P130. Does the utilization of comprehensive surgical planning software improve postoperative sagittal alignment: an interim multicenter analysis

BACKGROUND CONTEXT Postoperative sagittal malalignment has been shown to adversely influence clinical outcomes and reoperation rates following spinal reconstruction. PURPOSE The purpose of this study was to assess the effects of preoperative and intraoperative assessments of sagittal alignment on surgical planning, execution, and postoperative alignment using NuVaMap (Surgimap, Globus Medical, Inc. Audubon, PA) software. STUDY DESIGN/SETTING A prospective, multicenter, observational evaluation. PATIENT SAMPLE N/A OUTCOME MEASURES N/A METHODS We report an interim analysis on a prospective, multicenter evaluation of adult patients undergoing fusion for degenerative and deformity pathology between T1 and S1. Preop and 3 months postop full spine lateral radiographs were analyzed. Preop surgical plans were recorded before and after assessing spinopelvic parameters (LL, PI, PT, T1SPI, TK, SVA, and segmental lordosis at each operative level) (NuVaMap, Surgimap, Globus Medical, Inc. Audubon, PA). During surgery, further alterations in the surgical plan based on intraoperative imaging measurements (NuVaMap O.R., NuVasive, Inc., San Diego, CA) were likewise recorded. RESULTS A total of 280 patients (56% female), with mean age 63 yrs, BMI 30.7, and Charlson co-morbidity index score 3.3. Most common indications diagnoses were spondylolisthesis (29%), stenosis (27%), degenerative disc disease (22%) and scoliosis (6%). Changes in plan or procedure attributable to measurement of sagittal alignment parameters were observed in 26.8% of subjects (17.9% preop; 12.5% intraop; 3.6% both pre- and intra-op); 40.4% had preoperative malalignment, defined as PI-LL mismatch ≥10°; among these, 60% remained misaligned at 3 most postop.  Among the 59.6% who had acceptable preop alignment (PI-LL mismatch CONCLUSIONS In this interim analysis, preop surgical planning and intraoperative alignment assessment using specialized spinopelvic alignment software led to preoperative modification of planned procedure in 17.9% of patients, and intraoperative procedure change in 12.5%, with an overall change rate of 27%. This suggests that spine surgeons recognize the importance of sagittal alignment, and are likely to respond to information provided by alignment parameters. FDA DEVICE/DRUG STATUS NuVaMap OR and Surgimap are both medical devices (Class IIa) and are used on-label in this application.