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  • By Author: Hamilton, D. Kojo x
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Micheal Raad, Brian J. Neuman, Amit Jain, Hamid Hassanzadeh, Peter G. Passias, Eric Klineberg, Gregory M. Mundis Jr., Themistocles S. Protopsaltis, Emily K. Miller, Justin S. Smith, Virginie Lafage, D. Kojo Hamilton, Shay Bess, Khaled M. Kebaish, Daniel M. Sciubba and the International Spine Study Group

OBJECTIVE

Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity.

METHODS

This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively.

RESULTS

A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001).

CONCLUSIONS

The authors’ results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients’ preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.

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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.

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Themistocles S. Protopsaltis, Justin K. Scheer, Jamie S. Terran, Justin S. Smith, D. Kojo Hamilton, Han Jo Kim, Greg M. Mundis Jr., Robert A. Hart, Ian M. McCarthy, Eric Klineberg, Virginie Lafage, Shay Bess, Frank Schwab, Christopher I. Shaffrey, Christopher P. Ames and International Spine Study Group

OBJECT

Regional cervical sagittal alignment (C2–7 sagittal vertical axis [SVA]) has been shown to correlate with health-related quality of life (HRQOL). The study objective was to examine the relationship between cervical and thoracolumbar alignment parameters with HRQOL among patients with operative and nonoperative adult thoracolumbar deformity.

METHODS

This is a multicenter prospective data collection of consecutive patients with adult thoracolumbar spinal deformity. Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society-22 Patient Questionnaire (SRS-22), and 36-Item Short-Form Health Survey (SF-36). Cervical radiographic parameters were correlated with global sagittal parameters within the nonoperative and operative cohorts. A partial correlation analysis was performed controlling for C-7 SVA. The operative group was subanalyzed by the magnitude of global deformity (C-7 SVA ≥ 5 cm vs < 5 cm).

RESULTS

A total of 318 patients were included (186 operative and 132 nonoperative). The mean age was 55.4 ± 14.9 years. Operative patients had significantly worse baseline HRQOL and significantly larger C-7 SVA, pelvic tilt (PT), mismatch between pelvic incidence and lumbar lordosis (PI-LL), and C2-7 SVA. The operative patients with baseline C-7 SVA ≥ 5 cm had significantly larger C2-7 lordosis (CL), C2-7 SVA, C-7 SVA, PI-LL, and PT than patients with a normal C-7 SVA. For all patients, baseline C2-7 SVA and CL significantly correlated with baseline ODI, Physical Component Summary (PCS), SRS Activity domain, and SRS Appearance domain. Baseline C2-7 SVA also correlated with SRS Pain and SRS Total. For the operative patients with baseline C-7 SVA ≥ 5 cm, the 2-year C2-7 SVA significantly correlated with 2-year Mental Component Summary, SRS Mental, SRS Satisfaction, and decreases in ODI. Decreases in C2-7 SVA at 2 years significantly correlated with lower ODI at 2 years. Using partial correlations while controlling for C-7 SVA, the C2-7 SVA correlated significantly with baseline ODI (r = 0.211, p = 0.002), PCS (r = −0.178, p = 0.009), and SRS Activity (r = −0.145, p = 0.034) for the entire cohort. In the subset of operative patients with larger thoracolumbar deformities, the change in C2-7 SVA correlated with change in ODI (r = −0.311, p = 0.03).

CONCLUSIONS

Changes in cervical lordosis correlate to HRQOL improvements in thoracolumbar deformity patients at 2-year follow-up. Regional cervical sagittal parameters such as CL and C2–7 SVA are correlated with clinical measures of regional disability and health status in patients with adult thoracolumbar scoliosis. This effect may be direct or a reciprocal effect of the underlying global deformities on regional cervical alignment. However, the partial correlation analysis, controlling for the magnitude of the thoracolumbar deformity, suggests that there is a direct effect of cervical alignment on health measures. Improvements in regional cervical alignment postoperatively correlated positively with improved HRQOL.