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Kai-Ming G. Fu, Justin S. Smith, David W. Polly Jr., Christopher P. Ames, Sigurd H. Berven, Joseph H. Perra, Steven D. Glassman, Richard E. McCarthy, D. Raymond Knapp Jr., Christopher I. Shaffrey, and Scoliosis Research Society Morbidity and Mortality Committee

Object

Currently, few studies regarding morbidity and mortality associated with operative treatment of spinal disorders in children are available to guide the surgeon. This study provides more detailed morbidity and mortality data with an analysis of 23,918 pediatric cases reported in the multicenter, multisurgeon Scoliosis Research Society morbidity and mortality database.

Methods

The Scoliosis Research Society morbidity and mortality database was queried for the years from 2004 to 2007. The inclusion criterion was age 18 years or younger. Cases were categorized by operation type and diagnosis. Details on the surgical approach, use of neurophysiological monitoring, and type of instrumentation were recorded. Major perioperative complications and deaths were evaluated. Statistical analysis was performed with chi-square testing, with a p value < 0.05 considered significant.

Results

A total of 23,918 patients were included. The mean age was 13 ± 3.6 years (± SD). Spinal pathology included the following: scoliosis (in 19,642 patients), kyphosis (in 1455), spondylolisthesis (in 748), trauma (in 478), and other (in 1595 patients). The overall complication rate was 8.5%. Major complications included wound infections (2.7%), new neurological deficits (1.4%), implant-related complications (1.6%), and hematomas (0.4%). The most common medical complications were respiratory related (0.9%). Morbidity rates differed based on pathology, with patients undergoing treatment for kyphosis and spondylolisthesis having higher overall rates of morbidity (14.7% and 9.6%, respectively). Patients undergoing revision procedures (2034) or corrective osteotomies (2787) were more likely to suffer a complication or new neurological deficit. The majority of these deficits improved at least partially. Thirty-one deaths were reported for an overall rate of 1.3 per 1000. Respiratory complications were the most common cause of mortality (13 cases). Twenty-six of the deaths occurred in children undergoing scoliosis correction.

Conclusions

Spinal surgery in children is associated with a range of complications depending on the type of operation. Mortality rates for all indications and operations were low. Patients undergoing more aggressive corrective procedures for deformity are more likely to suffer complications and new neurological deficits.

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Justin S. Smith, Michael P. Kelly, Elizabeth L. Yanik, Christine R. Baldus, Thomas J. Buell, Jon D. Lurie, Charles Edwards, Steven D. Glassman, Lawrence G. Lenke, Oheneba Boachie-Adjei, Jacob M. Buchowski, Leah Y. Carreon, Charles H. Crawford III, Thomas J. Errico, Stephen J. Lewis, Tyler Koski, Stefan Parent, Virginie Lafage, Han Jo Kim, Christopher P. Ames, Shay Bess, Frank J. Schwab, Christopher I Shaffrey, and Keith H Bridwell

OBJECTIVE

Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.

METHODS

The ASLS-1 (Adult Symptomatic Lumbar Scoliosis–1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40–80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]–22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.

RESULTS

The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference −15.2 [95% CI −18.7 to −11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48–0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI −13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2–5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI −12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE −8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.

CONCLUSIONS

The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.