General Session: Value and Outcomes in Spine Surgery
Presented by: C. Cain - View Audio/Video Presentation (Members Only)
A. Noshchenko(1), E. Lindley(1), E. Burger(1), C. Cain(1), V. Patel(1)
(1) University of Colorado Anschutz Medical Campus, Denver, CO, United States
Purpose: The clinical relevance of successful fusion after lumbar arthrodesis has recently been questioned in the literature. Thus, the purpose of this study was to determine if patients with degenerative disc disease who achieve radiographic fusion after single level lumbar interbody arthrodesis have better clinical outcomes than patients with radiographic pseudarthrosis at 12 and 24 months postoperative.
Methods: Individual patient-level data of 4 RCTs were obtained from the Yale University Open Data Access Project (YODA) project and analyzed. Clinical outcomes (Oswestry Disability Index (ODI); Numeric Rating Scales (NRS) for back and leg pain) were compared between patients with radiographically confirmed fusion and those with radiographic nonunion 1 and 2 years postoperative. The results of each study were first analyzed separately, and then were pooled by meta-analysis. The GRADE approach was applied to evaluate the level of evidence.
Results: A total of 496 patients with complete clinical and radiographic data were identified. Of these, 5.5% [95%Cl: 3.7; 8.3] had nonunion which did not require reoperation. Patients with fusion had significantly better improvements in ODI (P< 0.001) and NRS back pain scores (P< 0.001), and a trend towards better NRS leg pain scores (P=0.078). Significantly more patients with fusion also had ODI and NRS back pain scores that exceeded the criteria for minimal clinically important differences (MCID) (ODI, OR=2.7, P=0.019; NRS back pain, OR=3.5, P=0.033). However, the predictive values of fusion for clinical outcomes were poor, with low specificity and low negative predictive values.
Conclusion: The presence of radiographic fusion is clinically significant, as patients with fusion had better clinical outcomes at 1 and 2 years postoperative than those with nonunion. However, patient-centered clinical outcomes should also be taken into consideration as independent, complimentary variables when assessing treatment success.