Scott L Zuckerman1, Meghan Cerpa1, Lawrence G Lenke1, Christopher I Shaffrey2, Leah Y Carreon3, Kenneth M C Cheung4, Michael P Kelly5, Michael G Fehlings6, Christopher P Ames7, Oheneba Boachie-Adjei8, Mark B Dekutoski9, Khaled M Kabeaish10, Stephen J Lewis6, Yukihiro Matsuyama11, Ferran Pellisé12, Yong Qiu13, Frank J Schwab14, Justin S Smith15. 1. Columbia University Medical Center, New York, NY, USA. 2. Duke University Medical Center, Durham, NC, USA. 3. Norton Leatherman Spine Center, Louisville, KY, USA. 4. Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong. 5. Washington University in St. Louis, MO, USA. 6. University of Toronto and Toronto Western Hospital, Toronto, Ontario, Canada. 7. University of California San Francisco, CA, USA. 8. The FOCOS Hospital, Pantang West, Republic of Ghana. 9. Marshfield Clinic Eau Claire Center, Eau Claire, WI, USA. 10. Johns Hopkins University, Baltimore, MD, USA. 11. Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan. 12. Hospital Universitari Vall d'Hebron, Barcelona, Spain. 13. Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. 14. Hospital for Special Surgery, New York, NY, USA. 15. University of Virginia, Charlottesville, VA, USA.
Abstract
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.
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.