Artikel
Morbidity and financial burden associated with reoperation after lumbar discectomy: results from a study evaluating annular closure
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Veröffentlicht: | 18. Juni 2018 |
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Objective: The purpose of this study was to examine the outcomes and costs of reoperation following primary discectomy, with or without an annular closure device (ACD) in patients at highest risk of reherniation.
Methods: This is a post-hoc analysis of a multicenter randomized controlled trial (RCT) comparing an ACD to conventional lumbar discectomy (Control) in patients with annular defect widths >6mm. All 550 patients from the RCT were included (69 reoperated; 481 non-reoperated). Patients were divided into 4 cohorts based on intervention (Control or ACD), and reoperated or non-reoperated (regardless of intervention) within 24 months. Follow-up visits were 6 weeks through 24 months after index procedure for all cohorts. Reoperations included any surgery at the index level. Outcome measures were VAS leg/back, Oswestry Disability Index (ODI), mental (MCS) and physical composite scores (PCS) of the Short Form-36, working status, missed work, physiotherapy time, and number of inpatient days due to serious adverse event. Minimally clinically important difference (MCID) was defined as >13 points improvement from baseline at 24 months from index operation. Literature-derived costs were applied to direct and indirect variables.
Results: At 24 months, reoperated patients had significantly worse scores for ODI, VAS leg/back, and MCS/PCS scores compared to non-reoperated (p < 0.0001). The rate of reoperated versus non-reoperated patients who did not achieve MCID in ODI at 24 months was 2.9 times higher (46% vs. 16%). Per patient costs were $69,484 in the reoperated group compared with $9,697 for non-reoperated through 24 months. In the ACD and Control groups, 24/267 (9%) and 45/283 (16%) patients underwent index-level reoperation (p = 0.01). Mean estimated cost per Control ($22,982) was 13.5% greater than ACD ($18,088) for all study patients after accounting for device cost.
Conclusion: Reoperation after lumbar discectomy results in significant patient morbidity and elevated costs. ACD reduced the rate of reoperation by 44% and per patient costs across the entire study population by 13.5%, the latter being due to the lower reoperation rate with ACD. Annular closure is worthy of consideration for addressing this challenging population.