113. Lumbar discectomy patients who undergo reoperation experience worse clinical outcomes and greater socioeconomic burden four years after the primary procedure

Abstract

BACKGROUND CONTEXT Multiple studies have observed that the clinical outcomes of patients who have undergone revision surgery after lumbar discectomy are less positive than outcomes in patients who did not require revision. Lumbar disc herniation patients with large annular defects undergoing discectomy are at significantly greater risk for symptom recurrence and revision, indicating that this population is also at significantly greater risk for worse clinical outcomes. The goal of this analysis was to assess the clinical and socioeconomic outcomes associated with post-discectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations in patients with large annular defects. PURPOSE Not applicable. STUDY DESIGN/SETTING Not applicable. PATIENT SAMPLE Not applicable. OUTCOME MEASURES Not applicable. METHODS This was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (≥6 mm) annular defects were randomized to treatment with limited discectomy alone (Control; n=278) or limited discectomy augmented by an annular closure device (ACD; n=272). Clinical outcomes included visual analog scale (VAS) for ipsilateral leg and back pain, Oswestry Disability Index (ODI), reoperations at the index-level, serious adverse events (SAE), and working status. Comparisons of clinical and socioeconomic outcomes were made between reoperated and nonreoperated patients, regardless of ACD or Control treatment, at 4 years following the primary surgery. RESULTS At 4 years, clinical outcomes data were available for 73% of the patients. Among patients with data at 4 years, 64 experienced at least one index-level reoperation (Reoperated group) and 340 were not reoperated (Non-reoperated group). The Kaplan-Meier estimate of subjects experiencing at least one index-level reoperation within 48 months was 14.4% in the ACD group and 21.1% in the Control group (p=0.03 log-rank). In all, 49 procedures were performed in ACD subjects and 77 procedures performed in Control subjects. The reoperated patients had significantly worse scores than non-reoperated patients for ODI (22 ± 16 vs 11 ± 13; p CONCLUSIONS Index-level reoperations following lumbar discectomy in patients with large annular defects are associated with worse clinical outcomes and greater socioeconomic burden. These findings are consistent with reports on outcomes from large registry analyses including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD was effective in minimizing the number of patients subject to revision, primarily through prevention of repeat discectomy, with 33% fewer patients undergoing at least one index-level reoperation. FDA DEVICE/DRUG STATUS Barricaid Annular Closure Device (ACD) - (Approved for this indication).