178. Full endoscopic vs open discectomy for sciatica: a randomized controlled trial

Abstract

<h3>BACKGROUND CONTEXT</h3> Open microdiscectomy (OM) is the standard procedure for the treatment of sciatica caused by a lumbar disc herniation. Percutaneous transforaminal endoscopic discectomy (PTED) is an alternative procedure which is performed under conscious sedation. <h3>PURPOSE</h3> To determine if PTED is noninferior to OM in leg pain reduction, among patients with sciatica caused by lumbar disc herniation. Furthermore, an economic evaluation was conducted. <h3>STUDY DESIGN/SETTING</h3> Randomized controlled trial. <h3>PATIENT SAMPLE</h3> PTED (n=304) or OM (n=309). <h3>OUTCOME MEASURES</h3> The primary outcome was self-reported leg pain measured by a 0-100 visual analog scale (VAS), assuming a noninferiority margin of 5. Secondary outcomes included self-reported functional status, back pain, health-related quality of life and self-perceived recovery. Costs were measured from a societal perspective. Outcomes were measured until one year following surgery and were longitudinally analyzed. <h3>METHODS</h3> A 12-month, pragmatic, randomized, controlled, noninferiority trial in which 613 patients were randomized at four clinics in the Netherlands, from February 2016 to April 2019. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 PTED patients who were the early cases performed by surgeons who did not perform PTED before the trial. <h3>RESULTS</h3> At 12 months, the mean (SD) VAS score for leg pain was statically significantly lower among patients who underwent 67.3 (21.7) PTED than for 69.9 (20.6) OM (adjusted between-group difference of 7.4, 95% confidence interval 3.5 to 12.0). The blood loss was smaller, mean length of hospitalization was shorter, and timing mobilization was shorter in the PTED-group. Within one year, 5.3% in the PTED group compared to 5.6% in the OM group, underwent repeated surgery. Secondary patient-reported outcomes were similarly in favor of PTED. Cost-effectiveness acceptability curves indicated that the probability of PTED being cost-effective compared with OM was almost 1.0 for both outcomes, regardless of the willingness-to-pay. <h3>CONCLUSIONS</h3> Results of the current study show that PTED is noninferior to OM in leg pain reduction. PTED resulted in more favorable results for patient self-reported leg pain, back pain, functional status, quality of life and recovery. Furthermore, results suggest that PTED is cost-effective compared with OM for patients with lumbar disc herniation from the societal perspective. Even though these differences are small and may not reach clinical relevance, PTED should be considered as an effective alternative to OM in treating sciatica. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.