Radiographical and Implant-Related Complications in Adult Spinal Deformity Surgery: Incidence, Patient Risk Factors, and Impact on Health-Related Quality of Life.
STUDY DESIGN: A multicenter, prospective review of surgical patients with adult spine deformity. OBJECTIVE: Assessment of the incidence, risk factor, and impact of radiographical and implant-related complications (RIC) on health-related quality of life measures. SUMMARY OF BACKGROUND DATA: This study provides assessment of the incidence of RIC in adult spinal deformity surgery and impact of these complications on need for reoperation. Risk factors for development of RIC are also assessed, as well as the impact of these complications on health-related quality of life (HRQOL) outcomes measures. METHODS: A multicenter, prospective database of surgical patients with adult spinal deformity was reviewed. All patients with complete 2-year follow-up were included. HRQOL was measured using the Oswestry Disability Index, General Health Survey (36-Item Short Form Health Survey [SF-36]), and Scoliosis Research Society-22 (SRS-22r) at baseline, 6 weeks, 1 year, and 2 years postoperatively. Univariate testing was performed as appropriate. Multivariate logistic regression modeling was used to determine independent predictors of RIC. Multivariate repeated-measures mixed models were used to examine HRQOL, accounting for confounders. RESULTS: A total of 245 patients met inclusion criteria. The incidence of RIC was 31.7% and 52.6% of those patients required reoperation. Rod breakage accounted for 47% of the implant-related complications, and proximal junctional kyphosis accounted for 54.5% of radiographical complications. Univariate analysis identified the following potential risk factors for RIC: weight, American Society of Anesthesiologists score, revision, stopping the fusion in the lower thoracic spine, worse SRS-Schwab classification modifiers (pelvic tilt++, pelvic incidence minus lumbar lordosis++, sagittal vertical axis++), higher T1 spinopelvic inclination, and higher T1 slope. Independent predictors of RIC as identified on multivariate logistic regression included American Society of Anesthesiologists (odds ratio: 1.75, P = 0.029) and sagittal vertical axis modifier ++ (odds ratio 3.43, P = 0.0001). The RIC and no RIC groups each experienced significant improvement over time, as measured on the Oswestry Disability Index (P = 0.0001), SF-36 (P = 0.0001), and SRS-22r (P = 0.0001). However, the rate of improvement over time was less for patients with RIC (SRS-22r P = 0.043, SF-36 P = 0.0001). CONCLUSION: This study identified that nearly one-third of patients undergoing adult spinal deformity surgery experienced a radiographical or implant-related complication, and that just more than one-half of these patients experiencing complication required a reoperation within 2 years of surgery. These complications significantly affected HRQOL measures. Baseline patient characteristics and parameters of the SRS-Schwab classification can be used to help identify those patients at greater risk. LEVEL OF EVIDENCE: 3.
Soroceanu, A; Diebo, BG; Burton, D; Smith, JS; Deviren, V; Shaffrey, C; Kim, HJ; Mundis, G; Ames, C; Errico, T; Bess, S; Hostin, R; Hart, R; Schwab, F; Lafage, V; International Spine Study Group,
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