(AS2) Long-term Effectiveness of Full-endoscopic Discectomy versus Microdiscectomy for Sciatica: Results of a Randomized Controlled Trial

Introduction: Microdiscectomy is the standardprocedure to treat sciatica caused by lumbar disc herniation. Percutaneous transforaminal endoscopic discectomy (PTED) is an alternative procedure which is performed under local anesthesia in an outpatient setting. Previous research has shown non-inferiority of PTED compared to microdiscectomy in leg pain reduction at 12 and 24 months of follow-up. Long-term results, however, are lacking and warranted.

Methods: A multicenter, non-inferiority, randomized controlled trial was conducted at four clinics across the Netherlands. Patients between 18-70 years of age with at least 6 weeks of excessive radiating pain were randomized between PTED or microdiscectomy in a 1:1 ratio. The primary outcome was self-reported leg pain measured by the 0-100 Visual Analogue Scale (VAS) with a non-inferiority margin of 5. Secondary outcomes include ODI, back pain, health-related quality of life, and self-perceived recovery. Outcomes were measured the day following surgery, at 2, 4, and 6 weeks, and at 3, 6, 9, 12, 24, and 60 months.

Results: At five years, 74% of the 613 randomized patients had data available. At 5 years, the VAS for leg pain was 14.5(SD21.8) for the PTED-group and 15.6(SD21.4) for the microdiscectomy-group (between-group difference 1.1, 95%CI -3.6 to 5.9). At 60 months, there were no differences in functional status, back pain, self-perceived recovery, quality-of-life, and satisfaction with treatment results. Complications were similar between both groups. At 24 months, 8 % of the patients in the PTED-group had repeated surgery, compared to 11% in the microdiscectomy group.

Conclusion : In patients with sciatica caused by lumbar disc herniation, PTED appears to be non-inferior to microdiscectomy in leg pain reduction. In contrary to dominance in cost-effectiveness and more favorable clinical results at 1-an- 2-years follow-up, PTED appears to have similar results to microdiscectomy at 5 years of follow-up. Therefore, PTED can be considered to be safe and effective.

ClinicalTrials.gov (NCT02602093)