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Max S. Riley, Keith H. Bridwell, Lawrence G. Lenke, Jonathan Dalton, and Michael P. Kelly

OBJECTIVE

Significant health-related quality of life (HRQOL) benefits have been observed for patients undergoing primary and revision adult spinal deformity (ASD) surgery. The purpose of this study was to report changes in HRQOL measures in a consecutive series of patients undergoing complex spinal reconstructive surgery, using Scoli-RISK-1 (SR-1) inclusion criteria.

METHODS

This was a single-center, retrospective cohort study. The SR-1 inclusion criteria were used to define patients with complex ASD treated between June 1, 2009, and June 1, 2011. Standard preoperative and perioperative data were collected, including the Scoliosis Research Society (SRS)–22r instrument. The HRQOL changes were evaluated at a minimum 2-year follow-up. Standardized forms were used to collect surgery-related complications data for all patients. Complications were defined as minor, transient major, or permanent major. Patients who achieved a minimum 2-year follow-up were included in the analysis.

RESULTS

Eighty-four patients meeting SR-1 criteria were identified. Baseline demographic and surgical data were available for 74/84 (88%) patients. Forty-seven of 74 (64%) patients met the additional HRQOL criteria with a minimum 2-year follow-up (mean follow-up 3.4 years, range 2–6.5 years). Twenty-one percent of patients underwent posterior fusion only, 40% of patients had a posterior column osteotomy, and 38% had a 3-column osteotomy. Seventy-five percent of patients underwent a revision procedure. Significant improvements were observed in all SRS-22r domains: Pain: +0.8 (p < 0.001); Self-Image: +1.4 (p < 0.001); Function: +0.46 (p < 0.001); Satisfaction: +1.6 (p < 0.001); and Mental Health: +0.28 (p = 0.04). With the exception of Mental Health, more than 50% of patients achieved a minimum clinically important difference (MCID) in SRS-22r domain scores (Mental Health: 20/47, 42.6%). A total of 65 complications occurred in 31 patients. This includes 29.8% (14/47) of patients who suffered a major complication and 17% (8/47) who suffered a postoperative neurological deficit, most commonly at the root level (10.6%, 5/47). Of the 8 patients who suffered a neurological deficit, 1 (13%) was able to achieve MCID in the SRS Function domain.

CONCLUSIONS

The majority of patients experienced clinically relevant improvement in SRS-22r HRQOL scores after complex ASD surgery. The greatest improvements were seen in the SRS Pain and SRS Self-Image domains. Although 30% of patients suffered a major or permanent complication, benefits from surgery were still attained. Patients sustaining a neurological deficit or major complication were unlikely to achieve HRQOL improvements meeting or exceeding MCID for the SRS Function domain.

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Owoicho Adogwa, Jacob M. Buchowski, Lawrence G. Lenke, Maksim A. Shlykov, Mostafa El Dafrawy, Thamrong Lertudomphonwanit, Mitchel R. Obey, Jonathan Koscso, Munish C. Gupta, and Keith H. Bridwell

OBJECTIVE

Pseudarthrosis is a common complication of long-segment fusions after surgery for correction of adult spinal deformity (ASD). Interbody fusions are frequently used at the caudal levels of long-segment spinal deformity constructs as adjuncts for anterior column support. There is a paucity of literature comparing rod fracture rates (proxy for pseudarthrosis) in patients undergoing transforaminal lumbar interbody fusion (TLIF) versus anterior lumbar interbody fusion (ALIF) at the caudal levels of the long spinal deformity construct. In this study the authors sought to compare rod fracture rates in patients undergoing surgery for correction of ASD with TLIF versus ALIF at the caudal levels of long spinal deformity constructs.

METHODS

We reviewed clinical records of patients who underwent surgery for correction of ASD between 2008 and 2014 at a single institution. Data including demographics, comorbidities, and indications for surgery, as well as postoperative variables, were collected for each patient. All patients had a minimum 2-year follow-up. Patients were dichotomized into two groups for comparison on the basis of undergoing a TLIF versus an ALIF procedure at the caudal levels of long spinal deformity constructs. The primary outcome of interest was the rate of rod fractures.

RESULTS

A total of 198 patients (TLIF 133 patients; ALIF 65 patients) underwent a long-segment fusion to the sacrum with iliac fixation. The mean ± standard deviation follow-up period was 62.23 ± 29.26 months. Baseline demographic variables were similar in both patient groups. There were no significant differences between groups in the severity of the baseline sagittal plane deformity (i.e., baseline lumbar-pelvic parameters) or the final deformity correction achieved. Mean total recombinant human bone morphogenetic protein 2 (rhBMP-2) dose for L1–sacrum fusion was significantly higher in the ALIF (100 mg) than in the TLIF (62 mg) group. The overall rod failure rate (cases with rod fracture/total cases) within this case series was 19.19% (38/198); 10.60% (21/198) were unilateral rod fractures and 8.58% (17/198) were bilateral rod fractures. At last clinical follow-up, there were no statistically significant differences in bilateral rod fracture rates between the group of patients who had a TLIF procedure and the group who had an ALIF procedure at the caudal levels of the long spinal deformity constructs (TLIF 10.52% vs ALIF 4.61%, p = 0.11). However, the incidence rate (cases per patient follow-up years) for bilateral rod fractures was significantly higher in the TLIF than in the ALIF cohort (TLIF 2.20% vs ALIF 0.70%, p < 0.0001). The reoperation rate for rod fractures was similar between the patient groups (p = 0.40).

CONCLUSIONS

Although both ALIF and TLIF procedures at the caudal levels of long spinal deformity constructs achieved similar and satisfactory deformity correction, ALIFs were associated with a lower rod fracture incidence rate. There were no differences between groups in the prevalence of rod fracture or revision surgery, however, and both groups had low bilateral rod fracture prevalence and incidence rates. One technique is not clearly superior to the other.

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Elizabeth L. Yanik, Michael P. Kelly, Jon D. Lurie, Christine R. Baldus, Christopher I. Shaffrey, Frank J. Schwab, Shay Bess, Lawrence G. Lenke, Adam LaBore, and Keith H. Bridwell

OBJECTIVE

Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.

METHODS

Patients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).

RESULTS

Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.

CONCLUSIONS

Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

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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.