Ferran Pellisé, Justin S. Smith, Kenneth M.C. Cheung, Christopher P Ames, Frank J. Schwab, Oheneba Boachie-Adjei, Mark B. Dekutoski, Leah Y. Carreon, Christopher I. Shaffrey, Yong Qiu, Michael G. Fehlings, Stephen J. Lewis, AO Spine Knowledge Forum Deformity, Khaled M Kabeaish, Meghan Cerpa, Yukihiro Matsuyama, Lawrence G. Lenke, Michael P. Kelly, Scott L. Zuckerman, Institut Català de la Salut, [Zuckerman SL, Cerpa M, Lenke LG] Columbia University Medical Center, New York, NY, USA. [Shaffrey CI] Duke University Medical Center, Durham, NC, USA. [Carreon LY] Norton Leatherman Spine Center, Louisville, KY, USA. [Cheung KMC] Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong. [Pellisé F] Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Adult spinal deformity; Patient reported outcomes; Spinal deformity surgery Deformidad espinal en el adulto; Resultados informados por el paciente; Cirugía de deformidad espinal Deformitat espinal de l'adult; Resultats informats pel pacient; Cirurgia de deformitat espinal Study Design: Prospective cohort. Objective: To prospectively evaluate PROs up to 5-years after complex ASD surgery. Methods: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures. Results: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values (P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without. Conclusions: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by AO Spine through the AO Spine Knowledge Forum Deformity, the Scoliosis Research Society (SRS), and Norton Healthcare. AO Spine Knowledge Forum Deformity is a focused group of international deformity experts. AO Spine is a clinical division of the AO Foundation, which is an independent medically-guided not-for-profit organization. Study support was provided directly through the AO Spine Research Department and the AO Innovation Translation Center, Clinical Evidence.