this population.

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Calibration of a comprehensive predictive model for the development of proximal junctional kyphosis and failure in adult spinal deformity patients with consideration of contemporary goals and techniques

Peter S. Tretiakov, Renaud Lafage, Justin S. Smith, Breton G. Line, Bassel G. Diebo, Alan H. Daniels, Jeffrey Gum, Themistocles Protopsaltis, D. Kojo Hamilton, Alex Soroceanu, Justin K. Scheer, Robert K. Eastlack, Gregory Mundis Jr., Pierce D. Nunley, Eric O. Klineberg, Khaled Kebaish, Stephen Lewis, Lawrence Lenke, Richard Hostin, Munish C. Gupta, Christopher P. Ames, Robert A. Hart, Douglas Burton, Christopher I. Shaffrey, Frank Schwab, Shay Bess, Han Jo Kim, Virginie Lafage, and Peter G. Passias

OBJECTIVE

The objective of this study was to calibrate an updated predictive model incorporating novel clinical, radiographic, and prophylactic measures to assess the risk of proximal junctional kyphosis (PJK) and failure (PJF).

METHODS

Operative patients with adult spinal deformity (ASD) and baseline and 2-year postoperative data were included. PJK was defined as ≥ 10° in sagittal Cobb angle between the inferior uppermost instrumented vertebra (UIV) endplate and superior endplate of the UIV + 2 vertebrae. PJF was radiographically defined as a proximal junctional sagittal Cobb angle ≥ 15° with the presence of structural failure and/or mechanical instability, or PJK with reoperation. Backstep conditional binary supervised learning models assessed baseline demographic, clinical, and surgical information to predict the occurrence of PJK and PJF. Internal cross validation of the model was performed via a 70%/30% cohort split. Conditional inference tree analysis determined thresholds at an alpha level of 0.05.

RESULTS

Seven hundred seventy-nine patients with ASD (mean 59.87 ± 14.24 years, 78% female, mean BMI 27.78 ± 6.02 kg/m2, mean Charlson Comorbidity Index 1.74 ± 1.71) were included. PJK developed in 50.2% of patients, and 10.5% developed PJF by their last recorded visit. The six most significant demographic, radiographic, surgical, and postoperative predictors of PJK/PJF were baseline age ≥ 74 years, baseline sagittal age-adjusted score (SAAS) T1 pelvic angle modifier > 1, baseline SAAS pelvic tilt modifier > 0, levels fused > 10, nonuse of prophylaxis measures, and 6-week SAAS pelvic incidence minus lumbar lordosis modifier > 1 (all p < 0.015). Overall, the model was deemed significant (p < 0.001), and internally validated receiver operating characteristic analysis returned an area under the curve of 0.923, indicating robust model fit.

CONCLUSIONS

PJK and PJF remain critical concerns in ASD surgery, and efforts to reduce the occurrence of PJK and PJF have resulted in the development of novel prophylactic techniques and enhanced clinical and radiographic selection criteria. This study demonstrates a validated model incorporating such techniques that may allow for the prediction of clinically significant PJK and PJF, and thus assist in optimizing patient selection, enhancing intraoperative decision making, and reducing postoperative complications in ASD surgery.

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Predictors of pelvic tilt normalization: a multicenter study on the impact of regional and lower-extremity compensation on pelvic alignment after complex adult spinal deformity surgery

Pooja Dave, Renaud Lafage, Justin S. Smith, Breton G. Line, Peter S. Tretiakov, Jamshaid Mir, Bassel Diebo, Alan H. Daniels, Jeffrey L. Gum, D. Kojo Hamilton, Thomas Buell, Khoi D. Than, Kai-Ming Fu, Justin K. Scheer, Robert Eastlack, Jeffrey P. Mullin, Gregory Mundis Jr., Naobumi Hosogane, Mitsuru Yagi, Pierce Nunley, Dean Chou, Praveen V. Mummaneni, Eric O. Klineberg, Khaled M. Kebaish, Stephen Lewis, Richard A. Hostin Jr., Munish C. Gupta, Han Jo Kim, Christopher P. Ames, Robert A. Hart, Lawrence G. Lenke, Christopher I. Shaffrey, Shay Bess, Frank J. Schwab, Virginie Lafage, Douglas C. Burton, and Peter G. Passias

OBJECTIVE

The objective was to determine the degree of regional decompensation to pelvic tilt (PT) normalization after complex adult spinal deformity (ASD) surgery.

METHODS

Operative ASD patients with 1 year of PT measurements were included. Patients with normalized PT at baseline were excluded. Predicted PT was compared to actual PT, tested for change from baseline, and then compared against age-adjusted, Scoliosis Research Society–Schwab, and global alignment and proportion (GAP) scores. Lower-extremity (LE) parameters included the cranial-hip-sacrum angle, cranial-knee-sacrum angle, and cranial-ankle-sacrum angle. LE compensation was set as the 1-year upper tertile compared with intraoperative baseline. Univariate analyses were used to compare normalized and nonnormalized data against alignment outcomes. Multivariable logistic regression analyses were used to develop a model consisting of significant predictors for normalization related to regional compensation.

RESULTS

In total, 156 patients met the inclusion criteria (mean ± SD age 64.6 ± 9.1 years, BMI 27.9 ± 5.6 kg/m2, Charlson Comorbidity Index 1.9 ± 1.6). Patients with normalized PT were more likely to have overcorrected pelvic incidence minus lumbar lordosis and sagittal vertical axis at 6 weeks (p < 0.05). GAP score at 6 weeks was greater for patients with nonnormalized PT (0.6 vs 1.3, p = 0.08). At baseline, 58.5% of patients had compensation in the thoracic and cervical regions. Postoperatively, compensation was maintained by 42% with no change after matching in age-adjusted or GAP score. The patients with nonnormalized PT had increased rates of thoracic and cervical compensation (p < 0.05). Compensation in thoracic kyphosis differed between patients with normalized PT at 6 weeks and those with normalized PT at 1 year (69% vs 35%, p < 0.05). Those who compensated had increased rates of implant complications by 1 year (OR [95% CI] 2.08 [1.32–6.56], p < 0.05). Cervical compensation was maintained at 6 weeks and 1 year (56% vs 43%, p = 0.12), with no difference in implant complications (OR 1.31 [95% CI −2.34 to 1.03], p = 0.09). For the lower extremities at baseline, 61% were compensating. Matching age-adjusted alignment did not eliminate compensation at any joint (all p > 0.05). Patients with nonnormalized PT had higher rates of LE compensation across joints (all p < 0.01). Overall, patients with normalized PT at 1 year had the greatest odds of resolving LE compensation (OR 9.6, p < 0.001). Patients with normalized PT at 1 year had lower rates of implant failure (8.9% vs 19.5%, p < 0.05), rod breakage (1.3% vs 13.8%, p < 0.05), and pseudarthrosis (0% vs 4.6%, p < 0.05) compared with patients with nonnormalized PT. The complication rate was significantly lower for patients with normalized PT at 1 year (56.7% vs 66.1%, p = 0.02), despite comparable health-related quality of life scores.

CONCLUSIONS

Patients with PT normalization had greater rates of resolution in thoracic and LE compensation, leading to lower rates of complications by 1 year. Thus, consideration of both the lower extremities and thoracic regions in surgical planning is vital to preventing adverse outcomes and maintaining pelvic alignment.